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Impaction Bone Grafting

in Revision Arthroplasty

edited by
Christian DeIIoye
Universite Catholique de Louvain
Brussels, Belgium

Gordon Bannister
Southmead Hospital
Bristol, England

MARCEL

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CONTENTS

1. The History of the Use of Bone Impaction Grafting in Primary


and Revision Total Hip Arthroplasty 1
Tom J. J. H. Slooff
I. Introduction 1
II. Bone Banking 4
III. Bone Grafts Combined with Total HIP Replacement 6
References 9

2. Harvest, Storage, and Microbiological Security of


Bone Allografts 11
Christian Delloye, B. Naets, Nathalie Cnockaert, and Olivier Cornu
I. Introduction 11
II. Donor Selection 12
III. Bone Retrieval 13
IV. Risk of Viral Transmission 14
V. Bacterial Transmission Risks 15
VI. Processing 15
VII. Preservation 16
VIII. Sterilization 17
IX. From Femoral Head to Bone Morsel 18
X. Record Keeping 18
XI. Conclusions 20
References 20

3. The Procurement, Processing, and Preservation of


Allograft Bone 23
Stephan Vehmeijer and Rolf M. Bloem
I. Introduction 23
II. Allograft Procurement 23
III. Disease Transmission 24
IV. Processing Methods 25
V. Preservation Techniques 28
v
vi Contents

VI. Recommendations 29
References 29
4. Conserving Stocks in the Bone Bank 33
David Finlayson and Philip Henman
I. Introduction 33
II. Availability of Bone 34
III. Identification of Potential Donors 36
IV. Alternative Donation Sites 36
V. Summary of Recommendations 39
References 39
5. Mechanical Considerations in Impaction Bone Grafting:
The Nijmegen Experience 41
N. Verdonschot, S. B. Bolder, Pieter Buma, and B. Willem Schreurs
I. Introduction 41
II. Inherent Mechanical Characteristics of Morselized Particles 42
III. Application to the Acetabular Side 44
IV. Application to the Femoral Side 50
V. Conclusions 53
References 53
6. Impaction Bone Grafting: A Mechanical Appraisal with
Reference to Soil Engineering 57
Douglas Dunlop
I. Introduction 57
II. Basic Science 57
III. Grading 58
IV. Mechanical Shear Testing 59
V. Results 67
VI. Discussion 68
VII. Summary 72
References 72
7. Stability of Impaction-Grafted Hip and Knee Prostheses:
Surgical Technique, Implant Design, and Graft Compaction 75
Jan Herman Kuiper, James Richardson, Ayman Soliman, and
Kevin Cheah
I. Introduction 75
II. In vitro Sawbone Experiments 76
III. Why is Graft Compaction Important? 84
IV. Discussion 89
Contents vii

Acknowledgments 92
References 93

8. Preparation of the Femoral Head Prior to Milling: Does


Inclusion of the Articular Cartilage Influence Impaction?—
An In Vitro Study with Human Femoral Heads 95
Ashit Bavadekar, Olivier Cornu, Bernard Godts, Christian Delloye,
Xavier Banse, and John Van Tomme
I. Introduction 95
II. Materials and Methods 96
III. Results 100
IV. Discussion 103
Acknowledgments 106
References 106

9. Impaction Bone Grafting with Processed Freeze-Dried


Allografts: Evolution of the Compactness and Stiffness
During Impaction 109
Olivier Cornu, Ashit Bavadekar, Bernard Godts, Christian Delloye,
Xavier Banse, and John Van Tomme
I. Introduction 109
II. Materials and Methods 110
III. Results 114
IV. Discussion 116
Acknowledgments 118
References 118

10. Bone Graft Substitutes for Impaction Grafting 121


Ashley W. Blom and Ian D. Learmonth
I. Xenograft 122
II. Polymethylmethacrylate (Bone Cement) 123
III. Calcium Sulfate (Plaster of Paris) 123
IV. Glass-Ionomer Ceramics 124
V. Polyhydroxy Acids 125
VI. Collagen Matrix 125
VII. Coralline-Derived Hydroxyapatite 126
VIII. Absorbable Ceramics 126
IX. Summary and Discussion 133
References 134
viii Contents

11. The Contribution of Synthetic Bone Grafting Material to


Impaction 141
Douglas Dunlop
I. Introduction 141
II. Mechanical Aspects 142
III. Biological Aspects 142
IV. In vitro Modeling 143
V. In vivo Modeling 143
VI. Summary 151
References 151

12. Comparative Dynamic Loading of Paired Femurs:


Comparison of Freeze-Dried Versus Fresh-Frozen Bone
Allografts 157
Bernard Godts, Ashit Bavadekar, Olivier Cornu, M. Verhelpen,
and Christian Delloye
I. Introduction 157
II. Materials and Methods 158
III. Results 166
IV. Discussion 169
V. Conclusion 173
References 174

13. The Influence of Particle Size at the Femur: Is Morsel Size a


Critical Parameter? Does It Influence the Stiffness of the
Impacted Layer? 177
Ashit Bavadekar, Olivier Cornu, Bernard Godts, Christian Delloye,
Xavier Banse, and John Van Tomme
I. Introduction 177
II. Materials and Methods 178
III. Results 182
IV. Discussion 184
References 185

14. Mechanical Studies of the Bone Particle Size at the Femur 187
Akio Kobayashi, Hirotsugu Ohashi, Yoshinori Kadoya, and Yuji
Tanabe
I. Introduction 187
II. Study 1 188
III. Study 2 195
Contents ix

IV. Discussion 201


References 202
15. Impaction Grafting: How Does It Work? 205
Magnus Tägil and Per Aspenberg
I. Introduction 205
II. Hypotheses 208
III. Impaction and Ingrowth 208
IV. Immunogenicity 211
V. Fracture Surface and Endogenous Proteins 212
VI. Impaction and Exogenous Growth Factors 213
VII. Bone Remodeling in Response to Load 214
VIII. The Fate of the Impacted Graft During Remodeling 216
IX. Is Remodeling Necessary? 218
X. Conclusions 219
References 219
16. Human Bone Histology After Morselized Cortico-Cancellous
Bone Impaction 225
Gösta Ullmark
I. Introduction 225
II. Biomechanical Aspects 225
III. Clinical and Radiological Results 226
IV. Healing of the Graft Bed Studied with PET 231
V. Histology of Impacted Bone Graft Incorporation 232
VI. Discussion 235
References 238
17. Histological Evaluation of Impaction Bone Grafting in
Humans and Animals 241
Pieter Buma, Sanne van der Donk, and B. Willem Schreurs
I. Introduction 241
II. Material and Methods 242
III. Results 245
IV. Discussion 251
References 253
18. Biological Enhancement of Bone Graft Materials by
Osteogenic Factors 257
Stephen D. Cook and Robert L. Barrack
I. Introduction 257
II. Preclinical Evaluation of the OP-1 Implant 259
x Contents

III. Discussion 263


References 266
19. Adding Growth Factors to Impacted Grafts: A Good Idea
that Might Be Bad 269
Per Aspenberg
I. Introduction 269
II. What Makes Impaction Successful? 269
III. Warning Against Using Growth Factors 270
IV. Conclusion 272
References 272

20. Acetabular Bone Impaction Grafting: Classification of the


Bone Stock Loss and Surgical Technique 275
Jean W. M. Gardeniers, Tom J. J. H. Slooff, and B. Willem Schreurs
I. Introduction 275
II. X-change Technique and the AAOS Classification 278
III. Surgical Technique 281
References 286

21. Long-Term Results of Acetabular Reconstruction Using


Impaction Bone Grafting and a Cemented Cup 287
B. Willem Schreurs, Jean W. M. Gardeniers, and Tom J. J. H. Slooff
I. Introduction 287
II. Clinical Results 290
III. Discussion and Recommendations 298
References 303

22. Impaction Bone Technique at the Acetabular Side 307


E. Winter
I. Introduction 307
II. Materials and Methods 308
III. Results 311
IV. Discussion 314
References 318

23. Impaction Bone Grafting on the Femoral Side 323


A. J. Timperley, P. Kenny, and G. A. Gie
I. The Exeter Technique—Indications 323
II. Preoperative Planning 323
III. Positioning The Patient 324
Contents xi

IV. Surgical Approach 325


V. Preparation of the Graft 329
VI. Preparation of the Femur 330
VII. Impaction of the Graft 333
VIII. Reduction and Closure 346
IX. Postoperative Management 346
X. Lessons We Have Learned During Evolution of the
Technique 346
References 347

24. Impaction Grafting of the Proximal Femur with Freeze-Dried


Bone in Revision Arthroplasty 349
A. Mazhar Tokgözoğlu, Bülent Atilla, and Egemen Turhan
I. Introduction 349
II. Surgical Technique 350
III. The Hacettepe Experience 352
IV. Scintigraphic Study 355
V. Discussion 358
References 360

25. Enmeshed Impacted Bone Allograft at the Femoral Side 363


Henri Migaud, Christophe Chantelot, François Giraud, Christophe
Jardin, and Antoine Duquennoy
I. Introduction 363
II. The Technique 365
III. Clinical Data 372
IV. Discussion 373
References 374

26. Impaction Bone Grafting at the Hip: A Clinical Review 377


Mickey S. Cho, Michael T. Casnellie, and Seth S. Leopold
I. Introduction 377
II. History of Impaction Allografting 380
III. Algorithm For Femoral Reconstruction 381
IV. Surgical Approaches and Technical “Pearls” 381
V. Problems and Complications of Impaction Allografting 388
VI. Clinical Results of Impaction Allografting 394
VII. Summary 394
References 395
xii Contents

27. Revision of Total Knee Arthroplasty by Impaction Bone


Grafting 399
Gary W. Bradley
I. Introduction 399
II. Indications 400
III. Technique 401
IV. Clinical Experience 409
V. Conclusions 413
References 414
28. Revision Knee Arthroplasty with Impaction Bone Grafting 417
Gösta Ullmark
I. Biomechanical Aspect 417
II. Surgical Method 417
III. Results 420
References 421
29. Revision Knee Arthroplasty with Impaction 423
I. C. Heyligers, E. H. van Haaren, and P. I. J. M. Wuisman
I. Introduction 423
II. Material and Methods 424
III. Results 430
IV. Discussion 433
References 436
30. Different Types of Biomechanical Tests on Morselized Grafts 439
Xavier Banse
I. Contained Compression Test 439
II. Biaxial Shear Test 439
III. Triaxial Shear Test 441
IV. Axial Compression on Cup 441
V. Shear on Cup 441
VI. Axial Compression on Stem 441
VII. Torsion on Stem 442
VIII. Walking Simulation 442
References 442
Index 443
CONTRIBUTORS

Per Aspenberg Linköping University Hospital, Linköping, Sweden, and Lund


University Hospital, Lund, Sweden

Bülent Atilla Hacettepe University Faculty of Medicine, Hacettepe, Ankara,


Turkey

Xavier Banse Université Catholique de Louvain, Brussels, Belgium

Robert L. Barrack Tulane University School of Medicine, New Orleans,


Louisiana, U.S.A.

Ashit Bavadekar Université Catholique de Louvain, Brussels, Belgium

Ashley W. Blom University of Bristol, Bristol Royal Infirmary, Bristol,


England

Rolf M. Bloem Reinier de Graaf Hospital, Netherlands Bone Bank Foundation,


Delft, The Netherlands

S. B. Bolder University Medical Center Nijmegen, Nijmegen, The Netherlands

Gary W. Bradley ALTA Orthopaedics, Santa Barbara, California, U.S.A.

Pieter Buma University Medical Center Nijmegen, Nijmegen, The Nether-


lands

Michael T. Casnellie William Beaumont Army Medical Center, El Paso,


Texas, U.S.A.

Christophe Chantelot University Hospital of Lille, Lille, France

Kevin Cheah Springfield Hospital, Chelmsford, Essex, England


xiii
xiv Contributors

Mickey S. Cho William Beaumont Army Medical Center, El Paso, Texas,


U.S.A.

Nathalie Cnockaert Université Catholique de Louvain, Bruxelles, Belgium

Stephen D. Cook Tulane University School of Medicine, New Orleans,


Louisiana, U.S.A.

Olivier Cornu Université Catholique de Louvain, Brussels, Belgium

Christian Delloye Université Catholique de Louvain, Bruxelles, Belgium

Douglas Dunlop Southampton University Hospital NHST, Southampton,


England

Antoine Duquennoy University Hospital of Lille, Lille, France

David Finlayson Raigmore Hospital, Inverness, Scotland

Jean W. M. Gardeniers University Medical Centre Nijmegen, Nijmegen, The


Netherlands

G. A. Gie Princess Elizabeth Orthopaedic Centre, Royal Devon and Exeter


Hospital, Exeter, United Kingdom

François Giraud University Hospital of Lille, Lille, France

Bernard Godts Université Catholique de Louvain, Brussels, Belgium

E. H. van Haaren Vrije Universiteit Medical Center, Amsterdam, The


Netherlands

Philip Henman Freeman Hospital, Newcastle upon Tyne, England

I. C. Heyligers* Vrije Universiteit Medical Center, Amsterdam, The


Netherlands

Christophe Jardin University Hospital of Lille, Lille, France

Yoshinori Kadoya Osaka City University Medical School, Osaka, Japan

*Current affiliation: Atrium Medical Center, Herleen, The Netherlands.


Contributors xv

P. Kenny Princess Elizabeth Orthopaedic Centre, Royal Devon and Exeter


Hospital, Exeter, United Kingdom

Akio Kobayashi Osaka City University Medical School, and Osaka Social
Medical Center Hospital, Osaka, Japan

Jan Herman Kuiper The Robert Jones and Agnes Hunt Orthopaedic and
District Hospital, Oswestry, Shropshire, England and Keele University, Keele,
Staffordshire, England

Ian D. Learmonth University of Bristol, Bristol Royal Infirmary, Bristol,


England

Seth S. Leopold University of Washington Medical Center, Seattle,


Washington, U.S.A.

Henri Migaud University Hospital of Lille, Lille, France

B. Naets Université Catholique de Louvain, Bruxelles, Belgium

Hirotsugu Ohashi Osaka City University Medical School, Osaka, Japan

James Richardson The Robert Jones and Agnes Hunt Orthopaedic and District
Hospital, Oswestry, Shropshire, England and Keele University, Keele,
Staffordshire, England

B. Willem Schreurs University Medical Center Nijmegen, Nijmegen, The


Netherlands

Tom J. J. H. Slooff University Medical Centre Nijmegen, Nijmegen, The


Netherlands

Ayman Soliman The Robert Jones and Agnes Hunt Orthopaedic and District
Hospital, Oswestry, Shropshire, England

Magnus Tägil Lund University Hospital, Lund, Sweden

Yuji Tanabe Niigata University, Niigata, Japan

A. J. Timperley Princess Elizabeth Orthopaedic Centre, Royal Devon and


Exeter Hospital, Exeter, United Kingdom
xvi Contributors

A. Mazhar Tokgözoğlu Hacettepe University Faculty of Medicine, Hacettepe,


Ankara, Turkey

Egemen Turhan Hacettepe University Faculty of Medicine, Hacettepe,


Ankara, Turkey

Gösta Ullmark Centre for Research and Development, Länssjukhuset, Gävle,


Sweden

John Van Tomme Royal Military Academy, Brussels, Belgium

Sanne van der Donk University Medical Centre Nijmegen, Nijmegen, The
Netherlands

Stephan Vehmeijer Leiden University Medical Centre, Netherlands Bone


Bank Foundation, Leiden, The Netherlands

M. Verhelpen Université Catholique de Louvain, Brussels, Belgium

N. Verdonschot University Medical Center Nijmegen, Nijmegen, The


Netherlands

E. Winter BG Unfallklinik, Tübingen, Germany

P. I. J. M. Wuisman Vrije Universiteit Medical Center, Amsterdam, The


Netherlands
1
The History of the Use of Bone
Impaction Grafting in Primary and
Revision Total Hip Arthroplasty
Tom J. J. H. Slooff
University Medical Center Nijmegen
Nijmegen, The Netherlands

I. INTRODUCTION

Bone reconstruction with grafts has a long history in medical science and
according to folklore goes back to ancient times. The miracle of the twin saints
Cosmas and Damian represents the first alleged bone and tissue transplant. The
legend tells the history of a pious sexton, who was lying in the Roman Forum
exhausted from the pain of bone cancer in his leg. In a dream, the twin brothers
came to help him, removed his diseased leg, and transplanted the leg of a Moor
who had just died. As the Moor had darker skin than the sexton, this miraculous
event has been recorded as “the miracle of the black leg.” Owing to the success of
the operation, the twin brothers were canonized, and over the years artists have
brought many spectacular masterpieces depicting this story to life on canvas
(see Fig. 1).
The early literature records that in 1674 the Dutchman Anthonie van
Leeuwenhoek [1] and Job van Meekeren [2] carried out excellent scientific work
on bone grafting and physiology. Van Leeuwenhoek, a contemporary of Jan van
Swammerdam and Reinier de Graaf, gained an international reputation from his
research into microscopy and for producing the first thorough description of the
histological structure of bone. In a well-documented study published in 1668, van
Meekeren, a surgeon from Amsterdam, described the first bone graft. The graft
was taken from the skull of a dog and used successfully to repair a traumatic
defect in a soldier’s skull. In this case, the graft material is known as a xenograft,
1
2 Slooff

Figure 1
History of Bone Impaction Grafting 3

which indicates bone donation from one species to another. An autograft refers to
bone that is transplanted from one location to another within the same individual.
In the tale of the Moor, the bone graft received by the sexton represents an
allograft, because the bone was donated by a member of the same species.
Through the centuries, the use of autografts and allografts in surgical
practice has varied. In the eighteenth and nineteenth centuries, bone grafting was
not an accepted surgical procedure; it was considered to be experimental with an
unpredictable outcome. However, the technique was developed out of sheer
necessity in clinical practice, and even today clinical expertise is more advanced
than the basic science of the subject.
At the end of the nineteenth century and the beginning of the twentieth
century, the use of bone grafts was strongly stimulated by well-known surgeons,
such as Ollier [3] from France, Macewen [4] from Scotland, Curtis [5] from the
United States, and Barth [6], Lexer [7], and Axhausen [8] from Germany.
Between 1947 and 1950, the laboratory scientists Bush [9] and Wilson [10]
started to develop and to perfect preservation techniques, which led to the
foundation of the National Naval Tissue Bank in Bethesda, Maryland. This made
it possible to use allograft clinically on a much larger scale, particularly to replace
bone lost traumatically or through tumor. Based on animal experiments and
clinical observations, they observed that the graft, whether an autograft or an
allograft, largely lost its vitality and then became revitalized from the host bone.
Major components in this incorporation process were considered to be the
periosteum tranplanted with the graft and the vascular network of the host.
Herndon and Chase [11], Burwell [12], and Campbell [13] demonstrated an
immune response in animals receiving allograft bone. They also concluded that
freezing of bone reduced this. In 1953 Marshall Urist [14] developed the theories
of osteoinduction and osteoconduction and introduced the bone morphogenetic
protein that induces bone formation.
Current knowledge about the use and the histological fate of a bone graft
differs very little from the original ideas of the past, and Axhausen’s theory,
originally presented in 1909, continues to be tenable. Today, it is generally
accepted that graft incorporation, whether autogenic or allogenic, represents a
sequence of events that reflects a partnership between graft- and host-derived
factors. The host contributes all the blood vessels and most of the cells required
for the repair process. The graft itself serves mainly as a scaffold on which the
host response occurs.
The graft matrix with the growth factors and the residual cells promote host
cellular activity, which is required for bone formation. Other important con-
comitant factors that influence the biology of graft incorporation are:

The origin of the tissue (autograft-allograft)


The type of tissue (cortical-cancellous)
4 Slooff

The size of the graft (large and small fragment grafts)


The preservation method (fresh-frozen, freeze-dried)
The stability of fixation
The loading pattern of the graft
The vascularity of the host bed
From animal experiments [15,16] and clinical experience [17], we know
that cortical allografts incorporate slowly, unevenly, and incompletely because of
the density of the structure. In contrast, cancellous grafts contain large marrow
spaces, permitting rapid and even revascularization and new bone formation
without mechanical weakening of the graft during incorporation. Cancellous
allograft can be used as structural or morselized bone and is generally indicated in
situations where the highest osteogenic capacity is required. There is also a
difference in the process of incorporation between a structural and a morselized
cancellous allograft. Structural cancellous grafts generally have cystic lesions
because of the degenerative process in the femoral head. They contain large
amounts of fatty marrow tissue that may decrease incorporation. Clinical studies
of massive structural trabecular allografts used in revision and tumor surgery
have shown that their incorporation is often confined to the outer few millimeters,
leaving a central necrotic core, which eventually causes failure of the graft.
We also observed that during a slow and incomplete incorporation process,
maintaining sufficient stability of the graft to the host bone is difficult to achieve
in a weight-bearing part of the hip. Obviously, the difference in the biological
behavior of the various grafts will affect their mechanical properties. It is well
known that an individual’s own bone, as an autograft, incorporates better than
allograft, owing to the high osteogenic capacity and the absence of immune
response. However, it is not always possible to harvest sufficient quantity of
autograft, and it is often of poor quality. Furthermore, the additional incision
necessary to harvest the bone causes additional morbidity and necessitates the use
of bank bone.

II. BONE BANKING

After the Second World War, American researchers and surgeons showed
increasing interest in bone grafting. This led to the foundation of the first bone
bank, the National Naval Tissue Bank, in Bethesda, Maryland. The bone bank
was responsible for acquiring, processing, storing, and distributing of tissue and
organs for transplantation. This was done according to the guidelines of the
American Association of Tissue Banks to guarantee the safety and predictable
biological and mechanical properties of the material issued. The banks had to
supply bone that was free from any possible disease and abnormalities that might
History of Bone Impaction Grafting 5

endanger the health of the recipient. In order to guarantee this, various factors,
such as donor selection, consent, sterile harvesting, processing, storage, distri-
bution, and documentation, formed important aspects that had to comply with
high-quality requirements. In Europe this development started later and more
slowly. Through private initiative, requests from clinical practice and surgical
experience, hospital bone banks were set up at a few Dutch orthopedic depart-
ments in the 1960s.
Their simple design comprised a domestic chest deep freezer with a
minimum temperature of 2208C, in which the bone was stored. In those days,
our bank, containing cadaveric bone, was run by an orthopedic “resident with
special interest” and supervised by the nursing staff from the operating theater.
Between 1964 and 1980, the bone, which was acquired in limited quantities from
fatally injured trauma patients, was chiefly used in major spinal fusions in
children, in adults with posttraumatic nonunion, and for defects after resection of
bone tumors. In the 1980s, more donor bone became available because of the
femoral heads that were removed during primary total hip replacements. After
careful selection and screening of these living donors, each femoral head was
deep frozen at 2208C and kept for a maximum of 6 months. No microbiological
cultures were taken during this period, but aerobic and anaerobic cultures were
taken when the donor bone was harvested and at a later stage during the bone
grafting procedure.
Over the past few years, the guidelines for donor screening have become
more stringent, because we are more aware of the possible transmission of
infectious, particularly viral, diseases via the bone graft. In addition, extensive
laboratory examinations of blood and bone tissue have been introduced in order
to adequately exclude viral infections such as human immunodeficiency virus
(HIV) and hepatitis. If there is the slightest doubt about bacterial or viral
contamination during the whole procedure of harvesting, processing, and preser-
vation, the bone is destroyed. To reduce the risk of infection and virus transmis-
sion, some countries recommend additional sterilization by gamma irradiation,
gas sterilization, or pasteurization. Because of the complexity of all these
measures, more and more hospital bone banks have become incorporated by
existing blood banks. With specialised and advanced techniques, such as freeze-
drying and deep-freezing to 2908C, these institutions store bone safely from
carefully screened, deceased donors for fairly long periods of time.
Obviously, special care must be taken during processing to preserve the
characteristic biological and mechanical properties of both cortical and can-
cellous types of bone graft to facilitate subsequent clinical application.
In clinical practice, a choice has to be made between cortical and cancel-
lous graft. Cortical grafts can be used as solid and structural segments and are
indicated if the stability of the surgical reconstruction needs to be increased, for
example, to bridge bone defects in the cortical tubes or as onlay grafts in femoral
6 Slooff

revision surgery to bridge cortical defects. Cancellous bone may be used in


structural or morsellized form and is indicated in situations where the highest
osteogenic capacity is required, such as filling cavitary and contained segmental
defects encountered in revision of failed total hip replacements.

III. BONE GRAFTS COMBINED WITH TOTAL HIP


REPLACEMENT

In the 1970s, a new application for bone grafting was introduced for the
reconstruction of acetabular defects in primary and revision total hip arthroplasty.
In primary total hip replacement, an acetabular defect was often congenital,
resulting in a peripheral, segmental acetabular rim defect. A primary cavitary
defect was seen fairly commonly at an advanced stage of rheumatoid arthritis.
This defect is usually described as “protrusio acetabuli.” In revision surgery, the
defect is caused by bone lysis, which causes cavitary, segmental, or combined
defects of the acetabulum.
In 1975, Hastings and Parker [18] published their first experience with
autologous cancellous bone fragments with a cemented total hip prosthesis in
protrusio acetabuli caused by rheumatoid arthritis. The thin medial wall was left
intact, was not reamed, and autogenous cancellous graft with cement was used to
lateralize the socket. This was supported with a coarse Vitallium mesh cup with a
narrow rim to spread the load peripherally.
Harris et al. [19] were the first to use femoral heads as a structural cortico-
cancellous graft, fixed to the pelvis with screws and bolts, in 38 primary
acetabular reconstructions. The indication for this surgical reconstruction was the
superior segmental acetabular defect in congenital dysplasia. This technique
remained popular for several years and was widely adopted in primary and
revision surgery. Harris started to use this technique in 1977 with both cemented
and cementless components. In 1990, after an intermediate 6-year follow-up, the
pioneers [20] of this popular technique reported that structural grafts were only a
short-term solution, and in 1993 [21] they published further reservations about
structural weight-bearing allografts.
Although Hastings and Parker reported favorable results in their series,
Coventry [22], in 1978, was pessimistic about graft viability. In primary
arthroplasties, he preferred to resect the femoral head from the neck, leave it in
situ in the acetabulum as a structural graft, and impact three dowel grafts into the
head/acetabular interface. The base of the fixed head and neck was then prepared
as for a normal acetabulum.
In 1978, McCollum and Nunley [23] reported their first experience with
bone grafting of acetabular protrusion. Their series started in 1968. They used a
1 cm thick slice from a frozen femoral head as a structural allograft in combina-
History of Bone Impaction Grafting 7

tion with a Smith Petersen cup. After 1971 they supplemented total hip replace-
ment with mostly autogenous bone grafting of the medial wall of the acetabulum.
Their series included 23 patients with acetabular protrusio and 2 with failed
primary total hip replacement. Their technique comprised drilling holes in the
ischium, ilium, and pubis. Then a slice of bone 1 cm thick was fashioned to fit the
central defect or the inner wall if there was no segmental defect. The structural
graft was then coated or overlaid with Gelfoam to prevent cement from coming
into contact with the bone graft. The graft was held in place by overlying fine
Vitallium mesh tucked into the holes with an impactor. An Eichler ring was
inserted followed by a cemented polyethylene socket.
In 1983, Marti and Besselaar [24] introduced a technique for protruded and
dysplastic acetabuli. Medial segmental defects were closed with a structural
cortico-cancellous graft and supplemented with autogenous chips. Intact ace-
tabular host bone was compressed with an impactor for cement fixation and rein-
forced with an Eichler ring. The peripheral segmental defects were repaired with
iliac crest grafts fixed with screws to the ilium.
In 1983, Roffmann et al. [25] investigated the fate of autogenous bone graft
chips under a layer polymethylmethacrylate (PMMA) cement in an animal model
with intrapelvic protrusio. Their model comprised an acetabular defect. Histo-
logical examination revealed that new bone grew from the acetabular wall into
the graft. The graft appeared viable, and new bone formed at the bone/cement
interface. After 10 months, solid bony union had been established between the
acetabulum and graft with complete incorporation. Based on these experimental
results in dogs, Mendes et al. [26] published the results of a clinical study on
primary cemented arthroplasties with autogenous bone fragments supported by
metal mesh for acetabular protrusion with good clinical results up to 6 years.
Since the late 1970s, impaction bone grafting with cemented total hip
arthroplasty has been our treatment of choice for restoring acetabular bone stock.
We modified the techniques developed by Hastings and Parker and McCollum
et al. and published our clinical experience [27] in 1984. The main modification
we made to their techniques was the use of larger fragments of fresh deep-frozen
trabecular bone, vigorous impaction of the graft fragments, and direct contact of
cement on graft. Support rings were not used, and we relied instead on the
stability of the cement-graft reconstruction. It was important to convert seg-
mental, non-contained defects into cavitary defects with flexible metal mesh.
This stabilized the graft during impaction.
In the course of time, various modifications of the Nijmegen Bone Grafting
Technique were introduced with cementless implants, structural or undersized
cancellous grafts, and metal reinforcement. Other methods were developed to
cope with extensive loss of bone stock. Deficient bone stock was replaced by
larger implants, more bone cement, and implants with coatings to promote
spontaneous bone growth.
8 Slooff

Orthopedic oncology has had many years of experience with massive and
structural bone grafting with special mega-prostheses for patients requiring
femoral reconstruction. In this specific group of patients, the clinical results were
moderate but acceptable. Incomplete and unpredictable incorporation of the graft
was the main problem, resulting in fracture or resorption of bone graft. In
emergency situations, this combination of structural, massive allografts and hip
prostheses is still employed. In the 1980s, the majority of femoral revisions after
failed total hip arthroplasty were performed with long stem components that
bridged the proximal defect and were fixed into the distal part of the shaft with
bone cement, or by press-fit prostheses with an osteoconductive surface finish. At
our clinic, we initially chose a conventional femoral component with a larger
diameter in combination with a larger quantity of bone cement. Clinical success
was short-lived and, just as on the acetabular side, a defect remained a defect after
recementing. All these older techniques sought a mechanical solution to restoring
the defect. Less attention was paid to a biological solution for the loss of cortical
and cancellous bone of the femur. Encouraged by our favorable experience of
acetabular reconstruction with tightly impacted morsellized allografts and
cement, we developed a similar technique for femoral defects. From the mid-
1980s our first cases were grafted without specialized instrumentation using trial
stems to pack bone chips into localized femoral lytic lesions.
At the same time this crude technique was also used in Exeter, inde-
pendently of Nijmegen. From 1990, in close cooperation with Ling and Gie from
Exeter and representatives of Howmedica International, femoral and acetabular
instruments were developed that would guarantee a sleeve of tightly impacted
bone chips in the enlarged medullary cavity and acetabulum (X-Change Revision
Instrumentation System). The initial clinical experience with femoral recon-
struction was reported in 1991 by Simon et al. [28], and in the same year,
Schreurs et al. [29] showed increased stability of the femoral component obtained
by combining impacted graft and cement experimentally.
The choice of the specific double-tapered, polished, and collarless Exeter
prosthesis was based on clinical analyses of total hip replacements at the Princess
Elisabeth Orthopaedic Hospital, Exeter, and on the research from the School of
Engineering of Exeter University [30]. In comparison with the many other
prostheses available at that time, Exeter had 20 years of clinical experience with
this type of stem. The Exeter prosthesis functions as a self-locking taper in the
bone cement. Its special design, with a broad proximal part and a narrow distal
part, is a unique way of transmitting stress into the bone cement and the femur.
The polished surface minimizes wear particles, reduces detrimental axial shear
stresses at the prosthesis/cement interface, and in this way protects the biological
cement/bone interface. The stem is centered in the femoral shaft, which
guarantees that it is completely surrounded by a layer of cement. These properties
protect the bone bed from local osteolysis. Over 20– 25 years, excellent, reliable,
History of Bone Impaction Grafting 9

and predictable results have been achieved with this prosthetic stem in primary
cemented total hip replacement. There has been a low incidence of radiolucent
lines at the cement/bone interface, minimal calcar resorption, and a very low
incidence of endosteal bone lysis. The survival curves of this femoral component
show a low failure rate for mechanical loosening.
In conclusion, as shown often before in the history of bone grafting, the
technique of impaction bone grafting was started when surgeons were confronted
with severe bone stock defects in hip replacement. Based on good clinical results,
laboratory research was started to study this reconstruction technique and
understand the method.
Detailed descriptions of acetabular reconstruction, postoperative treatment,
and clinical results with impacted bone grafts are presented in Chapters 5, 20,
and 21.

REFERENCES

1. Leeuwenhoek van A. Microscopical observations about blood, milk bones, the brain,
spittle, cuticula, sweet, fat and tears. Philes Trans R Soc Lond 1674; 9: 121– 131.
2. Meekeren van J. Heel- en geneeskundige aanmerkingen. Amsterdam: Commelijn,
1668.
3. Ollier L. Traite experimental et clinique de la regeneration des os et de la production
artificielles du tissue osseux. Paris: Victor Masson et fils, 1867.
4. Macewen W. Observations concerning transplantation of bones. Proc Soc Lond
1881; 32: 232– 247.
5. Curtis BF. Cases of bone implantation and transplantation for cysts of tibia,
osteomyelitic cavities and ununited fractures. Am J Med Soc 1893; 106: 30 – 37.
6. Barth A. Über histologische Befunde nach Knochenimplantationen. Arch Klin Chir
1893; 46: 409– 417.
7. Lexer E. Die Verwendung der freien Knochenplastik nebst Versuchen über
Gelenkversteifung und Gelenktransplantationen. Arch Klin Chir 1908; 86: 939– 954.
8. Axhausen G. Arbeiten aus den Gebiet der Knochenpathologie und Knochenchir-
urgie. kritische Bemerkungen und neue Beiträge zur freien Knochentransplantatio-
nen. Arch Klin Chir 1911; 94: 241– 281.
9. Bush LF. The use of homogenous bone grafts. A preliminary report on the bone
bank. J Bone Joint Surg 1947; 29A: 620– 628.
10. Wilson PD. Experience with the use of refrigerated homogenous bone. J Bone Joint
Surg 1951; 33B: 301– 315.
11. Herndon CH, Chase SW. The fate of massive autogenous and homogenous bone
grafts including articular surfaces. Surg Gyn Obstet 1954; 98: 273 –290.
12. Burwell RG, Gowland G. Studies in the transplantation of bone. The immune
response of lymph nodes draining components of fresh homogenous bone treated by
different methods. J Bone Joint Surg 1962; 44B: 131– 148.
10 Slooff

13. Campbell CJ. Experimental study of the fate of bone grafts. J Bone Joint Surg 1953;
35A: 332– 346.
14. Urist MR. Bone: formation by autoinduction. Science 1965; 150: 893– 899.
15. Goldberg VM, Stevenson S. Natural history of autografts and allografts. Clin Orthop
1987; 225: 7 – 17.
16. Stevenson S, Xiao Qing Li, Martin B. The fate of cancellous and cortical bone after
transplantation of fresh and frozen tissue-antigen-matched and mismatched
osteochondral allografts in dogs. J Bone Joint Surg 1991; 73A: 1143– 1157.
17. Enneking WF, Mindell ER. Observations on massive retrieved human allografts.
J Bone Joint Surg 1991; 73A: 1123– 1142.
18. Hastings DE, Parker SM. Protrusio acetabuli in rheumatoid arthritis. Clin Orthop
1975; 108: 76 – 84.
19. Harris WH, Crothers O, Oh I. Total hip replacement and femoral head bone grafting
for severe acetabular deficiency in adults. J Bone Joint Surg 1977; 59A: 752– 769.
20. Jasty M, Harris WH. Salvage total hip reconstruction in patients with major
acetabular bone deficiency using structural femoral head allografts. J Bone Joint
Surg 1990; 72B: 63 – 68.
21. Kwong LM, Jasty M, Harris WH. High failure rate of bulk femoral allografts in total
hip acetabular reconstructions at 10 years. J Arthroplasty 1993; 8: 341– 347.
22. Coventry MB. Preparation of the acetabulum for total hip arthroplasty. In: The Hip,
Proceedings of the Sixth Open Scientific Meeting of The Hip Society. St. Louis: The
C.V. Mosby Company, 1978: 113– 124.
23. McCollum DE, Nunley JA. Bone grafting in acetabular protrusio: a biologic buttress.
In: The Hip, Proceedings of the Sixth Open Scientific Meeting of The Hip Society.
St. Louis: The C.V. Mosby Company, 1978: 124– 149.
24. Marti RK, Besselaar PP. Bone grafts in primary and secondary total hip replacement.
In: Marti RK, ed. Progress in Cemented Total Hip Surgery and Revision.
Amsterdam: Excerpta Medica, 1983: 107– 129.
25. Roffmann M, Silberman M, Mendes D. Viability and osteogenity of bone coated
with methylmethacrylate cement. Acta Orthop Scand 1982; 53: 513– 519.
26. Mendes D, Roffmann M, Silberman M. Reconstruction of the acetabular wall with
bone graft in arthroplasty of the hip. Clin Orthop 1984; 186: 29 – 38.
27. Slooff TJJH, Huiskes R, van Horn JR, Lemmens AJ. Bone grafting in total hip
replacement for acetabular protrusio. Acta Orthop Scand 1984; 55: 593– 596.
28. Simon JP, Fowler JL, Gie GA, Ling RSM, Timperley AJ. Impaction cancellous
grafting of the femur in cemented total hip revision arthroplasty. J Bone Joint Surg
1991; 73B: s73.
29. Schreurs BW, Huiskes R, Slooff TJ. The initial stability of cemented and non-
cemented stems fixated with a bone grafting technique. Orthop Trans 1991; 15: 439–
440.
30. Fowler JL, Gie GA, Lee ACJ, Ling RSM. Experience with the Exeter total hip
replacement since 1970. Orthop Clin North Am 1988; 74: 1119– 1129.
2
Harvest, Storage, and
Microbiological Security of
Bone Allografts
Christian Delloye, B. Naets, Nathalie Cnockaert, and
Olivier Cornu
Université Catholique de Louvain, Bruxelles, Belgium

I. INTRODUCTION

Bone allografts have been used primarily for limb salvage procedures in
orthopedic oncology. Tissue banks have made bone readily available, and this
availability arose from the interest of surgeons treating more current bone loss
such as that associated with implant loosening. Bone allografts became part of the
reconstruction, and the need for banked bone has sharply risen with the spiraling
increase in revision arthroplasty. In Belgium, a country of 10 million inhabitants,
15,000 primary hip and 10,000 knee arthroplasties are performed each year. With
patients living longer and arthroplasty being performed in younger patients,
revision arthroplasty for loose hip and knee prostheses has become a major part of
current orthopedic practice. In Belgium, hip revision arthroplasties accounted for
12% of primary hip replacements in 2001. Most of these revisions are caused by
wear particles that generate an unopposed osteolysis around the implant with
progressive implant loosening. Restoration of a bone stock with a conventional
implant is a standard approach to dealing with loose cemented implants. In the
past, massive allografts were used [1,2], but these have been replaced by
morselized impacted bone to reconstruct a stable joint. This chapter describes the
current procedures used to select tissue donors, process bone, and preserve the
grafting material.

11
12 Delloye et al.

II. DONOR SELECTION

Selection of a donor is one of the major responsibilities of a tissue bank because


of the risk of disease transmission [3 – 5]. Because only unprocessed, fresh frozen
allografts have been documented as sources of viral infection in bone graft
recipients, efforts have been made to decrease this risk by processing the tissue
whenever possible [6]. Tissue implantation is never an emergency and is an
elective procedure. To reduce the risk, tissue banks perform donor screening
through a battery of questions about the lifestyle and medical history of the
potential donor and through a series of biological assays. To exclude donors at
risk for disease transmission, several updated guidelines have been published,
including those issued by the American Association of Tissue Banks (AATB) [7],
the European Association of Musculoskeletal Transplantation (EAMST), and the
European Association of Tissue Banks (EATB) [8]. The most important
exclusion criteria are:
Presence or suspicion of any dementia or any central nervous diseases such
as Alzheimer’s or Creutzfeldt-Jakob diseases
Risk factors for HIV or B or C hepatitis
History of chronic hepatitis or presence of an active hepatitis
History of extracted pituitary hormone
History or suspicion or presence of HIV or HTLV infection
History of malignant disease (basal cell carcinoma of the skin excluded)
Presence of connective tissue disease (e.g., lupus, rheumatoid arthritis) or
chronic steroid use
Presence or evidence of infection or prior irradiation at the site of donation
Unknown cause of death (without autopsy)
Any donor of tissue will be screened using premortem blood sample by
laboratory assays, including the following tests. The minimum serological tests
are:
Hepatitis B surface antigen (HBs-ag)
Hepatitis B core antibody (HBc-ab)
Hepatitis C virus antibodies (HCV)
HIV1-2 antibodies
Syphilis
Optional blood tests that can be performed include the following:

Polymerase chain reaction (PCR) for HIV, hepatitis viruses. When


quarantine is not possible, a negative PCR for HIV and hepatitis C might
be accepted if properly performed by an experienced laboratory.
HTLV 1-2 antibody (legal requirement in France, required also by AATB).
Graft Harvest and Storage 13

Alanine aminotransferase (ALT) for a living donor (legal requirement in


France). This last recommendation has been set for the detection of
patients with liver disease and possibly a viral hepatitis.
Rhesus factor, as it is known that a femoral head from a Rhesus-positive
donor is able to sensitize a Rhesus-negative recipient [9,10].
Consequently, Rhesus matching is necessary for a Rhesus-negative
female patient with childbearing potential.
HLA histocompatibility group matching is unnecessary for successful
allograft. Although bone allograft may elicit an immune response, its
significance has not been so far demonstrated [11,12]. Table 1 lists the
various kinds of bone allografts.

Table 1 Various Types of Bone Allografts

Source Bone Procedure

Living donor Femoral head Quarantine


Organ donor Massive bone Quarantine via the testing of organ
recipients tendons
Deceased donor Bone Premortem blood sample required (without
hemolysis); no quarantine possible;
validated tissue processing necessary

III. BONE RETRIEVAL

Femoral heads are harvested from living donors during primary hip arthroplasty
and larger bones recovered from organ donors. Consent for tissue retrieval is
obtained according to the national law or regulation. If there is no applicable
regulation, informed consent is obtained from the living donor and from the next
of kin in case of organ donors.
Bone recovery from a live donor is performed in aseptic conditions in an
operating theater, whereas harvest from an organ donor can be made either in
aseptic conditions or in a nonsterile but clean environment. In the latter case,
secondary sterilization will be necessary, usually by irradiation.
Contamination is assessed by culturing samples from the tissue im-
mediately after retrieval. Any positive culture with a pathogenic microorganism
is excluded. As bone has been shown to adsorb and release antibiotic [13,14],
long bones from dead donors are immersed (after bacteriological screening) in
14 Delloye et al.

1.2 g/L rifampicin solution for 45 minutes before final packaging. This
immersion is repeated at the thawing phase.

IV. RISK OF VIRAL TRANSMISSION

The risk of a viral transmission through an allograft can occur; the world
literature reveals that at least four recipients who received nonprocessed bone
have been contaminated by the HIV virus [6,15] and that four others have been
contaminated by hepatitis C virus [16]. The risk is associated with a seronegative
window during which a virus-contaminated donor can transmit the virus while
the serum remains negative. In 1989, the mean time to seroconvert from the time
of exposure to HIV virus [17] was 42 days. Recent improvement of the sensitivity
of HIV antibody assays has resulted in a significant shortening of this presero-
conversion window period. The time to seroconversion with the third-generation
assay varies. When the screening was performed with antibody assay alone,
Busch et al. [18] estimated the window period to be 22 days and Lelie et al. [19]
37 days.
Assuming that there is a 10-fold higher incidence of HIV infection among
tissue than blood donors, Lelie et al. estimated the risk of a “window donation”
for a tissue to be 6 per million tissue donors (one per 166,000 donors). With a
window of 14 weeks and an incidence of 610 per million tissue donors, the risk
for a hepatitis C –contaminated tissue would be 160 per million (one per 6,250
donors).
The risk of a window donation can be lowered by additional safety
measures.

A. Use of Amplification Tests


The polymerase chain reaction is an in vitro amplification of a viral genome that
might potentially be intercalated into the patient’s DNA. Because the selection
and amplification of the target DNA is independent of antibody response, an
infecting virus can be detected before seroconversion. This assay is very sensitive
and specific. HIV-DNA polymerase chain reaction is able to shorten the average
window period to 16 days from the day of exposure. The residual risk of an
infectious tissue would be reduced to 1 in 230,000 donations. HIV p24 antigen
testing has the same reduction as the HIV-DNA PCR on the window period. The
European standards [8] recommend the use of PCR or p24 antigen testing for HIV
and PCR for hepatitis C when tissue cannot be kept in quarantine.
Graft Harvest and Storage 15

B. Quarantine
The quarantine is a waiting period after which the living tissue donor is tested
again, as is the recipient of the organ in case of an organ donor. This is the safest,
the least expensive, and the most sensitive method of tracking hepatitis C and
HIV viruses. As such, tissue should be quarantined whenever possible.
In living donors, American [7] and European guidelines [8] recommended
a 6-month quarantine period. This interval remains the same despite the increased
sensitivity of HIV antibody assay because of the longer latency for hepatitis C
virus. In organ donors, the 6-month quarantine can be 3 months shorter, as a
contaminated vascularized organ should expose the recipient to a much earlier
viral load [15].
Today, the theoretical risk of viral transmission of HIV is less than one in a
million and for HCV, one in 200,000 in deep-frozen, nonirradiated, and
unprocessed bone procured from a selected and serologically screened donor.
This risk is further decreased for HIV virus to less than one in a billion after a
6-month quarantine and for HCV to one in 2 million. After validated tissue
processing, this risk is virtually eliminated.

V. BACTERIAL TRANSMISSION RISKS

The risk of tissue transmission of pathogenic microorganisms is rare, but it has


occurred. Very recently, the U.S. Centers for Disease Control (CDC) reported 54
cases of allograft-associated infections, of which half were from one U.S. tissue
bank [20]. This sudden increase appears to result from poor compliance with
“good tissue practices,” such as inadequate testing of incoming tissue and failure
to assess the degree of bacterial contamination of tissues immediately after
harvesting. This further emphasizes the importance of rigorous bacterial
screening before and after tissue processing.

VI. PROCESSING

Processing means any activity performed on tissue other than the tissue recovery.
It includes steps to inactivate and remove harmful agents.
One of the purposes of processing is shaping the graft material for its future
use (bone morsels, dowel, threaded cages, etc). Processing also allows de-
contamination of the tissue by eliminating bone marrow and cellular debris [21]
with fluids and detergents. The standard of decontamination should be confirmed
by validated methods before routine use.
16 Delloye et al.

Processing also improves the osteoconductive capacity in experimental


comparisons of marrow-free and marrow-containing bone [21]. Elimination of
marrow seems also to extract peroxidated lipids from irradiated bone. These
marrow by-products seem to be cytotoxic to cultured osteoblasts [22].
Solvent detergents such as chloroform, ethanol, acetone, and ether are often
used. These chemical agents are able to inactivate coated viruses such as HIV and
hepatitis B and C [23]. Hydrogen peroxide has been long used as a bleaching
agent and is also effective against viruses and bacteria due to its capacity to form
free radicals. For transmissible spongiform encephalopathy (TSE) – associated
prions, transmission through musculoskeletal tissue has not been demonstrated so
far. There are today two chemical treatments recognized as effective against
TSE-associated prions by the World Health Organization (WHO) [24]: sodium
hydroxide 1 M for 1 hour at 208C or sodium hypochlorite (2% chlorine available)
for 1 hour at 208C. However, there is no adequately validated method for these
TSE-associated prion decontamination procedures.
Water jet lavage is a physical method that may effectively decontaminate
tissue with one decimal reduction [25]. Another option is supercritical CO2 at
high pressure (280 bars) and at 508C for deep cleansing of bone fat [26].
The main advantage of this approach is that the power of penetration is not
limited by the size of the tissue. Other banks use a wide range of fluid pressure to
thoroughly eliminate particles and cellular material from tissue.

VII. PRESERVATION

There are two widely used preservation methods: deep-freezing and freeze-
drying. Deep-freezing is achieved by placing the tissue either in a 2808C
mechanical freezer or in liquid nitrogen at 21968C. From mechanical and
immunological viewpoints, there are no differences between both temperatures,
and deep-freezing has no detrimental effects on the original mechanical
properties of bone [11].
Freeze-drying will result in a dried material that can be kept at room
temperature. It contains less than 5% (w/w) of residual moisture [27]. Compared
to a deep-frozen bone, freeze-dried tissue does not elicit a humoral immune
response. However, freeze-dried and irradiated bone becomes brittle. The
brittleness of freeze-dried and irradiated bone could be an advantage when
impacted as bone morsels [28], but such bone should be mechanically protected if
used as a structural graft.
Graft Harvest and Storage 17

VIII. STERILIZATION

The basic aim in sterilizing musculoskeletal tissue is to reduce the probability of


finding viable microorganism on the sterilized tissue to one in a million [29]. To
achieve this, the bacterial load of tissue must be assessed first before being
sterilized. In addition, the processing of the tissue should be controlled and
standardized to keep the bacterial load as small as possible. The effectiveness of
the sterilizing method will depend on the initial bacterial load, the sensitivity of
the microorganism to the sterilizing agent, and the duration of exposure. It should
be emphasized at this point that the use of sterilization in tissue banking does not
replace the screening of the donor.

A. Irradiation
The two principal sources of irradiation are gamma rays from a cobalt 60 source
and accelerated electrons generated by an accelerator. Gamma rays have an
excellent penetration capacity. In contrast, electrons as charged particles cannot
penetrate deeply.
The usual and legal dose in most European countries to sterilize the tissue is
25 kGy (1 Gy ¼ 100 rad). Although this dose is appropriate for bacteria, it is not
effective against HIV [30 –32].
The radiosensitivity of hepatitis viruses is also not known, but recent
clinical data suggest that hepatitis C – contaminated tissues do not transmit the
virus after irradiation [16]. Prions are strongly resistant to radiation [33,34].
Mechanically, fresh-frozen irradiated cortical bones have their resistance
decreased by about 20% in flexion from a dose of 30 kGy and from 60 kGy in
compression [35,36]. In contrast, fresh-frozen cancellous bone is not affected by
25 kGy irradiation when tested in compression [37]. Compared to deep-freezing,
freeze-drying causes a 20% loss in compression, while adding 25 kGy irradiation
causes a further decrease to a final loss of 42% in compression. Biologically,
gamma irradiation of fresh-frozen bone containing bone marrow can generate
toxic effects on osteoblasts [22].

B. Ethylene Oxide
This alkylating gas has long been used but has now been discontinued in most
countries because the by-products generated produce an inflammatory reaction
[38]. Nevertheless, ethylene oxide is able to penetrate cortical bone to sterilize
musculoskeletal tissue and as such is still in use in some European countries
[39,40].
18 Delloye et al.

IX. FROM FEMORAL HEAD TO BONE MORSEL

Usually, femoral heads that are allowed to enter the circuit will be cut in two
halves. Any cartilage residue is removed as it can influence the mechanical
behavior of the morsels [41]. They are physically and chemically processed and
then milled to morsels (Fig. 1). Different models of bone mills vary in the particle
sizes they produce [42]. They are packed in plastic vials or envelopes, each
containing 15 cc of bone vole (Figs. 2, 3). A whole femoral head will give about 4
units. Depending on the wish of the surgeon, they are either freeze-dried or deep-
frozen. Freeze-dried morsels must first be reconstituted in saline for 10 minutes
before being used. Deep-frozen morsels will be thawed before use.

X. RECORD KEEPING

Records should accurately identify all the information pertaining to the donor and
all the steps in tissue processing, if any. Release of the tissue should be
documented, including the name of the recipient and date of use. All the data
about the donor, the donor’s family, and the recipients must be treated as
confidential. Record keeping should also be organized in such a manner that
tissue tracking is possible.

Figure 1 Morselization of processed bone originating from a femoral head.


Graft Harvest and Storage 19

Figure 2 Final aspect of a processed and freeze-dried bone morsels packed in a


double-wrapped vial. This envelope can be stored at room temperature.

Figure 3 The envelope has been opened in the operating theater. The surgeon
will now take from the vial the freeze-dried bone morsels for reconstitution and use.
20 Delloye et al.

XI. CONCLUSIONS

Tissue banking has many steps, each requiring constant attention, from donor
selection to final delivery to the surgeon. This is not easy and requires dedication
to high standards. The final aim is to provide a safe and appropriate grafting
material. The surgeon must assist the tissue bank in either participating at the 6-
month blood testing in case of femoral heads or verifying the appropriateness of
the graft to be implanted.

REFERENCES

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78-B: 22 – 25.
4. Nemzek J, Arnoczky S, Swenson C. Retroviral transmission by the transplantation of
connective-tissue allografts. An experimental study. J Bone Joint Surg 1994; 76-A:
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5. Tomford W. Transmission of disease through transplantation of musculoskeletal
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Transmission of human immunodeficiency virus type 1 from a seronegative organ
and tissue donor. N Engl J Med 1992; 326: 726– 732.
7. Standards for Tissue Banking. McLean, VA: American Association of Tissue Banks,
2001.
8. Common Standards for Musculo-skeletal Tissue Banking. Vienna: European
Association of Tissue Banks and European Association of Musculoskeletal Trans-
plantation, 1997.
9. Jensen T. Rhesus immunization after bone allografting. A case report. Acta Orthop
Scand 1987; 58: 584.
10. Johnson C, Brown B, Lasky L. Rh immunization caused by osseous allograft. Lancet
1985; 312: 121– 122.
11. Friedlaender G, Strong D, Sell K. Studies on the antigenicity of bone. I. Freeze-dried
and deep-frozen bone allografts in rabbits. J Bone Joint Surg 1976; 58-A: 854– 858.
12. Stevenson S, Horowitz M. The response to bone allografts. J Bone Joint Surg 1992;
74-A: 939 –950.
13. Hernigou P, Glorion C, Girard-Pipau F, Deriot H, Goutallier D. Libération in vitro et
in vivo des antibiotiques à partir des greffes osseuses. Rev Chir Orthop 1992; 78
(suppl 1): 217.
Graft Harvest and Storage 21

14. Witso E, Loseth K, Bergh K. Adsorption and release of antibiotics from morselized
cancellous bone. In vitro studies of 8 antibiotics. Acta Orthop Scand 1990; 70:
298– 304.
15. Simonds R. HIV transmission by organ and tissue transplantation. AIDS 1993; 7
(suppl 2): S35– S38.
16. Conrad EU, Gretch DR, Obermeyer KR, Moogk MS, Sayers M, Wilson JJ, et al.
Transmission of the hepatitis C virus by tissue transplantation. J Bone Joint Surg
1995; 77-A: 214– 224.
17. Horsburgh C, Ou C, Jason J. Duration of human immunodeficiency virus infection
before detection of antibody. Lancet 1989; 2: 637– 640.
18. Busch M, Lee L, Satten G, et al. Time course of detection of viral and serological
markers preceding human immunodeficiency virus type-1 seroconversion: impli-
cations for screening of blood and tissue donors. Transfusion 1995; 3: 91– 96.
19. Lelie P, Zaaijer H, Cuypers H. Risk of virus transmission by tissue, blood and plasma
products. Transpl Proc 1996; 28: 2939.
20. Allograft-associated bacterial infections. MMWR 2002; 51: 207– 210.
21. Thoren K, Aspenberg P, Thorngren KG. Lipid extraction decreases the specific
immunologic response to bone allografts in rabbits. Acta Orthop Scand 1993; 64:
44 – 46.
22. Moreau M.F, Gallois Y, Basle M.F, Chappard D. Gamma irradiation of human bone
allografts alters medullary lipids and releases toxic compounds for osteoblast-like
cells. Biomaterials 2000; 21: 369– 376.
23. Feinstone S, Mihalik K, Kamimura T, Alter H, London W, Purcell R. Inactivation of
hepatitis B virus and non-A, non-B hepatitis by chloroform. Infect Immun 1983; 41:
816– 821.
24. World Health Organization. Report of a WHO consultation on public health issues
related to animal and human spongiform encephalopathies. WHO/CDS/VPH/
92.104, 1992.
25. Anglen J, Apostoles P, Christensen G, Gainor B, Lane J. Removal of surface bacteria
by irrigation. J Orthop Res 1996; 14: 251– 254.
26. Fagès J, Marty A, Delga C, Condoret JS, Combes D, Frayssinet P. Use of super-
critical CO2 for bone delipidation. Biomaterials 1994; 15: 650– 656.
27. Delloye Ch. Bone banking in orthopaedic surgery. 55-020-E-10, Paris: Editions
Scientifiques et Medicales Elsevier SAS, 2000.
28. Cornu O, Banse X, Docquier PL, Luyckx S, Delloye Ch. Effect of freeze-drying and
gamma irradiation on the mechanical properties of human cancellous bone. J Orthop
Res. 2000; 18: 426– 431.
29. Darbord JC, Laizier J. A theoretical basis for choosing the dose in radiation
sterilization of medical supplies. Int J Pharma 1987; 37: 1 – 10.
30. Conway B, Tomford W, Mankin HJ, Hirsch MS, Schooley RT. Radiosensitivity of
HIV-1. Potential application to sterilization of bone allografts. AIDS 1991; 5: 608–
609.
31. Hernigou P, Marce D, Juliéron A, Marinello G, Dormont D. Stérilisation osseuse par
irradiation et virus VIH. Rev Chir Orthop 1993; 79: 445– 451.
32. Fideler B, Vangness T, Moore T, Li Z, Rasheed S. Effects of gamma irradiation on
the human immunodeficiency virus. A study in frozen human bone-patellar
22 Delloye et al.

ligament-bone grafts obtained from infected cadavera. J Bone Joint Surg 1994; 76-A:
1032– 1035.
33. Forsell J. Irradiation of musculoskeletal tissues. In: Tomford W, ed. Musculoskeletal
Tissue Banking. New York: Raven, 1993: 149– 180.
34. Dormont D. Creutzfeldt-Jakob disease and transplantation: facts and fables. Transpl
Proc 1996; 28: 2931– 2933.
35. Loty B, Courpied J, Tomeno B, Postel M, Forest M, Abelanet R. Radiation sterilized
bone allografts. Int Orthop 1990; 14: 237 –242.
36. Loty B. Allogreffes osseuses: aspects fondamentaux et techniques de conservation en
1992. In: Duparc J, ed. Conférences d’Enseignement 1992. Paris: Expansion
Scientifique Française, 1992: 211– 237.
37. Anderson M, Keyak J, Skinner H. Compressive mechanical properties of human
cancellous bone after gamma irradiation. J Bone Joint Surg 1992; 74A: 747– 752.
38. Jackson D, Windler G, Simon T. Intra-articular reaction associated with the use of
freeze-dried ethylene oxide-sterilized bone-patellar tendon-bone allografts in the
reconstruction of the anterior cruciate ligament. Amer J Sports Med 1990; 18: 1– 11.
39. Prolo D, Pedrotti P, White D. Ethylene oxide sterilization of bone dura mater, and
fascia lata for human transplantation. Neurosurgery 1980; 6: 529– 539.
40. Kearney J. Sterilization of human tissue implants. Tissue Cell Rep 1997; 4: 33 – 36.
41. Bavadekar A, Cornu O, Godts B, Delloye C, Van Tomme J, Banse X. Stiffness and
compactness of morselized grafts during impaction: an in vitro study with human
femoral heads. Acta Orthop Scand 2001; 72: 470– 476.
42. Brewster N, Gillespie W, Howie C, Madabhushi S, Usmani A, Fairbairn
D. Mechanical considerations in impaction bone grafting. J Bone Joint Surg.
1999; 81-B:118 – 124.
3
The Procurement, Processing, and
Preservation of Allograft Bone
Stephan Vehmeijer
Leiden University Medical Centre, Netherlands Bone Bank Foundation
Leiden, The Netherlands

Rolf M. Bloem
Reinier de Graaf Hospital, Netherlands Bone Bank Foundation
Delft, The Netherlands

I. INTRODUCTION

During the past decades the use of bone allografts has become widely accepted
for the filling of skeletal defects in a variety of surgical procedures. In particular,
in the field of orthopedic surgery the demand for allograft bone has increased
rapidly [1 – 6]. Grafts are primarily used to fill the skeletal defects associated with
the loosening of total joint replacements, either as morselized and then impacted
or as structural grafts [5,7,8].
The selection of an allograft for these procedures requires an understanding
of the procurement, processing, and preserving methods utilized by tissue banks.
In addition, the orthopedic surgeon should be aware of the risks associated with
the transplantation of allografts, in particular with the preventative measures
taken by a tissue bank. This chapter will describe the methods of bone allograft
procurement and will provide a brief overview of the different processing and
preservation techniques available to tissue banks.

II. ALLOGRAFT PROCUREMENT

Allografts may be obtained from either living or postmortem donors. Hospital-


based tissue banks mainly retrieve allografts from living donors undergoing
23
24 Vehmeijer and Bloem

primary total hip replacement for osteoarthritis or hemiarthroplasty for hip


fractures.
Larger (inter-) national operating tissue banks obtain allografts mainly
from postmortem donors. Large bone segments can be retrieved from these
donors, which can be used for reconstructive surgery in orthopedic oncology or in
revision arthroplasty [2,4,9]. Grafts can also be processed into smaller units and
applied in spinal fusions or used for the filling of bone defects associated with
bone cysts or loosening of total joint replacements [5,7,8,10,11].
Postmortem tissue retrieval may be performed in mortuaries. However, due
to the higher incidence of organisms cultured from grafts harvested in mortuaries
[12], some tissue banks prefer procurement in an operating theater under aseptic
conditions, thus minimizing the initial bacterial load of the grafts.

III. DISEASE TRANSMISSION

Standards have been developed that require tissue banks to perform thorough
screening of donors’ medical and social history combined with extensive sero-
logical and bacterial screening. These have improved the safety of musculo-
skeletal allografts in recent decades [13]. In adequately screened allografts, the
risk of transmitting human immunodeficiency virus (HIV) and other viruses has
been estimated to be one in 1.6 million [13]. Furthermore, in the past 10 years no
new cases of HIV or hepatitis transmission have been reported. The combined
standards for musculoskeletal tissue banking of the European Association of
Tissue Banks (EATB) and the European Association of Musculoskeletal Trans-
plantation (EAMST) require tissue banks to perform antibody tests for HIV 1/2,
hepatitis C, and syphilis, and antigen tests for hepatitis B [14]. A limited number
of tissue banks will also perform antigen or even polymerase chain reaction
(PCR) tests for HIV and hepatitis C for additional safety.
Bacterial infections seem to be more associated with the use of large
allografts in major reconstructions after the resection of bone tumors [2,15 –18].
The incidence of infections associated with the use of allografts in the impaction
technique is low [5,8]. No reports of graft-related infections with this technique
were found in the literature. However, a recent report on the death of one patient
due to bacterial sepsis after the transplantation of a femoral condyle allograft
proves the necessity of vigorous bacterial screening [19]. No microorganisms
were cultured from any of the cultures obtained from this patient. One other
patient who received grafts from the same donor, however, developed serious
infectious complications caused by Clostridium species.
It was presumably this anaerobic organism that caused the sepsis in the first
patient. Therefore, to decide whether a graft is adequate for transplantation
purposes, it is essential to determine whether and to what degree a procured graft
Bone Allograft Procurement and Processing 25

is contaminated with microorganisms. This is of even more importance if a tissue


bank decides to allocate minimally processed grafts for limited indications. This
should, however, also be applied to grafts that are processed because some
processing methods will only reduce and not eliminate the bacterial load.
The combined standards for musculoskeletal tissue banking require that
representative samples of each retrieved tissue are cultured if they are to be
aseptically processed without terminal sterilization [14]. Obtaining blood
cultures is recommended if procurement is performed on a postmortem donor as
an additional evaluation on the state of the donor and the eventual interpretation
of the culture results of the grafts themselves.
The majority of tissue banks perform only tissue cultures, as they consider
this a more direct method to determine the bacterial load. Samples from
representative areas of the graft are incubated in broth, which is then subcultured.
This method is highly sensitive for samples contaminated with microorganisms.
It is, however, unlikely that microorganisms present on the allografts surface are
evenly distributed. As a consequence, since samples are taken from a limited
number of sites on the graft, sampling error is possible.
Another method to determine the bacterial load of allografts is the swab
culture technique. The entire surface of a graft is swabbed. The swab stick is
inoculated onto culture plates, and the swab stick itself is incubated in broth that
is then subcultured. This method allows for a semi-quantitative assessment of the
bacterial load of a graft. The value of an additional broth culture has, however,
been disputed [20,21]. A major disadvantage of the swab culture technique is that
only the external surface is sampled. Microorganisms inside the graft, dis-
seminated hematogenously, can remain undetected.
To detect these organisms, some tissue banks, such as the Netherlands
Bone Bank Foundation, perform postmortem blood cultures. These cultures may
facilitate the detection of microorganisms that have spread hematogenously and
other organisms, such as anaerobic Clostridium species, which are difficult to
detect with either the tissue or the swab culture technique [22].

IV. PROCESSING METHODS

Bone and soft tissue allografts are often further processed to facilitate their use
and to provide additional safety. Allografts are debrided from soft tissue, cut to
size, and treated with disinfection or sterilization techniques using various
methods. These procedures are mainly aimed at reducing the risk of graft-
transmitted diseases, but they should be explicitly considered additional to
thorough screening of the donors’ medical and social history and bacterial and
virological screening tests.
26 Vehmeijer and Bloem

The extent to which a graft is processed and preserved is partly dictated by


its utilization. For the majority of grafts used in orthopedic procedures, including
the impaction technique, however, biomechanical and occasionally biological
properties are of lesser importance, and a wide range of disinfection or
sterilization and preservation techniques may be employed.

A. Cleaning and Debridement of Donor Tissue


Processing of bone tissue generally starts with the removal of excessive soft
tissue, periosteum, and bone marrow. This alone will reduce the risk of disease
transmission, as was demonstrated by Simonds, who described a case of
transmission of HIV-1 by transplantation of bone tissues [13]. Three recipients of
unprocessed fresh-frozen bone were infected with HIV-1.
The recipient, however, of tissue from which the bone marrow had been
removed by the transplanting surgeon tested negative for HIV-1 antibody, as did
three recipients of lyophilized soft tissue and 25 recipients of ethanol-treated
bone. This underlines the necessity for further processing, even if minimally, of
donor tissues.
After debridement of excessive tissue, grafts may be cut to size and
subsequently washed with or soaked in sterile water and detergents, which will
further decrease the risk of transmission.

B. Disinfection and Sterilization


Tissue banks employ different disinfection and sterilization techniques. In these
procedures, disinfection should be explicitly distinguished from sterilization.
Disinfection is the reduction of the number of viable microorganisms to a
level appropriate for safe use on a patient where sterilization of the device is
neither necessary nor possible. Disinfection may also be used as a preliminary
step to sterilization, if necessary. Sterilization is a validated process used to
render a device (or tissue) free from all form of viable microorganisms (ISO
11137, 1995).
The methods for disinfection and sterilization of donor tissue are
categorized as either aseptic processing or terminal sterilization. In aseptic
processing, grafts are procured using aseptic techniques and processed in clean
rooms under stringent sterile conditions. Steps to inactivate viruses may be
included and stringent bacterial monitoring is performed. Terminal sterilization
employs techniques such as irradiation or ethylene oxide to achieve sterility of
the tissues as a terminal processing step, while procurement and processing are
performed under less stringent conditions. Sterilization is performed with the
tissue in its final packaging.
Bone Allograft Procurement and Processing 27

C. Chemical Treatment
Different chemical agents are used for disinfection purposes. Alcohols
(methanol, ethanol) are used by a majority of tissue banks to remove fat, while
antibiotics and a variety of detergents are used to further disinfect the tissue.
Some of these methods have been studied extensively and were demonstrated to
affect neither the strength of the tissue nor the incorporation of the graft into the
host [24,25].
Other agents employed to disinfect the tissue include peracetic acid in
combination with ethanol. No thorough studies of the biomechanical and
biological effects of this agent on the graft have been described, but the bacterial
and viral inactivation capabilities seem favorable [26,27].

D. Irradiation
Sterilization or disinfection of tissue with gamma irradiation is primarily
performed using a 60 cobalt source. For aseptic processing purposes, irradiation
may be used to reduce the initial bacterial load present on the graft. Based on the
procurement culture results, grafts are pretreated with a low dose (10 – 18 kGy) of
gamma irradiation, which will effectively destroy microorganisms present on the
external surface of the graft. This method was shown to compromise neither the
strength of the graft nor the ability of the graft to effectively incorporate into the
host [25]. However, irradiation of large bone allografts, even in low dosages, was
associated with a higher rate of fracture when used for the replacement of defects
after removal of bone tumors [28]. The use of irradiated grafts for these purposes
should therefore be avoided.
Irradiation may also be employed to terminally sterilize grafts. Higher
doses up to 30 kGy are necessary to eradicate all bacterial microorganisms and
viruses, but these doses seriously impair the mechanical properties of various
types of grafts [29 –31]. In addition, it may negatively affect the osteoinductivity,
in particular when grafts are not properly demulsified [32 –34].

E. Gas Sterilization
Sterilization with ethylene oxide has had widespread use in tissue banking. Its
bactericidal and antiviral effect make it an excellent sterilization method for bone
allografts.
Two problems exist with the use of ethylene oxide. First, the agent is
possibly carcinogenic [35]. Second, acceptable levels of ethylene oxide or its
residuals in bone allografts have not been established, and toxic residuals may
still be present in the graft after sterilization. This causes an inflammatory
response in the recipient, which may lead to recovery of the graft [36]. In
28 Vehmeijer and Bloem

addition, bone incorporation was found to be impaired in ethylene oxide – treated


grafts [37], although controversy exists on this aspect [38].

F. Heat Treatment
Processing devices of femoral heads using moderate heat are now widely in use.
Grafts are heated up to 808C, which provides a bactericidal and antiviral effect. It
is easy to use and enables hospitals to continue their tissue banking activities
while providing additional safety. The method, however, seriously affects
osteoinductive capacities of the graft [39]. In addition, the material loses its so-
called stickiness, which is essential for the impaction technique [5,8].

G. New Technologies
Several new techniques have been developed that claim to disinfect or sterilize
bone allografts without affecting their essential properties. These include
treatment of grafts with supercritical CO2 [40,41] and the Biocleansew process.
There were no reports of the latter found in the literature. Both methods employ
proprietary techniques.

V. PRESERVATION TECHNIQUES
A. Freezing
Freezing to temperatures of 220 to 2808C is thought not to affect the
biomechanical properties of bone allografts adversely [42,43]. Furthermore, it is
thought to reduce the immunogenicity of the graft [44]. The technique is
therefore very appropriate for the preservation of bone and tendon allografts.
Despite the advantages of this method of preservation, the high costs associated
with the acquisition and maintenance of freezers forced many tissue banks to
search for alternatives.

B. Freeze-Drying
Freeze-drying has become a popular technique for the preservation of bone tissue
allografts. Employing this technique, moisture is eliminated from the tissue under
pressure at low temperature. This allows for storage of the grafts at room
temperature up to 5 years after packaging. The technique seriously affects the
mechanical strength of the material [43,45], which makes it unsuitable for the
preservation of large grafts and tendons. It does not, however, impair the
osteoinductive capacity of bone tissue [46] and therefore provides an alternative
to the preservation of tissues used for the filling of simple bone defects like
Bone Allograft Procurement and Processing 29

cysts [11]. Some surgeons also use freeze-dried allografts for the impaction
technique. However, in the centers that first employed this technique, only frozen
cancellous bone chips were used [5,8]. No studies into the mechanical stability of
the reconstructions after impaction have been performed that compare freeze-
dried with frozen bone chips. The long-term results of this technique with the use
of freeze-dried chips may prove to be different than when frozen chips have been
used.

VI. RECOMMENDATIONS

Orthopedic surgeons should be aware of the potential risks involved with the
transplantation of bone tissue. However, the adoption of international standards
by tissue banks involving, for example, guidelines for the screening of
transmissible diseases, has minimized these risks. In addition to donor screening,
processing provides improved safety. Different techniques are used for this
purpose. One should bear in mind that these processing techniques seriously
affect the mechanical and biological properties of a graft. The extent to which the
graft is processed and preserved is therefore partly dictated by its use.
For the impaction technique the biological properties, which determine
graft incorporation, are more important than the mechanical strength. It is also
important that the graft maintains its so-called stickiness.
A low dose of gamma irradiation (10 –20 kGy) will not affect the biological
properties of a graft and seems a suitable method of decontamination [25].
Additional chemical demulsification and decontamination procedures may
enhance incorporation and provide additional safety [24,25,33]. Either of these
methods or a combination of both will provide an effective and adequate graft.
Some tissue banks may provide frozen aseptically processed cancellous
bone chips that are cut to shape to the adequate size for the impaction technique.
These seem to be the most favorable to use.
For the surgeon who does not have a freezer at his disposal, freeze-dried
cancellous chips are available. There have been to date no reports, however, that
the results of revision arthroplasty in which these grafts were utilized have been
comparable to those in which frozen chips were used.

REFERENCES

1. Ghazavi MT, Stockley I, Yee G, et al. Reconstruction of massive bone defects with
allograft in revision total knee arthroplasty. J Bone Joint Surg 997; 79-A: 17 – 25.
2. Mankin HJ, Gebhardt MC, Jennings LC, et al. Long-term results of allograft
replacement in the management of bone tumors. Clin Orthop 1996; 324: 86 – 97.
30 Vehmeijer and Bloem

3. Noyes FR, Barber-Westin SD. Reconstruction of the anterior cruciate ligament with
human allograft. Comparison of early and later results. J Bone Joint Surg 1996;
78-A: 524 –537.
4. Ortiz-Cruz E, Gebhardt MC, Jennings LC, et al. The results of transplantation of
intercalary allografts after resection of tumors. A long-term follow-up study. J Bone
Joint Surg 997; 79-A: 97 –106.
5. Slooff TJ, Buma P, Schreurs BW, et al. Acetabular and femoral reconstruction with
impacted graft and cement. Clin Orthop 1996; 324: 108– 115.
6. van Arkel ER, de Boer HH. Human meniscal transplantation. Preliminary results at 2
to 5-year follow-up. J Bone Joint Surg 1995; 77-B: 589–595.
7. Garbuz D, Morsi E, Mohamed N, et al. Classification and reconstruction in
revision acetabular arthroplasty with bone stock deficiency. Clin Orthop 1996; 324:
98 – 107.
8. Gie GA, Linder L, Ling RSM, et al. Impacted cancellous allografts and cement for
revision total hip arthroplasty. J Bone Joint Surg 1993; 75-B: 14 – 21.
9. Head WC, Malinin TI. Results of onlay allografts. Clin Orthop 2000; 371: 108– 112.
10. Buttermann GR, Glazer PA, Hu SS, et al. Revision of failed lumbar fusions. A
comparison of anterior autograft and allograft. Spine 1997; 22: 2748– 2755.
11. Spence KF, Jr., Bright RW, Fitzgerald SP, et al. Solitary unicameral bone cyst:
treatment with freeze-dried crushed cortical-bone allograft. A review of one hundred
and forty-four cases. J Bone Joint Surg 1976; 58-A: 636– 641.
12. Bettin D, Harms C, Polster J, et al. High incidence of pathogenic microorganisms in
bone allografts explanted in the morgue. Acta Orthop Scand 1998; 69: 311– 314.
13. Tomford WW. Transmission of disease through transplantation of musculoskeletal
allografts. J Bone Joint Surg 1995; 77-A: 1742 –1754.
14. EAMST, EATB. Common Standards for Musculoskeletal Tissue Banking. Vienna:
European Association for Musculo Skeletal Transplantation and European
Association of Tissue Banks, 1997.
15. Lord CF, Gebhardt MC, Tomford WW, et al. Infection in bone allografts. Incidence,
nature, and treatment. J Bone Joint Surg 1988; 70-A: 369– 376.
16. Tomford WW, Thongphasuk J, Mankin HJ, et al. Frozen musculoskeletal allografts.
A study of the clinical incidence and causes of infection associated with their use.
J Bone Joint Surg 1990; 72-A: 1137– 1143.
17. Dick HM, Strauch RJ. Infection of massive bone allografts. Clin Orthop 1994; 306:
46 – 53.
18. Mnaymneh W, Malinin TI, Lackman RD, et al. Massive distal femoral osteoarticular
allografts after resection of bone tumors. Clin Orthop 1994; 303: 103– 115.
19. Update: allograft-associated bacterial infections—United States 2002. MMWR 2002;
51: 207– 210.
20. Silletti RP, Ailey E, Sun S, et al. Microbiologic and clinical value of primary broth
cultures of wound specimens collected with swabs. J Clin Microbiol 1997; 35:
2003– 2006.
21. Morris AJ, Wilson SJ, Marx CE, et al. Clinical impact of bacteria and fungi
recovered only from broth cultures. J Clin Microbiol 1995; 33: 161– 165.
22. Vehmeyer SB. Bacterial contamination of bone allografts. Thesis, Leiden Univer-
sity, Leiden, The Netherlands, 2002.
Bone Allograft Procurement and Processing 31

23. Simonds RJ, Holmberg SD, Hurwitz RL, et al. Transmission of human immuno-
deficiency virus type 1 from a seronegative organ and tissue donor [see comments].
N Engl J Med 1992; 326: 726– 732.
24. Boyce T, Edwards J, Scarborough N. Allograft bone. The influence of processing on
safety and performance. Orthop Clin North Am 1999; 30: 571– 581.
25. Jinno T, Miric A, Feighan J, et al. The effects of processing and low dose irradiation
on cortical bone grafts. Clin Orthop 2000; 375: 275– 285.
26. Pruss A, Kao M, Kiesewetter H, et al. Virus safety of avital bone tissue transplants:
evaluation of sterilization steps of spongiosa cuboids using a peracetic acid-methanol
mixture. Biologicals 1999; 27: 195– 201.
27. Wutzler P, Sauerbrei A. Virucidal efficacy of a combination of 0.2% peracetic acid
and 80% ethanol (PAA-ethanol) as a potential hand disinfectant. J Hosp Infect 2000;
46: 304– 308.
28. Lietman SA, Tomford WW, Gebhardt MC, et al. Complications of irradiated
allografts in orthopaedic tumor surgery. Clin Orthop 2000; 375: 214– 217.
29. Fideler BM, Vangsness CT, Jr., Lu B, et al. Gamma irradiation: effects on bio-
mechanical properties of human bone-patellar tendon-bone allografts. Am J Sports
Med 1995; 23: 643– 646.
30. Hamer AJ, Suvarna SK, Stockley I. Histologic evidence of cortical allograft bone
incorporation in revision hip surgery. J Arthroplasty 1997; 12: 785– 789.
31. Pelker RR, Friedlaender GE. Biomechanical aspects of bone autografts and allo-
grafts. Orthop Clin North Am 1987; 18: 235– 239.
32. Ijiri S, Yamamuro T, Nakamura T, et al. Effect of sterilization on bone morpho-
genetic protein. J Orthop Res 1994; 12: 628– 636.
33. Thoren K, Aspenberg P, Thorngren KG. Lipid extracted bank bone. Bone conductive
and mechanical properties. Clin Orthop 1995; 311: 232– 246.
34. Moreau MF, Gallois Y, Basle MF, et al. Gamma irradiation of human bone allografts
alters medullary lipids and releases toxic compounds for osteoblast-like cells.
Biomaterials 2000; 21: 369– 376.
35. Stayner L, Steenland K, Greife A, et al. Exposure-response analysis of cancer
mortality in a cohort of workers exposed to ethylene oxide. Am J Epidemiol 1993;
138: 787– 798.
36. Jackson DW, Windler GE, Simon TM. Intraarticular reaction associated with the use
of freeze-dried, ethylene oxide-sterilized bone-patella tendon-bone allografts in the
reconstruction of the anterior cruciate ligament. Am J Sports Med 1990; 18: 1 – 10.
37. Thoren K, Aspenberg P. Ethylene oxide sterilization impairs allograft incorporation
in a conduction chamber. Clin Orthop 1995; 318: 259– 264.
38. Aspenberg P, Lindqvist SB. Ethene oxide and bone induction. Controversy remains.
Acta Orthop Scand 1998; 69: 173– 176.
39. Urist MR, Silverman BF, Buring K, et al. The bone induction principle. Clin Orthop
1967; 53: 243– 283.
40. Fages J, Poirier B, Barbier Y, et al. Viral inactivation of human bone tissue using
supercritical fluid extraction. Asaio J 1998; 44: 289– 293.
41. Frayssinet P, Rouquet N, Mathon D, et al. Histological integration of allogeneic
cancellous bone tissue treated by supercritical CO2 implanted in sheep bones.
Biomaterials 1998; 19: 2247 –2253.
32 Vehmeijer and Bloem

42. Hamer AJ, Strachan JR, Black MM, et al. Biochemical properties of cortical allograft
bone using a new method of bone strength measurement. A comparison of fresh,
fresh-frozen and irradiated bone. J Bone Joint Surg 1996; 78-B: 363–368.
43. Pelker RR, Friedlaender GE, Markham TC, et al. Effects of freezing and freeze-
drying on the biomechanical properties of rat bone. J Orthop Res 1984; 1: 405– 411.
44. Stevenson S, Li XQ, Davy DT, et al. Critical biological determinants of incor-
poration of non-vascularized cortical bone grafts. Quantification of a complex
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45. Simonian PT, Conrad EU, Chapman JR, et al. Effect of sterilization and storage
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290– 296.
46. Hosny M, Arcidi C, Sharawy M. Effects of preservation on the osteoinductive
capacity of demineralized bone powder allografts. J Oral Maxillofac Surg 1987; 45:
1051– 1054.
4
Conserving Stocks in the Bone Bank
David Finlayson
Raigmore Hospital
Inverness, Scotland
Philip Henman
Freeman Hospital
Newcastle upon Tyne, England

I. INTRODUCTION

Impaction grafting is using increasing quantities of bone allograft. Not only are
the numbers of procedures increasing, but this technique is a new use for allograft
and, therefore, impinges on the existing supply of banked bone.
Greenwald et al. [1] have estimated that more than 500,000 bone graft
procedures are done annually in the United States. They suggest that double that
number are now being done worldwide. While at least some of these procedures
are in spinal surgery, the remainder include a variety of indications where there is
loss of bone stock. These include the increasing indication of impaction grafting
for the reconstruction of defects in revision hip surgery, first described by
Schreurs et al. for the acetabulum in 1984 [2] and later extended to the femur by
Gie et al. [3]. In a more recent report [4] acetabular reconstruction was described
as requiring between one and three femoral heads, but no further guidelines are
available to accurately describe the amount of bone that might be used for these
extensive reconstructions. In addition to the successful use of the technique in the
hip, some surgeons are now extending this to revision of the failed knee
replacement with bone loss.
The consequence of this increased activity and demand for allograft is an
existing shortfall in the supply of banked bone, and this is predicted to increase
[5]. Orthopedic surgeons are thus in competition among themselves to secure
supplies of scarce and expensive resource.

33
34 Finlayson and Henman

Table 1 Prices for Bone Allograft in Scotland

Femoral heads (fresh frozen) £320 ($512)


Tibial plateau (fresh frozen) £250 ($400)
Freeze-dried ground bone (35 cc) £356 ($569.60)
Freeze-dried ground bone (15 cc) £155 ($248)

Exchange rate as of Sep. 16, 2003.

Table 1 shows the current costs of allograft materials supplied by the tissue
division of the Scottish National Blood Transfusion Service. Although no charge
for these materials is made to Scottish Health Service Hospitals because of the
funding arrangements, this charge is levied for any bone supplied outside of
Scotland or indeed to the Scottish private sector. If the recommendations of
Schreurs et al. [4] are followed and three femoral heads are used for one
acetabular reconstruction, the problem of supply is easy to comprehend.
This chapter will present the reasons for and implications of the supply
problems in allograft bone and then consider the mechanisms that might be put in
place to increase the amount of bone available. More importantly, the principle of
issuing allograft bone by weight rather than number of pieces of bone will be
discussed as a means to enable self-sufficiency in this commodity.

II. AVAILABILITY OF BONE

The availability of bone is limited by a number of factors, not least of which is the
organization of the bone bank.
British hospital bone banks have traditionally been run on an ad hoc basis,
usually without significant funding and often with inadequate facilities to verify
the safety of the bone or integrity of the preservation process. In Scotland,
however, the national blood transfusion service has taken over by setting up
tissue banks in five regional blood transfusion centers. This has ensured strict
selection criteria for both live donors and cadaver harvesting. It has also enabled
consistent postharvest surveillance for transmissible infection and careful
monitoring of bacterial contamination of grafts at harvest and also at the point of
use.
This has allowed close monitoring of the potential donors who are rejected
at initial screening or postharvest testing. Galea et al. [5] estimated that 48% of
potential donors in Scotland are rejected after medical screening. The principal
reasons for such rejection in live donors at primary arthroplasty in the north of
Scotland include rheumatoid arthritis accounting for 22– 30% of deferrals each
year, and malignancy, accounting for 10– 21% [6]. While the precise reasons for
Conserving Stocks in the Bone Bank 35

such rejection may be subject to considerable geographical variation dependent


on the disease characteristics of the donor population, this pattern seems to be
similar to that elsewhere in the United Kingdom. Jones et al. [7] reported a similar
48% rejection rate from live donors at primary arthroplasty in Wales. Of the
patients accepted as suitable for bone donation, however, only 78% yielded an
allograft; among the reasons for this were included 6% of donations that
subsequently had positive microbiological specimens at harvest and some bone
that was accidentally dropped at the time of primary harvesting.
Such problems are likely to occur with all forms of bone harvest, and
Deijkers et al. [8] showed that 50% of cadaver grafts were contaminated by skin
commensal organisms at the time of harvest. Only 3% of their grafts, however,
were contaminated by organisms of high pathogenicity. More importantly, they
pointed out that for each staff member added to the procurement team, the risk of
contamination with organisms of low pathogenicity increased by a factor of 1.6,
showing that the so-called skin commensals are more likely to arise from the
procurement team than any other source.
While microbiological testing can be satisfactorily carried out with veri-
fication of graft sterility at the time of harvest and at the time of use, verification
of freedom from transmissible viral infection is more difficult. With live donors,
samples must be taken at the time of graft harvest and repeat serological testing
done at 6 months after harvest to guarantee identification of any patients who may
have seroconverted after the time of graft harvest but who may have been
infected at that stage. This policy is clearly not practicable with cadaver donors,
for whom the accuracy of a postmortem history taken from family members may
not be fully accurate. Identification of viral pathogen using the polymerase chain
reaction on such samples as is done for blood transfusion donations is the only
practicable means of ensuring the safety of such cadaveric grafts. Even with such
precautions, there may still be some concerns about microbiological contamina-
tion of grafts leading some bone banks to use radiation for sterilization, but this
may have adverse effects on both the mechanical properties and the potential for
osteoinduction [8].
The final concern with allograft bone is the possibility of occult pathology,
such as tumors, which has not been identified through careful history taking or the
available tests. Palmer et al. [10] analyzed 1146 osteoarthritic femoral heads
which were otherwise suitable for harvesting, and they found occult disease in
8%. This led them to recommend that since occult pathological conditions were
common, that histological examination should be part of the screening protocol
before storage of allograft in the bone bank. Their specimens, however, were all
sliced, with examination of only a single central slice being done. What is not
mentioned is the amount of bone that would be lost by such examination on a
routine basis. The recommendation has not yet become part of standard practice
within U.K. tissue banks.
36 Finlayson and Henman

All of the above concerns regarding allograft bone have been addressed in a
more rigorous fashion within the United Kingdom since April 2003. National
Health Service hospitals now must purchase allograft bone from tissue banks
accredited by the U.K. Medicines Control Agency. Since this will involve closure
of the informal tissue banks in English hospitals, there may be further shortfall of
bone.

III. IDENTIFICATION OF POTENTIAL DONORS

At present, the majority of allograft harvested by U.K. tissue banks comes from
live donors with osteoarthritis undergoing primary total hip replacement. It is
likely that this will remain the preferred route for bone harvesting for the
following reasons:
1. A full clinical history from the donor is available.
2. Bone harvest is an integral part of a surgical procedure with no
additional procedures required.
3. Harvesting is done under the best possible aseptic conditions.
In contrast, cadaver donation, while yielding bulk allografts that cannot be
obtained from live donors, has a number of problems, which have made it less
attractive within the U.K. setting as follows:
1. Difficulty with history taking and possible inaccuracies
2. Requirement for a separate tissue procurement team, increasing the
cost of harvest
3. Poor infection control
It is, therefore, clear that the most important means to improve the supply of
allograft bone for patients undergoing primary arthroplasty is to ensure
identification of potential donors at an early stage before surgery.
The amount of bone harvested from osteoarthritic patients can be increased
if the cancellous bone that is ordinarily removed from the femoral canal is also
harvested. This bone, however, may be difficult to quantify for the purposes of
releasing bone from the bank at the time of use, and the solution to this problem is
discussed below.

IV. ALTERNATIVE DONATION SITES

A further source of supply not regularly used is the elderly patient with a sub-
capital fracture of the hip, being treated by hemiarthroplasty. This bone is
assumed to be osteoporotic and hence of poor quality for the purposes of grafting,
Conserving Stocks in the Bone Bank 37

but once compacted there is in theory little difference between this bone and
compacted bone from the osteoarthritic patient. The problems of harvesting from
the elderly patient relate more to the difficulty of taking an accurate history from a
group of patients who are often losing their mental faculties and the possibility
that the patient may not survive long enough for postharvesting serological
testing rather than any specific concerns about the amount of quality of bone that
has been harvested.
Nonetheless, these patients may remain a valuable source of bone if the
concerns regarding history taking and serological testing can be addressed.
A final source of supply that has been little utilized to date is the knee at
primary arthroplasty for osteoarthritis. The off cuts from the usual resurfacing
knee prostheses may yield valuable cancellous bone, but there would seem to be
three objections to its regular use:
1. There may be thick articular cartilage still present on one or other side
of the knee with significant varus or valgus deformity, and it is difficult
to remove this once the bone is presented for use.
2. There is often significant soft tissue left attached to the off cuts with
present knee prostheses.
3. It is difficult to equate one set of knee off cuts with femoral heads,
which are the traditional measure of available banked bone.
It will be seen from the above that while the traditional method of issuing bone
via femoral heads allows an apparently easy means of identifying both how much
bone is in the bone bank and how much has been ordered for use, there are a
number of flaws with this system.
First, if the surgeon only orders bone bank by the femoral head, then only
femoral heads can be used, thus restricting the possibility of using bone from
other sources such as bone harvested from the medullary canal or bone taken at
primary knee replacement.
Second, it makes the assumption that all femoral heads are the same. There
is, therefore, no allowance made for the differing density of bone between
individual donors. Not all osteoarthritic femoral heads will have the same
density, and thus when compacted, the volume of bone will vary from specimen
to specimen. This area was investigated in a study at Raigmore Hospital [9]
which has issued bone by weight since 1994, approximately 2 years after bone
started to be used for this procedure in this hospital. A review of the mass of bone
used for impaction grafting procedure between 1994 and 1996 showed that most
impaction grafting procedures required approximately 200 g of bone. Studying
individual cases further suggested the following recommendations. If only one
component is loose without endosteal osteolysis greater than 2 cm in diameter on
one radiological view, 150 g of bone will be sufficient. In the presence of
loosening of both components with minor endosteal osteolysis or one loose
38 Finlayson and Henman

Table 2 Order Schedule for Allograft Bone

Number of loose components Extent of lysis Order Schedule

1—Acetabulum or femur None 150 g


1—Acetabulum or femur .2 cm 200– 250 g
2—Acetabulum and femur None 200– 250 g
2—Acetabulum and femur .2 cm .280 g

component with major endosteal osteolysis, 200– 250 g will be necessary. When
both components are loose and have evident endosteal osteolysis, at least 280 g
will be required. This series related, however, to the first 50 cases, and with
experience and care to ensure containment of the graft, it is possible to be more
economical than this. Nonetheless, these figures do provide a useful guideline
(Table 2).
This study was extended by taking some of the femoral heads that had been
harvested but subsequently discarded because of bacteriological contamination.
This showed, as would be expected, that femoral heads of the same diameter
could have great differences in mass. In consequence, when femoral heads of
different mass are morselized, differing volumes will be obtained. Since
morselization and impaction/compaction completely changed the gross bony
architecture of the allograft bone fragment, the precise source of the bone used is
irrelevant. It is, therefore, completely illogical to order bone by asking for
femoral heads and more logical to ask for bone by weight. This not only ensures
that adequate osteoarthritic bone will be provided, but allows bone to be used
from a number of different sources.
If harvested bone is weighed, it is a simple matter for the surgeon to order
the amount of usable graft he or she expects.
As supplies of fresh frozen allograft bone become inadequate to meet the
demand for impaction grafting procedures, all possible means must be taken to
ensure that supply is increased and usage is as efficient and effective as possible.
The measures suggested above and summarized below have been found to be
effective in one orthopedic unit with its own tissue bank. This has allowed not
only self-sufficiency in allograft bone since 1992, but also the ability to export
bone excess to requirements to neighboring hospitals.
The practice of weighing bone is clearly the most effective way to avoid
overordering and wastage of bone, which cannot be refrozen once issued. In
addition, with the increased regulatory stringency on U.K. tissue banks, bone
will increasingly have to be ordered from a tissue bank at a site remote from the
user hospital, which makes it all the more important for the surgeon to ensure
that the correct amount of bone is ordered and available. The weighing of all
Conserving Stocks in the Bone Bank 39

allograft bone prior to storage and issuing it only by weight must, therefore, be
strongly recommended as one of the most effective means of ensuring its proper
use.

V. SUMMARY OF RECOMMENDATIONS
A. Increasing Supply
1. Early identification of potential donors
2. Increased pool of potential donors by considering patients having knee
arthroplasty and hip fractures
3. Increased harvest from present donors by utilizing femoral canal
cancellous bone, which is normally discarded

B. Avoiding Wastage
1. Bone discarded as unsuitable for freezing because of microbiological
contamination should be sent for processing by freeze-drying and
sterilization.
2. Issue bone by weight only.
3. Use pieces of bone from varying sites.

REFERENCES

1. Greenwald AF, Boden SD, Goldberg VM, Khan Y, Laurencin CT, Rosier RN. Bone
graft substitutes: facts, fictions and applications. J Bone Joint Surg 2001; 83A
(suppl 2): 98 – 103.
2. Slooff TJJH, Huiskes R, Van Horn J, Lemmens AJ. Bone grafting in total hip
replacement for acetabular protrusion. Acta Orthop Scand 1984; 55: 593– 596.
3. Gie GA, Linder L, Ling RSM, Simon J-P, Slooff TJJH, Timperley AJ. Impacted
cancellous allografts and cement for revision total hip arthroplasty. J Bone Joint Surg
1993; 73-B: 14 – 21.
4. Schreurs BW, Slooff TJJH, Buma P, Gardeniers JWM, Huiskes R. Acetabular
reconstruction with impacted morsellised cancellous bone graft and cement. A
10 – 15 year follow up of 60 revision arthroplasties. J Bone Joint Surg 1998; 80-B:
391– 395.
5. Galea G, Kopman D, Graham BJM. Supply and demand of bone allograft for
revision hip surgery in Scotland. J Bone Joint Surg 1998; 80-B: 595– 599.
40 Finlayson and Henman

6. Kropp LC. Seventy-eight percent increase in bone donor referral for malignancy
1998– 2000—should Highlanders be worried? British Association for Tissue
Banking annual meeting, London, April 8 – 9, 2002.
7. Jones SA, Jones DA, Stephens M, Roberts P. “Bone banking”—what can you
expect? British Association for Tissue Banking annual meeting, London, April 8 –9,
2002.
8. Deijkers RLM, Bloem RM, Petit PLC, Brand R, Vehmeyer SBW, Veen MR.
Contamination of bone allografts analysis of incidence and pre-disposing factors.
J Bone Joint Surg 1997; 79-B: 161– 166.
9. Norman-Taylor SH, Villar RN. Bone allograft: a cause for concern? J Bone Joint
Surg 1997; 79-B: 178– 180.
10. Palmer SH, Gibbons CLMH, Athanasou NA. The pathology of bone allograft. J Bone
Joint Surg 1999; 81-B: 33 – 35.
11. Henman P, Finlayson D. Ordering allograft by weight. J Arthroplasty 2000; 15:
368– 371.
5
Mechanical Considerations
in Impaction Bone Grafting
The Nijmegen Experience

N. Verdonschot, S. B. Bolder, Pieter Buma,


and B. Willem Schreurs
University Medical Center Nijmegen
Nijmegen, The Netherlands

I. INTRODUCTION

Initial mechanical stability is a prerequisite for long-term survival of cemented


components. This has been elegantly shown by Kärrholm et al., who found that in
both revisions and primary cemented hips, those with a higher migration rate
failed significantly earlier than more stable reconstructions [1]. In primary total
hip replacement (THR), initial stability is usually no problem as the cement
secures the component firmly to the surrounding bone, but in cemented revisions
it is more difficult to achieve stable cup fixation.
Initial stability is an equally important issue when impaction bone grafting
is used. However, when using this technique it becomes less obvious how stable a
reconstruction should be, as a relatively “soft” layer of impacted morselized graft
is situated between the cement and the bone. In more extensive loss of bone stock,
segmental bone defects need to be reinforced with metal mesh. Obviously these
are not optimal conditions for stable reconstruction. This makes the clinical
success of impaction bone grafting highly dependent on the surgical technique
used. There are many choices that the surgeon has to make, and surgeons make
choices with the best of their ability but sometimes fail to achieve a satisfactory
result. This is illustrated by a number of reports in the literature of considerable
initial migration of prosthetic components implanted with the impaction bone
grafting technique. Eldridge et al. reported massive subsidence of the femoral
41
42 Verdonschot et al.

stem after using the impaction bone grafting [2], and Pekkarinen et al. noted a
high number of complications in their patients [3]. Masterson et al. observed a
considerable number of incomplete femoral cement mantles within the impacted
graft layer, resulting in significant migration in some patients [4].
The purpose of this chapter is to clarify some issues that influence the initial
stability of bone reconstruction with impaction grafting. This should be of use
to orthopedic surgeons who wish to optimize their technique and base their
decisions on scientific data. First the inherent mechanical characteristics of
morselized bone grafts will be described, after which some factors in acetabular
and femoral reconstruction are discussed.

II. INHERENT MECHANICAL CHARACTERISTICS OF


MORSELIZED PARTICLES

From a mechanical perspective, a volume of a morselized bone particle has


complex mechanical properties [5 – 7]. Its stiffness is variable over protracted
loading. It gradually deforms over time when loaded for a long period of time
(creep) and demonstrates viscoelastic behavior. This means that the deformation
is not instantaneous after load application, but is delayed. This is caused primarily
by the fluid in the graft volume, which needs time to escape from the impacted
bone when it is compressed. These mechanical characteristics of a volume of
bone graft material can easily be demonstrated by confined compression tests,
which we have previously reported [7] (Fig. 1). The morselized grafts were
manually impacted in an impermeable, cylindrical test chamber with a diameter
of 20 mm. A rigid, porous filter was placed on top of the impacted material,
allowing free fluid exudation during loading. On top of the filter, a load spreader

Figure 1 Schematic representation of a confined compression test.


Impaction Bone Grafting: Nijmegen Experience 43

ensured that the applied load was equally distributed over the whole surface of
the specimen.
Using a servo-hydraulic MTS testing machine, a dynamic force ranging
from 10 N (minimum force) to 840 N (2.68 MPa, maximum force) was applied
with a frequency of 1 Hz for a period of 900 seconds (“loading phase”). This load
level was chosen because it resembles the force expected around cemented cups
[8] and femoral implants [9]. After this loading period, the specimens remained
unloaded for another 900 seconds, allowing the exudated fluid to be sucked back
into the specimen. The deformation of the impacted material was measured by an
extensometer.
The stiffness changed from 85 MPa at the beginning of the test to 135 MPa
at the end of the loading period. Hence, the material underwent further impaction
by the dynamically applied load, which rendered the material stiffer. Obviously,
the values mentioned depend heavily on the initial impaction of the volume in the
test chamber. The more impaction applied at that time, the higher the initial
stiffness and the smaller the increase during the loading period.
The graft volume underwent significant creep deformation. At the end of
the loading phase the deformation was almost 50%. After removal of the load, the
morselized grafts recoiled until a total deformation of about 35% was maintained
(Fig. 2). Hence, if one starts with a 10 mm high impacted graft layer and loads it
dynamically, it may be compressed to a height of 5 mm. If the load is removed, a
layer of 6.5 mm is maintained. Again, these values depend on the quality of initial

Figure 2 Deformation of impacted bone grafts as a function of time. The first 900
seconds a dynamic load was applied; the last 900 seconds was an unloaded period.
44 Verdonschot et al.

Figure 3 The stress–strain relation of impacted bone grafts in a confined


compression test measured during one loading cycle. The graph shows that the
impacted material is viscoelastic. As an example, a curve of a linear elastic material
is also shown.

impaction. It is probably undesirable to have a layer that deforms so much, which


emphasizes the point that firm impaction in clinical cases is mandatory.
The viscoelastic behavior can be illustrated best by considering one loading
cycle (Fig. 3). A material without any viscoelastic properties would deform
immediately in response to the load. However, the fluid in the graft material is not
compressible, which means that the material can only deform if the fluid is
displaced out of the volume. Obviously there is some resistance to fluid transport
(depending on the permeability), resulting in a delay of the deformation of the
graft material relative to the applied force. Displacing the fluid costs energy and
the amount of energy lost is represented by the surface contour of the loading and
unloading phase on the stress–strain diagram. This kind of curve is called an
“hysteresis loop” (Fig. 3). The more the hysteresis, the higher the visco-
elastiticity of the material.

III. APPLICATION TO THE ACETABULAR SIDE

Relatively little work has been devoted to the analysis of prosthetic stability using
the impaction bone grafting technique on the acetabular side. However, it is
obvious that the surgical technique and decisions made by the surgeon will affect
Impaction Bone Grafting: Nijmegen Experience 45

the stability of the reconstruction. Variables that influence the initial stability are
the type of bone graft used, the size of the particles, and the method of impaction
applied.
The Nijmegen group has always used relatively large particles (8 –
10 mm in diameter). Initially the morselized chips were impacted by hammering
on trial cups; later special acetabular impactors were designed. The larger
particles are created with a rongeur by hand and consist of pure cancellous bone.
However, this is a time-consuming and tedious part of the procedure. Therefore,
surgeons opt to use bone mills for producing these bone chips.
After removal of the cartilage the heads are milled, so in contrast to
manually produced bone chips from the femoral heads, these chips produced by
mills also contain fragments of cortical bone. There is also a considerable risk
that cartilage particles are included if the cartilage layer is not removed com-
pletely. The other concern about using bone mills is that most available and used
bone mills produce relatively small particles (2 – 3 mm diameter).
To assess the effects of particle size on the stability of the acetabular
reconstructions, we performed two in vitro experiments. In both experiments we
found that smaller bone graft particles lead to a reduced acetabular stability. In an
in vitro study with human cadaveric pelvic bones, contained defects were created
and subsequently resconstructed with either small or large bone graft particles
[10]. The fresh-frozen pelvic bones were mounted on an MTS testing machine,
and the cups were dynamically loaded (Fig. 4). Migration (3 rotations and 3
translations) was measured using roentgen stereogrammetric analysis (RSA).
Cemented cups were more stable with the larger chips. Migration decreased by
35% if large bone chips were used instead of the smaller ones (Fig. 5). In addition
to these cadaveric experiments, we developed a synthetic acetabular model as a
practical means of examining more variables (Fig. 6) [11]. This model overcame
the limited availability of human cadaveric material, and testing became more
reproducible. The synthetic acetabula consisted of an epoxy cylindrical cortex
with a wall thickness of 3 mm and an inner porous part 68 mm in diameter made
of polyurethane foam. In this model we created a simple cavitary defect, with
diameters similar to the previously described cadaveric experiments. The cups
were dynamically loaded again, and the migration relative to the synthetic bone
was recorded using RSA.
Migration of the cemented cup decreased by 25% if the bone defect was
reconstructed with large bone chips. Hence, this model showed a similar
percentage as found in the cadaveric experiments (Fig. 5). We considered this a
validation of our synthetic model and a strong indication that with a similar
surgical technique one would obtain inferior stability with small morselized
particles. The latter conclusion is supported by other publications [13 – 17].
From the beginning we clinically used acetabular impactors and a hammer
to reconstruct acetabular bone defects with morselized grafts. However, firm
46 Verdonschot et al.

Figure 4 Experimental set-up of the in vitro test to assess the stability of


acetabular cups after impaction grafting in cadaver pelvic bones.

impaction does cost precious operating time, and of course these instruments
must be available.
Some surgeons use a quicker means to impact morselized bone grafts with
instruments available in every orthopedic theater; one example is the “reversed
Impaction Bone Grafting: Nijmegen Experience 47

Figure 5 Migration values of the cup relative to the bone in the cadaver pelvis and
the synthetic model at the beginning and end of the 1500 N loading period and at
the beginning and end of the 3000 N loading period. In these two models the chip
size was varied. More migration was found with the smaller grafts in both models.

reaming technique” (Fig. 7). Hereby, the acetabular reamer is used in reverse in
combination with manual compression on the reamer [12]. To assess whether this
technique provides adequate reconstructive stability, we simulated this technique
in our in vitro models and tested the obtained stability. Another variable we tested
in this model was the use of so-called slurry bone grafts. Some surgeons have
suggested the use of slurry grafts for bone impaction grafting on the acetabular
side. These slurry grafts can be obtained from the acetabulum reamers after the
reaming process. These slurry grafts can also be produced from femoral head
allografts with reamers. We assessed the reversed reaming and slurry graft
techniques by the same in vitro experiment with synthetic models and compared
the total migration with larger impacted morselized grafts (Fig. 8). Reversed
reaming with small particles increased migration by about 60% and with slurry
grafts by about 120%. Hence, slurry grafts and the reversed reaming method
should not be used in clinical practice, as it does not lead to a stable
reconstruction.
Another variable of current interest is washing the morselized grafts prior
to application and the influence of this on the mechanical stability of the
reconstruction [18]. Recently we tested this variable on small and large grafts in
our synthetic in vitro test and found that washing did indeed improve the stability
of the reconstruction [19]. The best stability was obtained with large washed
48 Verdonschot et al.

Figure 6 The synthetic model used to mimic the acetabulum.

Figure 7 The standard impaction (left) and the so-called reversed reaming
method (right).
Impaction Bone Grafting: Nijmegen Experience 49

Figure 8 Migration values of the cup relative to the synthetic bone. Variables
were large bone chips with standard impaction (large imp), small bone chips with
standard impaction (small imp), small bone chips with reversed reaming impaction
(small rr), and slurry grafts impacted with the reversed reaming method (slurry rr).

particles and the worst with small unwashed morselized grafts. Other authors
have suggested that there is an optimal distribution of particle size that would
improve the stability further. This is called “grading” of particle sizes [20].
Cartilage remnants are often included when the femoral head is milled but the
cartilage has not been removed completely. Cartilage adversely affects cup
stability [21].
The above-mentioned in vitro experiments used a loading configuration
that forced cups in a medio-superior direction, thereby simulating instability of
the cup and protrusio acetabuli under mainly compressive loads. However,
clinically, cups sometimes loosen due to impingement of the femoral neck on the
acetabular rim. This results in failure by shear. Compressive failure may not
equate to shearing. For this reason we developed an additional test in which the
reconstructed cup was rotated in the frontal plane. This test is referred to as the
lever-out test (Fig. 9). By recording the moment required for this rotation, the
fixation strength against shear is recorded. Again, the synthetic acetabulum
models were used, and we compared the large versus small grafts and the effect of
washing of the grafts prior to impaction.
The larger washed grafts produced a significantly higher degree of shear
resistance than the other types of impaction (Fig. 10). Washing smaller grafts
made little difference in our model. Ullmark [18] also reported that defatting,
which is a process similar to washing, produced a higher shear resistance.
50 Verdonschot et al.

Figure 9 Schematic representation of the lever-out test.

Based on these mechanical tests, we strongly recommend large bone chips


on the acetabular side. Several experiments prove that these chips provide the
best cup stability after bone impaction grafting, and all our long-term clinical data
on acetabular bone impaction are based on the use of large trabecular bone chips.

IV. APPLICATION TO THE FEMORAL SIDE

A number of studies have examined variables associated with impaction bone


grafting on the femoral side [13,14,22 –25].
Impaction Bone Grafting: Nijmegen Experience 51

Figure 10 Lever-out forces recorded in the lever-out test. Highest forces were
found for the large, washed bone grafts.

In 1988 we developed a special set of instruments to perform a reproduc-


ible impaction bone grafting on the femoral side in a goat model. Using this
instrumented bone graft impaction technique, we assessed the stability of femoral
stems with an in vitro RSA experiment. The stems were implanted in goat femora
with a circumferential layer of bone grafts. Both cementless as well as cemented
stems were used [23 – 25]. The cemented stems produced a considerably smaller
subsidence than the cementless components (subsidence values 0.5 mm vs.
2.9 mm for the cemented and cementless components, respectively). It was con-
cluded that the stability of the cemented stems was adequate, but that additional
means of enhancing the stability of cementless components were required.
The quality of fixation of cemented revision components has been con-
firmed by Malkani et al. [14], who compared the stability of primary cemented
stems and those reconstructed with impaction grafting and found little difference
between them.
In addition to an enlarged diameter of the femoral cavity, the surgeon is
often confronted with segmental bone defect. This is frequently seen in the calcar
area. It is mandatory to reconstruct these defects, otherwise the stems will be
rotationally unstable. This defect is most frequently reconstructed with metal
mesh in combination with cerclage wires but can also be repaired with a cortical
strut graft with cerclage wires. The question we were interested in was which of
the two techniques would provide the best initial stability. For this purpose we
performed an in vitro study on paired goat femurs [26]. A segmental defect was
created on the proximo-medial side (calcar region) and reconstructed with one of
the two techniques (Fig. 11). The femoral shaft was reconstructed with small
morselized bone grafts, after which the prosthesis was cemented in place. The
reconstructions were mounted on a MTS testing machine and dynamically loaded
such that the prosthesis was forced to rotate into varus, thereby loading the defect
52 Verdonschot et al.

Figure 11 Schematic representation of a femur with a segmental defect in the


calcar region (left), which is reconstruction either by a mesh or a strut graft.

maximally. The migration of the femoral components was measured using RSA
(Fig. 12). The stability of the two techniques was similar. Although the strut graft
group migrated a little further, the difference was not statistically significant.
Interestingly, the strut graft group migration was very variable with high standard

Figure 12 Varus-rotation values of the prosthesis relative to the bone showing


that, on average, the strut graft method and the mesh reconstruction lead to similar
prosthetic stability, but that the strut graft procedure leads to a higher variation in
prosthetic stability.
Impaction Bone Grafting: Nijmegen Experience 53

deviations, whereas the metal mesh group produced highly reproducible results.
We explained this phenomenon by the fit of the strut graft to the host bone. Very
good stability can be achieved if the fit is good, but if the fit is poor the stability
may be inferior. With the metal mesh the fit is less critical and results more
reproducible.
Firm impaction is important on the femoral side. This is demonstrated by
several researchers who found that subsidence was greater with poorer impaction.
Firm impaction is also important for the survival of the cement mantle. If a
cement mantle is surrounded by a soft impacted graft layer, the stresses in the
cement mantle will be relatively higher than to a firmly impacted graft layer. This
can be nicely demonstrated in finite element computer simulations [27]. Higher
stresses lead to earlier failure of the cement mantle, migration of the implant, and
failure of the reconstruction.
On the femoral side the size of the chips used is limited by the dimensions
of the femoral canal. Bone chips that can be used in the distal femur should be no
larger than 3– 5 mm. Larger chips can only be used more proximally. Hence, the
debate on the size of chips to be used is less controversial than on the acetabular
side. However, on the femoral side as well, the largest possible chips produce the
best stem stability.

V. CONCLUSIONS

Morselized bone graft is a viscoelastic material, the mechanical properties of


which depend on the quality of impaction. On the acetabular side, large particles
produce better stability than smaller ones. Washing improves the stability further.
Reversed reaming does not produce adequate stability. Impaction should be done
by using a hammer and a special set of instruments. Slurry grafts should not be
used as they do not provide a solid basis, but act more like quicksand. Firm
impaction is a prerequisite for clinical success on both the acetabular and femoral
sides. Smaller grafts may be used on the femoral side because of constraints of
size. Segmental defects on the femoral side can be reconstructed equally
successfully with either strut grafts or mesh. However, the fit between the graft
and the host bone is critical when using strut grafts. Firm impaction not only
improves the direct stability of the stem, but also protects the cement mantle
against high stresses and early failure.

REFERENCES

1. Kärrholm J, Borssén B, Löwenhielm G, Snorrason F. Does early micromotion of


femoral stem prostheses matter? 4 – 7 year stereoradiographic follow-up of 84
cemented prostheses. J Bone Joint Surg 1994; 76-B: 912– 917.
54 Verdonschot et al.

2. Eldridge JDJ, Smith EJ, Hubble MJW, Whitehouse SL, Learmonth ID. Massive
subsidence following femoral impaction grafting. J Arthroplasty 1997; 12: 535– 540.
3. Pekkarinen J, Alho A, Lepisto J, Ylikoski M, Ylinen P, Paavolainen T. Impaction
bone grafting in revision hip surgery. A high incidence of complications. J Bone
Joint Surg 2000; 82-B: 103 –107.
4. Masterson EL, Masri BA, Duncan CP. The cement mantle in the Exeter impaction
allografting technique. A cause for concern. J Arthroplasty 1997; 12: 759– 764.
5. Giessen EBW, Lamerigts NMP, Verdonschot N, Buma P, Schreurs BW, Huiskes
R. Mechanical characteristics of impacted morsellized bone grafts used in revision
total hip arthroplasties. J Bone Joint Surg 1999; 81-B: 1052– 1057.
6. Ullmark G, Nilsson O. Impacted corticocancellous allografts: recoil and strength.
J Arthroplasty 1999; 14: 1019– 1023.
7. Verdonschot N, van Hal CT, Schreurs BW, Buma P, Huiskes R, Slooff TJ. Time-
dependent mechanical properties of HA/TCP particles in relation to morsellized
bone grafts for use in impaction grafting. J Biomed Mater Res 2001; 58: 599– 604.
8. Dalstra M, Huiskes R. Load transfer across the pelvic bone. J Biomech 1995; 28:
715– 724.
9. Weinans H, Huiskes R, Grootenboer HJ. Effects of material properties of femoral hip
components on bone remodeling. J Orthop Res 1992; 10: 845– 853.
10. Bolder SB, Schreurs BW, Verdonschot N, Unen JMJ van, Gardeniers, JWM,
Slooff TJJH. Bone graft particle size and method of impaction influence initial
stability of cemented cups in bone impaction grafting. Acta Orthop Scand.
Submitted.
11. Bolder SB, Verdonschot N, Schreurs BW, Buma P. Acetabular defect reconstruction
with impacted morsellized bone grafts or TCP/HA particles. A study on the mech-
anical stability of cemented cups in an artificial acetabulum model. Biomaterials.
2002; 23: 659– 666.
12. Mallory TH, Lombardi Jr AV, Fada RA, Adams JB, Kefauver CA, Eberle RW.
Noncemented acetabular component removal in the presence of osteolysis. The
affirmative. Clin Orthop 2000; 381: 120–128.
13. Kuiper JH, Merry JC, Cheah K, Richardson JB. Graft composition influences early
mechanical stability in impaction grafting. Trans EORS 6th meeting Bergen,
Norway, June 15 – 16, 1996.
14. Malkani AL, Voor MJ, Fee KA, Bates CS. Femoral component revision using
impacted morsellised cancellous bone graft. J Bone Joint Surg 1996; 78-B: 973–
978.
15. Smith EJ, Richardson JB, Learmonth ID, Evands GP, Nelson K, Lee R, Dyson J. The
initial stability of femoral impaction grafting. Hip Int 1996; 6: 166– 172.
16. Eldridge JDJ, Hubble MJW, Nelson K, Smith EJ, Learmonth ID. The effect of bone
chip size on initial stability following femoral impaction grafting. J Bone Joint Surg
1997; 79-B: S3 – 364.
17. Wallace IW, Ammon PR, Day R, Lee DA, Beave RJ. Does size matter? An
investigation into the effects of particle size on the impaction grafting in vitro. J Bone
Joint Surg 1997; 79-B: S3 – 366.
18. Ullmark G. Bigger size and defatting of bone chips will increase cup stability. Arch
Orthop Trauma Surg 2000; 120: 445– 447.
Impaction Bone Grafting: Nijmegen Experience 55

19. Arts JJC, Verdonschot N, Schreurs B W, Buma P. Pulse lavage and larger bone graft
chip size improve the initial stability of cemented cups after bone impaction grafting,
J Arthroplasy, 2002, submitted
20. Brewster NT, Gillespie WJ, Howie CR, Madabhushi SPG, Usmani AS, Fairbairn
DR. Mechanical considerations in impaction bone grafting. J Bone Joint Surg 1999;
81-B: 118– 124.
21. Bavadekar A, Cornu O, Godts B, Delloye C, van Tomme J, Banse X. Stiffness and
compactness of morselized grafts during impaction: an in vitro study with human
femoral heads. Acta Orthop Scand 2001; 72: 470– 477.
22. Berzins A, Sumner DR, Wasielewski RC, Galante JO. Impacted particulate allograft
for femoral revision total hip arthroplasty. In vitro mechanical stability and effects of
cement pressurization. J Arthroplasty 1996; 11: 500– 506.
23. Schreurs BW, Huiskes R, Slooff TJJH. The initial stability of cemented and
noncemented femoral stems fixated with a bone grafting technique. Clin Mat 1994A;
16: 105– 110.
24. Schreurs BW, Buma P, Huiskes R, Slagter JL, Slooff TJ. Morsellized allografts for
fixation of the hip prosthesis femoral component. A mechanical and histological
study in the goat. Acta Orthop Scand 1994B; 65: 267– 275.
25. Schreurs BW, Huiskes R, Buma P, Slooff TJ. Biomechanical and histological
evaluation of a hydroxyapatite-coated titanium femoral stem fixed with an intra-
medullary morsellized bone grafting technique: an animal experiment on goats.
Biomaterials 1996; 17: 1177 –1186.
26. Bolder SD, Verdonschot N, Buma P, Schreurs BW. The initial stability of an Exeter
femoral stem after impaction bone grafting in combination with segmental defect
reconstruction. J Arthroplasty 2003. In press.
27. Verdonschot N, Huiskes R. The effects of cement-stem debonding in THA on the
long-term failure probability of cement. J Biomech 1997; 30: 795–802.
6
Impaction Bone Grafting
A Mechanical Appraisal with Reference
to Soil Engineering

Douglas Dunlop
Southampton University Hospitals NHST
Southampton, England

I. INTRODUCTION

An understanding of the correct environment for successful grafting needs to be


appreciated (Fig. 1) before good results can be achieved. In revision hip and knee
surgery, large quantities of graft may be required to replace extensive bone loss.
From a biological remodeling viewpoint, autograft would be the graft of choice,
but it is usually precluded due to donor site morbidity in harvesting the large
quantities required. The utilization of allograft bone is increasing as the number
of revisions of failed joint arthroplasty rises and techniques for bone replacement
gain wider acceptance [1,2]. Cadaveric harvest followed by irradiation, lyophil-
ization, or processing and freeze-drying are used at some centers, as is the use of
xenograft and synthetic materials instead of allograft. A greater understanding of
the mechanical properties of the grafts would be beneficial and could be analyzed
along similar lines to those described in this chapter.

II. BASIC SCIENCE

For centuries engineers have been laying foundations and building roads with
variable degrees of success as far as subsidence is concerned. The most durable
structures have been built on solid bedrock [3]. Properties of nonsolid materials
(aggregates) used for foundations have now been defined by soil mechanical
57
58 Dunlop

Figure 1 Remodeling of impacted graft depends upon inter-related factors.

engineers, using experimental and mathematical models of sand, gravel, and


boulder mixtures. These engineers are able to predictably produce firm founda-
tions for building support piles and embankments with minimal subsidence,
based on these models. These principles are applicable to morselized bone graft
aggregates (when suitably compacted in a contained environment), as the
principles are largely independent of the individual properties of the particle.
The relationship between density (% porosity) and material properties—so
characteristic of trabecular bone—cannot be applied to morselized graft, as the
graft no longer has structural continuity [4] (i.e., is not solid). The mechanical
strength of morselized grafts can be determined by dynamic shear testing, either
in two dimensions across a predetermined failure plane, as has been previously
reported [5 – 7], or in three dimensions (triaxial shear testing) [8], where the
aggregate is allowed to shear in its weakest plane. Because a well-compacted
graft is anisotropic (properties equal in all directions), a two-dimensional testing
regime can be applicable and is reported here. One disadvantage of the three-
dimensional (3D) method is the large amount of graft required for each test and
complexities of impacting samples in an elastic membrane.

III. GRADING

Production of a well-graded sample theoretically produces the aggregate most


resistant to shear. This grading has been determined for spherical particles by
Mechanical Properties of Grafts 59

Figure 2 Pyramid of spheres showing how specific smaller sizes can fill the gaps.

Fuller [9,10] and is best understood by considering the problem of making a


pyramid of marbles (Fig. 2). Fuller has mathematically determined a graphic
curve (Fig. 3) of particle distribution that represents the sequence of marble sizes
to fit the “gaps,” which, if carried to infinitely small sizes of marbles, will allow
an infinitely steep pyramid to be constructed (aggregate approaches properties of
a solid). When considering irregularly shaped particles, it is normal practice to
use a linear log of the range of available sizes to determine an ideal mixture
(Fig. 4). It is important to note that the volume of large particles is greater than
that of smaller particles, even though there are fewer large particles.

IV. MECHANICAL SHEAR TESTING


A. Theory
Shear strength is one of the most important physical properties of aggregates. It is
a measure of their ability to sustain stresses without failure. Preserved segmental
60 Dunlop

Figure 3 Particle size distribution for two theoretical ideals and the three test
mixtures.

bone has previously been shown to have different mechanical characteristics


from fresh bone [11 –15]. Previous work has been performed on formalinized
bone dried after washing in acetone and alcohol. The mechanical characteristics
of fresh milled human allograft from donated femoral heads have only recently
been reported [6,7]. All tests in this report were performed with fresh-frozen
morselized human femoral heads.

Figure 4 Theoretical relationship between bone mill size and particle size
distribution (grading). The arrow indicates predicted increasing graft strength.
Mechanical Properties of Grafts 61

The shear strength (tf) of a granular aggregate, like that of the bone graft,
depends upon the angle of internal friction (f) and interlocking (c) of the
particles. The frictional resistance varies in proportion to the effective normal
stress (s). The relationship between these parameters can be expressed by the
Mohr Coulomb failure law: tf ¼ c þ s tan f.
The angle of internal friction (f) or angle of shearing resistance is
determined mainly by the particle size distribution (grading) of a sample and, to a
certain extent, on the particle shape. Steeper pyramids of aggregates can be made
with improved grading, as the particle size distribution is brought closer to a
theoretical (“ideal”) distribution, which contains particles of all sizes.
The Mohr Coulomb equation for bone graft is experimentally developed
through shear tests on allograft samples. The shear strength is read from the shear
strain versus shear stress curves plotted for different normal stresses (Fig. 5).
From the Mohr Coulomb failure law it can be seen that f can be deduced from
the slope of the line (y ¼ mx þ c). The best-fit straight-line variation between
normal stress, s, and shear strength, tf , represents the Mohr Coulomb failure
envelope (Fig. 6). The intersection of this line with the shear stress axis represents
the interlocking of the particles (c).

Figure 5 Stress versus strain graph for a typical mixture (Mix A washed).
62 Dunlop

Figure 6 Mohr Coulomb graph for a typical mixture (Mix A washed).

B. Materials and Methods


Three different test groups, Mixes A, B, and C, were produced (Fig. 3) to analyze
the effect of grading (Fig. 4) using 45 fresh-frozen human femoral heads,
supplied by the regional bone bank:

Mix A—Large average particle size and poor grading. (15 femoral heads,
milled using an air-powered mill with a pair of intermeshing 8 mm teeth)
Mix B—Intermediate average particle size and average grading (15
femoral heads, milled using a 6 mm manual bone grater)
Mix C—Small average particle size with good grading (15 femoral heads:
5 femoral heads processed through the 6 mm grater and 10 femoral heads
processed through the 3 mm grater of the manual mill)

The femoral heads were picked at random and thawed in warm saline. All soft
tissue, cystic areas, and cortical bone remnants (e.g., residual neck and femoral
calcar) were removed. The femoral heads were divided into large chunks before
milling.
Two different types of mill used in clinical practice were chosen to produce
Mixes A and B. According to soil mechanics theory, well-graded samples of
similar shapes have higher shear strength as compared to poorly graded samples
[16] (Fig. 4). Based on this theory, Mix C was mathematically deduced to be a
theoretical improvement in the particle size distribution, utilizing the two grater
sizes—3 and 6 mm—provided with mill B. The equivalent of 5 femoral heads by
weight was used for sieve testing to determine the actual particle size distribution
for each mill. The remaining 10 femoral heads were combined for mechanical
Mechanical Properties of Grafts 63

testing. Each mix was evaluated 25 times, for mechanical strength after com-
paction, first unwashed and subsequently after washing. All tests were performed
with adherence to Health and Safety Guidelines and Universal Precautions to
safeguard personnel.

1. Sieving
The particle size distribution curve for each mix was determined by sieving
amalgamated graft produced from five femoral heads (Fig. 3). Each sample was
sieved according to BS 1377 guidelines.
Ten sieves were used (logarithmic fractionations 0.3– 8.0 mm inclusive),
allowing easy manufacture of well-graded mixtures. A sample was described as
well graded if there was a similar quantity of particles of each size within the
range and no intermediate sizes were lacking. The upper and lower limit of sieve
size matched the range of particles produced by currently available bone mills,
with less than 0.1% by weight outside this range.

2. Washing Technique
A technique for washing bone graft was devised so that it could be easily
performed in a sterile fashion in an operating theater. A British Standard sieve
tower was made, consisting of a large sieve (2 mm) over the 300 mm sieve, which
was placed over a drainage tin with suction attached (Fig. 7). The milled bone
from each of the three test mills was placed onto the top sieve and washed
through. The top sieve helped to hold large particles stationary during washing
and prevent blocking the lower 300 mm sieve. All particles larger than 300 mm

Figure 7 (a) Washing apparatus sieving tower. (b) Washed graft trapped in upper
2 mm and lower 300 mm sieves. (c) Graft combined.
64 Dunlop

were trapped in the two sieves. Washing was performed after the unwashed
mechanical tests were completed, with warmed 0.9% saline pulse-lavaged over
the graft until the graft appeared clear of macroscopically obvious fat and marrow
tissue, which passed through the sieve into the suction vessel. The contents of
the two sieves were then combined, and the fully saturated bone graft was then
tested mechanically without removing excess 0.9% saline by absorption or
centrifugation.

3. Mechanical Testing
The shear strength of all test materials was determined using the Cam
(Cambridge) shear tester. The test cell was 60 mm in diameter. Previous work on
impaction grafting of preserved bone utilized two currently available devices
normally used for testing civil engineering aggregates such as sand or clay. These
are the Proctors impactor, used to compact aggregates, and the Jenike shear
tester. Their use has been described previously [5]. Modifications were made to
allow adequate fluid drainage during compaction of wet materials. The impaction
energy applied to compact each test pellet was equivalent to the energy to
perform one standard femoral impaction, calculated from a simulation performed
on a force plate [5]. Five samples from each of the three test groups were tested
mechanically at five different compression loads. All samples were kept at room
temperature in moisture-retaining containers during the tests.

4. Sequence of Compaction
Each material to be tested was introduced into the top of the impactor (Fig. 8) in
three equal portions to ensure even compaction. The compaction piston was
lowered onto the sample, and the impaction weight was then dropped 24 times
from the height required to deliver the desired energy. The middle and final thirds
of the test sample were then layered sequentially, and the impaction process was
repeated.

5. Shear Testing
After compaction the test sample was transferred to the shearing rings.
The test cell of the Cam shear tester (Fig. 9) is comprised of a fixed lower
ring and a mobile upper ring. The normal stress was induced by weights resting
on an axial hanger. The upper ring was driven horizontally at a constant rate
(strain) relative to the lower ring, applying a shear stress to the cell contents. A
force transducer recorded the shearing force applied, while the displacement of
one ring relative to the other was recorded with a linearly variable differential
transformer (LVDT).
Mechanical Properties of Grafts 65

Figure 8 Impactor, showing lower chamber, piston, lid, and drop weight.

To generate a family of stress/strain graphs, five separate normal


(compressive) stresses were applied and tested independently for each sample.
The compressive stresses were 10 kPa (the hanger alone), 95 kPa, 180 kPa,
265 kPa, and 350 kPa (one-tenth the compressive strength of vertebral cancellous
bone [17]). These stresses were chosen to produce a family of curves within the
lower range of physiological compressive stress (calculated from a simple
analytical model) experienced by impacted graft in the clinical setting.

6. Sequence of Testing
The compressive load plate was placed over the test material and left to
equilibrate for 5 minutes. Shearing of the test cell was commenced, recording the
shearing force and displacement, from which the shear stress (kPa) and shear
strain (percent) were derived after appropriate calibration. The test sample was
then removed together with any lost fluid and retested in the same above
sequence, but with an additional compressive stress of 85 kPa. The sequence was
repeated until a family of curves had been generated for the one sample up to
350 kPa compressive stress. The Mohr Coulomb failure envelope was plotted for
each test, from which the shear strength and interlocking are derived.
66 Dunlop

Figure 9 Cam shear tester before (top) and after (bottom) shear testing.

7. Analysis of Results
The absolute values relative to previously documented results from known
aggregate mixtures gave an indication of initial differences. Grouped linear
regression analysis on observed means was performed to look for significant
differences at the 0.05 level.
Mechanical Properties of Grafts 67

V. RESULTS
A. Sieving
The grading of aggregates is best determined by direct observation of their
particle size distribution curve [10]. The grading curves for the different Mixes A,
B, and C, as well as the curve of the theoretical variation of particle size in the
range from 0.3 to 5.6 mm that will produce a well-graded mix, are shown in
Figure 3. It is widely accepted that for particles of irregular shape, a well-graded
mix will approach a straight line on a logarithmic grading chart. From this point
of view, Mixes B and C are reasonably well graded in the particle size range of
1 –5.6 mm. However, since Mix C has a larger range of particle sizes, it would be
regarded as better graded than Mix B. The curve for Mix A is flat in the small
particle size range and rises steeply in the large particle size range. This indicates
an absence of small particles and poor grading.

B. Shear Testing
The shear strength increased linearly with compressive stress (R2 . 0.98) for all
mixtures (Fig. 6), indicating that the grafts satisfy the Mohr Coulomb failure law
well. A comparison of interlocking, shear strength at a compressive stress of
350 kPa and friction angles is given in Table 1. Larger unwashed particles tend to
have increased interlocking. Washing the graft results in an increase of the

Table 1 Shear Testing Results

Shear strength (kPa)


Interlocking (kPa) Friction angle at s ¼ 350 kPa

Fresh graft
Mix A 10.2 29.9 212
Mix B 20.9 35.0 244
Mix C 21.8 30.9 208
Washed graft
Mix A 7.3 33.4 238
Mix B 13.5 37.5 282
Mix C 13.5 36.3 271
Grouped linear regression analysis:
Mix A washed versus Mix A fresh: p , 0.0001
Mix B washed versus Mix B fresh: p ¼ 0.0009
Mix C washed versus Mix C fresh: p , 0.0001
68 Dunlop

corresponding friction angle for all mixes and increases the interlocking of
smaller particles.
Thus, at high compressive stresses an unwashed graft mix has a lower shear
strength in comparison to the corresponding washed graft mix. All mixes are
significantly different from each other apart from Mix B and Mix C washed and
Mix A washed and Mix B unwashed.

VI. DISCUSSION

Recent interest in the role of contained fluid within morselized graft has shown
that this is an important feature when comparing samples that has often been
poorly controlled for in laboratory models. It is known that granular materials can
exhibit dilative or contractile behaviour on shearing, depending upon their initial
density. The addition of small amounts of fluid to the aggregate may be advan-
tageous, causing an increase in the shear strength (analogous to making sand-
castles). Soil mechanics theory recognizes this as a feature of suction created in
the pore fluid as the aggregate exhibits volumetric dilatation on shearing.
However, if too much fluid is present and not allowed to drain, the mechanical
strength of the mixture is reduced (analogous to quicksand). Again, this is
explained based on the positive pore fluid pressures generated as the aggregate
exhibits volumetric contraction. Tests in this report analyzed first the role of
different “gradings” of graft from different bone mills and second the role of
different fluids and their effect on mechanical strength. The role that fat and
marrow fluid play is affected by the choice of bone mill and by the effects of
washing. Other factors also play a role and are discussed below.

A. Particle Size/Choice of Bone Mill


Large series of published clinical data have shown the excellent outcome that can
be achieved with specific particle sizes. In Nijmegen [18] the favored particle size
for acetabular impaction grafting is large (10 mm), often with hand preparation
of “croutons” pinched from the donated cancellous bone of the femoral head
using nibblers. The Exeter group [19] recommends a particle size of 3– 5 mm
when performing femoral impaction grafting. This smaller size in part reflects the
usually smaller available space to pack graft around a revision stem, but also
reflects the fact that this group uses a bone mill to produce graft. They routinely
use a bone mill for both femoral and acetabular impaction bone grafting. The
Nijmegen group uses a bone mill for producing graft for femoral impaction
grafting.
According to engineering principles, to produce bone graft that is most
resistant to shear (the mode of failure of impacted graft) it should not be made up
Mechanical Properties of Grafts 69

of particles of a similar size, but of a broad spread of sizes [9,20]. This is highly
dependent on the individual properties of each bone mill. In the clinical setting,
an improvement in the spread of particles has been obtained by putting bone
through two different sizes of graters or passing some of the graft through the
same mill twice.
Experimentally it was noted that production of a well-graded graft by
adding graft from a small (3 mm grater) mill produced graft that was almost
liquid in consistency [20]. This was due to the bone chips being so small that they
were no longer complex cancellous chunks but simple spicules, and there was
thus a greater release of fat and marrow from the interstices (Fig. 10). This may
explain why some clinicians recommend the dryer larger chunks or croutons,
rather than the slurry produced by these mills [21]. This also explains why Mix C,
unwashed, is weaker than predicted (Fig. 4 and Table 1), but when washed
regains this strength.

Figure 10 Micrograph of cancellous bone showing that fluid release is dependent


on particle size production.
70 Dunlop

A recent report [22] suggested improved strength with larger bone chunks,
but this was in comparison to smaller bone chunks with no control over fluid
release, which has been shown as an important factor. This may be because un-
washed smaller particles are more difficult to impact properly due to the release
of excessive fat that may not be allowed to drain away and may dampen the
compactive effort. The interparticle lubrication effect may also be significant.
Experiments designed to adequately drain the graft during the compaction
process show improved results for improving graft particle spread when fluid
content is controlled for [20].
Future test scenarios should examine the mechanical characteristics of the
much larger particles or “croutons” used in Njimegen. From these experiments it
could be hypothesized that these particles may produce their clinical success in
resisting shear by releasing little fluid on production and having excellent
interlocking despite their poor grading. A direct comparison with these data
would be most illuminating. “Croutons” are undeniably effective clinically on the
acetabular side as shown by Slooff et al., and the graft may well be behaving as a
collection of mini structural allografts. The theoretical improvements in particle
size may only be worth pursuing on the femoral side (where there is insufficient
space for the larger “croutons”), as the detrimental effects of fluid release are
more relevant.
Of further interest is the grater design, as some mills produce rod-like
shapes (Noviomagus), which theoretically may have a function rather like the
metal rods in reinforced concrete. The transition from spongy cancellous
particles to individual solid particles is bound to also play a major role in the
further analysis of graft material.

B. Washing the Graft


The effect of particle size cannot be considered alone as it is intimately related to
fluid release. Removing excessive and lubricating fluid from the interstices of
graft for impaction grafting improves the overall graft strength [6,20]. This is
advantageous and based on sound engineering principles [9,10]. In the clinical
scenario it was also found to be a useful way to examine the graft to remove
“rubbish” such as cystic material or pieces of articular cartilage, which might
cause focal defects in the impacted mantle (Fig. 11). The improvement in
strength is due to an increase in the friction angle. This is thought to be due to the
removal of the fat and marrow tissues, allowing tighter graft compaction. The
particles when washed and dried have little lubrication at the contacts with other
particles, so the frictional resistance will be higher. However, with lubrication in
the form of fat and marrow at the contacts, the frictional resistance will be
reduced.
Mechanical Properties of Grafts 71

Figure 11 Removal of deleterious cystic material in a human operative case.

C. Immunogenic Load and Growth Factors


There will potentially be more interparticle spaces empty of dead foreign tissue
available for faster invasion by host angioneogenesis. The removal of fat and
marrow tissue from allograft, which is foreign to the host, may have the
additional benefit of reducing the immunogenic load experienced by the host,
damping the initial inflammatory phase of graft incorporation [23 – 27]. Whether
the potential reduction in the level of growth factors present in the washed graft
matrix is important is currently a matter for investigation. Previous work has
questioned the activity of donor graft growth factors [28 – 30]. Ultimately the
graft may be incorporated primarily by an increased expression of host growth
factors, analogous to fracture healing [27].
Immunogenic incompatability between donor and recipient is attenuated by
the act of freezing. The marrow elements within the cancellous bone are thought
to be responsible for the majority of this immunogenicity [26] and in the past
have been recognized as only a minor problem [23,24,31,32]. There has been
recent interest in the detrimental effect of this immunogenic response [26,27,33 –
37], with a number of authors already reporting improved incorporation and
biomechanical performance with washed [38] or histocompatability-matched
grafts [4].
72 Dunlop

D. Cartilage
Cartilage has an adverse effect if it has not been removed from the femoral head
prior to milling [39,40]. In the large reported clinical series the cartilage has
usually been removed (chondral abrasion using an oscillating saw prior to milling
or never included due to the use of a rongeur), although this has not been a
widespread clinical practice in other centers.

E. Compaction Energy
Adequate compaction can only occur when rigidly contained with adequate
drainage. This allows enhanced density of graft with a reduction in porosity and
increase in shear resistance. During surgery, the decision as to when the graft is
suitably compacted is subjective, and attempts are underway to quantify this
(J. Richardson, personal communication, 2001). Bone graft exhibits “strain
hardening” at increasing compactive effort [5], and previous experiments on
bovine bone have shown the clear advantage of using increasing compactive effort.
Aggressive compaction is required, and on the femoral side completion can
be gauged, when the phantom impactor is firmly seated, requiring a mallet to
extract it. A more reproducible and accurate measure may be when the line on the
guidewire reaches the mark in the window of the phantom and will not subside
further despite 10 standard mallet blows [20].

VII. SUMMARY

To produce an aggregate (milled bone graft) most resistant to shear stress, it


should:
Be rigidly contained
Have a well-graded particle size distribution (mostly large particles by
volume, but also smaller, “filler” particles)
Be porous to allow fluid escape and thereby minimize any pore fluid
generation
Have sequential layered compaction of well-mixed material
Use large compaction energies
Possibly be washed

REFERENCES

1. Behairy Y, Jasty M. Bone grafts and bone substitutes in hip and knee surgery. Orthop
Clin North Am 1999; 30: 661– 671.
Mechanical Properties of Grafts 73

2. Stockley I, Holt G. Provision of allograft bone for orthopaedic surgery: a census of


orthopaedic surgeons. Br Orthop News 1998; 18: 24 – 25.
3. The Holy Bible. 2000; Matthew 7: 24 – 27.
4. Davy DT. Biomechanical issues in bone transplantation. Orthop Clin North Am
1999; 30: 553– 563.
5. Brewster NT, Gillespie WJ, Howie CR, Madabhushi SP, Usmani AS, Fairbairn DR.
Mechanical considerations in impaction bone grafting. J Bone Joint Surg (Br.) 1999;
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74 Dunlop

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7
Stability of Impaction-Grafted
Hip and Knee Prostheses:
Surgical Technique, Implant
Design, and Graft Compaction
Jan Herman Kuiper and James Richardson
The Robert Jones and Agnes Hunt Orthopaedic and District Hospital
Oswestry, Shropshire, England and
Keele University
Keele, Staffordshire, England
Ayman Soliman
The Robert Jones and Agnes Hunt Orthopaedic and District Hospital
Oswestry, Shropshire, England

Kevin Cheah
Springfield Hospital, Chelmsford, Essex, England

I. INTRODUCTION

Potential early problems of impaction grafting relate to subsidence of the


prosthesis, which may be related to surgical technique (impaction, stem position-
ing, cementation), graft quality, host bone quality, and stem design. Eldridge et al.
studied 79 consecutive revision hip arthroplasties using morselized allograft,
bone cement and a double tapered, polished, collarless stem [1]. They reported
nine cases of massive subsidence (.10 mm) on the femoral side, which they
attributed to varus alignment of the stem. Franzen et al. used radiostereometric
analysis (RSA) in a small series of six hips in five patients followed up to one year
[2]. They found one-year subsidence of 0.4 –2 mm in five out of six hips and
4.9 mm in the sixth. They supposed that insufficient distal compaction had caused
the extra subsidence of the sixth hip.
75
76 Kuiper et al.

While these studies stress the importance of surgical technique, others


mention the importance of stem geometry to the ultimate outcome [3]. These
workers used double tapered polished Exeter stems and reported subsidence of
5 – 10 mm in 11 of 56 patients followed up between 18 to 49 months.
In a recent clinical follow-up, Gokhale et al. reported on migration of three
stem types in 56 patients [4]. They correlated stem migration with prosthesis type
and various factors characterizing aspects of the surgical technique or patient
population. Only variations in stem angulation could be predicted by these
factors. They found that angulation was not a matter of type, technique, or
patient, but that all three aspects were simultaneously important.
Laboratory experiments are probably better suited than clinical studies to
determine which of the factors that make up surgical technique and prosthesis
type are important, since all other variables can be kept constant. Even a study
confined to surgical technique and implant variations still needs to investigate
many separate factors, since a description of technique or design requires a
multitude of separate factors. For instance, surgical technique comprises impac-
tion itself (e.g., degree of compaction or evenness of impaction) and stem
insertion (e.g., stem angulation or positioning). Likewise, stem design comprises
for instance geometry, material properties, and surface finish.
Investigating multiple factors acting simultaneously is a common problem.
Efficient methods to cope with this problem have been developed in a branch of
statistics known as design of experiments (DOE) (see e.g., Ref. 5). The recom-
mended approach according to DOE is a two-stage one. Stage one is the
screening stage, in which all factors are efficiently varied such that a minimum
number of separate experiments can identify the effect of each factor. In this
chapter we use an in vitro model of hip stem impaction grafting for this purpose
and will find that graft compaction is probably the single most important factor.
Stage two is the analysis stage, in which the factor(s) found in stage one are
further analyzed using more elaborate specific models. In this chapter we will
show further experimental evidence that graft compaction is indeed likely to be
an important factor also for impaction grafting of tibial trays. In the final section
of the chapter we will discuss the reasons for and the implications of the
importance of compaction.

II. IN VITRO SAWBONE EXPERIMENTS


A. Factors Controlling Early Migration of Impaction-Grafted
Prostheses
Many factors could influence early migration of impaction-grafted stems. Those
most under direct influence of the orthopedic surgeon, and thus most relevant, are
probably operative technique and stem design. However, even a single item such
Impaction-Grafted Prostheses 77

as “technique” hides a larger number of factors, such as angle of insertion,


position of the cement restrictor, and graft compaction. To find out which of these
many factors is most relevant, we performed a screening experiment in which all
factors were varied systematically such that the various factors are not correlated
with each other. By doing so, the factors can be used as predictors in a regression
analysis with stem migration as outcome. However, systematically varying
aspects of surgical technique might be difficult because surgeons would be forced
to use an unfamiliar technique. Instead, we ensured a large spread of surgical
techniques by asking a large number of surgeons (n ¼ 9) to perform the
operations. Because we were not interested in the individual surgeon’s ability to
perform the operation, we measured factors that characterized the surgical
technique and did a regression analysis afterwards to check whether these factors
were uncorrelated.

1. Methods and Results


Briefly, the experiment used glass epoxy femora which were prepared by
removing the femoral head and all core material such that only a cortical shell
remained (Mallory type II defect). Surgeons then inserted a cement restrictor,
impaction-grafted human morselized bone into the cavity and cemented a
femoral component in place. Four types of implants and matching instruments
were used (Charnley Elite, Exeter, Ultima, and Stanmore). Surgical technique
was characterized from AP and ML x-rays taken after implantation by measuring
stem orientation in frontal and sagittal plane, height of the implant on insertion,
and distance between stem tip and cement plug. The density of the graft at two
locations (distal to the tip and at the calcar) was characterized by determining the
ratio of local gray level to that of the medullary cortex of the Sawbone on the
same x-ray. The bone with prosthesis was then positioned in a jig to ensure
physiological loading directions for the prosthetic head and the greater
trochanter, placed in a testing machine, and cyclically loaded up to a joint force of
2500 N. Movements of the prosthesis relative to the bone were measured at the
proximal level.
During the 100 cycles that the test lasted at each load level, the curve for
each movement component resembled a logarithmic function of time (Fig. 1).
Predominant movements of all stems were translation in longitudinal direction,
rotation around the longitudinal axis (retroversion), and rotation around the A/P
axis (varus/valgus). Average subsidence at 2.5 kN ranged from 0.20 mm for the
Stanmore to 0.80 mm for the Ultima stems. Rotation around the longitudinal axis
for all stems except one was to retroversion and ranged from 0.188 for the
Charnley to 0.478 for the Stanmore stems. Based on the observation that sub-
sidence followed a logarithmic function of time, we extrapolated from the 100
cycles forming the subsidence curve at 2.5 kN (+3.5 times body weight) to
78 Kuiper et al.

Figure 1 Typical pattern of subsidence as function of time at three load levels.


Raw data and fitted logarithmic curve are shown for an Ultima stem.

1 million cycles, equivalent to one year. The predicted average subsidence at one
year ranged from 0.38 mm for the Stanmore to 1.39 mm for the Ultima stem.
We then used regression analysis to determine whether stem type and
technical factors had a strong influence on migration of the implants, and which
technical factor in particular—insertion or bone density. Prosthesis type and
values of technical parameters (stem orientation on AP and ML x-ray, stem
position, cement plug position, and proximal and distal graft density) were used
as independent variables (predictors). Migration values were used as dependent
variables (outcomes). Unfortunately, the technique-related predictor factors were
not equally spread over the four stem types. The implication is that the regression
analysis could have difficulties to distinguish between prosthesis type and
surgical technique as predictor variable.
Stem subsidence after 100 cycles at 2500 N could be predicted equally well
by stem type (r 2 ¼ 0.69) and bone density around the tip of the implant
(r 2 ¼ 0.70) (Fig. 2). Similar results were found for prediction of stem subsidence
extrapolated to 1 million cycles (stem type: r 2 ¼ 0.67; tip density: r 2 ¼ 0.78).
All these correlations were highly significant, even after adjusting for the fact that
we tested seven predictors. Because the Ultima stem showed a significantly lower
distal graft density and higher subsidence than the other stems, it might skew the
results. Without the Ultima, distal graft density was equally spread over the stem
types. No good predictor for subsidence after 100 cycles was found. However,
Impaction-Grafted Prostheses 79

Figure 2 Relation between distal graft density, which reflects firmness of


impaction, and stem subsidence extrapolated to one million cycles (one year) at
2500 N. The open squares denote the results for the Ultima stem.

estimated subsidence at 1 million cycles correlated strongly with distal graft


density (r 2 ¼ 0.50, p ¼ 0.02) and less with prosthesis type (r 2 ¼ 0.20, p ¼ 0.19).
Varus rotation correlated with prosthesis type (r 2 ¼ 0.55) and orientation
in the sagittal plane (r 2 ¼ 0.56). In this case, only the correlation with orientation
was significant. Variations in retroversion did not correlate with any factor.
However, close inspection of the scatter plots revealed one outlier. Leaving it out
showed that retroversion correlated well with prosthesis type (r 2 ¼ 0.49) and
particularly stem orientation in the sagittal plane (r 2 ¼ 0.66). Only the corre-
lation with orientation was significant.

2. Conclusion
Clearly, the above screening experiment suggests that technical factors are strong
determinants of early stem migration. Stem subsidence was largely predicted by
graft density, which is a measure of graft compaction achieved by the surgeon.
Varus rotation and retroversion were both predicted by stem orientation at
insertion. We decided to focus the remainder of the work in particular on graft
compaction, evidently the distinctive feature of impaction grafting.

B. Graft Compaction as the Main Determinant of Early


Implant Stability
Both centers that pioneered impaction grafting recommend vigorous impaction
[3,6]. Two Scandinavian studies in which stem migration is monitored using RSA
80 Kuiper et al.

propose lack of sufficient compaction as the most likely explanation for sub-
stantial migration [2,7]. Although it evidently makes sense that more vigorous
impaction improves implant stability, none of these authors provide direct data
indicating how important impaction is.
The above screening experiment gives some indication of the importance:
between 50 and 80% of the variation in subsidence could be explained by density
of the compacted graft or, in other words, level of graft compaction. It was,
however, a study of many factors acting simultaneously. Moreover, graft density
was measured from normal x-rays, which may not be an ideal method. We
therefore decided to perform more experiments aimed directly at assessing the
influence of graft compaction on early implant stability.
The first experiment uses an alternative method to assess degree of graft
compaction. The problem of deciding whether an object has been hammered
down enough to support a load is not unique to orthopedics. The same problem
occurs during production of piled foundations for constructions on weak soil. One
needs to know at what point a pile has been driven down sufficiently to support
the load of the construction without risk of subsidence. One method used to
assess loading capacity of driven piles is based on an energy balance [8 –10]. The
energy generated by the dropping pile hammer is converted to elastic energy
(e.g., elastic compression of the pile) and an amount of work performed by the
resisting force (i.e., loading capacity) of the pile. The latter amount is equal to the
product of resisting force and permanent displacement of the pile or “set” [9,10].
In the most basic approach to calculate loading capacity of a pile, the loading
capacity is calculated as the ratio of hammer energy and set. We hypothesised
that “impaction set” (sinkage of the tamp per hammer blow) would be a direct
characterization of the firmness of impaction achieved. The aim of the study was
therefore to test that firmness of impaction is a major factor determining early
stem migration by correlating impaction set with stem migration under load. As a
second aim, we tested again the importance of stem design relative to firmness of
impaction by using widely differing stem designs in the study.
The second experiment was aimed at determining whether graft com-
paction was also a major determinant of implant stability in replacements of other
joints than the hip. For this purpose, we used an in vitro model of proximal tibial
joint replacement. Instead of x-rays, we used DXA scans to determine density of
the compacted graft.

1. Methods and Results


For the hip joint experiments, the same model of a Mellory Type II defect was
used as explained above. Two femoral stems were compared: the Stanmore
(n ¼ 4) and the Taperloc (n ¼ 5) femoral stem (both Biomet-Merck, Bridgend,
UK). The Stanmore is a collared cobalt-chromium stem, which has a tapered
Impaction-Grafted Prostheses 81

Figure 3 An implanted Stanmore (left) and Taperloc (right) femoral stem


following impaction grafting using morselized bone.

curved stem, rounded medially and laterally. The Taperloc is a collarless titanium
stem, with a plasma-spray coating covering the proximal 40% of the stem. The
stem has a tapered rectangular shape, very different from the Stanmore (Fig. 3).
Two experienced surgeons performed the impaction. They used their experience
to decide when compaction was sufficient. At that point, five standardized
impulses were generated on the final tamp by dropping the slaphammer, which is
part of the instrumentation set. This hammer has a mass of 0.806 kg and drops
from a height of 0.174 m, providing an amount of energy at impaction of
1.38 Nm and an impulse of 1.49 Ns. The sinkage per blow (or set) of the tamp
into the canal during these impacts was measured using a linear potentiometer
(Sakae Tsushin Kogyo Co, Kawasaki, Japan) (Fig. 4).
The average sinkage of the tamp per blow, or the impaction set, varied from
0 to 70 mm. The set did not differ significantly between the prosthesis types
(mean difference 7 mm; 95% C.L. 243 to 58 mm). During cyclical loading,
82 Kuiper et al.

Figure 4 Experimental set-up for measuring set during impaction.

predominant movements of the stems were translation in longitudinal direction


(subsidence) and posterior direction and rotation around the longitudinal axis.
Average subsidence at 4 kN was 0.45 mm for the Stanmore and 0.05 mm for the
Taperloc stems. Average posterior translation was 0.21 and 0.33 mm, respec-
tively. The average total translation, which is the vector sum of all three
components of translation, was 0.61 and 0.40 mm, respectively. Subsidence
correlated poorly with set (r ¼ 0.10). However, total translation correlated highly
with set (r ¼ 0.94; 95% C.L. 0.75– 1.00) (see Fig. 5). A small difference in total
translation (0.20 mm) was found between the stems, which was not significant
(95% C.L. difference 20.28 to 0.69 mm; p ¼ 0.36). When we repeated the
analysis with impaction set as a covariate (ANCOVA), the corrected difference
was smaller (0.12 mm), but still not significant ( p ¼ 0.098).
For the knee joint, eight artificial proximal tibiae were produced using a
rapid prototyping process. The cortex was replicated only, and the overall elastic
properties were similar to those of human tibiae. The medullary bone stock was
restored using impaction grafting of human morselized bone. Tibial trays
(PFC-Sigma, Johnson & Johnson/DePuy, Leeds, UK) were cemented in place,
ensuring full cortical support for four implants and support by impacted graft
Impaction-Grafted Prostheses 83

Figure 5 Stem translation after 100 cycles at 4500 N versus impaction set for the
two stems. The best-fit line and its 95% confidence limits are shown. Open circles
represent the Stanmore stem, and closed squares the Taperloc stem.

particles only for the remaining four. DXA was used to determine bone density
(g/cm2) of the compacted graft and was measured in the tip region of the stem
and proximally underneath the tray both medially and laterally. The trays were
loaded with 100 cycles each of 500 N on the medial side, 500 N on the lateral
side, increasing in steps of 500 N up to 1500 N. The tray movement relative to the
cortical bone was measured in 6 D.O.F., and the data converted to maximum total
cyclic and permanent displacement.
Density of the impacted graft ranged from 1.04 to 1.25 g/cm2 proximally
and from 0.96 to 1.85 distally in the tip region. Variations were therefore much
larger distally. Implant movement was a combination of subsidence and toggling.
Similar to femoral hip implants, resulting total displacement was a logarithmic
function of time. Medial loading caused largest movements. Maximum perman-
ent displacement varied from 0.8 to 4.6 mm for nonseated and 0.5 to 1.1 mm for
seated implants.
Cyclic total displacements varied from 0.47 to 0.79 for nonseated and 0.26
to 0.52 for seated implants. For both permanent and cyclic displacement, the
mean difference between the two was small (1.6 mm, p ¼ 0.17 and 0.22,
p ¼ 0.05 mm, respectively). However, when corrected for graft compaction
characterized by DXA, mean differences were larger and highly significant
(3.1 mm, p ¼ 0.0006 and 0.35 mm, p ¼ 0.007) (Fig. 6). When adjusted for
implant seating, there was a significant correlation between distal graft com-
84 Kuiper et al.

Figure 6 Maximum total permanent movement of tibial trays fixed by impaction


grafting. Two groups of trays are compared: those with full cortical support (seated)
and those without, (unseated). See text for further explanation.

paction and both permanent displacement (r ¼ 20.94, p , 0.002) and cyclic


displacement (r ¼ 20.77, p ¼ 0.04) (Fig. 2).

2. Conclusion
Further Sawbone experiments on both hip and knee implants confirm the
conclusion of the screening experiment, namely that early implant stability is in
large part influenced by graft compaction. Graft compaction is at least partly
under the control of the surgeon: more vigorous impaction will lead to more
compaction, which will increase stability. In addition, these experiments have
demonstrated a feasible method for intraoperative prediction of early implant
stability, namely by measuring impaction set.

III. WHY IS GRAFT COMPACTION IMPORTANT?

Compaction is defined as “an increase in bulk density (mass per unit volume) and
a decrease in porosity resulting from applied loads, vibration, or pressure. More
compacted soils (or other materials) can support greater loads (load-bearing
capacity). Bulk density can be increased by controlling the moisture content,
compaction forces and treatment procedures, as well as by manipulating the type
Impaction-Grafted Prostheses 85

Figure 7 Compaction curve of morselized cancellous bone, comparing bone


before and after impaction. Note logarithmic scale for stresses.

of material being compacted” [11]. Clearly, graft compaction is exactly what a


surgeon achieves and probably aims for during impaction grafting.

A. Compaction by Impaction: The Compaction Curve


Why compaction is so important can be understood from a compaction curve of
morselized bone (Fig. 7). This graph was produced by compacting small samples
of morselized human trabecular bone in a cylindrical mold using a materials
testing machine and shows the stress needed to compact morselized bone a given
percentage. Notice the line curves strongly upwards, so every extra compaction
has an increasing yield in terms of graft strength and load-bearing capacity. The
graph also shows that morselized bone can be compacted to become a very strong
material: stronger than intact cancellous bone (typical strength 4.2 MPa; [12])
and certainly stronger than the average compressive stress levels around
cemented stems (0.5 MPa; [13]). The same graph also shows the compaction
curve of bone samples that have received 20 standardized hammer impacts by
dropping a 0.7 kg weight from 10 mm. For large loads, the curve follows the
same path as the noncompacted graft. However, for smaller loads the compacted
graft is stiffer and deforms less. A more compacted graft will therefore reduce
migration of the implant.
To understand better what happens during graft compaction by impaction,
we used the same set-up as above to compact graft into a cylindrical mold using
standardized impulses, while measuring displacement of the plunger. The
86 Kuiper et al.

Figure 8 Displacement pattern of a plunger impacted onto a mass of morselized


cancellous bone.

displacement pattern of the plunger (Fig. 8) is similar to that of a pile during pile
driving [14].
Upon impact, the plunger is forced down by the hammer, deforming the
graft. After a short period (typically 10 msec), maximum deformation is achieved
and the graft partly recovers. During pile driving, this pattern is caused by elastic
compression of the pile and permanent sinkage (set) of the pile in the ground. It
forms the basis of calculating load-bearing capacity of piles from the set, as
mentioned in the previous section. This same pattern during graft impaction is
most likely caused by graft deformation, which is partly elastic and partly plastic
or permanent. The latter component is equivalent to the impaction set we referred
to in the previous section.
Typically, with each consecutive hammer blow the set reduces and the
elastic deformation increases. This pattern can be readily understood from the
compaction curve (Fig. 7). Upon impact, the kinetic energy of the hammer is
converted to elastic energy of the graft, which can be measured as the area under
the curve. At first impact, the energy will be the area under the curve AB (Fig. 9).
However, the graft is elastic and rebounds to C. This complete event takes
approximately 10 msec. The permanent displacement of the impactor, AC, is the
set. At the second impact, the impactor first travels along line CB and then
follows further the compaction curve up to point D. The area under CBD is again
the kinetic energy of the hammer. The graft then rebounds to E. The permanent
Impaction-Grafted Prostheses 87

Figure 9 Thick line represents compaction curve of morselized cancellous bone.


The letters and thin lines demonstrate events during impaction. See text for further
explanation.

displacement at second impaction, CE, is smaller than AC. In other words, the
impactor set becomes smaller at each subsequent impaction. On the other hand,
the elastic deformation at the second impact (DE) is larger than at the first impact
(BC). In the cylindrical mold with flat impactor, this process continues until the
point where all hammer energy is used to elastically compress the graft up and
down (line FG) and no further compaction occurs: the impactor set is zero.
Depending on the compaction curve, this occurs after approximately 20
blows. In this situation, the only way to achieve more graft compaction is to apply
more energy per impact, i.e., impact more vigorously.
In the cylindrical mold, the direction of compaction coincides with the
main direction in which the impactor moves. Compaction by impaction in that
case readily leads to the point where all further impaction only yields elastic
compression of the graft and no further permanent compaction (zero set).
Impaction grafting for acetabular revision is probably the most appropriate
clinical example of this situation. During impaction grafting for hip revision, the
tamp can, however, act as a wedge and gives compaction in a direction perpen-
dicular to the movement of the impactor. Elastic rebound of the graft would
require the tamp to be pushed out by the graft, which is less easy because the main
directions of graft pressure and tamp movement are perpendicular. A situation of
zero set may therefore not occur as readily, which probably explains why
impaction set is such a good predictor of early hip stem stability.
88 Kuiper et al.

B. Bone Density, Particle Size, and Impaction-Compaction


In the previous section we showed how more vigorous impaction increases graft
compaction and in this way will improve implant stability. Another way in which
implant stability would improve is use of morselized graft with a steeper
compaction curve. Even with the same hammer energy, such a graft would be
compacted to a stronger material since the hammer energy would be used more
efficiently.
Among factors that could influence the steepness of the compaction curve
are graft characteristics such as donor bone density and particle size. It stands to
reason that denser donor bone will produce stiffer and stronger graft.
Increasing particle size has also been shown to increase the stability of
impaction-grafted components, although not every surgeon would benefit equally
[6]. To determine the effects of these two factors on graft compaction, we
performed a study using uniaxial compaction. Bone samples with a range of
densities and sizes were compacted in a cylindrical mold using 20 blows of a
0.7 kg hammer dropping from 10 mm while measuring the position of the
plunger. Bone mineral density (BMD) was determined using DXA and particle
size distribution using image analysis of a digitized contact x-ray showing
individual bone particles.
In all cases, a straight line could be fitted between the logarithm of blow
number and plunger position, clearly demonstrating how each consecutive blow
produces a smaller plunger displacement or set and thus increases bearing
capacity. Earlier in this chapter, we showed that identical implant stability
requires identical set. The linear fit between logarithm of blow number and
plunger position allows calculating the number of blows needed to achieve an
identical set for each bone sample. This number turns out to be proportional to the
slope of the linear fit. This is logical: a steeper slope denotes a larger set at
identical blow number, and thus more blows are needed to reduce the set to an
acceptable level. Since the slope itself is proportional to the plunger sinkage, it
follows that the total number of blows required is proportional to plunger sinkage
after a given number of blows.
A plot of plunger sinkage as function of particle size and bone density
clearly shows the interaction between the three (Fig. 10). Compared to large
particles of high bone density, plunger sinkage increases for smaller particles or
donor bone of lower density. The difference is largest when small particles from
low-density donor bone are used, when sinkage is about four times as much.
Such particles would therefore need four times as many blows to achieve
similar bearing power, in other words, they have a low impaction efficiency. The
difference in bearing power between the two would be particularly clear when the
surgeon impacted less vigorously. Delivering more energy per hammer blow will
always give more compaction and is thus more likely to give sufficient bearing
Impaction-Grafted Prostheses 89

Figure 10 Total sinkage of plunger into a mass of morselized cancellous bone


after 20 standard blows as a function of host bone density and characteristic
particle diameter. Dots represent data points, and the curved surface is a thin plate
spline interpolant.

power whatever the graft quality. That surgeons who impact less vigorously
benefit more from larger particles was indeed shown in an in vitro experiment [6].
Donor bone is often in short supply, which makes it difficult to reject low-
density bone beforehand. To ensure good impaction efficiency, it thus seems
advisable to avoid morselizing them into small particles.

IV. DISCUSSION

This chapter presents two major messages. First, for medullary defects of either
proximal femur or proximal tibia, migration of the prosthesis is mainly a function
of technical aspects of the operation, in particular graft compaction achieved.
Graft compaction around hip stems proved a stronger predictor of subsidence
than stem design. Moreover, we demonstrated that early subsidence could be
predicted by measuring the set of the impactor during impaction. Second, both
donor bone density and particle size influence the amount of effort required by the
surgeon to achieve sufficient compaction to ensure implant stability. Lower donor
bone density and smaller particles increase effort to compact by as much as four
times.
Many factors can play a role in determining subsidence levels. They can be
related to patient activity, host bone quality and geometry, graft, surgical
technique, and stem design. This chapter concentrated on the last three because
they are most readily influenced by the surgeon. However, geometry and quality
of host bone and geometry and patient activity will clearly be important too.
90 Kuiper et al.

Major complications with the technique of impaction grafting seem mainly


related to fractures of the host bone, whether intraoperatively or later, suggesting
that host bone quality may well be the most important clinical factor [15].
However, many intraoperative fractures can probably be avoided by applying
cerclage wiring prophylactically [4,7,16,17].
Restricting attention to donor graft, surgical technique, and implant design,
this chapter provides strong evidence to suggest that technical aspects of the
operation form the major factor determining early stability of impaction-grafted
implants among these three, in particular the degree of graft compaction
achieved. Many authors have stressed the importance of impaction vigor. In their
original paper on impaction grafting for femoral components, Gie et al. [3]
recommend “vigorous impaction” and comment on the impressive stability that
can be achieved in this way. In their recommendations, Schreurs et al. [6] stress
that it is “imperative that the grafts be impacted very vigorously.” Two Scan-
dinavian studies in which stem migration is monitored using RSA propose lack of
sufficient compaction as the most likely explanation for substantial migration
[2,7]. Ornstein et al. [18] found that a considerable amount of migration of
impaction-grafted implants occurs during the first week after surgery, which they
regard strong evidence of graft compaction due to patient activity. The impor-
tance of graft compaction is therefore supported by much circumstantial
evidence, and clearly has a strong logical appeal. However, the work summarized
in this chapter provides the first direct research into the importance of graft
compaction compared to other factors.
Using density of compacted graft as a measure of graft compaction, 70% of
variation in stem subsidence was explained by graft compaction. With impaction
set, the sinkage of the impaction tamp per standard blow, as a more direct
measure of impaction vigor, almost 90% of variation in stem migration could be
explained. In both sets of experiment, hip implants of widely differing design
were used. A similar dependence of implant migration on graft compaction was
found for tibial trays. Moreover, we demonstrated that donor bone quality and
particle size of the morselized graft influence the impaction efficiency of the
graft, i.e., the number of blows required to achieve sufficient bearing strength.
Donor bone of low density milled into small particles requires up to four times as
many blows to compact to a comparable strength level.

A. Risks of Increased Compaction


Sufficient graft compaction is clearly important to ensure that the graft is
sufficiently strong to carry the implant load. Thus, a definite risk of under-
compaction exists. Is there also a risk of overcompaction? Probably the most
important risks of increased compaction are decreased porosity of the impacted
graft, possibly leading to reduced bone formation and cement penetration and
Impaction-Grafted Prostheses 91

host bone fracture. As indicated earlier, prophylactic wiring may be needed to


prevent host bone fracture. In addition, the work presented here has indicated a
trade-off between hammer impulse and required number of blows, in particular
for tapered stems. If host bone fracture were associated with high-impulse
hammer blows, then using less vigorous blows but applying more of them would
be a solution. However, this association does not necessarily exist because
wedging by the tamp could also cause host bone to fracture. Clearly, more
research is needed to clarify this aspect. Whatever the cause, quantification of
degree of compaction achieved, for instance by measuring impaction set, may
provide a way to standardize compaction and reduce the risk of fracture.
Graft compaction will also reduce the porosity of the graft. Reduced
porosity may make it more difficult for new bone to grow into the compacted
mass. Tagil and Aspenberg [19] compared bone ingrowth into noncompacted and
compacted bone and found that compaction reduced ingrowth. Pratt et al. [20]
compared bone ingrowth into compacted material with an ideally graded particle
size distribution (a distribution that ensures at each level that voids between
larger particles are filled with smaller particles) and a nonideally graded one
(leaving more open voids). They found more ingrowth into the nonideally graded
graft, again suggesting that reduced graft porosity may decrease bone ingrowth.
A second effect of smaller graft porosity may be to reduce its permeability to
bone cement, giving less cement penetration. For primary implants, cement/bone
interdigitation is regarded important to ensure good fixation. The optimum level
is under debate, but 3– 4 mm has been suggested as a reasonable compromise
[21]. Although level of cement penetration influences early stability of
impaction-grafted stems only marginally [22], it may well become important
after replacement of the graft by new bone. We have therefore investigated the

Figure 11 Cement penetration into a mass of morselized cancellous bone after


compaction with 20 standard blows as a function of amount of compaction and
characteristic particle diameter. Dots represent data points, and the curved surface
is a thin plate spline interpolant.
92 Kuiper et al.

influence of effective particle size and amount of compaction on cement pene-


tration by forcing cement into the compacted mass at a standard pressure of
200 kPa, which is a typical level [23]. The experimental set-up was the same as in
the previous section, and the amount of compaction was characterized by total
plunger sinkage. Within the range of particle sizes that we studied (3.2 –6.3 mm),
cement penetration ranged from 2.4 to 16 mm and proved to depend to a larger
degree on particle size than on degree of compaction (Fig. 11).
The correlation between effective particle size and penetration depth was,
however, not strong (r ¼ 0.47), probably because particle shape and the amount
of interlock vary widely. The data suggests minimal risk of too little cement
penetration under any circumstances, but does probably have some implications
for bone ingrowth. First, the minor dependence of penetration on degree of
compaction suggests that any extra compaction to improve stability will only
marginally affect bone ingrowth. Second, the stronger dependence of cement
penetration on particle size suggests the main risk to bone ingrowth stems from
inappropriate particle sizing. This ties in with Pratt et al.’s finding that particles
leaving small voids cause a reduction of bone ingrowth.

B. Conclusion
Early stability of impaction-grafted implants depends to a large extend on the
degree of graft compaction achieved. Morselized graft with larger particles and
higher donor bone density requires less impaction effort to compact enough to
carry the implant load. Producing larger bone particles will thus increase the
likelihood of a stable implant. In addition, larger particles increase permeability
of the compacted mass, facilitating cement penetration and formation of new
bone.

ACKNOWLEDGEMENTS

The authors thank Mr. Mike Haddaway, Mr. Ian May, Dr. Damien McLelland,
Dr. John Merry, Mr. Bernd Netzer, and Dr. Andy Toms for their help during the
experiments and all surgeons who performed the impaction grafting of the
femoral stems. We also thank Johnson & Johnson (Leeds, UK) and Biomet
(Swindon, UK) for their financial support, and Johnson & Johnson, Biomet, and
Howmedica (Staines, UK) for providing implants and instruments. Finally, we
thank the Oswestry and Clwyd bone bank for donating some of the bone used in
this study.
Impaction-Grafted Prostheses 93

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1. Eldridge JD, Smith EJ, Hubble MJ, Whitehouse SL, Learmonth ID. Massive early
subsidence following femoral impaction grafting. J Arthroplasty 1997; 12: 535– 540.
2. Franzen H, Toksvig-Larsen S, Lidgren L, Onnerfalt R. Early migration of femoral
components revised with impacted cancellous allografts and cement. A preliminary
report of five patients. J Bone Joint Surg 1995; 77B: 862– 864.
3. Gie GA, Linder L, Ling RS, Simon JP, Slooff TJ, Timperley AJ. Impacted cancellous
allografts and cement for revision total hip arthroplasty. J Bone Joint Surg 1993;
75B: 14 – 21.
4. Gokhale S, Dantas JP, Richardson JB, Soliman A, Cook F, Kuiper JH, Jones
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5. Box GEP, Hunter WG, Hunter JS. Statistics for Experimenters: An Introduction to
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6. Schreurs BW, Slooff TJ, Buma P, Verdonschot N. Basic science of bone impaction
grafting. Instr Course Lect 2001; 50: 211– 220.
7. Karrholm J, Hultmark P, Carlsson L, Malchau H. Subsidence of a non-polished
stem in revisions of the hip using impaction allograft. Evaluation with radio-
stereometry and dual-energy x-ray absorptiometry. J Bone Joint Surg 1999; 81B:
135– 142.
8. Smith GN. Elements of Soil Mechanics. 6th ed. Oxford: Blackford Science; 1995.
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10. Wilun Z, Starzewski K. Soil Mechanics in Foundation Engineering. 2nd ed. London:
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11. Felluga B. GEMET, General European Multilingual Environmental Thesaurus.
Copenhagen: EEA; 1999. http://eionet.eu.int/GEMET
12. Carter DR, Hayes WC. The compressive behavior of bone as a two-phase porous
structure. J Bone Joint Surg 1977; 59A: 954– 962.
13. Verdonschot N, Huiskes R. Mechanical effects of stem cement interface character-
istics in total hip replacement. Clin Orthop 1996; 329: 326– 336.
14. Smith EJ, Richardson JB, Learmonth ID, Evans G, Nelson K, Lee R, Dyson J. The
initial stability of impaction grafting. Hip Int 1996; 6: 166– 172.
15. Ornstein E, Atroshi I, Franzen H, Johnsson R, Sandquist P, Sundberg M. Early
complications after one hundred and forty-four consecutive hip revisions with
impacted morselized allograft bone and cement. J Bone Joint Surg 2002; 84-A:
1323– 1328.
16. Gie GA, Linder L, Ling RS, Simon JP, Slooff TJ, Timperley AJ. Contained
morselized allograft in revision total hip arthroplasty. Surgical technique. Orthop
Clin North Am 1993; 24: 717– 725.
17. Pekkarinen J, Alho A, Lepisto J, Ylikoski M, Ylinen P, Paavilainen T. Impaction
bone grafting in revision hip surgery. A high incidence of complications. J Bone
Joint Surg 2000; 82B: 103– 107.
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18. Ornstein E, Franzen H, Johnsson R, Sundberg M. Radiostereometric analysis in hip


revision surgery—optimal time for index examination: 6 patients revised with
impacted allografts and cement followed weekly for 6 weeks. Acta Orthop Scand
2000; 71: 360– 364.
19. Tagil M, Aspenberg P. Impaction of cancellous bone grafts impairs osteoconduction
in titanium chambers. Clin Orthop 1998; 352: 231– 238.
20. Pratt JN, Griffon DJ, Dunlop DG, Smith N, Howie CR. Impaction grafting with
morsellised allograft and tricalcium phosphate-hydroxyapatite: incorporation within
ovine metaphyseal bone defects. Biomaterials 2002; 23: 3309– 3317.
21. Walker PS, Soudry M, Ewald FC, McVickar H. Control of cement penetration in
total knee arthroplasty. Clin Orthop 1984; 155– 164.
22. Berzins A, Sumner DR, Wasielewski RC, Galante JO. Impacted particulate allograft
for femoral revision total hip arthroplasty. In vitro mechanical stability and effects of
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cement in total hip arthroplasty. J Arthroplasty 1993; 8: 585– 591.
8
Preparation of the Femoral Head
Prior to Milling: Does Inclusion of the
Articular Cartilage Influence
Impaction?
An In Vitro Study with Human Femoral Heads

Ashit Bavadekar, Olivier Cornu, Bernard Godts,


Christian Delloye, and Xavier Banse
Université Catholique de Louvain
Brussels, Belgium
John Van Tomme
Royal Military Academy
Brussels, Belgium

I. INTRODUCTION

The impaction bone grafting procedure has become an option in revision hip
surgery and has been popularized by Slooff et al. [1] for the reconstruction of
cavitary acetabular defects in revision hip arthroplasty. It was further modified by
Gie et al. [2] for the femoral revisions. The procedure involves progressive
impaction of morselized “cancellous” bone grafts in the femoral canal or the
acetabular cavity, which are both deficient in bone stock due to wear effects from
a previous arthroplasty. A standard prosthesis is then cemented directly in contact
with the impacted graft layer, which becomes a load-bearing material. The grafts
can be remodeled and progressively transformed in normal living bone, restoring
the patient’s bone stock. Achievement of correct implant stability is the technical
goal of this procedure as well as a prerequisite for further remodeling of the grafts [3].
95
96 Bavadekar et al.

Karrholm et al. [4] claim that hardness (or stiffness) of the impacted grafts is
of primary importance to be able to sustain the cyclical loading forces of
normal gait.
The practice of impaction bone grafting has led the surgeons to assume that
there is a relationship between impaction, compactness, and stiffness of the
grafts. However, such a relationship is not substantiated by the literature. If it is
obvious that impacting the grafts will aggregate the bone morsels, and repeated
shocks could theoretically damage them and cause a reduction in their individual
stiffness. Consequently, the first goal of this study was to address the relationship
between the number of impactions applied to the grafts layer and its resulting
compactness and stiffness.
The composition of the grafting material is another variable that may
deeply affect the mechanical properties. The osteoarthritic femoral head har-
vested during hip replacement is the most common source of fresh frozen
allografts for impaction bone grafting. It contains three different types of tissues:
cancellous bone in its bulk, cortical bone (mainly from the neck), and remnants of
articular cartilage or synovial lining. Regarding the tissues, our second goal was
to address two questions:
1. Is it really necessary to remove the residual articular tissues before the
milling of the head?
2. Can we leave and use the cortical bone from the femoral neck, or is it
mandatory to use only cancellous bone?

II. MATERIALS AND METHODS


A. Preparation of Morselized Grafts
Twelve fresh frozen human femoral heads from 12 patients (4 females and 8
males) were procured at the time of primary hip arthroplasty for osteoarthritis and
stored at 2808C. Each femoral head was subjected to plain radiography for a
qualitative assessment to exclude evidence of severe osteopenia or important
osteoarthritic cystic lesions.
Two separate batches were made of 6 femoral heads each. The median age
of the patients was 63 (58 – 73) years in batch 1 and 72 (51 –83) years in
batch 2. Each separate batch was processed to produce two types of graft, thus
allowing a paired comparison. The femoral heads were cut into two halves in the
coronal plane (anterior and a posterior half ), keeping the fovea femora capitis as
the reference point, on a band saw. Half-femoral heads were weighed separately
on a digital weighing scale (Mettler PE 3000, Zurich, Switzerland) before and
after processing to estimate the loss of material.
In the first batch, one half of each head (alternatively the anterior or the
posterior) was cleared of all adherent soft tissue, articular cartilage, and cortical
Femoral Head Preparation 97

Table 1 Particle Data for 5 g Samples: Mean (min-max)

Mean particle
Type of graft No. of particles size (mm2)

Batch 1 Cortico-cancellous with 222 (198– 262) 9.53 (7.37– 11.08)


cartilage (n ¼ 17)
Pure cancellous (n ¼ 18) 252 (213– 322) 8.63 (6.78– 10.50)
Batch 2 Cortico-cancellous (n ¼ 18) 210 (181– 234) 8.52 (7.20– 9.65)
Pure cancellous (n ¼ 18) 270 (214– 270) 7.46 (6.11– 8.99)

bone from the neck to obtain pure cancellous grafts. The clearance was
performed by holding the bone surface against the running blade of a band saw
until cancellous tissue could be seen.
This technique resulted in minimal bone loss. The other half of the same
head was left intact. These half heads were used to prepare the cortico-cancellous
grafts with articular cartilage. For the second batch, one half of each femoral head
was processed to obtain pure cancellous samples, in a similar way to the first
batch. Preparation of the cortico-cancellous graft samples involved the retaining
the cortical bone from the femoral neck, but removal of the articular cartilage and
adherent soft tissue.
In this experimental design, the pure cancellous bone in each batch bone
was considered as the “gold standard” or the control and the other type of graft
(cortico-cancellous with or without cartilage) as the test group.
These half heads were milled separately twice for each type, as done in our
surgical practice, with the small rasps of the Noviomagnus bone mill (Spierings,
Nijmegen, Netherlands) (Table 1). The size of the morselized particles was
3.3+1 mm (mean+SD). For randomization of the samples, each type of
morselized graft was mixed in a bowl and sampled in units of 5 g each. Eighteen
samples of each type were selected randomly for mechanical testing.

B. The Impaction Procedure


The impaction grafting was tested on a specially designed piece of apparatus
(Fig. 1) that consisted of an aluminium tube (inner diameter 14.6 mm) to contain
and confine the grafts. Thirty-six holes (1 mm diameter) facilitated the expulsion
of the bone marrow during the course of an impaction. The tube was fixed to a
solid aluminium block. A solid cylindrical aluminium impactor (diameter
14.4 mm) telescoped freely in the cylinder. A 1 m iron rod was placed on top of
the impactor. This served as a guide for a mass (simulating the classical
impaction instrumentation) of 455 g.
98

Figure 1 The grafts were impacted in a contained cavity with the vents for marrow expulsion
during the course of an impaction. The design was based on the ancillary for impaction bone
grafting, in which the weight travels over a fixed distance (see text).
Bavadekar et al.
Femoral Head Preparation 99

The bone comprised 5 g samples of morselized graft thawed at room


temperature 2 hours prior to the mechanical test. One sample at a time was loaded
in the cylinder and tested. Information from preliminary tests indicated that,
using this model, some changes could be expected for up to 150 impactions.

C. Parameters
Three parameters were measured to describe the evolution of the material during
impaction. Two of these, the height of the contained cylinder of morselized grafts
and its elastic modulus, were measured at the first, third, fifth, and tenth
impactions and thereafter in multiples of 10 up to the 150th impaction. The height
was measured between two points (the top of the cylinder and the top of the
impactor) with a digital calliper (Mitutoyo, Hiroshima, Japan) following the
telescoping of the impactor into the tube. Elastic modulus (or stiffness) was
measured by placing the testing device, without its guiding rod and mass,
between the plates of a testing machine (Zwick Machine, Zwick GmbH & Co.
Ulm, Germany). The upper plate of the machine gently compressed the impacting
material at a speed of 0.5 mm/min. The load was measured by a 2 KN load cell
and the displacement by an extensometer (Multisens, Zwick) positioned across
the tube and the impactor. To avoid excessive compression of the grafts during
elastic modulus measurement, the test was limited to a range of either 80 N of
force (0.5 MPa) or 0.3 mm of displacement. The elastic modulus (in MPa) was
calculated as the slope of the curve between 60 and 98% of maximal load (the
linear part of the curve). After reaching the measurement limit, the cylinder of
grafts was immediately unloaded.
Knowing the time-dependent mechanical properties of morselized grafts
(creep and recoil) [5], we chose to standardize the testing conditions for each
sample. The height and elastic modulus measurement were performed over a
constant time of one minute between impactions.
The third parameter was the development of the apparent density of the
impacted material. For the progession of density we stopped the procedure at
different levels of impaction, gently expressed the impacted cylinders of graft in
their original plastic tubes (diameter 15 mm), and rapidly froze the specimens.
Consequently, out of the 18 samples in each group, 4 were impacted until the
third impaction, 4 until the tenth impaction, 4 until the fiftieth impaction, and
6 until the final 150th impaction.
To assess the density, the frozen graft samples were subjected to peripheral
quantitative computerized tomographic scanning (XCT Research SA pQCT,
Pforhzeim, Germany). Density measurements were taken from four different
levels of the impacted graft cylinder (slice thickness 0.7 mm). These levels were
selected by dividing the height of the cylinder into four equal parts. The density
100 Bavadekar et al.

of a sample was calculated as the mean value of the four slices (g/cm3 of bone
content) according to calibrations performed under the same conditions.

D. Statistics
The differences in the evolution of the height and elastic modulus of the different
grafts were analyzed using repeated measure ANOVA. The within-subject
(sample) factor was the number of impactions, and the between-subject factor
was the type of graft. Because the density was analyzed on different samples
during the impaction, we compared the mean density of each type of graft at the
four different levels of impaction considered with a paired t-test. These analyses
were performed using SPSS 9.0 (SPSS Inc. Chicago, IL) separately for batch 1
and batch 2. Significance level was fixed at p , 0.05.

III. RESULTS
A. Material Weight Loss on Preparing Different Grafts
Preparing pure cancellous samples from a femoral head caused a mean loss of
36+6% of material in batch 1 and 40+7% in batch 2. In batch 2, removal of soft
tissue and cartilage caused a loss of 25+2% of material weight (Table 2).

Figure 2 The diminution of the height due to progressive impaction for batches 1
and 2. Note that the number of impactions is presented as a log scale. The line
represents the mean value and the bars the standard error of this mean value. Up to
3 impactions, n ¼ 18 (number of measurements performed); up to 10 impactions,
n ¼ 14; up to 50 impactions, n ¼ 10; up to 150 impactions, n ¼ 6 for each type of
graft.
Femoral Head Preparation 101

Figure 3 The evolution of the stiffness (Emod) of the material grafts with
progressive impaction. The same amounts of data as in Figure 4 are used for
mean and standard error of the mean (bars) calculations. In batch 1, note the
difference in the modulus values reached between the pure cancellous and the
cortico-cancellous with cartilage, while in batch 2 such a difference is not
observed.

B. Height
The height (Fig. 2) showed a steady decline corresponding to the log of the
number of impactions. In batch 1, the ANOVA with repeated measures showed
that height was higher for the cortico-cancellous with cartilage than for the pure
cancellous bone (p ¼ 0.018). In batch 2 there was a slight but non-significant
difference, with a faster impaction for the cortico-cancellous without cartilage
when compared to pure cancellous grafts ( p ¼ 0.06).

C. Elastic Modulus
The grafts were rendered progressively stiffer until the 30th impaction (Fig. 3). In
batch 1, rise in the elastic modulus was significantly higher for the pure
cancellous (p , 0.001) than for the cortico-cancellous with cartilage. The mean
final modulus of the pure cancellous impacted grafts was about 48.4 MPa while it
was 26.3 MPa for cortico-cancellous grafts with articular cartilage. Furthermore,
the cortico-cancellous with cartilage reached the same value of elastic modulus
after 150 impactions as compared to the pure cancellous after 5 impactions .
102

Table 2 Origin of Material and Weight Loss on Preparation of Morselized Grafts

Fresh frozen (FF)


Donor Whole head half head Freeze-dried (FD) half head

Weight Freeze-
without Treated dried
Age Weight cartilage Ant./Post. Weight Ant./Post. Weight weight weight
Name Sex (yr) (g) (g) half (g) half (g) (g) (g)

VP M 75 90.9 73.8 Post. 37.1 Ant. 35.0 18.5 12.5


PC F 61 86.0 67.0 Post. 35.2 Ant. 29.8 15.4 11.3
WM F 72 79.6 66.2 Post. 32.6 Ant. 31.8 13.7 9.4
DG M 53 100.9 66.8 Ant. 31.4 Post. 33.6 22.8 13.5
LC M 72 94.4 71.4 Ant. 39.0 Post. 35.1 15.2 10.2
TJ M 72 87.2 66.7 Ant. 32.4 Post. 32.5 18.7 12.6
Mean: 67.5 89.8 68.7 34.6 33.0 17.4 11.6
Bavadekar et al.
Femoral Head Preparation 103

In batch 2, rise in the elastic modulus was similar for the pure cancellous
and the cortico-cancellous without cartilage (p ¼ 0.62). Mean final elastic
modulus was, respectively, 41.7 and 41.9 MPa, cortico-cancellous having a
similar value to that of the pure cancellous impacted grafts.

D. Mean Density
The mean density increased in proportion to further impaction (Fig. 4). In batch 1
the pure cancellous grafts showed higher density values than the cortico-
cancellous with cartilage after 10 (p ¼ 0.013), 50 (p ¼ 0.045), and 150
impactions (p , 0.001). Mean density of the impacted cylinders in batch 2
showed significant differences between the pure cancellous and cortico-cancellous
grafts after 50 (p ¼ 0.032) and 150 impactions (p ¼ 0.001). Cortico-cancellous
grafts reached a slightly higher density than pure cancellous controls.

IV. DISCUSSION

Morselized grafts were obtained from human femoral heads that were harvested
during primary hip arthroplasties. The femoral heads were neither treated nor
defatted [6] to perform the tests with all their normal constituents, especially the

Figure 4 The increase in density (g/cm3) in batches 1 and 2 on successive


impactions. At 3, 10, and 50 impactions, density measurements were carried out on
four samples of each type of graft. At 150 impactions, six measurements were
done. Note the significant difference in the rise in densities between impactions 50
and 150.
104 Bavadekar et al.

marrow. In preparing the material for batches 1 and 2, the goal was to get two
groups of samples as homogeneous as possible and prepared from the same six
femoral heads. To rule out local discrepencies of bone quality due to different
trabecular patterns [7], the femoral heads were divided in the coronal plane in two
halves. Mixing the morselized grafts reduced the variability between the samples
that would be linked to the quality of each individual head [8]. Therefore, the
only difference between the groups could be linked to the presence or absence
of some constituent of the original femoral head (cartilage or cortical bone from
the neck).
The experimental impaction procedure was standardized in keeping
many parameters constant (e.g., time between every round of impactions
and the persons performing them). Grafts were impacted by intermittent blows
in rounds of 10 and were not continuously compressed to fit the clinical
impaction procedure [5,8]. The drop in mass was highly reproducible, but did
not exactly mimic the clinical situation. The characteristics of the shock wave
are certainly not the same as those found during an actual surgical procedure.
Expulsion of the marrow though small holes in the tube might not be as
complete and easily performed in the bleeding diaphysis. Keeping these
caveats in mind, it must be clear that the number of impactions presented in
this study do not correspond to the number of impactions that the surgeon
would have to perform. The experimental set-up simulated the impaction
procedure but not the progressive prosthetic migration observed in clinical
practice (subsidence). This implant migration is a process going on over
thousands of physiological loading cycles, while we tested the effect of a few
blows on the morselized grafts.
Studies have been carried out on the mechanical behavior of morselized
grafts considered as a material. Brewster et al. [6] investigated the shear modulus
of impacted grafts, showing, in a small number of samples, that there was a
relationship between shear strength and energy of impaction. Brodt et al. [8]
performed triaxial compression tests on unimpacted but slightly compressed
morsels. Giesen et al. [9] and Ullmark and Nilsson [5] worked on the time-
dependant properties (creep and recoil) of impacted material. Effective
impactions on the graft layer caused stiffening of the grafts in a more or
less tightly packed homogeneous layer from a loose particulate state towards a
well-impacted state. Compactness and compressive stiffness of the graft layer
were monitored to obtain insight into the evolution of the material during the
impaction process. The values of the elastic modulus may not be precise but do
give the reader an idea of the relative stiffness these grafts would reach on
receiving effective impaction blows.
Morselized grafts become consistently more deformed, compact, and
dense during the impaction. The decrease in height (a relative measure of
compactness) is due to the deformation of the grafts and expulsion of the
Femoral Head Preparation 105

marrow and fat globules through the vents in the testing tube. The evolution of
the height or density further fit a decimal log (log 10) of the number of
impactions (Figs. 2, 4). This suggests that the reduction in height was almost
the same during the first 10 impactions as from the 10th to the 100th impaction.
For the modulus such a relationship did not hold true. Beyond the 30th
impaction, the modulus stabilized and reached a plateau (Fig. 3). We observed a
limit of impaction beyond which, on further impactions, there was no further
rise of the elastic modulus. During that phase the aggregated particles were
probably accumulating damage. Structurally damaged cancellous bone is
known to present a dramatically reduced elastic modulus [10]. However, on
impacting the graft layer, such damage would be offset by the ongoing slow rise
in compactness of the morselized grafts.
On the other hand, in our experiment there was no drop in the modulus of
the grafts, so we have no experimental data to suggest that overimpaction is
dangerous for the mechanical integrity of the graft layer and hence for the initial
implant stability. The general relationship between number of impactions and
stiffness demonstrates that the quality of the impaction itself is of primary
importance to obtain a sufficiently stiff layer of grafts and a stable implant. The
data presented here were also aimed at giving the surgeon some experimental
indications about the best way to prepare femoral heads before milling. We
estimated that the minimal loss of material in preparing a femoral head for
obtaining pure cancellous bone is 40% of the initial graft mass. In comparison,
the minimal loss related to the removal of soft tissues and retaining the neck is
25%. This loss is mainly due to bone debris produced by the saw, and the mass of
cartilage on an osteoarthritic head probably represents less than 10% of the
cortico-cancellous morselized grafts with cartilage. Comparing the loss in
batches 1 and 2, it can also be calculated that the cortical neck represents 15% of
the mass of the allograft.
Although Slooff et al. [11] report the use of cancellous graft alone, Gie
et al. and other teams in United Kingdom morselize “the whole femoral head”
[6,12]. This terminology is somewhat confusing, but there are no reports
specifically stating that cartilage remnants were retained while milling the
heads.
The presence of cartilage prevents efficient impaction of the morselized
grafts, probably due to its elastic nature. At any level of impaction, the measured
elastic modulus of the graft layer with the cartilage was always about the half of
its pure cancellous control group. The presence of cartilage particles delayed
effective impaction and prevented the grafts from reaching a relatively high
density (Fig. 4) and a high modulus (Fig. 3). This confirms that cartilage must be
removed before milling.
The cortico-cancellous grafts without the articular cartilage had stiffness
values as good as their control group (Fig. 3). They reached slightly higher values
106 Bavadekar et al.

of compactness and density (probably due to cortical struts) (Figs. 2, 4) when


compared to their purely cancellous control. It seems unlikely that a few cortical
bone fragments will significantly alter the biological response of the graft.
However, our experiment did not address the biological aspect of the impaction
bone grafting technique, and further clinical follow-up studies or in vivo animal
studies should address this question. Leaving the cortical bone from the neck did
not interfere with the compaction of the morselized grafts or the creation of a stiff
layer of bone. In these days of imbalance between supply and demand of
allografts [13], saving 15% of material would be in the interest of bone banks
worldwide.

ACKNOWLEDGMENTS

The authors would like to extend their gratitude to Aimé Decoster for his constant
and skillful support in the mechanical testing.

REFERENCES

1. Slooff TJ, Huiskes R, van-Horn J, Lemmens AJ. Bone grafting in total hip
replacement for acetabular protrusion. Acta Orthop Scand 1984; 55:593 – 596.
2. Gie GA, Linder L, Ling RS, Simon JP, Slooff TJ, Timperley AJ. Impacted cancellous
allografts and cement for revision total hip arthroplasty. J Bone Joint Surg Br 1993;
75:14 – 21.
3. Ling RS. Femoral component revision using impacted morsellised cancellous graft
(letter; comment). J Bone Joint Surg Br 1997; 79:874– 875.
4. Karrholm J, Hultmark P, Carlsson L, Malchau H. Subsidence of a non-polished stem
in revisions of the hip using impaction allograft. Evaluation with radiostereometry
and dual-energy x-ray absorptiometry. J Bone Joint Surg Br 1999; 81:135– 142.
5. Ullmark G, Nilsson O. Impacted corticocancellous allografts: recoil and strength.
J Arthroplasty 1999; 14:1019– 1023.
6. Brewster NT, Gillespie WJ, Howie CR, Madabhushi SP, Usmani AS, Fairbairn DR.
Mechanical considerations in impaction bone grafting. J Bone Joint Surg Br 1999;
81:118 – 124.
7. Brown TD, Ferguson ABJ. Mechanical property distributions in the cancellous bone
of the human proximal femur. Acta Orthop Scand 1980; 51:429 –437.
8. Brodt MD, Swan CC, Brown TD. Mechanical behavior of human morselized
cancellous bone in triaxial compression testing. J Orthop Res 1998; 16:43 – 49.
9. Giesen EB, Lamerigts NM, Verdonschot N, Buma P, Schreurs BW, Huiskes R.
Mechanical characteristics of impacted morsellised bone grafts used in revision of
total hip arthroplasty. J Bone Joint Surg Br 1999; 81:1052– 1057.
Femoral Head Preparation 107

10. Keaveny TM, Wachtel EF, Guo XE, Hayes WC. Mechanical behavior of damaged
trabecular bone. J Biomech 1994; 27:1309 – 1318.
11. Slooff TJ, Buma P, Schreurs BW, Schimmel JW, Huiskes R, Gardeniers J. Acetabular
and femoral reconstruction with impacted graft and cement. Clin Orthop 1996;
324:108– 115.
12. Gie GA, Linder L, Ling RS, Simon JP, Slooff TJ, Timperley AJ. Contained
morselized allograft in revision total hip arthroplasty. Surgical technique. Orthop
Clin North Am 1993; 24:717– 725.
13. Galea G, Kopman D, Graham BJ. Supply and demand of bone allograft for revision
hip surgery in Scotland. J Bone Joint Surg Br 1998; 80:595– 599.
9
Impaction Bone Grafting with
Processed Freeze-Dried Allografts
Evolution of the Compactness and Stiffness
During Impaction

Olivier Cornu, Ashit Bavadekar, Bernard Godts,


Christian Delloye, and Xavier Banse
Université Catholique de Louvain
Brussels, Belgium
John Van Tomme
Royal Military Academy
Brussels, Belgium

I. INTRODUCTION

Impaction bone grafting is become an accepted procedure for managing revision


arthroplasties with bone defects. Most papers have reported good implant
stability and pain relief [1 – 4]. The aim of the procedure is to pack bone densely
into the cavity in which a new prosthesis will be implanted. One of the key factors
influencing outcome is the stiffness of the impacted material [2,5].
Usually the impaction bone grafting is performed with fresh-frozen femoral
heads. The use of this grafting material has the potential for disease transmission
[6], which is further increased when the grafts come from multiple donors. A hip
revision with impaction bone grafting usually requires two to three femoral heads
[7,8], and most bone banks currently face a limited supply of fresh-frozen
femoral heads [9].
Processed freeze-dried bone allograft has been used for selected indications
in orthopedics and is now a long tested material [10 –12]. Nowadays, preparation
of these grafts includes removal of marrow and bone cell, treatment with solvent-
detergent, prion inactivation treatment, freeze-drying, and finally gamma
109
110 Cornu et al.

irradiation. These steps all have a cumulative effect in reducing the risk of disease
transmission, producing very safe human grafting material. Due to the alteration
of the mechanical properties of bone by freeze-drying, mostly because of final
gamma irradiation [13,14], it has been used rather cautiously in clinical practice.
Irradiated freeze-dried bone is known to be less strong, less stiff, and significantly
more brittle than the fresh-frozen control when tested in static compression [15].
Because of this, Duncan et al. have questioned the suitability of freeze-dried graft
in impaction bone grafting [1].
It would be interesting to know if the altered mechanical properties of
freeze-dried grafts affect their ability to create a morselized bony layer of adequate
stiffness. To the authors’ knowledge, there has been neither a documented study
of use of freeze-dried, irradiated morselized grafts in impaction bone grafting nor
any study concerning their mechanical properties. The goal of this study was to
investigate, in vitro, the development of the density and stiffness of processed
freeze-dried cancellous bone during impaction grafting and explore its
mechanical suitability for this procedure.

II. MATERIALS AND METHODS


A. Donor Selection and Source of Grafts
Six fresh-frozen human femoral heads from six patients (two females and four
males) were procured at the time of primary hip arthroplasty for osteoarthritis and
stored at 2808C. The median age of the donors was 72 (53 – 75) years. Each
femoral head was weighed separately (Table 1) and radiographed to exclude
severe osteopenia or osteoarthritic lesions.

B. Graft Processing
In a previous study [16] it was shown that retaining the articular cartilage in the
preparation of the morselized grafts had a deleterious effect on the mechanical
outcome during impaction, while inclusion of the cortical bone from the neck had
no effect except to increase the amount of material. Consequently, the femoral
heads were cleared of all their soft tissues (articular cartilage remnants and
synovium), while the cortical neck was retained. The heads were then cut with a
bandsaw into two halves in the coronal plane, keeping the fovea femora capitis as
the reference point. Half femoral heads were weighed separately on a digital
weighing scale (Mettler PE 3000, Zurich, Switzerland) (Table 1). Two groups
consisting of six half femoral heads were made, with the anterior or posterior half
of the same head being alternatively included in one of the batches.
The half heads of the fresh frozen group were stored frozen at 2808C
(Forma Scientific Inc., Marietta, Ohio). The other halves underwent the following
Processed Freeze-Dried Allografts 111

Table 1 Origin of the Material and Weight Loss on Preparation of the Morsellized
Grafts

Fresh frozen
Donor Whole head (FF) half head Freeze Dried (FD) half head

Weight Freeze-
without Ant/ Ant/ Treated dried
Weight cartilage Post Weight Post Weight weight weight
Name Sex Age (g) (g) half (g) half (g) (g) (g)
VP M 75 90.9 73.8 Post 37.1 Ant 35.0 18.5 12.5
PC F 61 86.0 67.0 Post 35.2 Ant 29.8 15.4 11.3
WM F 72 79.6 66.2 Post 32.6 Ant 31.8 13.7 9.4
DG M 53 100.9 66.8 Ant 31.4 Post 33.6 22.8 13.5
LC M 72 94.4 71.4 Ant 39.0 Post 35.1 15.2 10.2
TJ M 72 87.2 66.7 Ant 32.4 Post 32.5 18.7 12.6
Mean: 67.5 89.8 68.7 34.6 33.0 17.4 11.6

processing. They were thoroughly washed under a jet of deionized water to


remove bone marrow and blood cells. Lipids were extracted by a 1: 1 (v/v)
chloroform-methanol solution renewed 3 times for at least 2 days and rinsed with
methanol and water [11]. Denaturation of the bone proteins (prion-inactivating
procedure) was then applied and followed once again by a 1-day rinsing in tap
demineralized water. At the end of this chemical treatment, the half heads were
gently centrifugated to eliminate the water and weighed to measure the loss due
to removal of some bone constituents.
Half heads from both groups were then morselized twice, when wet, with
the small rasps of the Noviomagnus bone mill (Spierings, Nijmegen,
Netherlands). The morselized grafts from the processed group were placed in
open vials separately, freeze-dried for 48 –72 hours (temperature condensor
2808C, temperature of the chamber 2308C, working vacuum 11024 mmHg)
and irradiated at a minimal irradiation dose of 25 kGy source of irradiation
Cobalt 60 [15]. After freeze-drying and irradiation, the residual moisture of the
bone was calculated by gravimetry to be 2.5% of dry material (Sartorius MA 30,
Goettingen, Germany).

C. Sampling and Randomization of Samples


The fresh-frozen morselized grafts were mixed in a bowl and separated into 5 g
samples. The processed morsels were also mixed to homogenize the whole
112 Cornu et al.

Figure 1 Typical appearance of the two types of morselized grafts. Note that 5 g
of fresh frozen morselized grafts corresponds to 1.75 g of freeze-dried. Their
apparent volume remains the same.

batch and sampled in units of 1.75 g (Fig. 1). The 5 g/1.75 g ratio was
determined according to our measurements of weight loss during the processing
(see Table 1), and equivalent amount of bone material was present in both types
of sample. Eighteen randomly selected samples of the two types of graft were
chosen for the mechanical testing. The experiment was designed so that the fresh-
frozen bone was the control and the processed bone the test group.

D. Impaction on the Grafts


The bone was impacted into a specially designed apparatus consisting of an
aluminum tube (inner diameter 14.6 mm) to contain and confine the grafts.
Thirty-six holes (1 mm diameter) were made in it to facilitate the expulsion of the
bone marrow during the course of an impaction. The tube was fixed to a solid
aluminum block. A solid cylindrical aluminum impactor (diameter 14.4 mm)
telescoped freely in the cylinder. A 1 m iron rod was placed on top of the
impactor and served as a guide for a mass (simulating the classical impaction
instrumentation) of 455 g. One fall of the mass on the impactor was considered as
one impaction [16].
The fresh-frozen morselized grafts were thawed at room temperature
2 hours prior to the mechanical test. The freeze-dried samples were separately
Processed Freeze-Dried Allografts 113

rehydrated with saline for 30 minutes [15] before being tested. One sample at a
time was loaded in the cylinder and tested. The impaction procedure was
interrupted regularly (at 1, 3, 5, 10, 20, and every 10 impactions up to 150) to
measure the height of the column of morselized grafts and its stiffness. The height
was measured with a digital caliper as the distance between the top of the tube
and a fixed point on the impactor. The compressive stiffness (or Emod, MPa) of
the impacted grafts was measured by placing the experimental setting in a testing
machine (Zwick model Z50/TH3A, Zwick GmbH, Ulm, Germany). The upper
plate of the machine compressed gently the impacting material at a speed of
0.5 mm/min. The load was measured by a 2 KN load cell and the displacement
by an extensometer (Multisens, Zwick) positioned across the tube and the
impactor (Fig. 2). To avoid excessive compression of the grafts during the
measurement, the test was limited to a range of either 80 N of force (0.5 MPa) or
0.3 mm of displacement. Stiffness was calculated as the slope of the curve
between 60 and 98% of maximal load (the linear part of the curve).

Figure 2 The experimental setting: the aluminum cylinder containing the grafts
placed between the plates of the testing machine for determination of the stiffness
of the impacted grafts. The same setting was used with a guiding rod and a gliding
mass to impact the samples before stiffness measurement.
114 Cornu et al.

After reaching the measurement limit, the cylinder of grafts was


immediately unloaded. Knowing the time-dependent mechanical properties of
morselized grafts (creep and recoil, [17]), we chose to standardize the testing
conditions for each sample. The height and stiffness measurements were
performed over a constant time of one minute between impactions. The third
variable was the development the density of the impacted material. To monitor
the densitometric changes, the procedure was interrupted at different levels of
impaction. The impacted cylinders were gently expressed from the aluminum
cylinder, placed in plastic tubes, and immediately frozen on dry ice.
Consequently, out of the 18 samples of each group, 4 were impacted until the
third impaction, 4 until the tenth, 4 until the fiftieth, and 6 until the final 150th.
The frozen impacted specimens were scanned using a pQCT (peripheral
quantitative computed tomography machine, model XCT Research SAþw,
Stratec, Pforzheim, Germany). Density value is expressed in g/cm3.

E. Statistical Analysis
Statistical analysis was performed using the ANOVA with repeated measures for
studying the differences in the mechanical parameters (height and stiffness)
between the graft types (SPSS 9.0, SPSS Inc., Chicago, IL). This analysis was
performed considering results from one to 3, one to 10, one to 50, and one to 150
impactions to investigate the initial part of the impaction procedure. As the
density was measured on different samples during the impaction, the mean
density obtained with both type of grafts was compared using a paired t-test. This
test was repeated for the four different levels of impaction.

III. RESULTS
A. Weight Loss
Removal of the cartilage from a femoral head caused, in weight, a loss of 24% of
material. During the processing, the removal of the bone marrow, fat, and cellular
debris with water jet and the chemical treatment yielded a drop of 47% of the
weight. After freeze-drying, the weight of these chemically treated bone samples
further dropped to 35% of their initial weight (Table 1).

B. Height
The density or the decrease in height of the column of grafts (deformation on
impaction) showed a considerable difference between the two types of grafts
(Fig. 3). Freeze-dried graft layer deformed to about one third of its initial height,
while the fresh-frozen control reached half of its initial height. Both the rate of
Processed Freeze-Dried Allografts 115

Figure 3 The evolution of the height during impaction for the two types of grafts.
Note that the number of impactions is presented as a log scale. The line represents the
mean value and the bars the standard error of this mean value. Up to three impactions,
n ¼ 18 (number of measurements performed); up to 10 impactions, n ¼ 14; up to 50
impactions, n ¼ 10; up to 150 impactions, n ¼ 6 for each type of graft.

deformity after up to 3, 10, or 50 impactions and the final height after up to 150
impactions was lower for the freeze-dried bone ( p , 0.001 ANOVA).

C. Stiffness
The pattern of increase in the stiffness of the two types of grafts showed the
following similarities and differences (Fig. 4). Both the freeze-dried and the
fresh-frozen grafts reached a final mean modulus of about 55 MPa after 150
impactions. The freeze-dried bone achieved this after only 20 impactions. In
contrast, the fresh-frozen morselized bone showed a slow but constant increase of
the modulus levels after successive impactions. After the 70 impactions, the
value was the same as for the freeze-dried bone.
The ANOVA with repeated trials showed that the stiffness increased
significantly faster up to 3 ( p , 0.001), 10 ( p , 0.001), and 50 ( p ¼ 0.005)
impactions but no more when considering the whole curve until 150. This
emphasizes that the difference between the two curves is noted only in the initial
stages of the experimental impaction procedure (Fig. 4).

D. Density
In both groups the density increased during impactions (Fig. 5). The mean density
of fresh-frozen morselized graft rose from a value of 0.45 g/cm3 at 3 impactions
116 Cornu et al.

Figure 4 The evolution of the stiffness (stiffness) of the two types of grafts with
progressive impaction. Same amounts of data as in Figure 3 are used for mean and
standard error of the mean (bars) calculations. Note the difference in the trends of
the curves, which reach more or less the same final modulus. This implies that the
freeze-dried morselized grafts are impacted faster as compared to the fresh frozen,
which steadily becomes stiffer, but never reaches a plateau in its values. ANOVA
indicated significantly higher modulus up to three impactions (p , 0.001, ), up to
10 impactions (p , 0.001, ), and up to 50 impactions (p ¼ 0.005, ), but not up
to 150 impactions (p . 0.05, NS).

to 0.65 g/cm3 at 150 impactions. In contrast, the freeze-dried morselized grafts


showed a rapid rise in density from 0.5 g/cm3 at 3 impactions to final value of
0.95 g/cm3 at 150 impactions. At 3, 10, 50, and 150 impactions the density was
significantly higher for the freeze-dried bone ( p ¼ 0.005, p , 0.001, p , 0.001,
and p , 0.001, respectively).

IV. DISCUSSION

For obtaining unbiased comparison of two types of morselized allografts, the


pairing of samples is a critical aspect of the experimental design. In this study, the
osteoarthritic femoral heads were split in two halves, and each half was accorded
to one group. This allowed us to obtain two groups of grafts coming from the
same set of femoral heads. After processing and milling, the morselized grafts
from each group were mixed to increase the homogeneity of the samples within
that group and reduce the between-sample variability. In the freeze-dried group
Processed Freeze-Dried Allografts 117

Figure 5 The evolution of density (g/cm3) for the two types of graft on successive
impactions. At 3, 10, and 50 impactions, density measurements were carried out on
four samples of each type of graft. At 150 impactions, six measurements were
done.

the weight of material for one sample was adjusted to account for loss of marrow,
fat, and water during the processing. Therefore, the same amount of bone matter
was poured in the cylinder. Although it not shown on the log chart (Fig. 3), the
mean height before impaction was the same for both groups (26 mm). All of these
experimental details standardized the comparison between the fresh-frozen and
the processed morselized bone grafts.
The encouraging mechanical properties of processed freeze-dried bone in
impaction bone grafting may seem inconsistent with the results of static
compressive tests previously performed in our laboratory [15]. As in the present
study, these tests were done after 30 minutes of rehydration on similarly treated
cancellous bone from femoral heads. The treatment induced a 42% reduction of
the strength, a 21% reduction in modulus, and 75% reduction in work to failure
(embrittlement of the bone). However, the mechanics of impaction morselized
grafting is completely different from static testing. This study confirmed that
stiffness of the graft layer was most dependent on the bone density achieved by
successive impactions [16]. Our model clearly shows that the processed bone
became impacted much faster than the fresh-frozen control (Fig. 4). This may be
caused by different factors. First, on impacting the grafts, the stress is applied at
high speed on the material. In such conditions, bone marrow may play an
important role [18], and hence, the replacement of bone marrow by saline in the
118 Cornu et al.

processed bone may accelerate the compaction of the grafts [2]. Second,
the embrittlement due to bone processing [15] may be helpful in impaction bone
grafting. The higher the brittleness, the faster the compaction, and even if the
morsels of graft has a 21% lower modulus [15], a faster rise in bone density leads
to a faster rise in stiffness (Fig. 5).
Although the main advantage of the processed bone is the striking
reduction of the risk of disease transmission because of multiple treatments, it
could also improve surgical practice. In practice, three to five times fewer
hammer blows are required to impact the processed bone correctly and get an
equivalent modulus to fresh-frozen bone.
In the operating room, this may spare surgical time and reduce the risks of
fracture of the femoral cortex, which remain one of the complications of the
impaction procedure [3,4,19]. Dispensed as ready to use and stored packed at
room temperatures, the morselized freeze-dried grafts could have further clinical
implications in saving the surgical time lost morselizing fresh-frozen femoral
heads. Finally, as there is no quarantine period for the processed freeze-dried
grafts [20], such grafts could be made more readily available than fresh-frozen
femoral heads. On the other hand, the use of processed bone may also be
disadvantageous. As shown by the height and density data, if the surgeon impacts
the processed grafts as much as the fresh-frozen ones, the amount of bone needed
to fill a given cavity will be 70% higher, but with the benefit of a more stable
reconstruction.
It can be concluded that, contrary to what was expected, the present model
of impaction failed to show that processed freeze-dried was mechanically inferior
to the fresh-frozen material. Because it can be impacted faster, it could be
mechanically more efficient than the fresh-frozen bone in surgical conditions.
The highest safety standards do not necessarily impair implant stability.

ACKNOWLEDGMENTS

The authors would like to extend their gratitude to Prof. J. P. Devogelaer for
obtaining density data.

REFERENCES

1. Duncan CP, Masterson EL, Masri BA. Impaction allografting with cement for the
management of femoral bone loss. Orthop Clin North Am 1998; 29:297– 305.
2. Karrholm J, Hultmark P, Carlsson L, Malchau H. Subsidence of a non-polished stem
in revisions of the hip using impaction allograft. Evaluation with radiostereometry
and dual-energy x-ray absorptiometry. J Bone Joint Surg 1999; 81:135 – 142.
Processed Freeze-Dried Allografts 119

3. Leopold SS, Jacobs JJ, Rosenberg AG. Cancellous allograft in revision total hip
arthroplasty. A clinical review. Clin Orthop 2000; 371:86 – 97.
4. Slooff TJ, Buma P, Schreurs BW, Schimmel JW, Huiskes R, Gardeniers J. Acetabular
and femoral reconstruction with impacted graft and cement. Clin Orthop 1996;
324:108– 115.
5. Ling RS. Femoral component revision using impacted morsellised cancellous graft
(letter; comment). J Bone Joint Surg 1997; 79(B):874– 875.
6. Tomford WW. Transmission of disease through transplantation of musculoskeletal
allografts. J Bone Joint Surg 1995; 77(A):1742– 1754.
7. Galea G, Kopman D, Graham BJ. Supply and demand of bone allograft for revision
hip surgery in Scotland. J Bone Joint Surg 1998; 80(B):595 –599.
8. Henman P, Finlayson D. Ordering allograft by weight: suggestions for the efficient
use of frozen bone-graft for impaction grafting. J Arthroplasty 2000; 15:368 –371.
9. Norman-Taylor FH, Villar RN. Bone allograft: a cause for concern? (editorial).
J Bone Joint Surg 1997; 79(B):178 –180.
10. Cornu O, de Halleux J, Banse X, Delloye C. Tibial tubercle elevation with bone
grafts. A comparative study of autograft and allograft. Arch Orthop Trauma Surg
1995; 114:324 –329.
11. Delloye C, Allington N, Munting E, Vincent A. Lyophilized banked bone. Technique
and results after 3 years of use. Acta Orthop Belg 1987; 53:2 – 11.
12. Fabry G. Allograft versus autograft bone in idiopathic scoliosis surgery: a
multivariate statistical analysis. J Pediatr Orthop 1991; 11:465– 468.
13. Anderson MJ, Keyak JH, Skinner HB. Compressive mechanical properties of human
cancellous bone after gamma irradiation. J Bone Joint Surg 1992; 74(A):747 –752.
14. Pelker RR, Friedlaender GE, Markham TC. Biomechanical properties of bone
allografts. Clin Orthop 1983; 174:54– 57.
15. Cornu O, Banse X, Docquier PL, Luyckx S, Delloye C. Effect of freeze-drying and
gamma irradiation on the mechanical properties of human cancellous bone. J Orthop
Res 2000; 18:426– 431.
16. Bavadekar A, Cornu O, Godts B, Delloye C, Van Tomme J, Banse X. Stiffness and
compactness of morsellised grafts during impaction: an in vitro study with human
femoral heads. Acta Orthop Scand 2001; 72(5):470 –476.
17. Ullmark G, Nilsson O. Impacted corticocancellous allografts: recoil and strength.
J Arthroplasty 1999; 14:1019 – 1023.
18. Carter DR, Hayes WC. The compressive behavior of bone as a two-phase porous
structure. J Bone Joint Surg Am 1977; 59:954– 962.
19. Pekkarinen J, Alho A, Lepisto J, Ylikoski M, Ylinen P, Paavilainen T. Impaction
bone rafting in revision hip surgery. A high incidence of complications. J Bone Joint
Surg 2000; 82(B):103 – 107.
20. European Association of Musculo Skeletal Transplantation (EAMST) and European
Association of Tissue Banks (EATB). Common Standards for Musculoskeletal
Tissue Banking. Vienna, 1997.
10
Bone Graft Substitutes for
Impaction Grafting
Ashley W. Blom and Ian D. Learmonth
University of Bristol, Bristol Royal Infirmary
Bristol, England

Total hip arthroplasty is one of the most successful surgical procedures of the last
century. Periprosthetic osteolysis and aseptic loosening is the most common
cause of failure. The incidence of revision surgery has increased with the
increasing number of primary hip arthroplasties performed annually worldwide.
Loss of bone stock is the major challenge at revision hip arthroplasty. This has
been addressed, with good medium-term results, by morselized impaction
allografting [1]. However, there are now concerns over availability [2 – 4],
infection [5 – 7], and cost [8].
An aging population will result in an increase in the number of primary
total hip replacements. Galea has warned of the impending shortage of donor
femoral heads and said: “This source cannot meet the demand for revision
surgery of the hip or for other operations because of the increase in the number of
revisions and the use of techniques which require more bone, such as impaction
grafting, which may use up to five femoral heads.” Other studies reached similar
conclusions [2 –4,9].
Allografts have the potential to invoke rejection by activating T-cell –
mediated immune responses from the host [10]. Friedlander et al. have identified
donor-specific anti-HLA antibodies in human recipients of freeze-dried allografts
[11]. Sensitization does not seem to adversely influence clinical outcome [12].
Viral, bacterial, and prion infections remain a potential problem with bone
grafting despite all the meticulous standard preventative measures. Hepatitis C
and human immunodeficiency virus (HIV) are of particular concern, the latter
121
122 Blom and Learmonth

more so because of the problem with effective screening consequent upon the
highly variable window between infection with HIV and the presence of
detectable antibodies [5,13,14]. The incidence of postoperative infection is twice
as high with allograft bone as compared with autograft bone [7] and is influenced
by a number of variables.
Burgeoning health care costs make cost containment an important
consideration. Meding et al. outlined the costs of the disposables used at
impaction grafting and noted that femoral heads cost $950 each, with up to five
being used at a time [8].
The issues of availability, antigenicity, infection, and expense can all be
addressed by the introduction of a less costly but equally effective bone substitute.
An ideal bone graft substitute needs to impart structural stability under load in
order to permit early weight bearing of the patient. It also needs to maintain this
stability over time while subjected to the biological processes and responses of the
body. Ideally the bone graft substitute should itself in time be replaced by living
host bone, thereby restituting bone stock loss. This would be particularly helpful
in younger patients, who would be expected to require further revision surgery.
The ideal bone substitute should:
1. Impart structural stability
2. Encourage neo-ossification by means of osseoconduction, substitution,
and osseoinduction
3. Be inexpensive
4. Have unlimited availability
5. Have no infectivity
6. Provoke no antigenicity
Bone grafts and bone graft substitutes can be broadly classified as shown in Table
1. More than 50 types of bone graft substitutes are now on the market, all
attempting to address the above problems (Table 2).

I. XENOGRAFT

Bovine bone has been investigated as a potential substitute for human allograft
bone since the 1960s [15]. More recently Levai and Boigard reported good results
in 27 out of 30 cases using bovine bone in acetabular reconstruction in total hip
revision [16]. Bovine bone is biocompatible for human osteoblasts [17]. Hubble
et al. showed that when cyclically loaded, bovine bone exhibited stability similar
to human bone when used as a morselized graft in impaction grafting of the
femur. Their pilot studies in sheep showed graft incorporation with new bone
formation comparable with allograft [18].
Bone Graft Substitutes for Impaction Grafting 123

Table 1 Classification of Bone Graft Substitutes

Biological/
Biological Biological Synthetic Synthetic synthetic
human nonhuman nonabsorbable absorbable combinations

Autograft Xenograft Methylmetha- Calcium Collagen


crylate sulfate matrix
(ceramic/
fibrillar
collagen)
Allograft Corraline Glass-ionomers Ceramic:
Hydroxyapatite
Tricalcium
phosphate
Other Polyhydroxy
(e.g., bamboo acids
[103,104], and
eggshell [105])

Other studies have highlighted problems with bovine xenograft. Begley


et al. demonstrated that bovine xenograft causes intense inflammatory reactions
that are not provoked by coral when used in identical circumstances [19]. There
are also fears with regard to prion infection and patient acceptability in view of
recent scares caused by bovine spongioform encephalopathy (BSE).

II. POLYMETHYLMETHACRYLATE (BONE CEMENT)

This is a nonabsorbable material widely used to fix prostheses in joint


replacement surgery. It is a filling material and not a glue. Although it has been
used as a bone graft substitute in tumour surgery [20], it has many limitations,
including low tensile strength, brittleness, and a tendency to provoke an
aggressive osteolytic response [21]. When used to replace lost bone stock in
revision total hip arthroplasty, the results have invariably been poor [22 –25]. Its
application as a bone graft substitute is therefore limited.

III. CALCIUM SULFATE (PLASTER OF PARIS)

Calcium sulfate was used as long ago as 1892 by Dreesman to fill bony defects
caused by tuberculous osteomyelitis [26]. Since then it has fallen into disfavor as
it is quickly absorbed (within 4 –8 weeks) and thus provides poor structural
124 Blom and Learmonth

Table 2 Commercially Available Allograft Substitutes

Allograft substitute Commercial products and sources

Bovine xenograft Bio-Oss (Osteohealth, Shirley, NY)


Unilab (Barrie, Ontario, Canada)
Pyrost (Stryker Howmedica, Rutherford, NJ)
Luboc (Ost Developpement, France)
Coralline hydroxyapatite Biocoral (INOTEB, Saint Gonnery, France)
ProOsteon (Interpore Cross Int., Irvine, CA)
Interpore 200 (Interpore Cross Int., Irvine, CA)
PMMA HTR-PMI (Lorenz, Jacksonville, FL)
Glass ionomer Ionogran (Ionos Medizinische Produkte, Germany)
Bioglass (US Biomaterials, Alachua, FL)
BioGran (Orthovita, Malvern, PA)
Calcium sulfate Hapset (Lifecore Biomedical, Chasla, MN)
TCP ceramics Biosorb (Aesculap, Lourdes, France)
Norian SRS (Synthes-Stratel, Cupurtino, CA)
BoneSource (Stryker Howmedica, Rutherford, NJ)
Alpha BSM (ETEX Corp., Cambridge, MA)
HA ceramics Osteogen (Impladent, Holliswood, NY)
Cerapatite (Ceraver Osteal, Roissy, France)
Synatite (Aesculap, Lourdes, France)
Cementek (Teknimed, Vic-en-Bigorre, France)
Biphasic HA þ TCP ceramics Triosite (Zimmer, Cedex, France) porous
Apacoram (Asahi Optical, Tokyo, Japan) porous
Calcitite (Calcitek International, Carlsbad, CA)
Ostilit (Stryker Howmedica, Rutherford, NJ) porous
Collagen matrix Collagraft (Zimmer, Cedex, France)
Callopat (Osteo AG, Switzerland)
Grafton (Osteotech, Eatontown, NJ)
Ne-Osteo (Stryker Howmedica, Rutherford, NJ)

stability [27,28]. In addition, it is prone to fracture when shear loaded.


Nevertheless, Coetzee [29] reported excellent results in 110 patients when using
calcium sulfate to repair cranial defects. He reported complete substitution of
calcium sulfate with bone within 8 weeks. There have been no other reports in the
literature to support these dramatic results.

IV. GLASS-IONOMER CERAMICS

These are formed by sintering glass in different proportions of SiO2, Al2O3, CaF2,
and AlPO4, with or without hydroxyapatite. Glass-ionomers are not resorbable,
Bone Graft Substitutes for Impaction Grafting 125

as bone cannot eliminate the silicate and aluminum from which they are
constructed. They have been demonstrated to have good osseoconductive
potential between particles, but not within them, as well as being biocompatible
without causing foreign body reactions [30]. After bony ingrowth has occurred,
the glass-ionomer remains permanently within the new fibro-osseus matrix [31].
It remains unclear whether this enhances structural stability or whether the
persistence of unresorbed foreign particles prevents restitution of normal
morphology with permanent weakening of the bone. These issues are still to be
resolved in long-term studies. An ovine study using a glass-ionomer as a bone
graft expander in impaction grafting of the femur performed at the University of
Bristol showed good clinical but poor histological results (with multiple voids
within the graft and little graft incorporation) at 6 months [32].

V. POLYHYDROXY ACIDS

Polyhydroxy acids have been used for the past 30 years to manufacture
absorbable sutures such as DexonR, which is made from polyglycolic acid (PGA)
[33]. Glycolic acid is a naturally occurring substance produced during normal
human metabolism. It belongs to the same family of acids as lactic acid.
PGA is most commonly used to manufacture multifilament yarns, but a
variety of substances can be manufactured, including screws [34], pins [35], rods
[36], and mesh [37]. These have a wide range of clinical applications ranging
from pinning wrist [38] and elbow [39] fractures to the fixation of osteotomies
[40]. These products have the advantage of obtaining good fracture fixation and
then gradually resorbing.
PGA and polylactic acid (PLA) multifilament yarns have been synthesized
as delivery agents for bone morphogenetic proteins (BMPs). These yarns have
very consistent and predictable rates of bioabsorption and thus produce a
controlled delivery of BMPs. In 1995 Robinson et al. described the use of blocks
of porous PGA, which structurally mimic cancellous bone, to repair calvarial
bone defects [41]. Polyhydroxy acids have not been demonstrated to provide the
structural support needed in high load-bearing bone, such as the acetabulum and
proximal femur.

VI. COLLAGEN MATRIX

These are formed by a combination of purified fibrillar collagen (usually bovine)


and ceramic composed of hydroxyapatite and tricalcium phosphate. The collagen
provides a structure similar to extracellular matrix, but it potentially has the same
126 Blom and Learmonth

problems of bovine bone xenograft with regard to infection and antigenicity.


Chapman et al. [42] reported raised antibody titers in 12 patients treated with a
bovine collagen – calcium phosphate graft material for long bone fractures.
Despite this, the patients showed no ill effects. With regard to fracture healing,
those treated with the collagen matrix material did as well as those treated with
autograft [42]. Collagen matrix substances have also been used experimentally in
animals as cranial onlay grafts [43] and to heal tibial defects in sheep [44] and
rabbits [45]. Not all reports have been favorable. Muschler et al. [46] compared a
collagen matrix substance to autograft when attempting spinal fusion in dogs.
The collagen matrix substance performed markedly worse than the autograft. At
present, these materials are available in a paste form and have U.S. FDA approval
for fixation of long bone fracture defects, providing they are used in conjunction
with internal or external fixation.

VII. CORALLINE-DERIVED HYDROXYAPATITE

This biomaterial is derived from reef-building coral of the genus Porites. The
calcium carbonate exoskeleton is converted to hydroxyapatite by means of a
hydrothermal chemical exchange, while still maintaining the original micro-
structure [47]. The microstructure of the coral is similar to bone, with a porous
structure and pore size that facilitates bony ingrowth [48]. A pore size of around
500 mm has been demonstrated to be optimal for bony ingrowth [49,50]. Coral
has a low potential for infectivity [51,52] and antigenicity [53].
Coralline hydroxyapatite has been shown to osseointegrate well in rabbits
[54], rats [55], dogs [56], baboons [57], and sheep [58]. It has been successfully
used in humans as a space-filling material in maxillofacial surgery [59,60].
However, it is fragile and does not appear to possess the mechanical strength [61]
to be used in load-bearing bone such as the proximal femur.

VIII. ABSORBABLE CERAMICS

Ceramics are manufactured by baking or firing minerals. The ceramics most


commonly used as bone graft substitutes are made of tricalcium phosphate
[Ca3(PO4)2] and hydroxyapatite [Ca10(PO4)6(OH)2]. Ceramic powder is
obtained by precipitation from an aqueous solution, e.g., by adding ammonium
phosphate [(NH4)HPO4] to a calcium nitrate solution [Ca(NO3)2] at pH 11– 12
[62]. This is then cold-pressed to form tablets. These are baked or fired at a
high temperature (.8008C), causing their crystals to fuse. This process, called
sintering, produces a dense material with a porosity by volume of 1 –5%
Bone Graft Substitutes for Impaction Grafting 127

(depending on parameters such as sintering temperature, sintering time, and


grain distribution).
A number of synthesis parameters have a profound effect on the behavior of
absorbable ceramics. These include structural strength, resorption of the ceramic,
and osseointegration and osseoconduction.

A. Structural Strength
Authors are divided as to whether absorbable ceramics have the required strength
to withstand the forces within the proximal femur [61,63]. Hanft et al. state: “The
principle limitation of calcium phosphate materials as hard-tissue implants has
apparently been their mechanical properties.” They go on to say, “Unfortunately,
these mechanical weaknesses have prevented this material from being used in
cases where they must bear the initial structural load alone” [64].
In rebuttal, Jarcho [63] cites compressive strength of porous calcium
phosphate as similar to that of cancellous bone, while the tensile strength is 72%
of the tensile strength of cancellous bone. Nonporous calcium phosphate has a
tensile and compressive strength far in excess of both cancellous and cortical
bone (Table 3). The structural strength would need to be determined for any
particular bone graft substitute constructed from these materials.
Bouler et al. [65] studied the influence of five synthesis parameters on
compressive strength of porous biphasic calcium phosphate ceramics. These
parameters were:
1. Chemical composition
2. Percentage of macropores
3. Mean size of macropores
4. Isostatic compaction pressure
5. Sintering temperature

Table 3 Compressive and Tensile Strength of Bone and Calcium Phosphate


Ceramics

Compressive strength Tensile strength


Material (103 psi) (103 psi)

Cortical bone 20 10
Cancellous bone 6–9 0.5
Porous calcium phosphate 1 – 10 0.36
Dense calcium phosphate 30 – 130 10 –28

Source: Ref. [64].


128 Blom and Learmonth

Macroporosity and final sintering temperature exerted the major influences on


compressive strength.
Two ratios of HA to TCP were studied—45% HA:55% TCP and 75%
HA:25% TCP. The lower ratio of HA provided slightly better compressive
strengths. Isostatic compression had comparatively little influence on compres-
sive strength. The more porous the ceramic, the less resistant it was to compressive
forces. For a given volume percentage porosity, a few 500 mm pores were better
than many 100 mm pores. When the thickness of the bridges between the pores
fell below a critical size, the ceramic structure disintegrated when subjected to
even low compressive forces. These findings are confirmed by data released by
SBM on their ceramic bone graft substitute (Biosorb), detailed in Table 4 [66].
Bouler et al.’s study [65] also showed that compressive strength increased
significantly with a rise in sintering temperature. At 9008C, boundaries between
grains of ceramic were formed. Mechanical properties of biphasic ceramics are
dependent on the number and size of these grain boundaries. At temperatures
between 900 and 11008C, densification (the elimination of connected and
nonconnected micropores) occurred. This densification corresponded with
further increase in compressive strength.
Blom et al. [67] and Grimm et al. [68] designed and mechanically tested
a biphasic ceramic bone graft substitute specifically for use in impaction grafting
at revision hip arthroplasty. Various ratios of the ceramic and allograft were
compared with pure allograft. Impaction grafting was performed in a specially
designed model, which was then cyclically block loaded in a servohydraulic
testing machine. The load cycle was up to 20,000 cycles, with forces up to 800 N.
Pure allograft subsided significantly when loaded. When ceramic was
added to the allograft, the composite was significantly more stable. This increased
stability was proportional to the amount of ceramic added. Not only did the
addition of ceramic make the composite more stable, it also made the behavior of
the composite more predictable (see Figure 2).

Table 4 Compressive and Bending Strength of a TCP


Ceramic as a Function of Porosity

Porosity (%)

5 30 45

Compressive 150 100 15


strength (MPa)
Bending strength 15 10 2
(MPa)
Bone Graft Substitutes for Impaction Grafting 129

Figure 1 Histology slide showing osseointegration between a ceramic bone graft


substitute and new bone. (From the authors’ work on the development of a bone
graft substitute for impaction grafting.)

B. Resorption of the Ceramic


The body resorbs ceramics at different rates, depending on their chemical
composition and structure. Two different biological processes govern resorption:
dissolution (in physiological solutions) and phagocytosis. Frayssinet et al. [69]
observed both these processes causing resorption of calcium phosphate cera-
mics implanted into sheep bone. Multinucleated giant cells caused localized
areas of resorption. In addition, a uniform dissolution was observed around the
implant surfaces. Guillemin et al. observed osteoclast resorption of implanted
coral-derived ceramic [70].
The dissolution of HA and TCP in both buffered acid and buffered basic
solutions has been compared. The HA and TCP ceramics studied were prepared
with similar structural characteristics, so that any difference in resorption would be
due to their chemical compositions. The TCP ceramic dissolved 12.3 times faster
in the acid and 22.3 times faster in the basic solution than the HA ceramic [71].
130 Blom and Learmonth

Kay [72] compared the dissolution rate of various calcium phosphates in an


aqueous solution at 378C and pH 7.3. TCP was 25 times more soluble than HA.
Calcium phosphate was 667 times more soluble than HA.
Shimazaki and Mooney compared both implant resorption and new bone
formation between HA and TCP ceramics implanted into rabbit tibiae. At 24 weeks
postimplantation, 46.4% of the TCP had resorbed compared with 27.5% of the HA.
The HA, however, allowed 8% more new bone formation than the TCP [73].

C. Osseointegration and Osseoconduction


Calcium phosphate ceramics have an ability to bond directly to bone at a
molecular level. This process is known as osseointegration. This has been noted
in a number of studies [74,75]. This process does not rely on a macro-interlock.
Dental studies have shown that, once osseointegration has occurred, the bond
between the bone and the ceramic is so strong that attempts to separate the two
usually result in fracture of either the ceramic or the bone, but rarely separation at
the interface [76].
Osseoconduction is a term used to describe the growth of bone along a
predetermined pathway or scaffolding. When used with reference to porous
ceramic bone graft substitutes, it usually refers to bony ingrowth into the pores
within the ceramic. This has two main effects. First, it allows osseointegration
within the ceramic particles and not only around the periphery. Second, it allows
neo-ossification within the ceramic, thereby increasing the total amount of new
bone formation possible within the construct (see Figure 1).
Tsugura et al. have demonstrated the importance of porosity in allowing
osseoconduction [49]. High porosity is achieved in the manufacturing process by
one of a number of methods, including the addition of glucose (which expands
when heated and is then combusted) or the addition of hydrogen peroxide
(H2O2) or naphthalene [77]. Tsugura et al. compared the same ceramic with
different pore sizes, thus isolating pore size as the only variable. Their studies
showed that a porosity of around 500 mm allowed greater bony ingrowth than
smaller pores.
Guillemin et al. [78] compared the bony ingrowth into two species of coral
implanted into both ovine and porcine long bones. Porites coral resorbed twice as
fast as Acropora coral and had twice the bony ingrowth. Interestingly, Porites has
a mean pore diameter of 250 mm (range 150 –400) and Acropora coral has a
mean pore diameter of 500 mm (range 200– 800). It would therefore appear that
both pore size and rate of resorption of the ceramic influence osseoconduction.
Porosity also allows a greater degree of resorption to occur (by both dissolution
and phagocytosis) as the surface area of the ceramic is increased.
Ceramics have been used extensively as bone graft substitutes in humans.
In a randomized study of spinal fusion in 341 patients, Ransford et al. obtained
Bone Graft Substitutes for Impaction Grafting 131

similar results with autograft and TriositeR (a ceramic consisting of 60%


hydroxyapatite and 40% tricalcium phosphate) [79]. As these materials contain
no proteins, they do not provoke an antigenic response from host tissue [80,81].
Porous hydroxyapatite was used to repair tibial plateau fractures in a series of 17
patients with fracture union occurring in all cases [82]. Hydroxyapatite and
tricalcium phosphate ceramics have demonstrated marked osseointegration and
osseoconduction, both radiologically and histologically, in a number of studies in
humans and animals [83 – 88].
There is, however, very little experience with ceramic bone graft substitutes
in impaction grafting. Blom et al. [89] compared allograft with mixtures of
allograft and two ceramic bone graft substitutes in impaction grafting. Sheep
underwent femoral impaction grafting with a cemented, custom-made, highly
polished double-taper prosthesis. At 2, 4, 6, 12, and 18 months postoperatively,
they were assessed functionally and radiologically and the bone mineral density
of the impacted area was measured. At 22 months the femora were harvested and
examined histologically. In all outcome measures the ceramic bone graft
substitutes performed as well or better than allograft. At 22 months the ceramic
demonstrated good osseintegration with a stable construct (Figure 1). The
ceramic, however, seemed to obstruct retrabecularization. Retrabecularization

Figure 2 Subsidence in impaction grafting. The blue bars show pure allograft.
The purple bars show a 50/50 mixture of allograft and ceramic bone graft
substitute. The yellow bars show a mixture of 90% bone graft substitute and 10%
allograft. (From Ref. xx.)
132 Blom and Learmonth

was clearly visible on the specimens of pure allograft, but not on the specimens of
ceramic and allograft (see Figure 4).
Oonishi et al. report excellent clinical results using hydroxyapatite to fill
massive acetabular [90] and femoral [91] defects at the time of revision hip
replacement, despite the loads of up to 240% of body weight achieved while
mobilizing with crutches [92]. An acetabular specimen of impacted
hydroxyapatite granules retrieved 2 years after implantation showed osseointe-
gration between granules and bone with bony ingrowth 20 mm into the mass of
granules [93].

Figure 3 Radiograph of impaction grafting with a bone graft substitute 3 years


after implantation.
Bone Graft Substitutes for Impaction Grafting 133

Figure 4 Radiograph from an ovine study showing ceramic granules still clearly
visible 2 years after impaction grafting.

IX. SUMMARY AND DISCUSSION

Allograft has problems of infection [94] and antigenicity [95,96]. Allograft is


unpredictably variable in quality [97]. Preparing allograft is laborious, expensive,
and time-consuming. It requires dedicated bone banks that pay rigorous attention
to graft preparation, or the consequences can be disastrous. For these reasons
attempts are being made to manufacture allograft substitutes. As yet there is no
134 Blom and Learmonth

commercially available ideal allograft substitute suitable for use in all cases of
bone stock loss.
Some substitutes do not address all the problems associated with the use
of allograft. For example, xenograft and collagen matrix substances can cause
infection or invoke antigenicity [98,99]. Other substitutes introduce new prob-
lems. Polymethylmethacrylate and glass-ionomers are nonresorbable and non-
porous, thereby preventing the restitution of normal bone morphology [100].
Calcium sulfate resorbs very quickly and thus does not provide long-term
stability [101,102]. Of the types of bone graft substitute discussed above, the
literature suggests that certain xenografts, ceramics, and corrallin-derived
hydroxyapatites may have the requisite strength to withstand the high forces
within the proximal femur.
Absorbable ceramics most nearly fulfill the requirements for an ideal bone
graft substitute. They have low potential for infectivity and antigenicity. They
can be completely reabsorbed and therefore potentially can be replaced by living
host bone. They can be manufactured so that their material characteristics are
uniform and reproducible. They can be manufactured at relatively low cost from
a nonbiological source. They have been successfully used in impaction grafting
in animals, with results comparable to allograft. Initial outcomes in impaction
grafting with ceramic bone graft substitutes in humans are encouraging, but there
is a need for long-term multicenter prospective randomized clinical trials
comparing allograft with ceramic bone graft substitutes.

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11
The Contribution of Synthetic Bone
Grafting Material to Impaction
Douglas Dunlop
Southampton University Hospitals NHST
Southampton, England

I. INTRODUCTION

Current estimates place the total number of hip replacements performed in the
United Kingdom as 50,000 (worldwide .800,000) per annum, with revision
rates around 15% in major centers. According to a survey of emerging
technologies in orthopedics, synthetic substitutes are on the verge of expanding
their current share of the market from 10% to a potential 35% in 2003 [1] as the
likely demand increases.
A large number of different graft types are therefore available to the
revision surgeon for impaction grafting. A greater understanding of their
mechanical and biological properties would be beneficial before widespread
adoption. Some of the mechanical and biological aspects of a few are addressed
in this and other chapters. A more detailed description of the mechanical testing
mentioned here is outlined in Chapter 5.
Bone graft alone, either morselized or whole, has had some success in
replacing lost bone stock [2 – 10], but limited supply and increasing concerns
regarding transmission of pathogens has prompted interest in synthetic materials.
There has been an increasing interest in bone substitute materials [1], which may
be osteoconductive [11,12] (providing a scaffold over which bone may grow) or
osteoinductive [13] (active stimulation of osteoblast activity 1+1 a scaffold),
although their current use and future role have yet to be defined, together with
cost-benefit analysis.
141
142 Dunlop

II. MECHANICAL ASPECTS

Inert materials with high mechanical strength have been tested clinically
[14 –19]. Pro-Osteon, a naturally occurring material, has been investigated as a
bone void filler in several studies [20]. Bone substitutes are often hard, brittle
materials that may be crushed on impaction, where available space becomes an
issue or, worse, causes femoral fracture or implant malposition. Constant
micromotion as found in the proximal femur might subject the particles to wear
and failure. The potential detrimental role of the particles as third body wear
particles is as yet unreported.
The addition of synthetic materials to morselized processed bovine bone
[21] or fresh frozen human bone [22,23] has been shown to enhance the
mechanical strength of the bone graft. This occurred in all test groups and when
used as either a bulking agent or to improve the particle size distribution
compared to bone graft alone.

III. BIOLOGICAL ASPECTS

Synthetic materials are not usually osteoinductive and interlock with the host,
allowing ingrowth or ongrowth along unnatural pathways. Apatite-wollastonite
(A-W) glass ceramic has been used in combination with milled allograft and
fibrin glue [15] with some success in revision total hip arthroplasty (THA). Direct
bonding between bone and A-W glass ceramic granules was seen histologically.
There is no replacement over time of the lost bone stock, should a subsequent
revision be necessary. Interest in bioactive materials has evolved to address this
problem. These include inductive agents, physical agents that can be remodeled,
and cellular agents. Osteogenic protein-1 (BMP-7) is a growth factor in the TGF-b
superfamily that has been shown to stimulate bone-producing cells in vitro and in
vivo [24 –27] and which may also enhance bone incorporation around implants.
Hydroxyapatite (HA) may be an alternative to bone allograft, as it allows
remodeling.
Developments in tissue engineering in which amplified autogenous marrow
elements are “seeded” onto processed/washed allograft or bone substitutes and
recent developments in gene therapy [28] are providing further avenues of study.
The smallest particle size allowable is problematic due to the potential to
restrict neovascularization and ingrowth [29] as well as handling and third body
wear problems. Experiments with particles down to 300 mm did not show
neovascularization and ingrowth to be a problem [22], which is not unsurprising
as capillaries are in the order of 15 mm. However, if these small particles are not
Synthetic Bone Grafting Material 143

inert, the particles with increased surface area have been shown to inhibit cellular
activity due to the high local ion concentration [22,30].

IV. IN VITRO MODELING

Previous work has shown that the addition of synthetic particles of the correct
size to bone graft can improve shear strength [23]. This is because the mechanical
properties of any collection of particles are more dependent upon the particle size
distribution and their shape than on the individual properties of the particle
material, unless there is a significant release of lubricant fluid.
Synthetic additives, including nonsilicated bioresorbable glass (Corglaesw
Giltech, Ayr) and a tricalcium phosphate – hydroxyapatite mixture (TCP/HA,
Stryker Howmedica), have been shown to uniformly improve graft strength when
used as either bulking or idealizing agents (to improve particle size distribution)
[21,22]. The bulking agent groups were produced as a 50/50 mixture, by volume,
of synthetic agent combined with bone graft. The “idealized” groups were
produced as bone graft from a specific mill of known particle size distribution
combined with the correct amount of synthetic agent in the relevant particle sizes
to make a well-graded sample.
The results of shear tests are shown in Table 1. It is thought that these
improvements were the result of adoption by the composite graft of the high shear
resistance characteristics of the synthetic materials when tested alone. Additionally,
a desiccant effect, reducing inter-particle lubrication, whereby free fluid from the
bone graft was adsorbed onto the synthetic materials, was observed.

V. IN VIVO MODELING

Trials of new synthetic materials have been compared in animal model defects or
revision hip simulation in animal models [22,31,32]. The graft in the defect
models can be loaded or unloaded. Unloaded defects are more akin to a fracture

Table 1 Shear Test Results

Shear strength
Interlocking Friction (kPa) at
(kPa) angle s ¼ 350 kPa

Graft & Corglaesw 50/50 3.0 36.8 264


Graft & TCP/HA 50/50 6.8 37.6 277
Graft idealized with Corglaesw 6.5 37.8 278
144 Dunlop

model and produce dramatically different results from revision hip simulation
[22]. Loaded defects behave variably and biological and immunological factors
affect incorporation rates independent of load, at least in the early stages [29].
Revision simulations appear to reproduce the mechanical as well as the biological
environment and may be more relevant.

A. Defect Model
An ovine model was used to investigate the in vivo properties of impacted – TCP-
HA [35 – 38]. Aggregates, varying in chemical composition (ratio of TCP to HA)
and particle size distribution (8 vs. 3 particle size ranges), were analyzed. An
impactor (Fig. 1) was designed to produce 15 mm diameter pellets that were
implanted in an ovine defect model. All aggregate pellets were impacted to a
standard compactive effort. Eight sheep underwent implantation of pellets in 4
metaphyseal defects in both rear limbs.
Treatment groups consisted of:
1. Allograft (clinical control)
2. 0/50 allograft/80% HA/20% TCP in 8 particle size ranges
3. 30/50 allograft/80% TCP/20% HA in 8 sizes
4. 50/50 allograft/80% HA/20% TCP in 3 sizes
Healing of defects was evaluated at 14 weeks with computed tomography,
histology, and histomorphometry. The computed tomography (CT) density
measured in all defects containing synthetic agents was higher than in defects
filled with allograft alone (p , 0.01). Defects containing 8 sizes of 80% HA/
20% TCP granules (group 2) achieved lower histological scores and contained

Figure 1 (a) Sample undergoing standardized impaction (b) pellet introduced into
one of the pre-drilled defects.
Synthetic Bone Grafting Material 145

less bone than the clinical control ( p , 0.05), whereas groups 3 and 4 did not
differ from the control. Although all synthetic agents were osteoconductive, the
results suggest that increasing the ratio of TCP over HA and limiting the number
of particle size ranges to 3 instead of 8 improves the performance of impacted
aggregates as graft expanders. Evaluation under loading conditions of morselized
allograft expanded with 80% TCP/20% HA (BoneSavew, Stryker Howmedica)
in 3 particle size ranges is warranted.
An ovine unloaded defect model was also used to examine a bioresorbable
glass (Corglaesw) [22,39]. The addition of small particles to optimize mechanical
strength did not inhibit revascularization. The ovine pellet model is a useful tool
for evaluating new synthetic graft materials, particularly due to the reproduction
of compaction, which has been shown to be an important variable [32]. It allows
comparison of three test samples (Fig. 2) with a positive control, a negative
control, and standard treatment (allograft).
The biological environment was clearly very different from loaded graft
seen in the revision hip simulation (below), which suggests that the resorption rate
of Corglaesw is much more rapid in this defect model than in the revision hip
scenario. Indeed, based on bone remodeling rate data, the defect model is similar in
vascularity to a fracture model and as such is only similar to the most proximal
environment of the femur in the revision model below. Future defect models
may consider the effect of loading the graft, as this has recently been reported to
have a variable effect [29,34,40]. Ideally, a revision hip simulation model should
be used.

B. Revision Hip Simulation Model


An ovine model to simulate femoral impaction grafting was developed [22,41],
based upon a previous primary hip replacement model [42,43]. Overreaming of

Figure 2 Pellet layout in a typical randomization.


146 Dunlop

the proximal femur produced a slippery tube, which visually appeared to emulate
the proximal femur of humans, which is often encountered by revision hip
surgeons after removal of the failed implant, cement, and lining membrane (Fig. 3).
Two groups of ten animals were randomized to either impaction grafting
with morselized allograft alone or impaction grafting with a 50/50 mixture by
volume of bone graft and Corglaesw.
After 12 weeks, eight animals remained in each group and the animals were
euthanized. Subsequent analysis was undertaken to determine subsidence of the
hemiarthroplasty, micromotion of the implant under physiological load,
histology, and histomorphometry.

1. Subsidence
Instead of using roentgen stereophotogrammetric analysis (RSA), which has been
described by others [44,45] along with certain complications [46,47], a simpler
system was developed.
We were able to reproduce the position of the femur in three dimensions
over an x-ray plate with reasonable precision on the two occasions that x-rays
were taken, hence reducing the need for stereo x-rays. Fortunately, as subsidence
tends to be relatively large in impaction models compared to primary cemented
models, the tolerable error was acceptable [measured errors (mean+2SEs):
technique error ¼ 71+0.16 mm, interobserver error ¼ 74.9+0.18 mm, intra-
observer error ¼ 74.7+0.04 mm).
Two radiographs were taken of each animal. The first radiograph was taken
immediately postoperatively, while the animal was still anesthetized to reduce
movement artefact, and the second radiograph was a contact radiograph of the
ex-planted femur. A standard technique for each procedure was followed, after
development of the most reliably accurate method from experimental trials. The
x-rays were examined for evidence of radiolucent lines, subsidence, fracture, or
other significant abnormality [48]. Measurements from each x-ray were then taken,
standardized for magnification variables, and compared. From these comparisons a
measure of the degree of subsidence of the femoral component down the femur
could be calculated for the 12-week period between the two x-rays. No statistical
difference in subsidence was detectable between the two groups.

2. Micromotion
The stability at the time of surgery and from thenceforward of the femoral stem is
a major determinant of long-term success. Relatively little movement has
prevented ingrowth for biological fixation [49,50]. Given that these movements
are around 0.1 mm, precise measurement of stability is not a simple task,
especially when the femur itself deforms on loading, providing us with the
challenge of a moving target. Previous authors have often concentrated on either
Synthetic Bone Grafting Material 147

Figure 3 (a) Femoral canal prior to impaction, (b) graft introduced with open
ended syringe around centralizer and (c) phantom impactor introduced.
148 Dunlop

axial or rotational instability [43,51 – 55], usually due to the ease of doing so. As
failure is usually a function of both of these components, ideally the three-
dimensional movement of the implant relative to the femur should be measured.
A physiological model of the gait cycle of a sheep hind limb during normal
walking was modeled. The harvested implants in their femora were tested, with
the load applied through the testing jig set up to model the acetabulum and the
five major muscle groups around the hip joint dynamically to simulate pelvic
movement (Fig. 4). To allow both mechanical testing and subsequent histological
assessment (more ethically satisfactory), the femora in our study were tested
fresh, after storage at 2708C, and then placed in a series of fixative solutions for
future histomorphometry.
The system was validated by a microstrain assessment of the proximal
femur. The load and application positions were seen to reproduce femoral
microstrains within the in vivo range previously reported by Lanyon et al.
[56 –60] in the medial and lateral proximal femur.
Two targets, one on either side/end of the implant, allowed determination
of six degrees of freedom of movement of the implant relative to the overlying
femur (Fig. 5). Real-time measurement during the dynamic loading cycle was
performed using LASER target cubes, referenced to linear variable displacement
transducer’s (LVDTs) on the adjacent femur (Fig. 6). This technique reduces
problems of interfacial strains and other errors by adaptation of a similar reported
technique [61].

Figure 4 Testing jig alignment (AP and lateral views) with X/Y table above and
fixed knee below, together with strap muscles (abductor, iliotibial band, adductor/
hamstrings and quadriceps with strain guage).
Synthetic Bone Grafting Material 149

Figure 5 Target set-up (a) antero-superior laboratory view (b) AP x-ray view.

Repeatability studies were performed and showed a high level of


conformance. Instrument calibration showed an error of +20 mm for the
LASER/LVDT coupling.
There are no other reported systems that are capable of recording implant
interface micromotions in three dimensions at two points simultaneously. Those
that have measured three-dimensional micromotion at single points can be
divided into three groups.
The first group includes that of Buhler et al. [61], who mounted their
measuring device through a single drill hole and referenced the femur via this
overlying drill hole. Our methodology is similar to this first group, but our system
is less compact (and hence cheaper and easier to modify) and simultaneously
records data at two points.
The second group comprises authors [50,62,63] who mounted their
measuring devices onto the implant proximally and referenced variable points on
the femur. This group may be considered rather unsatisfactory due to difficulty in
obtaining rigid fixation to the stem and errors in the choice of the femoral
reference point, which was often at a distance. Deformation in the femur during
loading becomes a significant factor with these systems.
The third group comprises those authors who have used noncontact
measuring devices. These authors do not clearly address the fixation problem [64]
and describe problems with performing experiments in total darkness [65] when
using photosensitive devices (PSDs).
150 Dunlop

Figure 6 (a) Instron set-up (b) close-up of distal targets orthogonal LASER/LVDT jig.

When interpreting the results, three bands of motion were determined prior
to analysis:
1. ,50 mm: stable bone/cement/graft/implant
2. 50– 150 mm: probably stable/fibrous ingrown bone/cement/graft/
implant
3. 150 mm: loose
Mechanical testing showed stable or probably stable implants in 15 of
16 animals, with excessive micromotion in one implant know to be infected.
No statistically significant difference between the two groups could be
determined.

3. Histology/Histomorphometry
Bone graft incorporation was common though not complete by harvest at 12
weeks postsurgery. Angioneogenesis of the graft had occurred distally, but was
more rapid from the proximal end. Corglaesw was present primarily in the distal
portion of the graft mantle, suggesting a more biologically isolated environment
than the defect model described above. Centripetal vascularization occurred
more slowly. There was no fibrous tissue at the cement/graft interface,
suggesting stable component fixation in all samples.
Synthetic Bone Grafting Material 151

VI. SUMMARY

Corglaesw and TCP/HA appear to be worthy of consideration as potential


synthetic agents. They can be used to improve graft strength by improving particle
size distribution or simply as bulking agents. These agents may ultimately be used
as carriers for growth promoters, which may counteract any negative effects of
washing. The addition of growth factors to scaffolds, including bone graft, has
been a subject of recent interest [66 – 70], and clinical trials are in progress.

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12
Comparative Dynamic Loading of
Paired Femurs
Comparison of Freeze-Dried Versus
Fresh-Frozen Bone Allografts

Bernard Godts, Ashit Bavadekar, Olivier Cornu, M. Verhelpen,


and Christian Delloye
Université Catholique de Louvain
Brussels, Belgium

I. INTRODUCTION

Arthroplasty failure is multifactorial and most often results from an interplay of


biological and mechanical factors [1 – 8]. In assessing new implant design, new
techniques of reconstruction, or different bone grafting materials, it is important
to have available instruments to compare new items to standard ones. A hip
simulator has the advantage of reproducing in vitro the mechanical behavior of a
reconstructed proximal femur. Compared with in vivo investigation, this method
is more accurate and allows variables such as load, frequency of loading, and load
case to be tested in reproducible conditions [1,9]. With two hip simulator stations,
it was possible to compare two methods provided that the testing devices gave
comparable results. An in vitro experiment was performed to compare the initial
stability of implants in a reconstructed upper femur [1 – 8]. The investigations
were designed to analyze initial stability of a hip component under cyclic loading,
measure the micromotion of a cemented prosthesis at 106 cycles, compare motion
on both sides, and compare the prosthetic behavior in both femurs impacted with
two different bone grafting materials. Impaction bone grafting has been
advocated as a method to restore bone stock deficiency during a revision hip
arthroplasty [10,11]. Two different kinds of bone morsels were tested: freeze-dried
157
158 Godts et al.

and gamma-irradiated bone morsels (FDFH) and fresh-frozen morsels (FFFH)


from femoral heads in both a short- and long-term comparative mechanical study.

II. MATERIALS AND METHODS


A. Hip Simulator
A full and detailed description of the simulator has been previously reported
[12,13]. Several modifications were made for this study and will be further
described. In brief, a cyclical load was applied to the femur by a pneumatic
actuator that acted directly on the prosthetic head. The acetabulum comprised a
cup of high-density polyethylene.
The loading cycle pattern reproduced force and movement following the M-
shape curve close to those of a single limb phase of the slow gait cycle described by
Kotzar [14] and Davy et al. [15]. Figure 1 shows a typical load-time curve.
During a cycle, the maximum applied load represented 1.5 times the body
weight and the minimum was fixed at about 30 N, the force necessary to avoid
separating the cup from the prosthetic head with each cyclical load. The loading
frequency was about 1 Hz, which represents a mean of 90,000 cycles a day. One
test required 10 days (240 hours) to reach a total of 900,000 cycles. The applied

Figure 1 Typical cyclic loading force acting on the femoral head. This resultant
force is similar to that encountered during in vivo level walking.
Comparative Dynamic Loading of Paired Femurs 159

load had an angle of 208 in the frontal plane and 128 in the sagittal. The influence of
muscle force was not taken into account. Any deformation was balanced by movement
of the implant and the elasticity of the bone, cement, and implant in the reconstructed
femur. Two stations were available for allowing two concurrent testings.
A load cell (Entran, ELF-26-5000, Les Clayes sous Bois, France) placed
between the actuator and the acetabular cup measured the force applied on the
femoral head. The values obtained by the load cell were validated by making 10
consecutive measures, and the observed variation was less than 2%. The load cell
output was recorded to an A/D conversion card through a Wheatstone bridge. All
tests were performed under load control and in real time. No preload cycle was
used because it is a cyclic dynamic test.

B. Human Material
Eleven pairs of femurs were harvested within 24 hours of death and kept frozen at
2308C until the time of testing. Five were used to validate the right and left sides of the
simulator, whereas six pairs were investigated for comparison of impacted allografts.
Bone quality and analysis of mineral content was performed by
osteodensitometry (QDR-2000 DEXA, Hologic, Waltham, MA). Femora that
varied from right to left were discarded. X-rays with lateral and antero-posterior
views were taken for each pair of femora. The femur was cleared of soft tissue,
wrapped in moistened bandage, and continuously irrigated during the test with
2% formalin in 0.9% saline.

C. Prosthetic Insertion and Instrumentation


A great deal of trouble was taken to position the implant reproducibly. The femur was
meticulously resected and instrumented using ancillary templates and jigs (Fig. 2).
Each femur was kept upright by embedding 10 cm of the distal metaphysis
in a polymer cement (Fig. 3). The symmetry of the anteversion angle was
obtained with the help of a laser pointer that was fixed on the prosthesis. By
measuring the projection of the laser on a reference plane, the anteversion angle
could be measured accurately and reproduced on the both femora. Neutral
positioning of the implant in the coronal plane was achieved by implanting the
prosthesis with imaging fluoroscopy.
Each femur was prepared for a hip replacement according to standard
protocol and by the same surgeon. The femoral canal was reamed with standard
rasps and washed to remove marrow and bone debris. A tightly fitting bone plug
was inserted in the medullary canal 2 cm beyond the distal tip of the prosthetic
stem. The cement (Palacos E flow with Gentamicin, Schering-Plough, Brussels,
Belgium) was injected retrograde using a pressure gun. A straight stem prosthesis
160 Godts et al.

Figure 2 The femur was osteotomized cautiously with a band saw in light of the
anteversion angle and the positioning of a neutral valgus-varus angle.

with a collar (Charnley-Kerboull CMK 3, Bone and Joint Research, Luxembourg,


L) was introduced 5 minutes after mixing the cement.
For the comparative bone grafting material study, a cavitary bone defect
was created by reaming the medullary cavity to 18 mm diameter. The proximal
femoral cortex was further thinned out with broaches to allow the implantation of
a 403 Charnley-Kerboull hip prosthesis.

D. Bone Grafting Materials and Preparation


Osteoarthritic human femoral heads were used as grafting material. The median
age of the donors was 67.5 (53 – 75) years. To exclude osteopenia or osteolytic
lesions, femoral heads were weighed and radiographed.
The femoral heads were cleared of articular cartilage [16] and soft tissue
while the neck was retained. The six heads (1 –6) were then cut into two halves in
the coronal plane—anterior (A) and posterior (P)—with a band saw. Half femoral
heads were weighed separately on a digital weighing scale (Mettler PE 3000,
Zurich, Switzerland) (Table 1).
Two groups were formed:
The FFFH group consisted of halves numbered P1, A2, P3, A4, P5, and A6,
which were stored frozen at 2808C (Forma Scientific Inc., Marietta,
Ohio).
Comparative Dynamic Loading of Paired Femurs 161

Figure 3 A square is used to cement reproducibly the femur in an upright


position.

The FDFH group included halves numbered A1, P2, A3, P4, A5, and P6, which
were washed with a jet of distilled water to remove bone marrow and blood,
treated chemically with chloroform-methanol solution for 5 days, rinsed
with methanol and water [17], and finally treated chemically to prevent
bovine spongiform encephalopathy (BSE). The halves from both groups
were then morselized twice with the small rasps of the Noviomagnus
bone mill (Spierings, Nijmegen, Netherlands). The grafts from the
FDFH group were freeze-dried for 72 hours and gamma-irradiated at a
25 kGy dose.

E. Impaction Bone Grafting


Prior to the impaction procedure, the freeze-dried morselized grafts were
rehydrated in 0.9% saline for 30 minutes. For both the FDFH and FFFH groups,
162

Table 1 Origin of Material and Weight Loss on Preparation of Morselized Grafts

Fresh-frozen (FF) half


Donor Whole head head Freeze-dried (FD) half head

Weight Freeze-
without Treated dried
Weight cartilage Ant./ Weight Ant./ Weight weight weight
Name Sex Age (g) (g) post. half (g) post. half (g) (g) (g)

VP M 75 90.9 73.8 Post. 37.1 Ant. 35.0 18.5 12.5


PC F 61 86.0 67.0 Post. 35.2 Ant. 29.8 15.4 11.3
WM F 72 79.6 66.2 Post. 32.6 Ant. 31.8 13.7 9.4
DG M 53 100.9 66.8 Ant. 31.4 Post. 33.6 22.8 13.5
LC M 72 94.4 71.4 Ant. 39.0 Post. 35.1 15.2 10.2
TJ M 72 87.2 66.7 Ant. 32.4 Post. 32.5 18.7 12.6
Mean: 67.5 89.8 68.7 34.6 33.0 17.4 11.6
Godts et al.
Comparative Dynamic Loading of Paired Femurs 163

the following procedure was applied. Reconstruction was carried on with the
X-change revision set (Howmedica, Brussels, Belgium). An intramedullary plug
was chiseled out from the resected femoral head. Impaction was performed
retrograde, layer by layer, by introducing and impacting a few grams of bone
morsel. The procedure was stopped when the final impactor could not be driven
any further by the operator’s slap hammer. Final proximal impaction was
achieved using the tamps. Palacos E flow with Gentamicin cement (Schering
Plough, Brussels, Belgium) was inserted retrograde in the newly constructed
canal at the third minute after mixing and maintained pressurized until the fifth
minute. A 301 Charnley-Kerboull hip prosthesis (Bone and Joint Research,
Luxembourg, Luxembourg) was cemented under image intensifier control.

F. Stability Measurement
The initial interface motion between proximal femur and prosthesis was
measured by two commercial digital extensometers. One extensometer (QLR
digit) measured axial motion between femur cortex and prosthesis. It had a
sensitivity of 10 mm and a measure range of 7.5 mm deflection around the zero
position. It was fixed to an aluminum frame, which was rigidly secured to the
femur, just below the resection, with 10 pointed stainless screws. It reacted
perpendicularly to its axis against a corrected surface of a second frame, which
was fixed at the prosthetic neck. No relative motion occurred between the
assembly extensometer and its frame or between the frame and bone.
A second extensometer (Digimatic Indicator, 543-551D, Mitutoyo, Japan)
was used to measure the magnitude of the rotational movement between femur
and implant. This extensometer was fixed to the second aluminum frame, which
was firmly secured around the prosthetic neck. It reacted perpendicularly against
a corrected surface of the first frame. It had a resolution of 1 mm and was linear up
to 12.5 mm about the zero position. The fixation system of these extensometers
was placed just below the resection, while their opposite counterpart was just
above the resection (Fig. 4). In this manner, we minimized the influence of bone
deformation.
Rotational angles were calculated as arc tangent (horizontal displacement
measure by extensometer/offset of the extensometer). The accuracy of this
measuring system was checked by repeating 15 consecutive measurements.
Motion between femur and prosthesis could be determined with an accuracy of
less than 10 mm and less than 0.018.
Figure 5 shows a pair of instrumented femur in simulators. Before and after
each test, every pair of instrumented femurs was radiographed accurately using
orientation devices to get the same projection angle and magnification factor.
164 Godts et al.

Figure 4 The implant stability was evaluated by measuring the displacement


between the proximal femur and the prosthesis in both the frontal and sagittal
planes by two extensometers.

G. Definitions
The following definitions were used (Fig. 6):

Axial micromotion (recoverable motion): position difference between


loaded and unloaded state at each cycle
Axial subsidence (unrecoverable motion): position difference between first
and current cycle with regard to the unloaded femur
Total axial displacement: axial micromotion þ axial subsidence
Rotational micromotion: difference in degree of rotation between loaded
and unloaded state at each cycle
Comparative Dynamic Loading of Paired Femurs 165

Figure 5 This two-station hip dynamic simulator using a pair of human femora
allowed the comparison of conventional prosthesis as well as new surgical
techniques and new prosthesis design.

Permanent rotational displacement: degree of unrecovered rotation


between first and current cycle with regard to the unloaded femur
Total rotational displacement: rotational micromotion þ permanent
rotational displacement

H. Measurements
Measurements were made every 50,000 cycles to minimize the amount of data.
For each measurement, eight variables were measured on the femur: number of
cycles, load, total axial displacement, axial subsidence, axial micromotion, total
rotation, rotational micromotion, and rotational subsidence.
Each displacement curve was modeled for statistical analysis according to
the law y ¼ ax b. The parameters a and b obtained for each curve of the five right
166 Godts et al.

Figure 6 Graph with definitions of terms that have been used.

femurs were compared with those obtained for the five left femurs by a paired
Student t-test (Systat 8.0 Data, SPSS Inc., Chicago, IL). The difference was
considered statistically significant at p , 0.02 to account for the small number of
specimens and observations.

III. RESULTS
A. Cemented Prosthesis in Normal Right and Left Femurs
All specimens were carried out to over 900,000 loading cycles without failure of
bone, failure of the cement mantle, or loosening of the implant. The mean
displacement and standard deviation for each of the 10 femora are shown in
Table 2.
A typical stability curve of femoral component is presented in Figure 7.
The x-axis represents the number of loading cycle, while the y-axis represents the
movement of the implant. The axial subsidence, total axial displacement, and
axial micromotion for the right and left femora are indicated for the loaded and
unloaded situations.
All specimens subsided rapidly during the first 100,000 cycles, decreasing
over subsequent cycles. The axial displacement during implant positioning had a
mean value of 151+54 mm during the first day of testing and despite a strong
collar-calcar contact. The axial subsidence from 100,000 to the end of loading
test was 55+57 mm. The measured total axial displacement had a mean of
181+80 mm. No significant difference in the motion (qualitative and
quantitative) between both sides was found (p . 0.1). Displacement included
both movement of the prosthesis within the cement and displacement of the
cement mantle in the femur.
The total rotational displacement had a mean value of 0.188 (range 0.08–
0.34). Comparison of variables a and b on the curves that represented axial
Comparative Dynamic Loading of Paired Femurs 167

Table 2 Data for Five Femoral Pairs Used to Validate Right/Left Symmetry (mm)
Total axial Axial Axial
displacement micromotion subsidence Subsidence Subsidence
after 9  105 after 9  105 after 9  105 rate Swing rate Stance
cycles cycles cycles phase of gait phase effect

Left Right Left Right Left Right Left Right Left Right

DJ 110 120 90 90 20 30 1 3 1 8
DN 110 120 90 90 20 30 0 23 1 21
CJ 290 320 130 180 160 130 13 10 10 16
GR 170 160 90 90 80 70 1 9 0 0
HJ 230 180 90 130 140 310 3 33 3 0
Mean þ SD 182 180 98 116 84 114 4 10 3 5
78 82 18 40 65 117 5 13 4 7

Implant
positioning
total axial Implant Implant
displacements positioning positioning
after 1  105 axial axial
cycles micromotion subsidence

Left Right Left Right Left Right


DJ 100 60 90 50 10 10
DN 100 130 80 80 20 50
CJ 210 190 150 140 60 50
GR 170 160 100 160 70 0
HJ 210 180 90 130 120 50
Mean þ SD 158 144 102 112 56 32
55 52 28 45 44 25

displacement, i.e., subsidence, axial micromotion, and total axial displacement,


showed no difference (p ¼ 0.3). Similarly, no significant difference (p ¼ 0.5)
was observed in the curves recording rotation. Figure 8 shows an x-ray of the
same specimen at the first cycle and after 900,000 cycles. No radiolucent lines
were seen at either the bone/cement or the stem/cement interface. No
radiological analysis was performed because motion was too minute to be
measured. There was no gross failure in any of the experimental models.

B. Cemented Prosthesis in Right and Left Impacted Femurs


Comparing FDFH and FFFH, 1.5 heads were used in the fresh-frozen group while
2 –2.5 heads were needed in the freeze-dried group to fill a femoral defect. There
168 Godts et al.

Figure 7 The right-left symmetry is shown on this graph and represents the
unloaded and loaded curves from a paired femur during 1  106 cycles.

was good implant stability throughout the experiment. All femora tolerated
900,000 cycles without bone, cement, or impacted bone graft failure. The
micromotion of the prosthesis in the FDFH group (110 mm) was significantly
lower (p ¼ 0.049) than in the FFFH group (175 mm). Micromotion was not
significantly affected by the number of cycles in either the control or the freeze-
dried group, and there was no significant change in micromotion during the entire
test.
In both groups, axial subsidence of the prosthesis increased rapidly during
the first 100,000 loading cycles, as observed during right and left standardization.
After initial settling of the prosthesis, axial subsidence decreased. As in axial
micromotion, subsidence was lower in the FDFH group than for the FFFH group.
At the end of the test, the subsidence of the implant was 265 mm (+34 mm) in the
FFFH group and 81 mm (+16 mm) in the FDFH group. Analysis of variance with
repeated measures showed that axial subsidence was less in the freeze-dried
group than in the fresh-frozen group ( p ¼ 0.012) and that this variable was
dependent on the number of cycles in both groups ( p , 0.001). From 1  105 to
9  105 cycles, the subsidence rates were higher for the fresh-frozen than the
freeze-dried group (p , 0.05).
The rotational micromotion of the implant was extremely small in both
groups (,0.18). Very small angles of rotational migration (,0.58) were
observed. They were overall smaller in the freeze-dried group (p ¼ 0.022) and
had a tendency to rise during the test as it progressed in both groups ( p , 0.05).
No implant migration or radiolucent lines were observed on x-rays. Implant
recovery and push-out were more difficult in the FDFH than the FFFH group and
Comparative Dynamic Loading of Paired Femurs 169

Figure 8 On the left, the femur filled with impacted freeze-dried bone during the
first cycles is shown. On the right, the same femur after 900,000 loading cycles.

required the use of a hammer. The impacted graft layer was fixed firmly enough
to resist at the push-out test. It was always the stem/cement interface that failed,
whereas the cement mantle was intact.

IV. DISCUSSION
A. Cemented Prosthesis in Normal Right and Left Femurs
In this study, the degree of implant stability was assessed from the immediate
postoperative period up to an average 6- to 12-month period after loading
equivalent to slow walking. We measured the total displacement, i.e.,
170

Figure 9 Implant positioning after 1105 cycles of the six pairs of the impacted femurs.
Godts et al.
Comparative Dynamic Loading of Paired Femurs

Figure 10 Total axial displacement after 9  105 cycles as obtained with the six pairs of impacted femurs.
171
172 Godts et al.

displacement of the stem in relation to the femur (including the relative


displacement into the cement and the cement itself). The maximum load equated
to 1.5 times the body weight, as suggested by Kotzar et al. [14]. Most published
studies [18 –22] have assessed the behavior of hip prostheses over the short term
(,5000 cycles), whereas a long-term study was needed to further document
implant behavior.
There was comparable migration between right and left sides with a mean
of 182 mm total axial displacement on the left and 180 mm on the right. The
implant was stable throughout with a mean axial subsidence of 99 mm after
900,000 cycles.
Several conditions were taken into account in this investigation. In contrast
to studies [8,20,23] using synthetic bone, pairs of human femurs of variable size
were used. Preparation was rigorous to obtain full collarcalcar contact and a
reproducible setup of the femur. During the prosthesis implantation, special care
was taken to obtain an average thickness and continuity of the cement mantle, as
already emphasized by others [24,25].
Comparison of these results with those from other studies [21,22,26 –32]
must be guarded because loading conditions, measurement protocol, and testing
environment were different. Nevertheless, the observed results matched those
from previous studies.
Loudon and Charnley [33] measured by x-ray a mean subsidence of
0.54 mm in a cemented prosthesis after one year. McKellop et al. [20] found
subsidence of 0.2 mm for a cemented stem in synthetic femurs with a load of
2000 N during 5000 cycles. Walker et al. [1] found 42 mm for a cemented stem
loaded statically with a force of 1000 N and a torsion of 0.0188.
No fracture in the cortex or in the cement were detected by x-rays. The
analysis of the cement mantle after the removal of the prosthesis showed no
fracture. This suggests that it is the expansion of the cement mantle by creep that
causes prosthetic subsidence. The absence of fracture confirms the results
obtained by the extensometers and emphasizes the stability of the prosthesis.
Most of the implant migration took place during the 100,000 first cycles,
which would correspond to about 2 months in a patient’s life. This early
subsidence concurs with other clinical observations [34,35] where subsidence,
when present, was apparent within the first 6 months. At unloading there was a
permanent migration of the implant. This can be explained by the fact that the
stem was unpolished and that creep occurred in the cement.
This study had the following limitations:

The influence of particulate debris was not considered [36].


Dead bone has no capacity to adapt itself to new stresses.
There was no alternate rest period during which stress relaxation could
occur [37].
Comparative Dynamic Loading of Paired Femurs 173

The effects of muscles and soft tissue were not included in this study. The
applied load is only equilibrated by the elasticity of the bone.
The experiment was performed at room temperature, giving more
standardized observations than would occur in an actual patient’s life.
Despite these limitations, the long-term behavior of these implants was similar on
both sides and imitated the clinical observations rather well.

B. Cemented Prosthesis in Right and Left Impacted Femurs


Throughout this study, every detail for adequate and symmetrical positioning was
considered. The two displacements measured in the impacted femurs described
the early stability of the prosthesis in two different settings.
From a mechanical point of view, processed freeze-dried bone was superior
to fresh-frozen. The implants in the freeze-dried group showed less micromotion
than in the fresh-frozen one. Their subsidence as well as subsidence rate were
much lower. Rotational micromotion and migration confirmed these results. It is
noteworthy to observe that no loosening was found in either group.
Displacements were small in this investigation and could be explained by
various reasons. The loading regimen was not at the level of a full weight-bearing
gait or in the range value used by others [38]. A nonpolished stem that limited
subsidence of the implant into the cement mantle was used [39]. The impaction
was more efficient than in an operating theater and performed on a femur firmly
fixed on a rigid base with no capacity to absorb shock. The alignment between
the implant and the actuator was never perfect (this is technically difficult),
generating a torque ranging from 0 to 5 N/m. The higher stability (less
micromotion) and the lesser subsidence and subsidence rate of the stems inserted
in processed freeze-dried morselized grafts was probably related to the grafts’
ability, when impacted properly, to create a layer that had a higher density/
compactness and hence higher modulus (see Chapter 9). This hypothesis is
supported by the fact that for filling similar femoral defects, the operator had to
use more freeze-dried bone (2 – 2.5 heads) than fresh-frozen (1.5 head). The long-
term simulation (900,000 cycles) showed survival of the stability that was not
compromised by cyclical loading. Previous work emphasized the importance of
the time-dependent properties of the impacted grafts [40,41].

V. CONCLUSION

In this study, we directly measured the stability under conditions that were
close to the surgical procedure. The freeze-dried bone was found superior to
174 Godts et al.

fresh-frozen bone when the mechanical properties of the impacted bone were
dynamically assessed using two hip simulators.

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press-fit femoral stem prostheses. J Biomech 1987; 20:693 – 702.
2. Berzins A, Sumner DR, Andriacchi TP, Galante JO. Stem curvature and load angle
influence the initial relative bone-implant motion of cementless femoral stems
[published erratum appears in J Orthop Res 1995 Jan; 13(1):151]. J Orthop Res 1993;
11:758 – 769.
3. Berzins A, Sumner DR, Wasielewski RC, Galante JO. Impacted particulate allograft
for femoral revision total hip arthroplasty. In vitro mechanical stability and effects of
cement pressurization. J Arthroplasty 1996; 11:500 – 506.
4. Sumner DR, Turner TM, Urban RM, Galante JO. Experimental studies of bone
remodeling in total hip arthroplasty. Clin Orthop 1992; 83 –90.
5. O’Connor DO, Burke DW, Jasty M, Sedlacek RC, Harris WH. In vitro measurement of
strain in the bone cement surrounding the femoral component of total hip replacements
during simulated gait and stair-climbing. J Orthop Res 1996; 14:769–777.
6. Burke DW, O’Connor DO, Zalenski EB, Jasty M, Harris WH. Micromotion of
cemented and uncemented femoral components. J Bone Joint Surg Br 1991;
73:33 – 37.
7. Callaghan JJ, Fulghum CS, Glisson RR, Stranne SK. The effect of femoral stem
geometry on interface motion in uncemented porous-coated total hip prostheses.
Comparison of straight-stem and curved-stem designs. J Bone Joint Surg Am 1992;
74:839 – 848.
8. Sugiyama H, Whiteside LA, Engh CA. Torsional fixation of the femoral component
in total hip arthroplasty. The effect of surgical press-fit technique. Clin Orthop 1992;
187– 193.
9. Naidu SH, Cuckler JM, Burkholder T, Ducheyne P. Initial stability of a modular
uncemented, porous-coated femoral stem: a mechanical study. Am J Orthop 1996;
25:829 – 834.
10. Gie GA, Linder L, Ling RS, Simon JP, Slooff TJ, Timperley AJ. Impacted cancellous
allografts and cement for revision total hip arthroplasty. J Bone Joint Surg 1993;
75-B:14 – 21.
11. Ling RS, Timperley AJ, Linder L. Histology of cancellous impaction grafting in the
femur. A case report. J Bone Joint Surg 1993; 75-B:693 – 696.
12. Munting E, Verhelpen M. Mechanical simulator for the upper femur. Acta Orthop
Belg 1993; 59:123 – 129.
13. Munting E, Verhelpen M. Fixation and effect on bone strain pattern of a stemless hip
prosthesis. J Biomech 1995; 28:949– 961.
14. Kotzar GM, Davy DT, Goldberg VM, Heiple KG, Berilla J, Heiple-KG J, Brown RH,
Burstein AH. Telemeterized in vivo hip joint force data: a report on two patients after
total hip surgery. J Orthop Res 1991; 9:621– 633.
Comparative Dynamic Loading of Paired Femurs 175

15. Davy DT, Kotzar GM, Brown RH, Heiple KG, Goldberg VM, Heiple KG J, Berilla J,
Burstein AH. Telemetric force measurements across the hip after total arthroplasty.
J Bone Joint Surg 1988; 70-A:45 – 50.
16. Bavadekar A, Cornu O, Godts B, Delloye C, Van Tomme J, Banse X. Stiffness and
compactness of morsellised grafts during impaction: an in vitro study with human
femoral heads. Acta Orthop Scand 2001; 72:470 – 476.
17. Delloye C, Allington N, Munting E, Vincent A. Lyophilized banked bone. Technique
and results after 3 years of use. Acta Orthop Belg 1987; 53:2 – 11.
18. Hua J, Walker PS. Relative motion of hip stems under load. An in vitro study of
symmetrical, asymmetrical, and custom asymmetrical designs. J Bone Joint Surg
1994; 76-A:95 – 103.
19. Malkani AL, Voor MJ, Fee KA, Bates CS. Femoral component revision using
impacted morsellised cancellous graft. A biomechanical study of implant stability
[see comments]. J Bone Joint Surg 1996; 78-B:973 –978.
20. McKellop H, Ebramzadeh E, Niederer PG, Sarmiento A. Comparison of the stability
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cemented total hip arthroplasty. Clin Orthop 1998; 355:103– 112.
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loosening of Charnley femoral stems. Comparison between first-generation and
subsequent designs. J Bone Joint Surg 1993; 75-B:259 – 265.
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three-dimensional micromotions of press-fit femoral stem prostheses. Med Eng Phys
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28. Markolf KL, Amstutz HC, Hirschowitz DL. The effect of calcar contact on femoral
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29. Nunn D, Freeman MA, Tanner KE, Bonfield W. Torsional stability of the femoral
component of hip arthroplasty. Response to an anteriorly applied load. J Bone Joint
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A biomechanical comparison of cementless and cemented prostheses. J Bone Joint
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176 Godts et al.

31. Schreurs BW, Buma P, Huiskes R, Slagter JL, Slooff TJ. Morsellized allografts for
fixation of the hip prosthesis femoral component. A mechanical and histological
study in the goat. Acta Orthop Scand 1994; 65:267– 275.
32. Sugiyama H, Whiteside LA, Kaiser AD. Examination of rotational fixation of the
femoral component in total hip arthroplasty. A mechanical study of micromovement
and acoustic emission. Clin Orthop 1989; 122– 128.
33. Loudon JR, Charnley J. Subsidence of the femoral prosthesis in total hip replacement
in relation to the design of the stem. J Bone Joint Surg Br 1980; 62-B:450 – 453.
34. Onsten I, Akesson K, Besjakov J, Obrant KJ. Migration of the Charnley stem in
rheumatoid arthritis and osteoarthritis. A roentgen stereophotogrammetric study.
J Bone Joint Surg Br 1995; 77:18 – 22.
35. Karrholm J, Malchau H, Snorrason F, Herberts P. Micromotion of femoral stems in
total hip arthroplasty. A randomized study of cemented, hydroxyapatite-coated, and
porous-coated stems with roentgen stereophotogrammetric analysis. J Bone Joint
Surg Am 1994; 76:1692 – 1705.
36. Brien WW, Salvati EA, Betts F, Bullough P, Wright T, Rimnac C, Buly R, Garvin K.
Metal levels in cemented total hip arthroplasty. A comparison of well-fixed and loose
implants. Clin Orthop 1992; 66 – 74.
37. Verdonschot N, Huiskes R. Acrylic cement creeps but does not allow much
subsidence of femoral stems. J Bone Joint Surg Br 1997; 79:665 – 669.
38. Berzins A, Sumner DR, Wasielewski RC, Galante JO. Impacted particulate allograft
for femoral revision total hip arthroplasty. In vitro mechanical stability and effects of
cement pressurization. J Arthroplasty 1996; 11:500 – 506.
39. Karrholm J, Hultmark P, Carlsson L, Malchau H. Subsidence of a non-polished stem
in revisions of the hip using impaction allograft. Evaluation with radiostereometry
and dual-energy x-ray absorptiometry. J Bone Joint Surg Br 1999; 81:135– 142.
40. Giesen EB, Lamerigts NM, Verdonschot N, Buma P, Schreurs BW, Huiskes R.
Mechanical characteristics of impacted morsellised bone grafts used in revision of
total hip arthroplasty. J Bone Joint Surg Br 1999; 81:1052– 1057.
41. Ullmark G, Nilsson O. Impacted corticocancellous allografts: recoil and strength.
J Arthroplasty 1999; 14:1019– 1023.
13
The Influence of Particle Size
at the Femur
Is Morsel Size a Critical Parameter? Does It
Influence the Stiffness of the Impacted Layer?

Ashit Bavadekar, Olivier Cornu, Bernard Godts,


Christian Delloye, and Xavier Banse
Université Catholique de Louvain
Brussels, Belgium
John Van Tomme
Royal Military Academy
Brussels, Belgium

I. INTRODUCTION

Bone mills in current practice produce morselized grafts of sizes that are more or
less standardized when their mean sizes are plotted on a graph [1]. Rotating bone
mills in current practice are usually equipped with coarse and fine rasps to obtain
both large and small bone morsels, respectively. These morsels, when impacted
in the medullary cavity of a femur during revision hip arthroplasty, form a “neo-
medullary cavity.” Clinically the outcome of a revision arthroplasty depends on
the mechanical integrity of this layer of impacted graft and its ability to support a
revision prosthesis as well as other factors [2 – 5]. Thus, we were interested in
investigating the mechanical integrity of impacted grafts at various levels of
impaction, keeping all other factors constant except the morsel size. The tests
were aimed at establishing whether morsel size was critical in influencing the
efficiency of impaction. A series of in vitro impaction tests were performed on
morselized grafts of two different sizes obtained from the same rotating type of
177
178 Bavadekar et al.

bone mill (Noviomagnus, Spierings, Nijmegen) currently used by surgeons at


the University hospital (St-Luc University Hospital, Brussels).
The literature suggests that an impacted layer of large particles would be
mechanically superior, as a greater magnitude of force would be required to
deform and break (impact) the large particles compared to smaller morsels.
Previous experiments on impacted layers of graft [1 –4,6] clearly indicate that
larger morsels (particles) resist deformation on cyclical loading better than
smaller ones. Small morsels give a higher elastic recoil than large ones [3]. These
studies were carried out on layers of graft after an unknown number of impactions
[3,4,6], which were then tested for creep and elastic recoil after loading with a
cemented prosthesis.
The aim of this study was to identify the changes taking place when a loose
slurry of bone particles was impacted into a tightly organized material. Dynamic
creep studies [3,4,6 – 8] suggested that morsel size would be a critical factor in
determining the stiffness or mechanical superiority of layers of impacted graft.
This study was done in two parts. The first part involved a thorough particle
analysis and measurement of each bone morsel included in the mechanical
testing. The data were then plotted on histograms to give the reader a clearer
picture of the spread of the particle size and their frequency. The second part was
mechanical testing in which morsels, divided in samples of 5 g, were put through
a series of in vitro impaction tests in containment. The experiments were carried
out in exactly the same manner as a study done by the same team of researchers in
the past to investigate if the basic tissue content of the graft influences an efficient
impaction [9].
We chose the same mechanical outcome measures: the height (or the extent
of deformation) of a column of morselized graft, the stiffness (or the elastic
modulus in Mpa), and the density of the grafts reached after successive impactions.

II. MATERIALS AND METHODS


A. Graft Origin
Three fresh-frozen human femoral heads from three male patients of median age
65 (53 –78) years were obtained at primary hip arthroplasty for osteoarthritis.
These heads were stored at 2808C in sterile conditions. Each femoral head was
analyzed by plain radiography for evidence of severe osteopoenia or significant
osteoarthritic cystic lesions.

B. Preparation and Sampling of Morselized Grafts


The heads were cut into the frontal plane by a band saw to obtain an anterior and a
posterior half of each head. Each half head was randomly selected to be passed
Particle Size at the Femur 179

through the rotating bone mill (Noviomagnus, Spierings, Netherlands) to obtain


large and small particles (Fig. 1). Half-femoral heads were weighed separately on
a digital weighing scale (Mettler PE 3000, Zurich, Switzerland) before and after
processing to estimate the loss of material. The femoral heads were prepared by
carefully removing all articular cartilage and soft tissue but retaining the cortical
neck in place on the basis of our previous research. Cortico-cancellous femoral
morselized grafts without cartilage of two different sizes was mechanically
tested. As small morselized grafts were more commonly used for impaction bone
grafting in practice, the large particles were the test group and smaller particles
represented the control.
The half heads used for the smaller particles were passed twice through
the bone mill separately as in surgical practice using the fine rasps of the
Noviomagnus bone mill (Spierings, Nijmegen, Netherlands). The other half heads

Figure 1 Appearance of the femoral heads on shaving the articular cartilage and
cutting in the coronal plane.
180 Bavadekar et al.

used for the large particles were passed only once through the coarse rasps of the
same bone mill. To randomize the samples, each type of morselized graft was
mixed in a bowl and stored as samples of 5 g (Fig. 2). Eighteen samples of the
different-sized morselized graft were selected randomly for the particle analysis
and mechanical testing.

C. The Analysis of Particle Profile


Each 5 g of grafts loaded in plastic tubes (Fig. 3) was analyzed one at a time for
particle analysis. This commenced with thawing of the grafts for 30minutes and
then laying them out on clear glass plates, avoiding any loss of material.
Following this, each morsel was manually separated by a pair of microsurgical
forceps. This involved a careful dissection of each morsel from any obvious soft
tissue adhesions and separating it from any of its neighboring morsels. These
morsels were then laid out on clear plastic plates in rows at a distance of about
0.5 mm from each other.

Figure 2 On morselization, large pieces of cortical struts (held in the forcep) resist
fragmentation and remain as relatively large sized particles.
Particle Size at the Femur 181

Figure 3 Plastic tubes containing 5g of graft each. Large particulate morselized


graft (left) show an initially greater height than their small particulate counterparts
(right).

The plastic plates with the spread-out morselized grafts were then subjected
to contact x-rays at the following exposure (0.4 mA; 12 mV for 9 minutes) after
placing them on x-ray films (Kodak 20  14 cms). The developed x-ray plates
were then fed into the computer by scanning each of the x-rays separately. These
images had the appearance of white polygons (the morsels) on a black background
(Fig. 4).
Particle analyses were done on these converted files for each sample using
the perimetric area occupied by each morsel. The number of particles occurring in
5 g samples of morselized graft was calculated. Particle size was calculated as a
perimetric evaluation of each morsel in mm2 using the Scionimage image analysis
program downloaded from the Internet (Scion Corporation, Frederick, MD).

D. Morselized Grafts in Mechanical Testing


(The Impaction Procedure)
See Chapter 8.

E. Mechanical Parameters
See Chapter 8.
182 Bavadekar et al.

Figure 4 Morselized grafts spread out on plastic plates and subjected to contact
x-ray for particle measurements and analysis. Particles were measured in mm2
representing their perimetric area.

F. Statistics
The differences in the evolution of the height and elastic modulus due to the type
of grafts were analyzed using repeated-measures ANOVA. The within-subject
(sample) factor was the number of impactions, and the between-subject factor
was the type of graft. Because the density was analyzed on different samples
during the impaction, we compared the mean density of each type of graft at the
four different levels of impaction considered with a two-sample t-test. These
analyses were performed using SPSS 9.0 (SPSS Inc., Chicago, IL) separately for
batches 1 and 2. Significance level was fixed at p , 0.05.

III. RESULTS
A. Material Weight Loss on Preparing Different Grafts
Preparing the cortico-cancellous samples by removing the articular cartilage and
soft tissues adhesions from a femoral head and retaining the neck caused a mean
loss of 25% (SD 2%) of material by weight. In the present era of imbalance
Particle Size at the Femur 183

between the demand and supply for tissues from bone banks [10], a loss of
one quarter of the femoral head by weight would cause concern to some bone
bankers.
A further 2% of material is lost on passing the heads through the bone mill.
This could be attributed to the loss in bone marrow with soft tissue and very
minute bone morsels that are stuck on the rasps of the mill. Loss in material
weight was three times more when femoral heads were passed through coarse
rasps than fine rasps.

B. Particle Analysis on Morselized Grafts


The morselized grafts presented in a malleable slurry form consist of a mixture of
bone particles with soft tissue remnants, bone marrow, blood vessels, articular
cartilage, and fat. To carry out the particle analysis for studying the dimensions,
size, and number of morsels in a 5 g sample, every attempt was made to isolate
the bone morsels. Particle analysis was carried out on 18 5-gram samples of the
two morselized graft types. There were 26 (+12) large morsels and 258 (+24)
small morsels of bone in each 5 g of morselized graft (Table 1). The mean particle
size of morsels passed through the fine rasp was 9 mm2 and through the coarse
rasp 48 mm2.

C. Mechanical Outcome on Impaction


1. Height (Extent of Deformation)
The height of the column of a fixed quantity of grafts (Fig. 5) declined
progressively in proportion to the log of the number of impactions. The larger
morsels occupied a greater height when filled into the impaction cylinder that the
smaller morsels, which were more compact and made a shorter column. Both
graft types deformed to the same extent, and their final heights showed no
significant differences (p , 0.05). This would infer that morsel size does not
interfere with the extent of deformity in the size range studied.

Table 1 Characteristics of 18 Graft Samples

Mean particle size Mean number of


Particle type (mm2) particles

Small particles 9 26 (+12)


Large particles 48 258 (+24)
184 Bavadekar et al.

Figure 5 Evolution of height on progressive impaction. (Note the initial greater


height of the large particles compared to the small ones.) Both grafts deform to the
same extent and show no difference in compactness.

2. The Elastic Modulus (Stiffness)


Both types of graft were rendered successively stiffer with progressive impaction,
but the increase in stiffness (Emod) was different. Larger morsels seemed to reach
a plateau in their stiffness at the end of the seventh impaction blow, beyond which
there was a slight decline in the stiffness curve rate ( p , 0.05). By contrast, the
smaller morsels got stiffer up to the 30th impaction, and beyond that there was no
apparent decline in their stiffness curve (Fig. 6). All parts of these two stiffness
curves were analyzed by ANOVA, but there was no significant difference in the
two moduli.

3. Evolution of Densities
Both types of graft showed the same pattern in density increase, although the
smaller one was ultimately denser.

IV. DISCUSSION

Two distinct sizes of morselized graft obtained using two different rasps showed
no significant difference in their compressive axial stiffness during progressive
impaction in a contained volume. The source of the morselized grafts and their
milling was similar to the actual surgical procedure.
Many interesting papers have referred to the superior quality of a graft layer
made up of large bone morsels compared to the smaller ones [3,4,6–8]. This holds
Particle Size at the Femur 185

Figure 6 Stiffness of both types of graft increased progressively with every


impaction. However, at higher levels of impaction (.10), large particle stiffness
declined while smaller particle stiffness continued to rise.

true when the impacted graft layer is subjected to dynamic compression and serially
loaded to see its extent of deformation and recoil. Impacting the grafts deforms
them to the same extent, and their stiffness is similar independent of morsel size.
In this simple model for impaction, morsel size is not a critical factor
during impaction, and a similar mechanical outcome can be expected on
progressively impacting the grafts. If a denser layer of graft is desired with more
bone content, smaller morsels are better, as more bone is packed into the same
area than with large morsels.
These preliminary findings were designed to model femoral impaction, and
no shear tests were performed [7]. The grafts were tested only in compression
(impaction), and any inferences from the study should not be confused with the
preference for large particles when reconstructing the acetabulum. Acetabular and
femoral grafts are subjected to different forces, so these findings should not be
generalized. Future research is needed to test morselized grafts of different
shapes, in different types of containment, and in different mechanical environ-
ments to define the differences between femoral and acetabular impaction grafting.

REFERENCES

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Mechanical consideration in impaction bone grafting. J Bone Joint Surg 1999;
81B:118– 124.
186 Bavadekar et al.

2. Brodt MD, Swan CC, Brown TD. Mechanical behavior of human morselized
cancellous bone in triaxial compression testing. J Orthop Res 1998; 16:43 – 49.
3. Ullmark G, Nilsson O. Impacted corticocancellous grafts: recoil and strength.
J Arthroplasty 1999; 14:1019– 1023.
4. Giesen EB, Lamerigts NM, Verdonschot N, Buma P, Schreurs BW, Huiskes R.
Mechanical characteristics of impacted morsellised bone grafts used in revision of
total hip arthroplasty. J Bone Joint Surg 1999; 81B:1052– 1057.
5. Gie GA, Linder L, Ling RS, Simon JP, Slooff TJ, Timperley AJ. Impacted cancellous
allografts and cement for revision total hip arthroplasty. J Bone Joint Surg 1993;
75B:14 – 21.
6. Kobayashi et al. Comparison of morsellised grafts in compression: comparative
study of grafts obtained from reciprocating and rotating bone mills. Oral Presentation
at the 8th Annual EAMST meeting, Rhodos, Greece, June 6, 2001.
7. Gösta Ullmark. Bigger size and defatting of bone chips will increase cup stability.
Arch Orthop Trauma Surg 2000; 120:445– 447.
8. Griffon DJ, Dunlop DG, Howie CR, Gilchrist T, Salter DM, Healy DM. Early
dissolution of a morsellised impacted silicate-free bioactive glass in metaphyseal
defects. J Biomed Mater Res 2001; 58(6):638– 644.
9. Bavadekar A, Cornu O, Godts B, Delloye Ch, Van Tomme J, Banse X. Stiffness and
compaction of morselized grafts during impaction: an in vitro study on human
femoral heads. Acta Orthop Scand 2001; 75(5):470– 476.
10. Galea G, Kopman D, Graham BJ. Supply and demand of bone allograft for revision
hip surgery in Scotland. J Bone Joint Surg 1998; 80-B:595 – 599.
14
Mechanical Studies of the Bone
Particle Size at the Femur
Akio Kobayashi
Osaka City University Medical School
and Osaka Social Medical Center Hospital
Osaka, Japan

Hirotsugu Ohashi and Yoshinori Kadoya


Osaka City University Medical School
Osaka, Japan
Yuji Tanabe
Niigata University
Niigata, Japan

I. INTRODUCTION

It has been generally accepted that the polyethylene wear and subsequent
osteolysis is the most critical factor causing aseptic loosening, which is the
principal limiting factor in the long-term survival in total hip arthroplasty (THA).
In such loose prostheses, massive bone loss in the proximal femur is frequently
observed and surgical reconstruction of the defect and restoration of bone stock is
the aim of revision THA.
Impacted morselized cancellous allograft technique has been developed for
such deficient bone stock, and favorable results have been reported compared to
conventional reconstruction with bone cement alone [1]. However, early and
significant subsidence of the femoral stems was also reported, which might have
resulted from poor mechanical properties of the grafted bone [2,3]. Preparation of
the morselized allograft and impaction technique are both considered to be
important factors for the mechanical properties of the graft and initial stability of
the femoral stem. However, there has been a paucity of data about preparation
187
188 Kobayashi et al.

methods such as preimpaction graft treatment (wash and defating), elimination of


the cartilage, and the optimum size of the bone particles.
In this study, we compared mechanical properties of the graft from two
commercially available bone mills in four different conditions to examine the
effect of the bone particle size on the mechanical properties. Two series of studies
were performed as follows:
Study 1: Mechanical property of cylindrical specimens of graft was
evaluated under quasi-static compression and shear with special
reference to the range and distribution of particle sizes, and the number
of dynamic impactions.
Study 2: Axial and torsional load tests were performed on femoral stems
fixed in model bones with bone cement on to impacted morselized graft.

II. STUDY 1
A. Graft Bone Preparation
Seventy-five human femoral heads were obtained from patients with
femoral neck fractures (47 patients) and osteoarthritis (28 patients) during
primary THA. The femoral heads were stored at 2708C until tested. After
removing soft tissue and cartilage, the femoral heads were cut equally into four
pieces and divided into four groups at random to minimize heterogeneity among
the groups.
Morselized allografts were prepared in four different conditions made by
two types of bone mills of the rotating rasp type (Tracer Designs, Santa Paula, CA)
and reciprocating blade type (Recipro) (Lere Bone Mill, DePuy, Warsaw, IN). In
the rotating type, three kinds of rasps were used: coarse, medium, and fine (Fig. 1).

B. Measurement of Particles Size of Morselized Graft


To determine the size of the bone particles, seven specially designed sieves were
made of plastic plates with drilled holes. The size of the drill holes ranged from 2
to 8 mm with 1 mm increment. The sieves were used in order of decreasing hole
diameter with the largest at the top. Approximately 500 mg of morselized bone
was first washed in ethanol in order to remove fat and prevent aggregation, then
passed through the sieve with the largest holes. The sieve was manually shaken
until there was no further passage of fragments. The same procedure was applied
to the other sieves.
The weight of the graft bone remaining in each sieve was measured, and the
percentage of the graft in each sieve was calculated. This procedure was repeated
four times to process the four quadrants.
Bone Particle Size at the Femur 189

Figure 1 (a-1) Rotating rasp–type bone mill with (a-2) three kinds of rasps
(coarse, medium, and fine). (b) Reciprocating blade –type bone mill.

C. Evaluation of the Impact Force Using Operating Devices


The magnitude of an impact force was calculated based on the one-dimensional
elastic wave propagation theory [4] in a simulated operation using morselized
allograft and plastic model bones (Sawbones, Pacific Research Laboratories,
Vashon, WA). We used exactly the same devices and procedure as used clinically
(CPT, Zimmer, Warsaw, IN). Two sets of strain gauges were attached on the
femoral packer, as shown in Figure 2. The impact force (Fc) applied to the upper
end of the bone at any time (t) could be calculated by the following equation:
Fc ¼ A{sa (t þ t1 ) þ sa (t  t1 )  sb (t)}
where
sa , sb ¼ stress histories detected by strain gauges at point a and b (Fig. 2),
respectively
A ¼ cross-sectional area of the femoral packer
t1 ¼ time required for stress wave propagation from point a to b or
from point b to a
Ten consecutive impacts were applied for each trial procedure, and the impact
force was standardized during the first 10 impacts. Thus, we chose the value at the
tenth impact as a representative value for each trial. The average after five
experiments was 4.2 kN.
190 Kobayashi et al.

Figure 2 The femoral packer. Strain gauge (a, b) location is shown on the
schema (L1 ¼ L2 ¼ L3). Four-gauge method was used to evaluate impact load
applied to the graft.

D. Production of Cylindrical Bone Specimens by Dynamic


Impaction
Cylindrical graft specimens 10 mm in diameter and 10 mm in length (Fig. 3)
were prepared by a specially designed dynamic impaction apparatus (Fig. 4).
The apparatus consisted of a striker bar, a force transmitter bar, a setting table,
and recording equipment. Approximately 500 mg of the morselized bone was
packed into the hole of the setting table and the force transmitter bar was placed

Figure 3 Cylindrical graft bone specimen.


Bone Particle Size at the Femur 191

Figure 4 A specially designed dynamic impaction apparatus.

on it. The striker bar struck the upper end of the force transmitter bar generating
a pulse of compressive force traveling down it dynamically loading the
morselized bone. The magnitude of an impact force selected was the same as
that observed in the simulation described in the previous section and set at
approximately 4.2 kN by monitoring with strain gauges on the force transmitter
bar. The impact force was applied to the bone 15 or 30 times to investigate the
effect of the number of impactions on the mechanical properties of the graft
preparations.

E. Mechanical Testing
Quasi-static uniaxial compression tests as well as quasi-static shear tests at
various normal compression loads were performed using an Instron-type
materials testing machine (Autograph AG-25TD, Shimadzu Co. Ltd., Kyoto,
Japan). The specimens were tested without lateral constraint in the
compression tests. A new shear testing apparatus modified from the commercial
one used in the previous study [5] was made for this study (Fig. 5). The
cylindrical bone specimen was put into a cylindrical plastic container with a
load of 9.8, 19.6, or 29.4 N applied by a spring and then sheared by moving the
cross-head downward at a constant speed (3 mm/min) at room temperature
(208C).
All specimens were kept moist during testing. Ten specimens were used for
each test and each graft group. The results were statistically analyzed among four
groups of bone specimens using ANOVA with a statistical software program
(SPSS Inc., Chicago, IL).
192 Kobayashi et al.

Figure 5 Experimental set-up for quasi-static shear tests.

F. Results
1. Particle Sizes in Morselized Bone
The size distribution of bone particles in each group is shown in Figure 6.
Compared to rotating rasps (coarse, medium, and fine), morselized bone prepared
by the reciprocating blade (Recipro) contained larger bone particles with greater
size distribution.

Figure 6 Percentage size distribution of graft bone for different milling conditions.
Bone Particle Size at the Femur 193

2. Stress-Strain Behavior of Impacted Bone


Specimen Under Compression
Nonlinear or downward convex characteristics were found in nominal
compressive stress-strain curves of all specimens independently of the number
of times they were impacted. Stiffness in compression defined by the tangent
modulus at strain of 0.2 on the stress-strain curve in each group is shown in
Figure 7. The stiffness generally increased in proportion to the number of
impactions in each group, but the difference between 15 and 30 times was not
significant in every group. After 30 impactions, specimens prepared by the
reciprocating blade (Recipro) showed significantly higher stiffness than those
prepared by any other rotating rasp (coarse, medium, and fine) (p , 0.01).

3. Mechanical Strength of Impacted Bone


Specimen Under Shear
Load-displacement curves of all specimens under quasi-static shear obtained in
this study were upward convex. Shear strength, defined as the maximum shear
stress on the curve, was determined as a function of axial compressive stress
(Fig. 8). As the number of impactions had no effect on the relationship between

Figure 7 Stiffness of cylindrical bone specimens in quasi-static compression for


each graft group.
194 Kobayashi et al.

Figure 8 Shear strength of cylindrical bone specimens impacted 30 times plotted


against axial compressive stress.

shear and axial compressive strength, only the results for the specimens impacted
30 times are shown in this study. The average of shear strength can be formulated
by the Mohr-Coulomb equation [5,6] given as

tu ¼ c þ sa tanf (1)

where
tu ¼ shear strength
sa ¼ axial compressive stress
c ¼ cohesive force
f ¼ angle of shearing resistance or angle of internal friction
The shear strength parameters, c, f, and tu , of each group are listed in Table 1.
Impacted bone specimens prepared by the reciprocating blade (Recipro) showed
significantly higher shear strength than those prepared by any other rotating rasp
(coarse, medium, and fine) ( p , 0.01).
Bone Particle Size at the Femur 195

Table 1 Shear Strength Parameters for Eq. (1)

Average shear
strength (tu )
Angle of (0.37 MPa
Cohesion (c) internal friction compressive
Group (MPa) (f) (rad) stress) (MPa)

Fine 0.34 0.38 0.49


Medium 0.22 0.46 0.37
Coarse 0.28 0.48 0.46
Recipro 1.07 0.25 1.27a

p , 0.01 compared to the other three groups.


a

G. Summary
The results of study 1 indicated that the mechanical properties of cylindrical
specimens were affected by the preparation method of morselized bone and the
number of impactions. The size distribution varied among the four types of bone
mill.
The main factors that influenced the mechanical properties of impacted
morselized bone were not identified, but the samples with larger bone particle
size and/or broader particle size distribution seemed to have superior mechanical
properties.

III. STUDY 2
A. Preparation of Femoral Models
The mechanical characteristics of impacted morselized allograft were assessed
in more clinically relevant conditions. Plastic model femora (6 in each group)
(Sawbones, Pacific Research Laboratories, Vashon, WA) were overreamed
(15 mm in diameter at the distal end of the femoral stem) (Fig. 9) to
reproduce the bone deficit seen in aseptic loosening. Four kinds of morselized
allograft were prepared under the same conditions as used in study 1. The
impaction allograft procedure was performed exactly like an operative
procedure with specially designed instruments (CPT, Zimmer, Warsaw, IN).
Collarless polished tapered femoral stems (CPT, Zimmer, Warsaw, IN)
(Fig. 10) were cemented into the impacted bone bed with acrylic bone cement
(Fig. 11).
196 Kobayashi et al.

Figure 9 Plastic model femur over-reamed by 15 mm in diameter canal reamer to


reproduce the bone-deficient condition.

B. Mechanical Testing
Cyclic compression and torsional tests were performed using Instron-type
mechanical tester (Autograph AG-25TD, Shimadzu Co. Ltd., Japan) (Fig. 12).
Cyclic loading was applied between 440 and 690 N at a frequency of 0.4 Hz up to
200 cycles. In this test, stiffness and absorbed energy were calculated from the
relationship between load and displacement of the stems.
Stiffness was defined as the Young’s modulus of the loading curve.
Absorbed energy was defined as the area surrounded by the loading and
unloading curves at given cyclic compression. Torsional test was performed with

Figure 10 Collarless polished tapered femoral stems (CPT).


Bone Particle Size at the Femur 197

Figure 11 CPT fixed into the reconstructed femoral canal with acrylic bone
cement.

an axial load of 440 N at angular rate of 2.0 degrees/s. Stiffness in torsion was
defined as the tangent modulus at 14 degrees of the twist angle in torque-twist
angle curve. Results were statistically analyzed among four groups using
ANOVA with a statistical software program (SPSS Inc., Chicago, IL).

C. Results
1. Cyclical Compression Test
The greatest subsidence was seen during the first 50 cycles, but stems became
stable afterwards. The differences among the four groups were not statistically
significant (Fig. 13). Stiffness in the Recipro group was significantly higher than
in the rotating rasp groups (coarse, medium, and fine) ( p , 0.01) (Fig. 14).
Absorbed energy in the Recipro group was also smaller than in rotating groups
(p , 0.01) (Fig. 15).

2. Torsional Test
Stiffness in the torsional test showed a similar tendency as seen in compression
test, but the differences between bone mill types were not significant (Fig. 16).

D. Summary
These findings indicated a similar tendency as observed in study 1. The femoral
stems fixed with morselized bone containing large bone particles were more
stable under compressive and torsional conditions.
198

Figure 12 Experimental set-up for cyclic compression test and torsional test.
Kobayashi et al.
Bone Particle Size at the Femur 199

Figure 13 Axial displacement (subsidence) under cyclic compression. The


differences among groups were not significant (NS).

Figure 14 Stiffness under cyclic compression. In Recipro group, stiffness was


significantly higher than those in rotating rasp groups (coarse, medium, and fine).
200 Kobayashi et al.

Figure 15 Absorbed energy under cyclic compression. In Recipro group,


absorbed energy was smaller than those in rotating groups (coarse, medium,
and fine).

Figure 16 Stiffness in torsional test. A similar tendency was seen as in


compression test, but the differences among groups were not significant.
Bone Particle Size at the Femur 201

IV. DISCUSSION
A. Experimental Procedure
Several studies have been done on the mechanical behavior of morselized graft in
vitro. In some recent reports, morselized graft was considered to be a particulate
aggregate, and its mechanical behavior was characterized by engineering soil
mechanics [5,7]. Giesen et al. [8] and Bavadekar et al. [9] analyzed the
mechanical properties of the graft in a contained cavity under compression
simulating the clinical conditions in the femoral canals. Malkani et al. [10] and
Berzins et al. [11] used cadavers to reproduce the impaction grafting procedure.
In the current study, however, plastic model bones were used. The mechanical
properties of the model bones were considerably different from that of human
femora, and the definite values of the result in our study 2 might be influenced by
this difference. However, the authors believe that the comparison among the
groups is still valid and provides useful information. In fact, there is a definite
advantage in using the model bones. The model bones are more consistent than
cadaveric bones, and thus it is easier to reproduce the bone defect in the proximal
femur to standardize the experimental conditions.

B. Influence of Bone Preparation Condition on Mechanical


Properties of the Graft
Clinically, it is practically difficult to obtain pure cancellous bone as the source of
morselized allograft. Contamination of some soft tissue, cartilage, and cortical
bone is inevitable.
Bavadekar et al. [9] compared the mechanical behavior of pure cancellous
and cortico-cancellous bone and revealed that there was no difference between
them, reporting that the contamination of the cartilage weakened the stiffness of
the graft specimens. Ullmark [12] and Hostner et al. [13] assessed the effect of
washing and defatting on morselized bone before impaction and discovered that
they strengthened the impacted specimens.

C. Influence of Particle Size of Morselized Graft


There have been few reports on the influence of bone particle size on the
mechanical properties of the graft. Brodt et al. [7] sieved the morselized bone and
divided it into three size range groups (,0.53 mm, 0.53 –1.14 mm, and 1.52 –
2.46 mm), showing no difference among the groups. Ullmark and Nilsson [14]
compared two different bone mills (particle volume range up to 40 mm3 and up to
12 mm3), and larger bone chips had superior mechanical properties. In our study
the Recipro group, which included both larger bone particles and a wide range of
size distribution, demonstrated superior mechanical properties. This is exactly
202 Kobayashi et al.

Figure 17 A stone wall in Himeji Castle, Himeji City, Hyogo, built in 1609, a
national treasure and World Heritage site. Broad size distribution may provide a
stable structure.

like the stone walls of ancient Japanese castles, which survived despite exposure
to repeated earthquakes (Fig. 17).
Morselized bone prepared by the reciprocating blade type bone mill
contained larger bone particles with a wide variation of size and showed
significantly higher stiffness and shear strength compared to those prepared by
rotating bone mills. Although there were no significant differences in torsional tests
among the bone mill types, the tendency to superior stability in the Recipro group
was demonstrated, indicating that the selection of bone mill is very important when
using impaction morselized allograft for revision total hip arthroplasty.

REFERENCES

1. Gie GA, Linder L, Ling RS, Simon JP, Slooff TJ, Timperley AJ. Impacted cancellous
allografts and cement for revision total hip arthroplasty. J Bone Joint Surg 1993;
75-B:14 – 21.
2. Eldridge JD, Smith EJ, Hubble MJ, Whitehouse SL, Learmonth ID. Massive early
subsidence following femoral impaction grafting. J Arthroplasty 1997; 12:535– 540.
3. Pekkarinen J, Alho A, Lepisto J, Ylikoski M, Ylinen P, Paavilainen T. Impaction
bone grafting in revision hip surgery. A high incidence of complications. J Bone
Joint Surg 2000; 82-B:103 – 107.
Bone Particle Size at the Femur 203

4. Tanabe Y, Kobayashi K, Sakamoto M, Hara T, Takahashi H. Identification of the


dynamic properties of bone using the Split-Hopkinson pressure-bar technique.
Biomaterials’ Mechanical Properties, ASTM (American Society for Testing and
Materials, Philadelphia) 1994; STP1173:127– 141.
5. Brewster NT, Gillespie WJ, Howie CR, Madabhushi SP, Usmani AS, Fairbairn DR.
Mechanical considerations in impaction bone grafting. J Bone Joint Surg 1999;
81-B:118– 124.
6. Craig RF. Soil Mechanics. 5th ed. London: Chapman and Hall, 1993.
7. Brodt MD, Swan CC, Brown TD. Mechanical behavior of human morselized
cancellous bone in triaxial compression testing. J Orthop Res 1998; 16:43– 49.
8. Giesen EBW, Lamerigts NM, Verdonschot N, Buma P, Schreurs BW, Huiskes
R. Mechanical characteristics of impacted morsellised bone grafts used in revision of
total hip arthroplasty. J Bone Joint Surg 1999; 81-B:1052– 1057.
9. Bavadekar A, Cornu O, Godts B, Delloye C, Van Tomme J, Banse X. Stiffness and
compactness of morselized grafts during impaction: an in vitro study with human
femoral heads. Acta Orthop Scand 2001; 72:470 – 476.
10. Malkani AL, Voor MJ, Fee KA, Bates CS. Femoral component revision using
impacted morsellised cancellous graft. A biomechanical study of implant stability.
J Bone Joint Surg 1996; 78-B:973 – 978.
11. Berzins A, Sumner DR, Wasielewski RC, Galante JO. Impacted particulate allograft
for femoral revision total hip arthroplasty. In vitro mechanical stability and effects of
cement pressurization. J Arthroplasty 1996; 11:500– 506.
12. Ullmark G. Bigger size and defatting of bone chips will increase cup stability. Arch
Orthop Trauma Surg 2000; 120:445– 447.
13. Hostner J, Hultmark P, Karrholm J, Malchau H, Tveit M. Impaction technique and
graft treatment in revisions of the femoral component: laboratory studies and clinical
validation. J Arthroplasty 2001; 16:76 –82.
14. Ullmark G, Nilsson O. Impacted corticocancellous allografts: recoil and strength.
J Arthroplasty 1999; 14:1019 – 1023.
15
Impaction Grafting:
How Does It Work?
Magnus Tägil and Per Aspenberg
Lund University Hospital
Lund, Sweden

I. INTRODUCTION

The initial problems in hip arthroplasty with infection, poor implant design, and
fatigue fractures of the implant have essentially been solved, and some authors
even doubt the need for further research in these fields [1]. However, the problem
of what to do when prosthetic loosening occurs remains. The results of revision
surgery are not as good as those of primary replacements [2,3]. When there is
major bone loss, bone grafts are used in the proximal part of the femur or the
acetabulum. Autogeneic and allogeneic structural grafts have been used in the
acetabulum with good initial results [4], but resorption of the graft and
subsequent loosening of the implant have been reported to occur later [5,6].
Others have reported more favorable mid-term results with a similar technique
[7]. On the femoral side, good short- and medium-term results have been
obtained with structural grafts [8 –10].
In the late 1970s, the Slooff-Ling technique, named after its inventors, was
introduced (Figs. 1 and 2), based on Hastings and Parker’s [11] operation for
acetabular protrusion in rheumatoid arthritis. Hastings and Parker placed an
autograft in the acetabulum and cemented a cup with a vitallium mesh between
the graft and the cement. In 1978 Slooff started to use this method for acetabular
component loosening with osteolysis. Instead of the autograft, he used allograft
chips, which were impacted into the acetabular cavity, and a cup was cemented
directly onto the graft. The results were reported in 1984 [12]. One year later,
Ling started to use the same technique for femoral reconstructions [13]. With this
205
206 Tägil and Aspenberg

Figure 1 Schematic drawing of a femoral revision with morselized and impacted


graft between the cortex and the cement.

technique, the bone chips are impacted with a phantom into the femoral canal. A
cavity is produced, surrounded by a layer of tightly impacted allograft chips
forming a compact lining of the thin cortical walls (Fig. 1). The graft is contained
within the cortex of the femur. A cemented prosthesis is then inserted in the same
way as in a primary hip replacement with the cement pressurized into the graft
during cementation.
Theoretically, the impacted allograft would be expected to fail. A large
volume of necrotic tissue placed under high mechanical stress should resorb and
collapse, just as the necrotic bone collapses after avascular necrosis of the hip or
Impaction Grafting 207

Figure 2 (A) Hip revised with impaction grafting. The marrow cavity was cleansed
of soft tissue and bony debris and filled with morselized allograft, which was
impacted with a phantom. A prosthesis was cemented into the cavity surrounded by
a wall of impacted bone within the thin cortex. (B) The postoperative radiograph
(left) shown in higher magnification. Note the thin cortex. (C) One year after the
operation, the cortex looks thicker.

knee, without being able to maintain its volume during healing and remodeling.
Moreover, the morselized and impacted graft is of allogeneic origin, and an
immunological reaction with activation of macrophages and osteoclasts would
further enhance the resorption and lead to graft collapse and loosening again.
Compared to the rather drastic introduction of a 0.5– 1 cm thick layer of necrotic
tissue, much more subtle changes in the periprosthesic tissue have been
incriminated as the cause of aseptic loosening, e.g., heat necrosis, fibrous layer
development, and inflammatory cytokines.
However, the clinical results of the Slooff-Ling technique are good in the
hands of the innovators, with re-revision rates no higher than after a primary
208 Tägil and Aspenberg

arthroplasty [14 – 16]. Others have also reported good short- and mid-term results
with this method, but poor results have also been noted, raising concerns over a
high rate of subsidence [17 –19].

II. HYPOTHESES

Why does the method of using morselized and impacted allograft work so well?
Often, when the clinical need for a solution is great, clinical trials start before the
theoretical basis of the method is clear. Ingrowth of host bone into a large,
structural, nonmorselized allograft is usually limited to a few mm [20 –23],
whereas in the morselized and impacted graft a distance of at least 10 mm in the
trochanteric region is considered to be remodeled or in the acetabulum even
more. Why should a thick layer of morselized necrotic, allograft bone become
better incorporated, without causing the resorption and recurrent loosening often
encountered in structural grafts? Several years ago, we decided to test three
hypotheses that we thought could explain the excellent long-term results of
impaction grafting:
1. Impaction improves the osteoconductive properties of the graft.
2. The production of a large fracture surface area by fracturing the bone
during morselization permits release and access to biologically active
substances in the graft.
3. The compliance of the impacted graft enables mechanical load to cause
deformations, which stimulate bone formation.

III. IMPACTION AND INGROWTH

Does impaction improve osteoconduction and enhance ingrowth into the graft?
Theoretically the ingrowing tissue could benefit from a decreased distance
between the graft trabeculae, the network being more dense compared to a
cancellous graft but without the transient weakening of a cortical graft during
remodeling. The morselized and impacted graft could be seen as the ideal
grafting material, being an intermediate between cortical and cancellous graft,
and combining the advantages of both [24].
To study the remodeling of an impacted graft in an animal model, we
developed an impacting device consisting of a hollow cylinder and an impacting
piston. Two cancellous rat bone grafts were manually impacted into
approximately the size of one. This procedure increased the volume fraction of
osseous material in the graft from 35% to 65% (Fig. 3) (25). The bone conduction
chamber (BCC) (Fig. 4) rat model was used, and impacted and unimpacted grafts
were compared for bone ingrowth distances after 6 weeks. A striking reduction of
Impaction Grafting 209

Figure 3 (A) Structural graft (left) before insertion into the chamber, with
unfractured trabeculae, fat, and marrow cells. (B). Impacted bone graft (same
magnification) before insertion, with fractured trabeculae and reduced inter-
trabecular space. Smaller amount of fat and marrow cells are present than in
A. (Reproduced by permission of Clinical Orthopedics).
210 Tägil and Aspenberg

Figure 4 The bone conduction chamber. (A and B). The bone conduction
chamber (BCC, Aspenberg and Wang, 1993) is screwed into the proximal tibia of a
rat. The interior of the chamber is a standardized space of 2  7 mm. Tissue can
grow into the chamber from the osseous compartment via two ingrowth openings
(arrows) at one end, but not from the surrounding soft tissues. The interior can be
left empty and the chamber fills with mesenchymal tissue, which gradually
differentiates into bone. The chamber can also be filled with an osteoconductive
material, which can be further processed using growth factors, defatting, etc. Bone
grafts were prepared from donor rats by resecting a 2  6 mm cancellous bone rod.
The impacted graft consisted of two graft pieces compacted into the size of one
using an impactor. The grafts were then inserted into the chambers, which were
then screwed into the proximal tibias of recipient rats. After harvest, the grafts
were taken out, decalcified, cut and stained with hematoxylin and eosin. (C) The
area of newly formed bone was measured histomorphometrically by circumscribing
it on a digitizing table, using a computerized video system. The area (A) was divided
by the width (W) of the specimen to obtain the mean ingrowth distance (I) of new
bone in each specimen. All rats had chambers implanted bilaterally; one side
serving as the experiment side and one as the control side. Paired statistical tests
were used to analyze the data.
Impaction Grafting 211

Figure 4 Continued.

bone ingrowth into the graft was found due to the impaction, not an increase as
hypothesized [25]. To determine whether the ingrowth was permanently reduced
or only delayed, we studied the ingrowth of new bone into an impacted graft at
both 6 and 12 weeks [26]. A reduction in ingrowth was again found at 6 weeks,
but no detectable difference between the impacted and the structural grafts was
found at 12 weeks. We found no support for the concept that impaction would
increase the ingrowth or remodeling per se. On the contrary, remodeling was
decreased or at least retarded.

IV. IMMUNOGENICITY

It has been speculated that the amounts of immunogenic cells and cell remnants
are minimized in the morselized and impacted graft, because most of the marrow
is squeezed out [15]. Since the graft is of allogeneic origin, the immunogeneic
host-graft reaction is minimized, which could be beneficial for the remodeling. In
animal studies, cancellous bone, containing marrow, was more immunogenic
than cortical bone, and removal of the marrow reduced the immunogenicity
[27 – 30]. In the BCC model, chemical lipid extraction of structural grafts
212 Tägil and Aspenberg

Figure 4 Continued.

increased the bone ingrowth distance in structural grafts [31]. Perhaps the
morselization and impacting procedure can be regarded as a mechanical defatting
procedure comparable to a chemical one, which we know is beneficial. Our
impacted bone pellets had reduced amounts of fat and marrow cells (Fig. 3).
However, in two further series of experiments, impaction decreased bone
ingrowth in both syngeneic and allogeneic grafts [26]. Thus, although impaction
may reduce marrow content and thereby immunogenicity, ingrowth due to
impaction decreased in the BCC model.

V. FRACTURE SURFACE AND


ENDOGENOUS PROTEINS

Bone graft incorporation appears to mimic fracture healing, and local regulatory
factors are probably important for activating local cells and regulating the release
Impaction Grafting 213

of biochemical messengers [32,33]. Hippocrates suggested an endogenous


product, able to heal bone, to be present in the human body [34]. A fresh fracture
surface exposes the bone matrix to the surrounding tissues without a protective
layer of lining cell and osteoid. Do the fracture surfaces created by morselization
have a growth-promoting effect by permitting the release or presentation of bone
morphogenic proteins (BMPs) or other growth factors within the mineralized
matrix that would not have been released if the lining layer was intact?
Bone matrix contains growth factors that modulate osteoblast differen-
tiation [35], but it is not known whether the endogenous proteins from the graft
play an active role in incorporation and remodeling, although their presence has
been emphasized [36 – 38]. Exogenously added growth factors accelerate healing
in numerous animal and human studies. In different bone chamber models
exogenously applied bFGF [39,40], BMP-7 [26], and BMP-2 [40] accelerate and
increase ingrowth into bone grafts. To establish whether the endogenous proteins
present in the bone matrix would influence the remodeling of a bone graft, we
produced grafts in which these proteins were destroyed. Femoral and tibial
diaphyses from rats were defatted and ground. One portion was slowly heated
with water to 2708C at an autogenic pressure of 55 bar for 4 hours (a ceramic
procedure) in order to destroy the proteins of the graft but leave the mineral phase
of the bone unchanged. As a control, similarly ground but not heated bone powder
was used. The rat bone conduction chamber was used, and the ingrowth distance
of new bone into the graft was studied (Fig. 4). The ingrowth of new bone was
reduced when the proteins were destroyed. The hypothesis that the morselization
procedure would release or present growth factors at fracture surfaces was
consistent with this finding. However, other effects of persisting proteins might be
responsible, for example, proteins as a substrate for cellular attachment.

VI. IMPACTION AND EXOGENOUS GROWTH FACTORS

In a study of spinal fusion in rabbits using morselized autograft bone, the central
grafted volume of the fusion mass was compared to a more peripheral one, and
the extent of healing differed in relation to the distance into the graft [41,42].
Peripherally in the graft, the healing was faster and the mechanical strength
showed an earlier increase than in central parts of the graft, where healing was
slower and did not become complete. The authors discussed whether the central
graft is “compromised geographically” and concluded that, if the molecular
events responsible for the delay in the central zone could be controlled, this might
be the key to eliminate nonunions. Using RT-PCR, different gene expression
patterns were found in the central and peripheral parts of the graft [43]. The peaks
of gene expression in the central zone lagged 1– 3 weeks behind the peripheral
parts of the graft. This correlated to the delay in bone formation, seen
214 Tägil and Aspenberg

histologically, and the fact that nonunions, which occur in 35– 45% of rabbits in
this model, do so in the central fusion mass. Addition of a rhBMP-2 lowered the
nonunion rate to 0% [44]. Gene expression analysis of the BMP-treated fusion
mass showed a marked increase in BMP-6 in the outer zone as well as elimination
of the central lag of BMP-6, BMP-2, collagen, and osteocalcin [43].
In our BCC model, the markedly decreased ingrowth caused by impaction
was also reversed by adsorbing a BMP (OP-1) to the impacted graft [26]. The
ingrowth was even greater than in the unimpacted grafts in the other groups. The
effects of osteoinductive proteins on the osteoblasts have been studied
extensively. In our study and in the rabbit spine fusion study [43], the
osteoclastic resorption might have been increased by an osteoinductive substance
as suggested by some studies [40,45,46]. Increased resorption would then
compensate for a relative blockade of tissue from intruding between the packed
trabeculae. This blockade could be related to the reduced porosity of the graft.
The effect of OP-1 might be to overcome this blockade by stimulating
osteoclastic resorption. This would permit the ingrowing new tissue to extend
further into the graft.

VII. BONE REMODELING IN RESPONSE TO LOAD

Our bone chamber studies were designed to separate various factors and
mechanisms to find impaction-related factors that increase bone ingrowth into the
graft. Such an increase would have been possible to measure as increased
ingrowth distance of new bone into the graft. Unexpectedly, we found a decrease
or delay with impaction and not an increase. We therefore had to find another
explanation for the good clinical results with impaction grafting.
The better clinical results with the impacted grafts than with structural
grafts have been ascribed to a better response to mechanical stimulation. Gie et al.
[13] suggested that the load is “directed through the graft during healing.” Load
would increase remodeling just as an externally applied growth factor would.
Indeed, mechanical stimulation of graft incorporation might be mediated by
increased production of growth factors [47]. A rabbit knee prosthesis model was
designed to study the effect of a mechanical load on the remodeling process [48].
In that model, a loaded or unloaded tibial prosthesis stem was inserted into
the impacted graft (Fig. 5). In consequence, the graft into which the stem was
inserted was either mechanically stimulated or not. In the loaded stems, the
knee joint forces acting on the tibial plateau of the prosthesis loaded the graft
surrounding the stems with each step. In the unloaded stems, the tibial tray was
cut off, leaving only the stem, and the articulation took place between the
remaining articular surfaces.
Impaction Grafting 215

Figure 5 Rabbit knee prosthesis model. (A) A tibial prosthesis was designed for
this experiment and implanted in skeletally mature lop-ear dwarf rabbits. The
prosthesis consists of a titanium plate replacing the tibial surface and a 25 mm long,
conical shaped, unpolished stem. The articular surface is convex in the sagittal
plane and tilted posteriorly. (B) In the unloaded experiments, stems without a
bearing surface were inserted into the graft bed. The femoral condyles then rested
on the remainder of the tibial articular surface, without transferring a load onto the
prosthetic stem and the impacted graft. No cement was used for fixation.
Cancellous bone grafts were harvested from donor rabbits and manually cut into
1–1.5 mm pieces and frozen. The bone marrow cavity was enlarged, and
all cancellous bone removed. A distal rubber plug was inserted into the marrow
cavity 25 mm down, and the space between the stem and cortex was filled with
graft and impacted with a prosthesis. Either the complete prosthesis or only the
intramedullary stem was then inserted and, consequently, the bone graft
surrounding the stems was either loaded or not. (C) After harvest, the bone was
sawed into segments perpendicular to the tibial axis and were decalcified, cut,
and stained with hematoxylin and eosin. Four segments, at a distance of 4 mm,
were blinded and analyzed from each animal. In all sections, the inner 0.9 mm, the
area of interest (boxes) at the three sides to the triangular-shaped stem void, was
examined by a Merz grid. The percentages of new bone, remaining dead graft, and
other tissues were recorded. The means of the three regions of interest in each
section were calculated, and the means of all four segments were then used to yield
one final value for each animal. The findings were analyzed by t-test.
216 Tägil and Aspenberg

Figure 5 Continued.

In this model, the load increased the remodeling of the graft. Both
formation of new bone and resorption of the graft were increased. Around the
unloaded stems, the proximal metaphyseal bone remodeled to some extent, but in
the diaphyses, the graft was mostly resorbed without much formation of new
bone. In a second series OP-1 was added to the morselized and impacted graft to
see if one could speed up the remodeling even more but no increased remodeling
was found [49]. However, just like the chamber model, this rabbit prosthetic
model cannot detect an increased ingrowth distance or penetration of new tissue
into the graft, exceeding the 2 –3 mm mentioned previously [20], because the
distance from the cortex to the prosthesis is too short.

VIII. THE FATE OF THE IMPACTED GRAFT


DURING REMODELING

Thus, we could conclude that mechanical stimulation is important for the


incorporation and remodeling of a morselized impacted graft. However, a
prerequisite for all grafting procedures is initial and permanent mechanical
stability, essential for graft-host union and further remodeling. In structural
nonmorselized grafts, some authors have stressed that instability may lead to
fatigue fractures and nonunion can cause the graft to resorb [50]. In the
morselized graft, stability, in spite of its nonstructural appearance, is also
important. A morselized graft in a high-stress and unstable environment
Impaction Grafting 217

was uniformly resorbed when implanted into the acetabulum in bipolar hip
prostheses [51].
Various bench studies have shown what to expect from the initial stability
from the impacted graft-prosthetic construct during the initial phase after surgery.
It seems possible to achieve acceptable initial stability [52,53], even though
morselized grafts have a nonstructural nature [54]. However, the graft must
maintain its volume and shape, not only during the initial weight bearing, but also
during the entire remodeling period, which involves osteoclastic resorption of the
graft and simultaneous osteoblastic new bone formation. High stresses are
exerted on the cancellous bone around a femoral prosthesis. In a finite element
analysis, the stresses in the cancellous bone next to a primary hip prosthesis were
near or above its yield point [55,56]. We do not know how the impacted graft
reacts to these fairly high loads and stresses. Some hypothetical scenarios can be
discussed.

1. If the graft or part of the graft is revascularized and the new bone
apposition by the osteoblasts can compensate for the weakening
caused by osteoclastic resorption, equilibrium is achieved. Newly
formed trabecular bone, adapted to the stresses during its formation,
will ultimately replace the graft. This has been shown to happen in
animal studies in the goat and horse, without mechanical weakening
during remodeling [57 – 59]. For this to occur, the graft volume
probably must be small and the stresses within certain limits. If at some
stage the stresses exceed the yield-stress of the newly forming tissue, it
will deform.
2. If the graft, or parts of it, do not revascularize, it will retain its
mechanical properties, which we know roughly from bench studies.
The stiffness is minimal, consisting mainly of trabecular interlocking
and friction between fragments [54]. Creep, which in this case would
be a sliding and packing of the bone chips relative to each other, is still
possible. Fatigue fractures are not likely to occur, since the graft
already consists of fractured bone.
3. If the front of resorption extends further into the graft than the front of
bone apposition, just as in osteonecrosis of the hip, the graft will
collapse and lose its volume. If this affects a very thin layer of the graft,
only a slow distal migration of the prosthesis might occur. If the layer
of resorption were thicker, clinical failure would ensue.
4. If the graft is revascularized and invaded by fibrous tissue surrounding
the trabeculae, resorptive activity and new bone formation will be
reduced and the mechanical properties preserved, as is thought to
happen in some areas of the osteonecrotic hip [60,61]. Even improved
resistance to torsional or shear stresses can be expected, due to the
218 Tägil and Aspenberg

fibrous coating of the trabeculae [62], similar to the consolidation


phase of fracture healing. During compression, the graft will act as a
cushion, like a disc or meniscus distributing stresses over a larger area.
In reality, these biological scenarios probably occur in varying proportions
throughout the graft. In patients operated on for a fractured vertebral body with
morselized and impacted autograft, we found that large volumes of the graft had
not remodeled as long as 1.5 years postoperatively, although the fractures were
clinically and radiographically healed [63]. Even if some parts of the grafts had
remodeled with apparently normal marrow, other parts consisted only of dead
graft trabeculae in necrotic avascular tissue. In yet other parts of the graft, the
trabeculae showed no signs of remodeling, but were surrounded by revas-
cularized fibrous tissue. Such incomplete remodeling occurred, despite the use of
autologous cancellous bone.

IX. IS REMODELING NECESSARY?

This incomplete graft incorporation that we found in human vertebrae


corresponds to some extent with published histological findings in series using
morselized and impacted grafts in patients after hip revision [59,64 –67].
Remodeling increases with time, but scattered areas in various stages of healing
are found even after a long time. The composition in space and time of the
various healing stages will predict the outcome of the grafting procedure. Since
large volumes of graft are used, some parts of it will not revascularize and
remodel within a given time. In such parts of the grafts, one might expect that the
bone chips would slide relative to each other (“creep”) and that the graft would
lose height in the direction of the load. This probably explains why increased
distal migration occurs initially in clinical series compared to primary prostheses.
However, in radiostereophotogrammetry (RSA) studies, which are able to detect
relative micromotion down to 0.2 mm between the prosthesis and the femur, this
initial migration slows down after 1– 2 years [68,69] similar to stabile primary
prostheses [70,71]. At the time when the migration slows down, the remodeling
may have come to an end, just as in large structural allografts or osteonecrosis of
the hip, and the proportions of remodeled and unremodeled bone may not change
much more.
Human histological studies of hip revisions indicate that the graft
remodels from the cortex towards the cement [66]. The part near the cement
seems to be the least remodeled and often consists of dead graft in fibrous
tissue. But even this unremodeled composite material of necrotic bone and new
fibrous tissue apparently provides adequate load-bearing support for the
prosthesis. This compacted unremodeled graft appears as an inert implant
Impaction Grafting 219

without causing an immune response [72], with the fibrous tissue adding to its
strength [62]. Total remodeling might even cause the prosthesis to loosen when
the remodeling process reaches the bone/cement interface, where it could then
form a loosening membrane. One probably should be careful in attempts to
enhance or accelerate the remodeling by adding growth factors, since so little is
known about their effect on resorption. Speeding up the remodeling might also
speed up the resorption, with the risk of mechanical weakening of the construct
and reloosening. BMPs are capable, apart from stimulating bone formation
[73], of stimulating the osteoclast lineage [45,74]. In a series of hip revisions
with morselized impacted allograft supplemented with OP-1, severe bone
resorption was encountered in 2 out of 10 cases with concomitant loss of
prosthetic position [75]. The secret of the morselized impacted allograft may
lie in its being revascularized and remodeled more slowly than structural grafts
and the fact that the living bone – graft – fibrous tissue composite can provide
sufficient support without being totally remodeled. If further development of
the method is to be undertaken, methods of decreasing resorption, such as
adding bisphosphonates or using nonresorbable hydroxyapatite or titanium
beads, should be tried, rather than increasing remodeling with bone-forming
proteins.

X. CONCLUSIONS

1. Endogenous bone proteins play a role in the incorporation of a bone


graft.
2. Adding an exogenous growth factor such as OP-1 can increase new
bone ingrowth into an impacted graft.
3. An exogenous growth factor such as OP-1 might also increase
resorption with deleterious effects.
4. Impaction of a frozen bone graft, regardless of allo- or autogenous
origin, delays the ingrowth of host bone into the graft, and not even
autografts always become fully remodeled.
5. Mechanical loading of an impacted morselized graft increases graft
remodeling.
6. Fibrous ingrowth increases the mechanical strength of an impacted graft.

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radiographic observations in 6 autopsy femurs and 8 biopsies. Acta Orthop Scand
2000; 71:543 – 552.
73. Bostrom MP, Lane JM, Berberian WS, Missri AA, Tomin E, Weiland A, Doty SB,
Glaser D, Rosen VM. Immunolocalization and expression of bone morphogenetic
proteins 2 and 4 in fracture healing. J Orthop Res 1995; 13:357– 367.
74. Kaneko H, Arakawa T, Mano H, et al. Direct stimulation of osteoclastic bone
resorption by bone morphogenic protein (BMP-2) and expression of BMP receptors
in mature osteoclasts. Bone 2000; 27:479– 486.
75. Höstner J, Kärrholm J, Hultmark P. Early failures after femoral revisions using
milled allograft bone mixed with OP-1. 56th meeting Svensk Ortopedisk Förening,
Vaxjo, Sept. 5 – 8, 2000.
16
Human Bone Histology
After Morselized Cortico-Cancellous
Bone Impaction
Gösta Ullmark
Centre for Research and Development
Gävle, Sweden

I. INTRODUCTION

Impaction morselized bone allograft has become the most promising method of
restoring living bone lost after loosening of a joint replacement. However, the
method of impaction grafting is still in its early phases. Much remains to be
learned. In this chapter our current knowledge will be summarized, with
emphasis on the bone metabolism during healing of a graft bed as well as on the
histological findings during the healing period.

II. BIOMECHANICAL ASPECTS

Brewster et al. [1] found that the size of the impacted graft particles should be
spread through an optimal mix of sizes represented by a logarithmic curve to
obtain the optimal shear strength. The range of chip sizes should, however, be
rather large. A mix of not only cancellous chips, but also cortical chips is not a
disadvantage as long as the cortical chips are not too big. On the contrary, cortical
chips might be advantageous to the strength of the impacted graft bed.
Mechanical studies comparing chips from two different milling machines, one
with a larger volume range (0.0002 – 40 mm3) and the other with a smaller range
(0.0002– 12 mm3) [2], showed that larger chips were more resistant to load.
225
226 Ullmark

Comparing the same two kinds of chips in another study [3], shear strength was
higher with the larger chips.
Fat removal from bone chips reduces stem migration in an in vitro model
[4]. In another in vitro acetabular model, rotational shear strength was greatly
increased by fat removal [3].
One of the most important factors in creating a stable graft bed is to use
high compaction energy. However, there is a phenomenon of recoil of the graft
bed as the impaction phantom is released. This phenomenon will reduce or might
even eliminate space for the cement mantle [2]. Particularly when collarless,
polished, tapered stems designed to subside within the cement mantle are
implanted, the cement mantle must not be too thin [5,6].
Noncontained bone defects, where the cortical shell is absent, have to be
converted to contained defects using metal mesh to be able to perform an
adequate impaction using the mesh to constrain the graft chips [7].
The vitality of bone graft is best maintained using fresh frozen,
unprocessed bone. Defatting of the bone graft is beneficial to bone healing [8].
Blood clot instead of marrow in the graft bed improves bone healing [9 – 11].
Heating the bone graft to 658C barely affects ingrowth, but 1008C severely
impairs it [12,13]. In between those temperatures there is gradual reduction of
bone healing. Freeze-drying of the bone graft may reduce the bone healing, but
good clinical short-term clinical results have been reported [14].
The surgical method must include removal of all the membrane covering
the host bone bed. The membrane contains both phagocytosed polyethylene
particles and bone-resorbing cells. A cutter should also preferably roughen the
host bone surface. The femoral stem has to be of sufficient length to bridge any
cortical weakness or perforation by 2 – 4 cm, or the bone defect can be protected
with strut grafts or plates to reduce the risk of periprosthetic fracture [15].
One of the most important factors contributing to a successful result is
a well-impacted graft. In the femur this might require a prophylactic wiring of the
femur. Any noncontained acetabular defect must be covered with a sufficiently
stable metal mesh anchored with multiple screws. There might be difficulty
achieving adequate impaction of the acetabulum with a smooth acetabular
impactor. I have found that when the surface of the acetabular impactor has
a rough microstructure such as in Figure 1 (Waldemar Link GmbH & Co,
Hamburg, Germany), the graft bed can be impacted more firmly.

III. CLINICAL AND RADIOLOGICAL RESULTS

Acetabular revision using impaction grafting has been in clinical practice longer
than femoral and thus has longer follow-up.
Histology After Bone Impaction 227

Figure 1 Acetabular impactor designed with micro tracks for a sturdy grip at the
bone chips to achieve a stable graft bed.

We reviewed 28 acetabular revision arthroplasties with both cavitary and


segmental bone defects (Type III AAOS classification). Impaction grafting was
combined with semi-flexible (0.5 –0.8 mm) titanium mesh (Waldemar Link
GmbH & Co, Hamburg, Germany) to cover the cortical defects (Fig. 2) and
add stability to the cup. The acetabular impaction was performed using the
above mentioned impactors with a rough surface. The polyethylene cups were
cemented only onto the impacted graft bed. The results after a median 52
months were good (3.5% mechanical failure and 3.5% septic failure) [7].
Histological results from two of those cases are described later. Using metal
rings in the acetabulum as a mechanical augmentation for the cup is meant to
add mechanical stability to the impacted graft bed. However, in a literature
review (Table 1) metal rings have inferior results because of infection and
mechanical loosening. Metal rings may prevent loading of the graft bed, which
is a disadvantage because dynamic load promotes bone healing [16].
Impaction grafting of acetabula with noncontained defects is better when semi-
flexible metal mesh is used instead of larger metal rings, but thin wire mesh
might be inadequate [17].
228 Ullmark

Figure 2 Acetabular rim mesh from 0.8 mm pure titanium for converting a
segmental, non-contained acetabular bone defect to a contained defect before
impaction grafting.

The clinical and radiological midterm results after impaction grafting in


the femur are good. The problems reported include subsidence of the stem
using polished collarless stems and postoperative femoral fractures related to
short stems. Another issue of concern is the variety of the results (Table 2).
Impaction grafting in the femur is performed in a wide variety of ways
by many surgeons in various centers. Those variations are; the diagnosis, the
sizes of the bone chips, processing of the chips, cleaning and preparation of
the host bone bed, hardness of the impaction, thickness of the cement mantle,
blood clot containment of the graft bed, length of the stem, and postoperative
migration of implant and cement mantle. The wide variety of clinical results
from a literature review (Table 2) is probably the result of the above-
mentioned variation in surgical technique. There is an interesting debate
about the merits of combining impaction grafting with a polished collarless
stem or with a matte stem, with or without a collar. According to the
literature review in Table 2, there seems to be less mechanical loosening in
the collared matte stems. However, this debate remains to be resolved
scientifically.
Table 1 Findings in Clinical Studies of Impaction Allografting in the Acetabulum at THA

No. of acetabular Mean duration of Percent mechanical Percent septical


reconstr. follow-up (yr) loosening failure

Metal rings, morselized bone


graft and a cemented cup
Udomkiat et al. [18] 64 4.6 10 12
Rosson et al. [19]a 66 5 8 0
Peters et al. [20] 28 2.8 0 0
Berry et al. [21] 42 5 12 12
Van der Linde et al. [22] 42 10 2 7
Histology After Bone Impaction

Perka et al. [23] 63 5.5 5 3


Morselized bone graft and
a cementless cup
Hubble et al. [24] 68 5 9 3
Morselized bone graft and
a cemented cup
Azuma et al. [25] 24 5.8 0 0
Bolder et al. [26]b 27 7.6 4 0
Schreurs et al. [27]c 34 13 6 0
Olivier et al. [28] 46 2.7 2 2
Slooff et al. [29] 88 5 10 1
Ullmark et al. [7]d 28 4.4 4 4
Boldt et al. [17] 173 4 3 2
a
3/4 of the cases had morselized bone graft, of which one half had autograft and the other half allograft. Half of the cases were revisions.
b
Primary THA for congenital hip dysplasia using autologous graft.
c
23 primary THA and 18 revision THA.
d
Combined cavitary and segmented defects (Type III AAOS classification).
229
Table 2 Findings in Clinical Studies of Impaction Allografting in the Femur at THA
230

Mean duration Percent


of follow-up Percent mechanical
Study No. of THA (mos) subsidence looseninga

Polished stems without a collar


Ling et al. [30] Exeter 44 84 79 7
Elting et al. [31] CPT 67 31 48 5
Eldridge et al. [32] Exeter, CPT 79 13 23 10
Meding et al. [33] CPT 34 30 44 6
Masterson et al. [6] Exeter 35 — 20 14
Van Biezen et al. [34] Exeter 21 60 81 19
Mikhail et al. [35] CPT 43 60 – 84 86 0
Knight et al. [36] CPT 30 31 50 3
Lind et al. [37] Exeter 74 43 11 3
Collared stems with a roughened
surface
Nivbrant et al. [38] Lubinus 12 58 0b 0
Kärrholm et al. [39] Spectron 22 30 0b 0
Ullmark et al. [40] Lubinus 23 64 14 4
Ullmark et al. [40] Charnley 26 64 8 4
Leopold et al. [41] Harris 29 63 8 12
Boldt et al. [17] Charnley 79 48 9 5
Collared stems, polished or matte
Fetzer et al. [42]c 20 72 5 0
a
Loosening defined according to Harris and McGunn [43].
b
0.3–0.4 mm mean in a RSA study.
c
Iowa stems, Triumph stems, Heritage stems and Harris Precoat stems.
Ullmark
Histology After Bone Impaction 231

IV. HEALING OF THE GRAFT BED STUDIED WITH PET

Positron emission tomography (PET) is a nuclear medical modality used to


quantify chemical processes in vivo. PET is found to be a sensitive method to
detect metabolic events like angiogenesis and bone healing in a bone graft bed.
In a study of five patients having a revision THA, including impaction
grafting and a cemented matte stem with a collar, 170 mm long (Lubinus SP-II,
Waldemar Link GmbH & Co, Hamburg, Germany), revision THA was performed
for loosening and osteolysis (bone loss grade II–IV Endo Klinik Classification) of a
primary hip arthroplasty [50]. Plain radiographs showed stable stems in all patients.
The clinical results were good in all patients 3 years after surgery. [15O]-water PET
was used to quantify bone blood flow and [15O]-carbon monoxide to determine
blood volume in the allograft surrounding the femur stem. Kinetic [18F]-fluoride
PET was used to produce quantitative images of new bone formation in the graft
beds. All patients were asssessed at two different times: 1–8 days and 12 months
after surgery. Three patients were also studied 4 months after surgery.
Even 8 days after surgery there was highly increased blood flow and bone
formation adjacent to allograft (60% and 400%, respectively). After 4 months the
highest activity was seen within the graft material (Fig. 3). One year after surgery
bone blood flow had declined to the levels of the contralateral femoral shaft in

Figure 3 Density, blood flow ([15O]-water), and bone formation rate ([18F]-
fluoride) PET in a patient 4 months after surgery.
232 Ullmark

most of the graft bed. On radial profile analyses of bone healing inside the femur,
the maximum bone-forming activity at one week after surgery was found to be at
a distance of 22 mm (which is the interface between cortex and the graft bed).
One year after surgery this maximum bone-forming activity had advanced and
was 13 mm apart, which is adjacent to the cement mantle (Fig. 4). These analyses
using the sensitive PET technique provided evidence that angiogenesis and new
bone formation occurred early following impaction grafting in the femur.

V. HISTOLOGY OF IMPACTED BONE


GRAFT INCORPORATION

Whether impacted bone chips heal to living bone, have fibrous tissue ingrowth
around dead graft particles, or even remain dead as a filling material can now be

Figure 4 Peak to peak distance of transverse sections using 18fluoride PET in a


patient 1 week and 1 year after surgery.
Histology After Bone Impaction 233

determined. We evaluated the histological findings of 34 tissue samples from 22


cases in 20 different patients (Table 3). The samples were taken 1– 48 months
after revision arthroplasty and impaction grafting in the hip (Lubinus SP-II
prosthesis or Charnley Elite Plus prosthesis) and the knee (Link Rotation Knee)
[44,45]. The histological findings one month after surgery were that a fibrous
stroma and some newly formed woven bone were found in the graft beds (Fig. 5).
Four months after surgery, the fibrous stroma had advanced in the graft bed.
Many of the dead trabeculae in the graft beds had layers of living bone and

Table 3 Histologically Evaluated Bone Grafts in 22 Cases in 20 Patients (20 Hips


and 2 Knees)

X-ray
Histology,
months Subsid.
Pat No. Gender Age Prosth. p.o. Mm Trab. Bone def.

1h F 71 Lub 1 0 Yes III


2h M 77 Ch 1 0 Yes II
3h M 74 Lub 3 0 Yes III
4h M 65 Lub 4 0 Yes III
5h F 66 Lub 4 0 No II
6h F 78 Ch 4 0 Yes II
7h F 75 Ch 4 0 Yes II
8h M 74 Lub 6 4 No II
9h M 66 Lub 6 0 Yes II
10 h F 68 Lub 6 0 Yes III
11 h M 62 Ch 7 3 No II
12 h M 68 Ch 7 3 No II
13 h F 76 Ch 8 0 Yes II
14 h F 74 Ch 8 0 Yes II
15 h F 87 Ch 8 0 Yes II
16 h M 69 Lub 8 0 Yes II
17 h M 62 Lub 9 6 No III
18 h F 74 Lub 11 0 Yes II
19 k M 63 Rot knee 14 0 No 3
20 h F 81 Ch 6 0 — III
1k F 71 Rot knee 23 0 No 3
2h M 77 Ch 48 0 Yes III

Subsid; mean subsidence of the matt stem inside the femur during the first months after surgery, visible
on plain radiographs. Trab; mean new trabeculae formation visible on plain radiographs somewhere in
the transplanted area two to four years after surgery. Bone def; mean preoperative bone defects
classified according to the Endo Klinik classification for the hip and according to Engh for the knee.
234 Ullmark

Figure 5 One month postoperatively. Remnants of fibrin clot and granulocytes


together with some fibrous stroma. Dead trabeculae from bone graft (G) together
with a layer of living bone (B). (Hematoxylin eosin 280)

osteoid in all samples (Fig. 6). Fluorochrome revealed some bone-forming


activity in the 3 mm layer inside cortex.
Six to 7 months after surgery, the healing had advanced close to the cement
layer in terms of more abundant amount of osteoid also in those areas. The
fluorochrome revealed bone-forming activity.
Six months after surgery in one postmortem femoral specimen, most
transplanted areas were revascularized. In the proximal femur there was new
bone formation peripherally, but with a substantial amount of fibrous stroma
embedding graft pieces closer to the cement. In the diaphysis new bone formation
had proceeded to within less than 0.5 mm of the cement.
Eight to 11 months after surgery, the 3 mm layer at the inside of the cortical
bone showed less fibrous tissue and more normal fatty marrow compared to
earlier biopsies. The layer of living bone surrounding the necrotic graft particles
was enlarged compared to earlier biopsies (Fig. 7). The innermost layer of the
biopsies close to the cement showed a mixture of necrotic graft surrounded by
fibrous tissue. The amount of osteoid had increased in this central part. The
fluorochrome revealed bone-forming activity.
Forty-eight months postoperatively in one postmortem femoral specimen,
all areas of former graft bed were transformed into living bone (Fig. 8) except for
Histology After Bone Impaction 235

Figure 6 Three to 4 months postoperatively. New bone (B) and osteoid formation
(arrow) on necrotic bone graft (G). (Goldner, 140)

the proximal section. In this area a composite of living bone and areas of dead
trabeculae surrounded by a layer of living bone and fibrous tissue was seen all the
way into the cement layer (Fig. 9).

VI. DISCUSSION

We found rapid-onset bone healing onto an impacted graft bed consisting of hard
impacted, fresh frozen, morselized, and fat-reduced homologous bone. Blood
flow was increased in the soft tissue adjacent to a graft impacted femur one day
after surgery. Eight days after surgery, bone healing had started in the interface
between endosteum and graft bed. Three to 4 weeks after surgery, a very cellular
fibrous tissue together with capillaries were replacing the blood clot surrounding the
bone chips. At this time osteoid and woven bone had started forming on some of
the graft chips. Six months after surgery, the bone-forming activity had taken place
throughout most of the graft bed, even in close contact to the cement mantle. One
year after surgery, the maximum bone-healing activity had advanced throughout
the graft bed and was now in close contact to the cement mantle. Four years after
236 Ullmark

Figure 7 Nine months postoperatively. A thick layer of new bone (B) and osteoid
(arrows) on a minor piece of necrotic bone graft (G). (Goldner, 280)

Figure 8 Forty-eight months postoperatively. Cortex (C) continuous transition


into new living bone trabeculae (B). Hematopoietic marrow (HM). Dissolved cement
layer (DC). (Goldner, 40)
Histology After Bone Impaction 237

Figure 9 Same patient as in Figure 8. A mixture of living new bone (B), and
necrotic bone graft (G) embedded partly in a fibrous stroma (F) and partly in
desolved cement (DC).

surgery, most of the former graft mantle surrounding a femoral stem consisted of
living bone with trabecula arranged in the direction of load. Residual necrotic graft
particles were most likely to be found in the proximal end of the former graft bed
surrounding a femoral stem. Any area where the cortical shell was absent at the time
of revision but was covered by a sturdy fitting metal mesh had normal healing.
Less successful healing occurs and has been described in the literature
[46 – 48]. At present we do not really know the critical variables that influence
graft healing. The method of filling bone defects in the acetabulum by morselized
bone graft using reversed reaming can hardly be characterized as “impaction,”
merely a filling of the defects probably producing inferior biomechanical
characteristics. Dynamic loading of the graft bed stimulates healing, as does
blood clot in between the necrotic trabecula of the graft bed. A personal reflection
is that the diagnosis pelvospondylitis ossificans (or the related drugs) might be a
disadvantage in terms of bone healing and clinical success for impaction grafting.
We are optimistic about the present and the future prospects of
reconstructing missing bone using impaction grafting, cemented prostheses,
and metal mesh.
238 Ullmark

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240 Ullmark

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2000; 71:543 – 552.
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17
Histological Evaluation of
Impaction Bone Grafting in
Humans and Animals
Pieter Buma, Sanne van der Donk, and B. Willem Schreurs
University Medical Centre Nijmegen
Nijmegen, The Netherlands

I. INTRODUCTION

Most total hip arthroplasties, both cemented and cementless, fail due to aseptic
loosening, a slow but progressive process often resulting in bone stock loss. The
stability of the implant becomes compromised, and the components start to
migrate in the bone bed.
The key problems in revision surgery are how to manage the periprosthetic
bone loss and how to create a new long lasting stable hip replacement. Bone
impaction grafting with a cemented cup is clinically a well proven technique.
The technique is supported by data from various animal models, which show that
the impacted fresh frozen allograft bone completely incorporates into a new bony
structure [3,4]. However, histological studies of human retrievals have shown
areas that are not incorporated [5,6]. The studies involved were series and did not
quantify the different tissues described.
In the first part of this chapter we describe the process of bone graft
incorporation qualitatively and quantitatively in a large series of biopsies of
acetabular impaction graftings in humans. In the second part of this chapter we
describe the effect of rinsing on the incorporation of impacted bone graft in an
animal model. Rinsing of allograft bone prior to impaction is used by some
groups, and it may reduce the immunological response to the allograft [7 – 9].
Therefore, we hypothesize that a simple processing step like rinsing of allograft
241
242 Buma et al.

bone might improve the incorporation of allograft bone. We studied this in a bone
chamber model [10,11]. On the other hand, impaction of bone graft will also
expose growth factors in the bone matrix that have the potential to enhance
incorporation of the bone graft. It has been shown that after impaction TGF-b is
released from the impacted bone [12]. This indicates that by rinsing after
impaction, which is performed by some clinicians to improve the cement
penetration and clean the bone bed, growth factors that are exposed by the
impaction process are washed away. Therefore, we performed a second rinsing
experiment in which we rinsed the bone graft after the first impaction and then
impacted again.

II. MATERIAL AND METHODS


A. Acetabular Patient Biopsies
Twenty-four biopsies of 20 patients, which were collected during a period of 15
years, were processed for histology. Biopsies were obtained after 5 impaction
graftings in primary THA and 19 reconstructions in revisions. The mean follow-
up period was 48 months (3 – 170 months). In 3 of the 5 primary cases autograft
from the femoral head was used. In 2 primary cases autograft was combined with
femoral head allografts. Fresh frozen femoral head allografts were used in all
revision cases. All were obtained from the local bone bank and morselized during
surgery into chips of about 1⁄2 – 1 cm3. This was done by hand with a rongeur in
76% of the cases. In 19% a specially designed bone mill was used to make the
chips (Novio Magnus bone mill, developed by Spierings, Nijmegen, the
Netherlands) and in 5% a combination of both techniques was used. The number
of femoral heads used varied from one to three, depending on the severity of the
acetabular defect. Defects were classified as cavitary (10 cases), or a combination
of both cavitary and segmental defects (11 cases), according to the American
Academy of Orthopedic Surgeons (AAOS) classification system [13]. In all
patients the surgical technique was performed as described previously [14 –16].
Biopsies were taken during revision operations, which were performed for
dislocation (6 cases), septic loosening (7 cases), aseptic loosening of the cup
(7 cases), aseptic loosening of stem (1 case), sciatic nerve problems (2 biopsies
from one patient), or femoral fracture (1 case).

B. Histological Analysis
In the histological sections we determined the surface area of incorporated bone
graft (new bone structure), nonincorporated bone graft remnants, areas of fibrous
tissue without bone graft, and a tissue type with active incorporating bone graft
[17]. We also recorded cartilage remnants in the nonincorporated bone graft.
Histological Evaluation of Impaction Bone Grafting 243

C. Rinsing Study: Preparation of Materials


An animal study was performed in the goat using the bone conduction chamber
(BCC), developed by the group of Aspenberg (Fig. 1) [10,11,18]. Trabecular
autograft was obtained from the distal femur during the same operation as the
implantation of the bone chambers. Trabecular allograft was obtained from the
sternum of donor goats. Donor and recipient goats were not related. A pool of all
the bone was made to avoid large differences in individual immunological
reactions, and thereafter the bone was stored at 2808C until use. Before impaction
the grafts were nibbled with a rongeur to a chip size of approximately
2  2  1 mm and rinsed and impacted according to the protocol (Table 1). The
chambers were filled with either auto- or allograft. Three different treatment
protocols were applied to each type of bone graft. In the first group the grafts were
impacted without any further preparation and acted as controls. In the second
group the grafts were washed prior to impaction with high-pressure saline. The
lavage was standardized for pressure, temperature (378C), and volume. During the
washing the red graft particles acquired a white appearence, indicating that all
blood and marrow tissue was removed successfully. In the third group, the lavage
was repeated to wash out additional growth factors exposed after the first
impaction; thus, grafts were washed, impacted, washed, and impacted again before

Figure 1 Bone conduction chamber. The bone conduction chamber consists of


two half-cylinders (C) held together by a screwcap (S). A disc (D) is used to lower
the two ingrowth openings (I) just below the tibial cortex (T). New bone and tissue
ingrowth (N) into the graft (G) is now possible via the marrow (M). [10]
244 Buma et al.

Table 1 Experimental Protocola

Graft treatment Autograft Allograft

Impaction only 10 10
Rinsing and impaction 10 10
Rinsing, impaction, 10 10
rinsing and impaction
a
N ¼ 10 goats for each graft treatment for each graft type.
Source: Ref. [36].

insertion in the bone chamber. New bone and total tissue ingrowth were measured
as indicators of potential for incorporation [17]. After impaction for 2 minutes with
a static pressure of 25 Mpa in a specially designed instrument (Fig. 2), a graft
cylinder (2 mm diameter) was obtained, which fit exactly in the BCC.
Ten mature Dutch milk goats (Capra Hircus Sana) weighing about 55 kg
(range 41 –69 kg) received three BCCs at each side in the cortical bone of the
proximal medial tibia for a period of 6 weeks. Insertion of the bone chambers is
described elsewhere in detail [18]. On both legs the BCCs were placed at a
distance of 10 mm from each other (Fig. 3). Within one animal, all BCCs with
allograft were placed on one side and all BCCs with autograft on the other to
prevent the grafts from influencing each other. The position of implantation
among the three chambers was randomized, as was the side for each type of graft.
All animals were allowed unrestricted movement in their cages and had free
access to water and food after the operation.

Figure 2 Impaction device. Morselized bone grafts are inserted into a cylinder.
A piston (P) is inserted into this cylinder to impact the morselized bone graft with
25 MPa for 2 minutes. After impaction the bottom (B) is screwed off to remove the
graft out of the cylinder. (From Ref. [36].)
Histological Evaluation of Impaction Bone Grafting 245

Figure 3 Radiographs of bone conduction chambers in the proximal medial tibia


of the goat. (Left) anteromedial view; (right) anterolateral view. (From Ref. [36].)

After 6 weeks the goats were killed, tibiae removed, and the contents of the
chamber were processed for serial sectioning. Areas of new bone formation, graft
remnants, and total tissue ingrowth were scored. The area of bone ingrowth
included marrow cavities, new bone formation, and new bone formed on graft
remnants [18].
Bone ingrowth and total tissue ingrowth values of the three sections per
bone chamber specimen were used for statistical analysis. The effects of graft
type and graft treatment on the ingrowth distances were analyzed with a three-
way analysis of variance (ANOVA) for the factors goat, graft type, and graft
treatment. Tukey’s test was used for post hoc multiple comparison to identify
significant differences among the treatment groups. All analyses were performed
with SPSS (Chicago, IL).

III. RESULTS
A. Human Acetabular Biopsies
1. Short-Term (0– 6 Months)
Particularly in the biopsies taken at 3, 4, and 5 months after impaction grafting, the
transitions between the dead graft of the reconstruction (bone particles with empty
osteocyte lacunae embedded in necrotic fibrin deposits), the revascularization
front, and the newly incorporated bone graft were present (Fig. 4A). During the
revascularization of the graft, osteoclastic activity was high. New woven bone
246 Buma et al.

Figure 4 Histology of human biopsy specimens. (A) A human core biopsy with a
short-term follow-up, showing the presence of different stages in one biopsy. Note
the dead grafts (top), fibrous tissue (middle), and active bone remodeling (bottom),
stain HE, magnification 20. (B) New bone (nb) is formed on a cellular graft
remnants (gr), stain HE, magnification 120. (C) New woven bone is formed in
interstitial fibrous tissue, stain HE, magnification 70. (D) Bone is apposited on
graft remnants (arrow heads), surrounded by fibrous marrow. Note the active
mineralizing bone surface (arrows), stain Goldner, magnification 35. (E) Areas of
necrotic marrow (nm) are present in the spaces between the avital trabecular bone
structure (ab), stain HE, magnification 170. (F) A dark precipitate (arrow heads)
surrounds no incorporated graft remnants (gr), stain HE, magnification 90. (G) A
thick layer of fibrous tissue (ft) is formed directly under the mesh (mesh removed for
histotechnical reasons), but direct bone contact also is present (arrows), stain HE,
magnification 45. (H) Fibrocartilage has formed near a no incorporated graft
remnant at the interface of cement with graft, stain Goldner, magnification 190.
(I) Large pieces of cartilage (c) showed no incorporation, stain HE, magnification
30. (From Ref. [36].)
Histological Evaluation of Impaction Bone Grafting 247

formation was found directly on the graft remnants (Fig. 4B) and in the interstitial
fibrous tissue (Fig. 4C). Fibrin remnants were also covered by new woven bone.
Locally, dense areas of lymphocytes were present in the fibrous tissue and in the
medullary tissue of the newly formed trabecular bone. The semi-quantitative
results clearly showed that in the first 6 months about 30% of the graft was
incorporated (Fig. 5).

2. Mid-Term (7 Months– 9 Years)


In all specimens taken 8 – 30 months after revision, the amount of non-
incorporated graft had diminished. Graft remnants within the newly formed
trabecular bone were extremely rare. The amount of woven bone was clearly less
than in the earlier biopsies, and more lamellar bone was found. Initially the
medullary tissue in the woven bone was fibrous, but concomitant with the
remodeling of the woven bone into normal lamellar bone, vital, cell-rich
medullary tissue with many fat cells predominated (Fig. 4D). Areas with dense
trabecular or almost cortical bone were also seen.

3. Long-Term (10 Years)


In general, the bone graft was almost completely incorporated into new bone with
normal medullary tissue. Occasionally, the medullary tissue of the bone showed
accumulation of macrophages that had deeply penetrated into the bone. Larger

Figure 5 Distribution of the three different stages during the incorporation


process. Short-term: 0– 6 months; mid-term: 7 months –9 years; long-term: 10
years or longer. Stage 1: nonvascularized graft remnants. Stage 2: active
incorporating bone graft with revascularization. Stage 3: newly formed trabecular
bone. Loose fibrous tissue was scored separately. (From Ref. [36].)
248 Buma et al.

areas of the medullary tissue of trabecular bone with a normal morphology were
completely necrotic, which was particularly seen in the biopsies taken after
aseptic loosening (Fig. 4E). On the necrotic trabeculae and in the necrotic
medullary tissue, a precipitate was seen, which stained positively with the
hematoxylin (Fig. 4E).

4. Interface
In a few biopsies the graft/cement interface was still present. Case 7 was the only
case in which the interface with the cement layer was not aseptically loosened.
Locally living bone was found in direct contact with the cement, but at most
locations a thin soft tissue layer interfaced with the cement. In two biopsies taken
at 22 and 72 months, no intact interface was present due to the loosening process,
but there was only living bone without graft remnants. The interface with the
cement layer had, if present, the normal characteristics of interface tissue as in
primary aseptic loosened cups. Focal necrotic areas were found, alternating with
areas that contained macrophages with various wear particles. A thick layer of
fibrous tissue had formed directly under the mesh (Fig. 4G).

5. Fibro-Cartilage
In a number of biopsies fibro-cartilaginous tissue was present (Fig. 4H). In one
case it had formed on the bony side of the mesh that was used to contain the graft.
Particularly in cases of aseptic loosening, fibrocartilage was present at the
interface of the incorporated graft with the soft tissue interface with the cement
layer.

6. Cartilage
All biopsies in which the graft had been processed by a bone mill contained large
fragments of necrotic donor cartilage (Fig. 4I). In contrast, only one of the
manually processed grafts contained cartilage remnants. The large fragments
were not calcified and appeared as red in the Goldner staining. The smaller
fragments were only slightly calcified on the edges. Since no osteoclastic activity
was found that had resorbed the cartilage fragments, the pieces were generally
not incorporated into a new trabecular structure. In some cases a thin fibrous
capsule surrounded the fragments.

7. Nonincorporated Graft
Irrespective of the follow-up period of the specimens, in some areas of variable
sizes, localized nonincorporated bone graft was found (Fig. 4F). In these areas,
fibrous tissue surrounded the acellular bone graft. In contrast to the relatively
high percentage of incorporation seen in the other biopsies at mid-term, two
Histological Evaluation of Impaction Bone Grafting 249

biopsies of 59 and 79 months postoperatively showed large areas with graft


remnants of 40% and more. Both graftings were failures: one aseptic (59 months)
and one septic loosening (79 months).

8. Infection
Almost all biopsies from patients with an infection had a follow-up of less than
30 months. Only one infection was diagnosed after 79 months. Most of these
infected cases showed complete and normal graft incorporation, with either
normal or fibrotic medullary tissue. Accumulations of polymorphonuclear
granulocytes were present in the marrow in between the incorporated bone graft.

B. Bone Chamber Study


All 60 implants except 2 in the allograft group were well fixed after 6 weeks. In
all cases new bone or fibrous tissue, irrespective of the contents of the chamber,
covered the bone chambers. No new bone formation was seen at the endosteal
surface of the tibial cortex.

1. Histological Analysis
In the chambers new bone was growing by intramembranous ossification,
upwards from the ingrowth openings to the top of the chamber. The new bone
was separated from the original inserted graft material in the top of the chamber
by a layer of well-vascularized fibrous tissue (Fig. 6A), which preceded the bone
ingrowth front. The fibrous tissue was more loosely organized at the transition
with the graft remnants. In this area, osteoclasts were actively resorbing the graft
(Fig. 6B).
More chambers filled with autograft showed new bone formation (28 of 30
chambers) as compared to the BCCs with allograft (23 of 28 chambers). The
amount and appearance of the new bone varied between specimens from young,
woven bone, surrounded by active osteoblasts, to more mature lamellar bone with
fatty marrow and trabeculae (Fig. 6C,D). Active osteoblasts and osteoid were still
seen after 12 weeks (Fig. 6E). Particularly in the BCCs with autograft, more graft
remnants were incorporated into the new bone (in 13 of 30 autograft specimens
and 3 of 28 allograft specimens).

2. Histomorphometry
The estimated means (with 95% confidence intervals) of bone and total tissue
ingrowth are shown in Figure 7. Allografts, as a group, had less bone and total
tissue ingrowth than autografts (p , 0.001 and p ¼ 0.001, respectively).
Washing affected total tissue ingrowth (p , 0.001), which was higher in grafts
250 Buma et al.

Figure 6 Histology on hematoxylin and eosin (A –D) and Goldner (E) stained
sections (figure at the end). (A) Graft remnants (gr) were still present in the top of
most specimens. They were invaded by fibrous tissue (ft). New bone formation (nb)
took place from the ingrowth openings (arrows) up to the top of the chamber, with
an irregular ingrowth front (10). (B) Graft remnants, surrounded by loosely
organized fibrous tissue, are resorbed by active osteoclasts (arrows) (165). (C)
Mature lamellar bone trabeculae within fatty marrow could be found at the bottom of
the bone chamber (40). (D) New bone formation often was adjacent to blood
vessels along the longitudinal axis of the chamber (85). (E) Osteoblasts are
appositing new bone (arrows). Osteoid is colored black (85). [18]

Histological Evaluation of Impaction Bone Grafting 251

Figure 7 Histomorphometric results. Estimated means for bone ingrowth (A) and
total tissue ingrowth (B) with 95% confidence intervals. Grafts were treated
according to the protocol; impacted grafts; rinsed, and impacted grafts; and rinsed,
impacted, rinsed, and impacted grafts [From van der Donk et al., CORR, in press].

washed once than in unwashed grafts ( p , 0.001). The effect of washing on bone
and total tissue ingrowth was different in autografts and allografts, because of the
interaction of graft type and treatment (p ¼ 0.035 and p , 0.001 for bone and
total tissue ingrowth, respectively). Bone ingrowth increased after rinsing once in
allografts, but decreased in autografts. The increase in total tissue ingrowth
after rinsing once was more pronounced in allografts than autografts. After
washing once before impaction and twice before and after impaction, there
was significantly greater bone ingrowth in autografts compared to allografts
(p ¼ 0.02). Graft type and rinsing interacted. There was less total tissue ingrowth
in autografts washed twice than those washed once (p , 0.01).

IV. DISCUSSION
A. Acetabular Biopsies
Although biopsies, apart from postmortem retrievals of impaction graftings, are
the only way to study the incorporation process, they have one serious dis-
advantage. The main disadvantage is that biopsies are only taken during reopera-
tions and the histology of the (incorporated) graft is in many cases compromised
by the failure process, which will adversely affect the outcome. Therefore, we
believe that the proportion of new healthy bone in long-term functioning
impaction graftings is higher than found in this study.
So far, the few reports on the histology of bone graft incorporation in the
acetabulum or femur after impaction grafting are descriptions of retrieval
material or describe a relatively small number of biopsies or retrievals
252 Buma et al.

[5,6,19,20]. Incorporation was seen in most of these biopsies and retrievals, but
the small number of specimens studied failed to quantify the completeness of the
incorporation. In our series we could do this, and it appeared that incorporation
of the impacted graft in the acetabulum was, as in previous animal studies
[3,21 –23], a mixed process of osteoconduction on the remnants of the graft and
osteoinduction. In the latter process woven bone is produced first and later
remodeled into lamellar bone.
The main difference with animals is that it seems that the incorporation
process in humans is slower and less complete even after very long follow-up.
More than one factor could be responsible for this observation. The patients
involved in this study are relatively older than animals. The animal bone had not
been subjected to the insult of a failed joint replacement. We can only speculate
why these nonincorporated areas remain. The size of the graft, the location within
it, the local loading conditions, and important patient variables such as the
vascularity of the host bone bed, the immune response, the level of activity, and
the age of the patients may all play a role.
Based on the histology, fibrin seems to be a powerful stimulator of bone
formation in the early phase of bone graft incorporation. The role of fibrin may be
explained by its content in bone active growth factors. This suggests that
extensive lavage of the graft after impaction should be avoided to retain active
bone-inducing factors.
The fact that cartilage fragments were found in the more recent biopsies of
grafts from milled bone suggests that all cartilage should be removed before
impaction. Only one biopsy, in graft that had been prepared manually, showed
large pieces of cartilage, probably included during the process of cutting the graft
into smaller pieces. When using a bone mill, instead of manually preparing graft,
one should therefore be extremely careful to exclude all cartilage remnants.

B. Bone Chamber Study


The results of the study in the BCCs showed that washing allograft improved its
incorporation. Particularly in allograft, new bone formation was found directly on
graft remnants. Although in general the immunogenicity of bone allograft is low
[24], the soft tissues are responsible for this response [9,25]. Other techniques to
reduce the immunogenicity of allograft bone include freezing [26], lyophylization
[27], fat removal by chloroform or ethanol [28] but are less effective [26], reduce
the mechanical strength of bone [27], or may have toxic side effects [28]. An
additional advantage of washing out fat with saline is improved strength and
initial mechanical stability [2,29]. However, these studies were done with small
bone graft sizes (3  5 mm), and similar experiments with large bone graft in an
artificial acetabulum model [30] showed a significant effect on the initial
mechanical stability of rinsing of the graft in a realistic acetabular model. The
Histological Evaluation of Impaction Bone Grafting 253

observation that in autografts and washed allograft bone more of the original bone
graft is incorporated into a new bone structure supports the idea that the immu-
nological reaction induces osteoclast activity during incorporation of the graft.
Not only the bone ingrowth, but also the total tissue ingrowth was higher in
autografts than in allografts. Removal of blood, marrow, and fat improved the
ingrowth of allografts. The beneficial effect of fat removal on graft incorporation
was earlier reported in bone chamber study in rabbits, although cancellous bone
allografts were used instead of impacted morselized cancellous bone grafts [31].
The second hypothesis was that washing the graft after impaction would
remove the effect of exposed growth factors, resulting in less bone formation
compared to grafts not washed after impaction. Bone-derived growth factors may
be exposed or released by impaction and provide sufficient biological activity to
stimulate new bone formation [12]. These biologically active factors accelerated
bone healing in numerous animal as well as human studies when applied
exogenously [32 –35]. However, in our study, there was no significant reduction
in bone formation in grafts washed after impaction. The static compaction
applied in this study might not have freed large quantities of growth factors.
Equally, the effects of small quantities of biologically active factors might have
been either too small or obscured by other growth factors produced in the soft
tissue after insertion of the bone graft, as occurs in fracture healing.
In summary, we can state that bone graft incorporation is never complete.
Washing bone grafts may promote quicker and more complete incorporation. The
effect of washing after impaction has no serious biological implications, but the
effect on cement penetration and initial stability is being currently investigated.

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18
Biological Enhancement of
Bone Graft Materials by
Osteogenic Factors
Stephen D. Cook and Robert L. Barrack
Tulane University School of Medicine
New Orleans, Louisiana, U.S.A.

I. INTRODUCTION

The number and complexity of total hip arthroplasty cases continues to


increase. The challenges of complex hip arthroplasty include bone loss in the
proximal femur and acetabulum as well as deformity, cortex perforation, and
periprosthetic fracture. The use of bone graft material has become routine in
many of these cases [1 –3]. The added surgical time, limited supply, and
morbidity associated with the autogenous bone graft harvest has resulted in the
use of various types of allograft bone in the vast majority of cases. Contained
defects are effectively managed with morselized cancellous allograft. While
allograft bone can heal defects, ingrowth does not occur from the defect to a
porous ingrowth surface. This can compromise component stability if extensive
defects are present. In addition, when there is a need for immediate structural
support, cortical allografts are often used, which have a much slower rate of
incorporation.
Allograft bone is an attractive alternative to autograft bone because it
supports bone formation, supply is less limited, and large structural restorations
are possible. However, allograft bone has only a fraction of the osteoinductive
capacity of autograft bone [4] and a lowered capacity to incorporate with host
bone [5 – 7]. Cortical allografts have the added disadvantage of slower
incorporation and a higher rate of nonunion compared to cancellous allograft
257
258 Cook and Barrack

[8,9]. Nonetheless, cortical strut grafts are widely utilized in conjunction with hip
arthroplasty when biomechanical support is required. Allograft also carries
a small risk of disease transmission and requires extensive testing of donors.
Some methods of sterilization such as high-dose radiation and freeze-drying
compromises the mechanical properties of allograft bone.
Recent research has centered on the use of osteoinductive materials such
as osteogenic proteins (OPs) or bone morphogenetic proteins (BMPs) to aid
in the healing of bone. These proteins, either alone or in combination with
other regulatory molecules, induce new bone formation [10 – 16]. Osteogenic
proteins are members of the transforming growth factor-b (TGF-b) superfamily
of proteins involved in the cascade of cellular events of tissue formation and
regeneration, including stem cell commitment, differentiation, and proliferation
[12]. Osteogenic proteins have been produced in highly purified form
from the bones of a variety of species and have been found to induce
bone formation at ectopic and orthotopic sites in small and large mammals
[12,17 –19]. The most recent advance in the development of OPs is the
cloning and expression of recombinant human bone proteins. Recombi-
nant human osteogenic protein-1, also referred to as bone morphogenetic
protein-7 (rhOP-1, rhBMP-7) and bone morphogenetic protein-2 (rhBMP-2),
have been proven safe and efficacious in improving and accelerating bone
healing in orthotopic animal models [20 – 25]. Osteogenic protein-1 has also
been shown in a randomized, prospective study to heal tibia fracture nonunions
clinically and radiographically equivalent to autogenous iliac crest bone
graft [26].
An osteogenic protein-1 device (OP-1 Implant, Stryker Biotech,
Hopkinton, MA) consists of 3.5 mg of rhOP-1 combined with 1 g of highly
purified bovine bone – derived Type I collagen. The carrier does not have
cartilage or bone inductive properties [27]. The final preparation is freeze-dried
and sterilized by gamma irradiation. The device is reconstituted with sterile
saline at the time of surgery, producing approximately 4 cc of a granular graft
material that offers no structural capacity.
The use of an OP-1 Implant in conjunction with autograft or allograft bone
offers many potential advantages. Containment of the OP-1 Implant at the site
may be enhanced by combination with the bone graft material, resulting in
greater and better localized new bone formation. When a structural graft is
required or if a bone defect volume is large, the use of the OP-1 Implant alone
may not be satisfactory since it has no structural integrity. Under such
circumstances there would be a substantial advantage to enhancing the healing
potential of the autograft or allograft material so that extensive bone formation
and mechanical strength could be achieved more rapidly and reliably. In addition
to better defect healing, bone ingrowth to a porous surface may be enhanced
with the use of the OP-1 Implant when placed with allograft bone. This should
Osteogenic Enhancement of Bone Graft 259

speed the rehabilitation process and shorten the time of protected weight bearing
and attendant functional disability for the patient.

II. PRECLINICAL EVALUATION OF THE OP-1 IMPLANT


A. Morselized Autograft and Allograft Bone with an
OP-1 Implant
Bilateral, critical size, osteoperiosteal segmental defects were surgically created
in mid-ulna of 24 adult male dogs [28]. Either autograft bone, allograft bone, or
OP-1 Implant alone or various combinations of the OP-1 Implant mixed with
allograft or autograft bone were implanted in the segmental bone defects.
Combinations used included 67% bone graft/33% OP-1 Implant and 33% bone
graft/67% OP-1 Implant. Healing of the defects was assessed radiographically
and in biomechanical and histological studies at 12 weeks postoperative.
The use of the OP-1 Implant alone or any combination of autograft or
allograft bone and the OP-1 Implant improved radiographic, mechanical, and
histological healing of the critical sized defects compared to autograft or allograft
bone alone (Table 1). Earlier and greater volume of new bone formation was
observed with the presence of the OP-1 Implant. The amount of new bone, degree
of remodeling, and graft incorporation was proportional to the amount of rhOP-1
implanted. Histologically, only 22% of defects treated with allograft bone alone
healed completely, while 67% of defects treated with autograft bone alone
were completely healed at 12 weeks. Treatment of defects with the OP-1 Implant
alone or any combination of bone graft and the OP-1 Implant healed 93% of cases
at 12 weeks. These differences were significant at p , 0.05. The highest
radiographic grade, histological grade, and mechanical strength were achieved with
the use of 33% allograft/67% OP-1 Implant, although no significant differences in
healing were observed among the groups containing the OP-1 Implant. Defects
treated with any amount of the OP-1 Implant obtained two times the mechanical
strength obtained by autograft bone alone at 12 weeks postoperative.

B. Cortical Allograft with the OP-1 Implant


Fourteen adult male dogs underwent bilateral onlay allograft strut procedures to
the mid-femur utilizing stainless steel cables [29]. In each animal one femur
received the OP-1 Implant interposed between the graft and host bone while the
contralateral femur strut graft served as an untreated control. The animals were
studied with biweekly radiographs and histological and microradiographic
evaluation at sacrifice periods of at 4, 8, and 12 weeks postoperative.
The radiographic results showed that the healing of cortical strut grafts to
the femur was improved and accelerated by the addition of the OP-1 Implant
260 Cook and Barrack

Table 1 Radiographic, Histological, and Mechanical Testing Evaluation of Defect


Healing with the OP-1 Implant and Bone Graft at 12 Weeks

Treatment group Radiographica Histologicb Mechanicalc

Allograft
At least one cortex bridged 3/9 2/9 0.15+0.30 (9)
All cortices bridged 0/9 3%
67% Allograft/33%OP-1 Implant
At least one cortex bridged 6/6 5/6 1.60+1.43 (6)
All cortices bridged 5/6 38%
33% Allograft/67%OP-1 Implant
At least one cortex bridged 6/6 6/6 3.18+1.68 (6)
All cortices bridged 6/6 74%
Autograft
At least one cortex bridged 5/9 6/9 1.33+1.42 (9)
All cortices bridged 4/9 31%
67% Autograft/33%OP-1 Implant
At least one cortex bridged 5/6 5/6 2.76+1.69 (6)
All cortices bridged 5/6 64%
33% Autograft/67%OP-1 Implant
At least one cortex bridged 5/6 6/6 2.85+1.40 (6)
All cortices bridged 5/6 66%
OP-1 Implant
At least one cortex bridged 5/6 5/6 2.74+1.60 (6)
All cortices bridged 5/6 64%
a
Number of defects/sample size.
b
Number of defects healed histologically/sample size.
c
Maximum torque to failure (Nm) [mean+SD, (sample size)] and % intact ulna strength.

(Table 2). The OP-1 Implant –treated sites also had significantly greater
histological and microradiographic grading scores at all time periods. Rapid
formation of new bone and graft incorporation was observed in sites treated with
the OP-1 Implant.
While cortical strut allografts were shaped intraoperatively to fit the
femur, immediate postoperative radiographs often revealed that areas of
nonconformity existed. Histological sections demonstrated that extensive new
bone completely filled gap regions between the host and the strut graft as early
as 4 weeks postoperative in sites treated with the OP-1 Implant. In control
struts the gaps were slower to fill and were not completely filled with new
bone at 8 weeks postoperative. Strut healing with the OP-1 Implant at 4 weeks
postoperative was radiographically and histologically superior to control sites
at 8 weeks.
Osteogenic Enhancement of Bone Graft 261

Table 2 Radiographic Grading of Cortical Strut Graft Healing with the


OP-1 Implant

Control
Postoperative mean+SD OP-1 mean+SD
week (sample size) (sample size) p-value

2 0.04+0.13 (14) 0.86+0.07 (14) 0.0005


4 0.82+0.54 (14) 2.50+0.59 (14) 0.0001
6 0.80+0.82 (10) 3.30+0.89 (10) 0.0002
8 1.88+0.63 (4) 4.13+0.06 (4) 0.0194
All times 0.65+0.75 (42) 2.30+1.33 (42) 0.0001

Grade:
0 ¼ No visible new bone formation.
1 ¼ Minimal new disorganized bone.
2 ¼ Disorganized new bone bridging graft to host.
3 ¼ Organized new bone of cortical density bridging both ends.
4 ¼ Loss of graft-host distinction.
5 ¼ Significant new bone formation and remodeling.

C. Acetabular Defects with the OP-1 Implant


Acetabular defect healing and bone ingrowth from an acetabular defect into a
porous coating was evaluated. Six canines underwent bilateral total hip
arthroplasty with a cementless press-fit porous coated acetabular component. A
defect 8 mm in diameter and 5 mm in depth was created in the superior weight-
bearing area of each acetabulum. The right defects of each animal were filled
with the OP-1 Implant. Each contralateral defect was filled with either allograft
bone, left empty (defect healing control), or no defect was created (porous
ingrowth control). The degree of defect healing and bone growth into the porous
acetabular component surface was quantified histologically and radiographically
at 6 weeks postoperative.
The OP-1 Implant treated defects healed more completely (37% bone
density) than allograft bone (23%) or empty defect (14%) ( p , 0.05) and
achieved a bone density equivalent to the no-defect controls (34%). Bone
ingrowth also occurred to a significantly higher degree in the OP-1 Implant (37%
bone ingrowth) compared to the allograft (18%) or empty defects (16%)
( p , 0.05) achieving a degree of ingrowth equivalent to the no-defect controls
(30%) (Fig. 1).
The osteogenic bone protein device was successful in achieving complete
healing of the acetabular defects such that the percent cancellous bone volume
was not significantly different from the control hips in which no defect was
present. In addition, bone growth into the porous acetabular cup surface was
262 Cook and Barrack

Figure 1 Contact radiographs of the acetabular defect areas seen at 6 weeks


postsurgery. Examples of (A) an acetabulum with no defect, (B) a defect treated
with osteogenic protein, (C) a defect grafted with allograft bone, and (D) an unfilled
defect (x1). Considerable defect filling with new trabecular bone was observed
in the osteogenic protein treated defect (B) as well as gap filling and new bone
contact with the porous coated surface of the acetabular component. The defect
treated with allograft bone (C) shows some defect filling but only limited new bone
contact with the porous surface. Very little new bone was observed filling the empty
defect (D) at 6 weeks postoperative.
Osteogenic Enhancement of Bone Graft 263

comparable to that which occurred without a defect present. In larger defects the
combination of the OP-1 Implant with morselized allograft would appear to be an
attractive treatment option.

III. DISCUSSION

Preclinical studies have demonstrated that the osteoinductive capacity of


autograft and allograft bone can be improved with the addition of the OP-1
Implant. The combination of autograft or allograft bone with the OP-1 Implant
consistently improved the amount and rate of new bone formation compared to
bone graft alone. Earlier graft incorporation and consolidation of the new bone
and graft was also observed.
Although morselized autogenous bone graft in combination with the OP-1
Implant performed similarly in preclinical studies, the complications associated

Figure 2 The OP-1 Implant with morselized allograft bone was placed at the host
bone interface of a proximal femoral allograft in a re-revision of a Charnley hip
replacement (left). The initial revision had also utilized a proximal femoral allograft
due to severe bone loss but failed due to periprosthetic fracture. The radiographic
appearance at 6 months (right) postoperative displayed significant new bone
formation in the area where the OP-1 Implant was placed.
264 Cook and Barrack

with the donor site can be eliminated by using allograft without reducing the
efficacy of the bone graft in the clinical situation. Aside from the risks of bleeding
and infection, patients frequently complain of more postoperative pain from the
autograft donor site than the primary operative site following a major
reconstructive procedure [30,31]. The clinical cases to date suggest efficacy of
allograft bone with the OP-1 Implant in promoting new bone formation and graft
incorporation (Fig. 2). The clinical use of the OP-1 Implant at the interface of a
porous coated acetabular device exhibited extensive new bone formation in
histological evaluation of tissue retrieved at revision surgery (Fig. 3). These
results are also consistent with preclinical studies that indicate the OP-1 Implant
may be efficacious in promoting earlier and greater bone ingrowth or implant
apposition [23].

Figure 3 A noncemented total hip replacement was performed for osteoarthritis


due to a previous hip fracture. At surgery an OP-1 Implant was placed at the
interface of the porous coated acetabular cup and host bone. At 4 weeks
postoperative the patient dislocated and was unstable after closed reduction
(left). At revision surgery bone from the acetabular bone/prosthesis interface
was obtained and examined histologically. Histological evaluation revealed
extensive new bone formation (right). A transition from mesenchymal tissue to
mature mineralized bone through an osteoid zone with prolific osteoblasts was
observed.
Osteogenic Enhancement of Bone Graft 265

Figure 4 (A) Immediate postoperative radiographic appearance at the distal end


of a cortical strut allograft in which the OP-1 Implant was placed in a revision total
hip arthroplasty (left) and 3-month radiographic appearance (right) showing new
bone formation in the area where the OP-1 Implant was placed. (B) Computed
tomography scan at 3 months (left) and 6 months (right) postoperative revealed
good new bone formation at the junction of the host femoral cortex and cortical strut
where the OP-1 Implant was placed, which matured and consolidated at the latter
time period.
266 Cook and Barrack

Preclinical study also demonstrated that healing of structural cortical strut


allografts to the femur was enhanced by the addition of the OP-1 Implant. Both
the quantity and the quality of the graft incorporation was improved based on
objective grading of plain x-rays, microradiographs, and histology. The overall
scores were significantly higher in the rhOP-1 – treated group and the subscores
for new bone formation and graft incorporation were significantly higher as well.
Most importantly, the time course of healing was significantly accelerated.
Clinical application of the OP-1 Implant with a cortical allograft strut
demonstrated new bone formation at 12 weeks postoperative (Fig. 4).
Consolidation of the new bone and graft was observed at later time periods.
Enhancement in strut healing was observed clinically in spite of the more
challenging biological environment compared to the preclinical studies.
Improving and speeding the course of cortical strut graft healing would be
of substantial clinical benefit in providing earlier biological and mechanical
stability to the construct. These benefits should lower the risk of graft nonunion
and shorten the time of protected weight bearing and attendant functional
disability for the patient.
The OP-1 Implant, either alone or in combination with bone graft, appears
to be an attractive alternative to autograft bone. The use of rhOP-1 in
combination with morselized or structural allograft appears to be an ideal
combination. Further work has shown the OP-1 Implant to be equally effective
when used with bone graft substitute materials such as calcium phosphate and
calcium sulfate materials. Compared to autograft bone alone, new bone formation
and graft incorporation is improved with the use of the OP-1 Implant. However,
in any clinical application, an osteogenic protein cannot overcome a poor
biological or biomechanical environment. Osteogenic proteins require a viable
cell source and vascularity, as well as mechanical stability, to induce bone
formation and remodeling. Failure to provide the prerequisite biological and
mechanical conditions will likely result in graft failure. In addition, maintenance
of the osteogenic protein at the implantation site and delivery by an appropriate
carrier material are essential for successful osteoinduction.

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3. Head WC, Malinin TI, Mallory TH, Emerson RH Jr. Onlay cortical allografting for
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Oppermann H. OP-1 cDNA encodes an osteogenic protein in TGF-beta family.
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Ozkaynak E, Oppermann H, Rueger DC. Bovine osteogenic protein is composed of
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(a bone morphogenetic protein) on the formation of bone in orthotopic segmental
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19
Adding Growth Factors to Impacted
Grafts
A Good Idea That Might Be Bad

Per Aspenberg
Linköping University Hospital
Linköping, Sweden

I. INTRODUCTION

If impaction grafting were suggested as a new method to a bone biologist who did
not know it already exists, he would find it an absurd idea with minimal chance of
success. He would point at the introduction of necrotic bone material together
with decomposing fat and marrow into an area with extreme demands on
mechanical stability, and where early osseous incorporation of the implant—in
primary procedures—has been shown to be crucial for ultimate success [1,2].
One would think that the only chance for success in such a situation would lie in
very fast remodeling of the graft into living, stable bone. However, this is not
what we see in histological retrieval studies [3]. The graft is not always
completely remodeled, and if so, this takes months and years. Yet the patient is
pain-free and walking shortly after the operation.

II. WHAT MAKES IMPACTION SUCCESSFUL?

I was puzzled by the clinical success of impaction grafting, and our group
performed a series of animal experiments trying to understand why impaction
grafting works so well. When planning those studies, we leaped to the false con-
clusion that clinical success must be related to successful osseous incorporation
269
270 Aspenberg

of the graft. We therefore tried to find out which aspect of impaction grafting led
to better bone ingrowth in bone chamber experiments. It was when we saw
retrieval data that we first realized that bony incorporation and clinical success
might be unrelated and that necrotic bone granula in a fibrous stroma might
constitute an excellent biomaterial for hip revision (see Chapter 15).
However, in some of our earlier work we also tried to improve graft
incorporation by adding growth factors (bFGF and BMP-7) to the graft. This was
successful in the bone chamber model in rats [4,5] but has so far failed in a larger
animal model with a loaded prosthesis (unpublished). One principal line of
thought now is to use bone stimulatory substances together with bone grafts in the
hope of achieving more complete and consistent bone regeneration [6]. Bone
morphogenetic protein (BMP) preparations are now available to the clinician and
might become valuable in fracture treatment. However, it is also possible to mix
this substance with cancellous bone grafts during revision surgery. I fear this
could be a serious mistake.

III. WARNING AGAINST USING GROWTH FACTORS

I would like to warn against adding BMPs or other growth factors to impacted
bone grafts for three reasons. First, there is only a small marginal for improve-
ment. The results of impaction grafting are approaching those of primary total
joint replacements [7 –9]. Suppose there is a large chance that a growth factor
decreases the risk of failure, and has a small risk of complications. The vast
majority of patients that already have a good prognosis without the factor would
run the risk of complications without any benefit, and only the few patients with a
bad prognosis would, perhaps, be better off. A small risk of complication might
then be enough to cause an overall negative effect. Thus, one has to be quite sure
that growth factor additives are good, and this will have to be based on theoretical
reasoning, because the number of patients and time needed to statistically
demonstrate an improvement are excessive.
Second, there are considerable theoretical risks with BMPs in this context,
because BMPs can also stimulate bone resorption, which has been observed both
in vivo [10] and in vitro [11]. Increased resorption poses a risk for a transition
phase of increased resorption within the graft before it becomes completely
remodeled. This could be detrimental to the mechanical stability. Höstner et al.
[12] reported a series of 10 cases of hip revisions where they added a BMP to
impacted grafts and followed the result with radiostereometric analysis. In 2
cases they saw dramatic resorption of the graft and early gross failure. This
observation caused them to stop the series. It cannot be excluded that this was a
rare, random occurrence of resorption—simply bad luck—but it must be taken as
a serious warning. Resorption has also been described in a case of a vertebral
Adding Growth Factors to Impacted Grafts 271

fracture, where the vertebral body was packed with collagen granules carrying a
BMP [10]. Dramatic graft and vertebral resorption caused collapse and gibbosity
formation before, eventually, the anabolic effect of the BMP took over and the
resorptive lesion became ossified.
Third, even if complete and faster osseous remodeling could be achieved with
a BMP and the risk of deleterious side effects could be eliminated, this would not
necessarily lead to a better clinical result. The composite of necrotic bone and
fibrous scar tissue might be an ideal biomaterial, preferable to complete remodeling.
It is clear that a composite of necrotic bone fragments and an armoring fibrous
stroma is sufficient for good function during the first postoperative months or years
[3]. The question is whether complete osseous remodeling is necessary for good
long-time results, i.e., whether there must be host bone all the way up to the cement
or implant. Also, in cases with good results, large parts of the graft can remain a
composite of necrotic bone fragments and a fibrous stroma. It thus appears that
complete osseous remodeling is not necessary. The next question is whether
complete osseous remodeling is desirable. Here we can only speculate.
The osseous remodeling must start in the periphery, where there is living
host bone. It can then work its way as an advancing frontier through the necrotic
bone towards the implant. Resorptive activity, however, can normally be
increased in front of such a frontier, as, for example, in osteonecrosis of the
femoral head [13,14]. Thus, when remodeling finally reaches the vicinity of
the implant, resorption might come first and the prosthesis could loosen. This
may not be likely to happen in every case, but it is a theoretical risk that should be
considered. One study in goats appears to suggest that loosening can occur in this
way, although other explanations for the results are possible [15].
If increased resorption poses the main risk with BMP additives, what about
blocking resorption with a bisphosphonate?
Bone grafts can be soaked in a bisphosphonate before implantation. In a rat
chamber model this completely inhibited graft resorption and also increased the
amount of new bone appositioned to the cancellous surfaces [16]. In this model a
cylindrical graft is enclosed in a chamber, so that host tissue can only grow into
the graft from one end. We can then measure how far into the graft the different
tissue components reach. After 6 weeks one sees a fibrous or granulomatous
tissue ingrowth frontier about 5 mm into the graft. Behind this frontier there may
be occasional graft resorption, but most of the graft is intact. A bone formation
frontier is seen about 2 mm into the graft and, shortly behind, a resorption frontier
that takes away both graft and host bone, to form a marrow cavity. When the graft
has been pretreated with a bisphosphonate it stays entirely intact, and thus,
instead of a marrow cavity, one sees the cancellous graft, with all surfaces
covered with new host bone. The bone density is increased several-fold.
However, the bone formation frontier has not reached farther into the graft. If a
BMP is added to the graft (and no bisphosphonate), the bone formation frontier
272 Aspenberg

often reaches the other end of the graft, i.e., 5– 7 mm into it, and on average the
bone ingrowth distance is doubled [5]. Again, a marrow cavity will occupy
almost the entire osseous compartment.
We combined a bisphosphonate with a BMP in the hope of finding that the
increased ingrowth distance due to the BMP would combine with the increased
bone density due to the bisphosphonate. However, this was not the case [17].
Indeed, the density was increased as with a bisphosphonate alone, but the
ingrowth distance now did not differ from controls. Evidently, resorptive activity
within the graft is a prerequiste for the increased ingrowth distance due to the
BMP. In other experiments, the graft was compacted to a much higher degree
than in clinical practice. Antiresorptive therapy diminished the ingrowth
distance below control level, but the ingrowth could then be rescued with a BMP.
These experiments indicate that there is an intricate interplay between
resorption and the effects of a BMP on graft incorporation and that we cannot be
sure that bisphosphonate treatment would solve our problem. The bisphos-
phonate took away the benefit of the BMP. In fracture repair the situation is
different: the negative effects of the early resorptive response to a BMP appear to
be reduced by bisphosphonate treatment [18]. This is conceivable, because in
fracture repair new bone formation is induced outside the preexisting bone that is,
or is not, undergoing resorption. Thus, no bone needs to be removed.

IV. CONCLUSION

I think there is much to lose and little to gain from adding BMPs to impacted bone
grafts, mainly due the risk of increased resorption, and bisphosphonate treatment
is far from certain to eliminate this problem.

REFERENCES

1. Ryd L, Albrektsson BE, Carlsson L, Dansgard F, Herberts P, Lindstrand A, Regner L,


Toksvig-Larsen S. Roentgen stereophotogrammetric analysis as a predictor of
mechanical loosening of knee prostheses. J Bone Joint Surg 1995; 77-B:377 – 383.
2. Karrholm J, Herberts P, Hultmark P, Malchau H, Nivbrant B, Thanner
J. Radiostereometry of hip prostheses. Review of methodology and clinical results.
Clin Orthop 1997; 344:94– 110.
3. Linder L. Cancellous impaction grafting in the human femur: histological and
radiographic observations in 6 autopsy femurs and 8 biopsies. Acta Orthop Scand
2000; 71:543 – 552.
4. Wang JS, Aspenberg P. Basic fibroblast growth factor enhances bone-graft
incorporation: dose and time dependence in rats. J Orthop Res 1996; 14:316– 323.
Adding Growth Factors to Impacted Grafts 273

5. Tagil M, Jeppsson C, Aspenberg P. Bone graft incorporation. Effects of osteogenic


protein-1 and impaction. Clin Orthop 2000; 371:240 – 245.
6. Schreurs BW, Buma P. Impaction bone grafting. Acta Orthop Scand 2001;
72:661– 663.
7. Ling RS. Cemented revision for femoral failure. Orthopedics 1996; 19:763– 764.
8. Slooff TJ, Buma P, Schreurs BW, Schimmel JW, Huiskes R, Gardeniers J. Acetabular
and femoral reconstruction with impacted graft and cement. Clin Orthop 1996;
324:108– 115.
9. Ornstein L, Atroshi I, franzen H, Johnsson R, Sandquist P, Sundberg M. Early
complications after one hundred and forty-four consecutive hip revisions with
impacted morselized allograft bone and cement. J Bone Joint Surg 2002; 84-
A:1323– 1328.
10. Laursen M, Hoy K, Hansen ES, Gelineck J, Christensen FB, Bunger CE.
Recombinant bone morphogenetic protein-7 as an intracorporal bone growth
stimulator in unstable thoracolumbar burst fractures in humans: preliminary results.
Eur Spine J 1999; 8:485– 490.
11. Kaneko H, Arakawa T, Mano H, Kaneda T, Ogasawara A, Nakagawa M, Toyama Y,
Yabe Y, Kumegawa M, Hakeda Y. Direct stimulation of osteoclastic bone resorption
by bone morphogenetic protein (BMP)-2 and expression of BMP receptors in mature
osteoclasts. Bone 2000; 27:479– 486.
12. Höstner J, Kärrholm J, Hultmark P. Early failures after femoral revisions, using
milled allograft bone mixed with OP-1. 56th meeting Swedish Orthopaedic
Association, Vaxjo, Sept 5 –8, 2000.
13. Glimcher MJ, Kenzora JE. The biology of osteonecrosis of the human femoral head
and its clinical implications: 1. Tissue biology. Clin Orthop 1979; 138:284– 309.
14. Gardeniers J. Behaviour of normal, avascular and revascularizing cancellous bone.
PhD dissertation, Catholic University of Nijmegen, Nijmegen, The Netherlands,
1988.
15. Schimmel JW, Buma P, Versleyen D, Huiskes R, Slooff TJ. Acetabular
reconstruction with impacted morselized cancellous allografts in cemented hip
arthroplasty: a histological and biomechanical study on the goat. J Arthroplasty
1998; 13:438 –448.
16. Aspenberg P, Astrand J. Bone allografts pretreated with a bisphosphonate are not
resorbed. Acta Orthop Scand 2002; 73:20 – 23.
17. Jeppsson C, Wang J-S, Tägil M, Aspenberg P. No augmentation of morselized and
impacted bone graft by OP-1 in a weight-bearing model. Acta Orthop Scand.
Accepted for publication.
18. Seeherman HJ, Li XJ, Gavin D, Wozney J, Bouxsein ML. Bisphosphonate limits
initial bone resorption without decreasing bone induction in rhBMP-2/ACS treated
non-human primate core defects. Bone 2002; 30:44S.
20
Acetabular Bone Impaction Grafting
Classification of the Bone Stock Loss and
Surgical Technique

Jean W. M. Gardeniers, Tom J. J. H. Slooff, and


B. Willem Schreurs
University Medical Centre Nijmegen
Nijmegen, The Netherlands

I. INTRODUCTION

Acetabular bone defects can be encountered in primary and revision arthroplasty.


Primary defects are either congenital or acquired or result from diseases that
affects the bony structure of the acetabulum. These defects are associated with
inflammatory disorders, especially rheumatoid arthritis, congenital hip dysplasia,
trauma, osteoarthritis (protrusio acetabuli), previous surgery (acetabular
fractures), and metabolic disorders, tumors, infection, or iatrogenic causes.
Loss of bone stock is frequently encountered during revision arthroplasty.
Aseptic loosening is associated with osteolysis and component migration
resulting in damage to acetabular bone, which can be extensive, especially after
multiple revisions.
Our approach to acetabular reconstruction in both primary and revision
surgery is to reconstruct the hip to its anatomical center of rotation, obtain
implant stability, and restore acetabular integrity and continuity [1 – 3]. Surgeons
use different techniques depending on the extent of the bone loss, so it is essential
to study the available x-rays to plan the operative procedure.
For simple bone stock defects, many surgeons use cementless cups,
sometimes in combination with bone graft. Many surgeons use a porous-coated
hemispherical component fixed with screws. In larger defects there is a trend to
275
276 Gardeniers et al.

use of oversized jumbo acetabular components or even bi-lobed, oblong, double


bubble cups. Other solutions are a high hip center, metal reinforcement ring
support with bone graft and structural allograft with a standard or revision
components. Several authors advocate the use of rigid metal reinforcement, like
the Eichler or Muller ring or the Kerboull plate. Our approach is bone impaction,
which we use in all cases.
There are several classifications of acetabular bone loss. Frequently used
classification systems are those of the American Academy of Orthopedic
Surgeons by D’Antonio et al. [4], Engh and Glassman [5], Chandler and
Penenburg [6], Paprosky and Magnus [7], and Garbuz et al. [8]. A classification
system should be as simple as possible and should help the surgeon choose the
correct technique for acetabular reconstruction. It should also facilitate the
comparison of clinical outcome studies presented in the literature. However, all
classification systems have limitations.
The Paprosky classification is based on the ability of to acetabulum to
provide rigid support to uncemented cups [7]. In the type 1 defect there is only
limited bone stock loss. The only grafting needed is some morselized bone. In a
type 2 defect the acetabular rim still is capable of supporting an uncemented cup
and no structural grafts are needed. There may be some superolateral defect in the
acetabular rim and a medial defect may exist, but this is not essential for cup
stability. Type 3 defects have severe rim defects and require major structural
allografts.
The Gross classification is based on the type and size of bone graft
needed to reconstruct the acetabulum [8]. A type 1 defect is a contained
cavitary defect with an intact medial wall and no segmental rim defects.
Reconstruction can be performed with either cemented or uncemented cups,
in combination with morselized bone graft, which can be impacted in the
defect. The type 2 defects are not contained. In type 2A minor column
defects are seen, but less than 50% of the acetabulum is defective. They can
be reconstructed with a so-called flying buttress structural graft. The type 2B
are the major column defects, in which one or both columns are affected and
at least 50% of the acetabulum is involved. Extensive structural grafting is
needed.
For our reconstruction technique of bone impaction grafting with metal
mesh to reconstruct segmental defects, the AAOS system was the most useful in
predicting the most suitable type of reconstruction. The AAOS Committee on the
Hip published the classification for acetabular bone deficiency in June 1989
describing the bone defects in both primary and revision reconstruction of the
acetabulum [4]. The AAOS classification system can be used in both primary and
revision acetabular reconstruction and is becoming more widely quoted in the
literature. The classification was intended to be generic in terms of the method of
treatment used (Table 1).
Classification of Bone Stock Loss 277

Table 1 Classification of Acetabular Deficiencies

Type I: Segmental deficiencies


Peripheral
Superior
Anterior
Posterior
Central (medial wall defect)
Type II: Cavitary deficiencies
Peripheral
Superior
Anterior
Posterior
Central (medial wall intact)
Type III: Combined deficiencies
Type IV: Pelvic discontinuity
Type V: Arthrodesis

Source: Ref. [4].

Bone defects are divided into five categories:


Type I: Defects that include the acetabular rim, peripheral and/or medial
wall are called segmental. Segmental defects are not contained and can be
located anteriorly, superiorly, posteriorly, or centrally in the medial wall.
Type II: Defects leaving the rim of the acetabulum intact are cavitary and
can be located superiorly, anteriorly, posteriorly, or medially. Debris
from third body wear may cause these large cavitary lesions, and their
location can vary depending on the type of acetabular component used,
the duration of the loosening, or damage caused by infection.
Type III: A combination of these two types are classified separately. This is
the most common type of defect encountered in revision surgery. A
failed cemented acetabular component often migrates superiorly as well
as medially, but bone defects can be located in any quadrant of the
acetabulum.
Type IV: The AAOS classification system also includes pelvic
discontinuity, which is the most severe defect that can be encountered
during revision arthroplasty and after pelvic trauma. This is defined as
a defect in which the anterior and posterior columns are completely
separated by a fracture.
Type V: Finally, arthrodesis of the hip is included. There is no bone defect,
but it is included in the classification because the acetabulum as such no
longer exists.
278 Gardeniers et al.

When acetabular bone impaction grafting is planned, it is important to


know whether the defect is contained or not. In contained bone defects, impaction
grafting can be done without mesh. If there is a segmental wall defect, it should
be closed first with metal mesh to create a confined cavity into which bone graft
can be impacted. Although the AAOS classification is based on radiographs, the
definitive classification in Nijmegen is done after exposure of the hip joint during
the operation. The primary aim of the technique is to contain and solidly impact
trabecular bone chips of substantial size. In any defect this principle is more basic
than the classification. The reconstruction must achieve:
Full acetabular integrity
Full socket coverage with bone or wire mesh
Complete confinement of the graft
Complete fixation of the graft
Complete fixation of the new implant
The creation of normal hip mechanics
To achieve these goals it is important to understand the classification and use it
diligently during the operation.

II. X-CHANGE TECHNIQUE AND


THE AAOS CLASSIFICATION
A. Type I: Segmental Defects
In our view this type of defect is rare. Most segmental defects seen in revision
surgery are combined cavitary and segmental. The segmental defect must be
closed with mesh. After closing the defect, a bone impaction grafting can be
performed. The newly created cavitary defect is filled with tightly impacted
sequential layers of bone chips (Fig. 1). The acetabular rim is reconstructed as
anatomically as possible with wire mesh that is trimmed to the appropriate size
and fixed solidly with small screws. The new cup is placed against the transverse
ligament in the anatomical position. The new acetabular wall is mainly created
peripherally and medially.

Figure 1 Reconstruction of a segmental and a combined deficiency.


Classification of Bone Stock Loss 279

B. Type II: Cavitary Deficiencies


The acetabular rim and the medial wall is intact. A cavitary defect exists, and it is
filled with sequential layers of impacted bone chips to create a new acetabular
wall at least 5 mm thick. Again mainly the superior, anterior, and posterior wall is
reconstructed (Fig. 2).

C. Type III: Combined Deficiencies: Segmental and


Cavitary Defects Combined
Close the defects with wire mesh or small structural grafts taken from the femoral
(donor) head. The acetabular rim and the medial wall is reconstructed as
anatomically as possible, and the new cup is placed against the transverse
ligament. A cavitary defect is created and filled with tightly impacted sequential
layers of bone chips. The acetabular wall is mainly created peripherally and
medially (Fig. 1, views 3 –5).

D. Type IV: Pelvic Discontinuity


Treat this severe defect as a fracture and follow the rules of fracture treatment. If
the fracture is not properly fixed, movement exists and primary stability will
never be achieved. One of the most important prerequisites of impaction grafting,
stability, is absent, and failure is inevitable. Therefore, the anterior and posterior
columns must be fixed with pelvic reconstruction plates as wire mesh is not
strong enough to support the fracture. After plating the columns, the rim defects
are anatomically reconstructed with wire mesh or small structural grafts. The
medial wall is closed with wire mesh and or structural grafts and a cavitary defect
is created. Finally, this defect is filled with layers of impacted bone chips (Fig. 3).

Figure 2 Reconstruction of a cavitary deficiency.


280 Gardeniers et al.

Figure 3 Reconstruction of pelvic discontinuity.

E. Type V: Arthrodesis
The old acetabulum does not exist anymore and is obliterated. The bone inside
the acetabulum is often atrophic and cannot support the cup adequately. After
osteotomy of the femoral neck a new acetabulum can be created with acetabular
reamers. The osteoporotic bone and walls can be reinforced using impacted bone
chips.

F. Congenital Hip Dysplasia


Congenital hip dysplasia is a special problem, especially the Crowe Class II, III,
and IV [9]. The anterior wall is deficient due to the abnormal position of the psoas
muscle in these cases. The muscle crosses the acetabulum from the lesser
trochanter, over the transverse ligament to the first lumbar vertebral body. From
birth onwards it creates a substantial defect in the anterior wall. The high position
of the femoral head in the false acetabulum causes an underdeveloped medial
wall, true acetabulum, and a deficient superior rim. The posterior wall is less
affected, but when the cup is positioned against the transverse ligament, this
posterior wall needs also reconstructing. After reaming the true and false
acetabulum, the anterior wall must be reconstructed using structural graft if a
large defect exists. A quarter of the resected autogenous femoral head is fixed to
the existing acetabulum supplemented with wire mesh fixed with small screws to
Classification of Bone Stock Loss 281

the medial wall. The superior rim of the acetabulum is reconstructed with a thick
mesh, and a cavitary defect is created and filled with layers of impacted bone
chips. The patient’s own femoral head is used, but often, especially in Crowe
class III and IV hips, the amount of bone that can be obtained is inadequate and
fresh frozen allograft bone from the bone bank must be added (Fig. 4).

III. SURGICAL TECHNIQUE

We routinely use the postero-lateral approach with the patient in the lateral
position. The patient is stabilized on the operating table with pubic and lumbar
pads. In time-consuming revision operations, we use these pads in combinations
with a vacuum mattress. The drapes used should facilitate an incision that can be
extended to the region of the anterior superior iliac spine if necessary. Care
should be taken to ensure free movements of the extremity and provide a clear
view of the posterior, lateral, and anterior aspects of the hip joint. In revision
surgery, antibiotics should given only after taking the deep cultures.
The postero-lateral approach enables extensive exposure of the acetabulum
and proximal femur, and a trochanteric osteotomy is seldom necessary. In
revision surgery, the major landmarks and the sciatic nerve must be identified to
understand the local anatomy, as it may have been disturbed by previous surgery

Figure 4 Reconstruction of congenital hip dysplasia.


282 Gardeniers et al.

and scarring. Suitable landmarks are the tip of the greater trochanter, the lesser
trochanter, the tendineous part of the gluteus maximus muscle, and the borders of
the medius and minimus gluteal muscles.
Extensive exposure is essential. Aspiration of the hip joint can be
performed to obtain joint fluid for Gram staining and culture. We try to open the
hip joint while conserving the posterior part of the hip capsule. By using stay
sutures in this tissue, the sciatic nerve can be protected from direct trauma. Before
dislocating the hip joint, the proximal part of the femur is extensively exposed
and carefully mobilized to prevent fracturing the often very weak femur. It may
be necessary to put circlage wires around the femur before dislocation to prevent
an accidental fracture. After dislocation, the femoral component is removed,
exposing the entire socket and all scar tissue. Next the cup is removed, avoiding
any additional bone damage. Biopsies from the acetabular and femoral interface
tissues are obtained and sent for frozen section and bacterial culture. At this stage
systemic preoperative antibiotics are administered.
The medial wall of the acetabulum is examined meticulously for segmental
defects. It is also imperative to determine the strength of the medial wall. If
weakness is suspected a medial wall mesh might be considered to prevent
fracture during vigorous impaction (Fig. 5, view 1).
The complete rim is exposed to examine the peripheral wall for segmental
defects. To restore normal hip biomechanics, we always try to reconstruct the cup
at the original center of rotation. In most cases the transverse ligament can be
located at the caudal part of the acetabulum; it is used as a reference point for
positioning the cup. A trial cup is inserted using the ligament as a reference, and
the extent of the peripheral wall defect is established. Damage to the superior
gluteal muscles and the nerve can be prevented by subperiosteal dissection. The
abductor muscles are elevated from the bone to facilitate positioning of the mesh.
The mesh is placed on the outer side of the acetabular rim (Fig. 5 view 1). The
flexible metal mesh is trimmed and adapted to the peripheral wall defect using
special scissors and clamps. It must be fixed with screws or, at locations with very
thin cortical bone, circlage wires. In cases with extensive peripheral wall defects,
it sometimes is impossible to achieve stability with mesh on the outer side of the
acetabulum. In these special cases, the mesh can be applied to the inner side and
fixed with more central screws.
After all the soft tissue interface remnants have been removed, a small
acetabular reamer is used to remove the sclerotic cortical bone. This creates a
fresh bleeding trabecular bone bed, which is essential for incorporation of the
impacted bone graft. In addition, multiple drill holes should be made to create a
bleeding host bone bed and promote vascular invasion into the graft. This is
extremely important in the sclerotic areas.
Medial wall defects can also be covered by a metal mesh. In most cases,
adequate stability of the mesh can be achieved without screw fixation.
Classification of Bone Stock Loss 283

Figure 5 Reconstruction technique using wire meshes and bone impaction


grafting.

However, the use of one or two very short screws can prevent problems.
After closing the segmental wall defects in this way, the acetabulum is contained
and the situation has been converted into a cavitary defect. The foundations have
been laid for bone impaction grafting.

A. Preparation of the Bone Graft


All of our long-term data are based on the use of fresh-frozen femoral heads,
which were obtained from a local bone bank. We have no experience with
processed bone or irradiated bone. The femoral head is stored at 2808C and is
284 Gardeniers et al.

only used after testing the donor at donation and at 6 months after donation. The
femoral head is thawed, cleaned of all soft tissues, and divided into four parts.
Morselized grafts are produced by hand, using a bone nibbler. We try to avoid the
inclusion of cartilage remnants from the femoral head cartilage.
Alternatively, a specially designed bone mill can be used, which produces
fairly large bone chips. We recommend a chip size of 7– 10 mm, but most
commercially available bone mills produce substantially smaller bone chips
(2 –4 mm), which are not recommended for acetabular reconstruction.

B. Acetabular Reconstruction
The acetabular bone bed is cleaned using pressure lavage, and the acetabulum is
packed with bone chips.
First the small cavities are filled, and then the entire socket, layer by layer.
The bone chips are vigorously impacted using special instruments and a hammer
(Fig. 5, view 2). If there is any danger of fracturing the weak medial wall, a metal
mesh should be used medially to support this structure, but the force of impaction
should not be reduced. Start with a small impactor and progress to increasingly
larger ones. When the impaction technique has been performed correctly, the
graft layer will be stable in the acetabulum after removal of the impactor. The
defect is filled layer by layer until the planned cup position has been achieved
(Fig. 5, view 3). A substantial layer of bone material must be accumulated of at
least 5 mm thick, otherwise the graft may become saturated with bone cement
during cementation (Fig. 5, view 4). The last impactor should be 4 mm larger
than the proposed cup size to create a sufficiently large mantle of cement. The
position of the socket should be brought down to the level of the transverse
ligament. After impaction, the preexisting enlarged acetabular diameter will have
been reduced to standard size. We do not use pressure lavage on the bone graft
before cementation. During preparation of the antibiotic-loaded bone cement,
pressure is maintained on the graft with the impactor last used.
After insertion, the bone cement is pressurized to obtain good
interdigitation with the graft (Fig. 5, view 5). Next the cup is guided into
position and held in place with a pusher until the cement has set (Fig. 5, view 6).
After reconstruction of the femur, it is essential to be very careful during
trial reduction. The acetabular reconstructions are strong in compression, but not
in tension. During dislocation after the trial reduction, one should control the cup
manually and compress it to avoid loosening the cup from the bone graft bed.

C. Postoperative Care
Postoperative treatment includes anticoagulation therapy and systemic
antibiotics for 24 hours. Immediately after the operation, indomethacin is
Classification of Bone Stock Loss 285

administered for 7 days to prevent heterotopic ossification. Mobilization of the


patient is individualized according to the extent of the original defects. In the case
of simple cavitary defects, the patient is mobilized within 2 days with partial
weight bearing on crutches. We mobilize the more extensive cases after 2 weeks
with partial weight bearing. In contrast to our earlier reports, only cases with a
extensive defects of the medial wall have 6 weeks of bed rest. All patients are
kept on crutches for 3 months.

D. Critical Factors
The technique is not simple, and the possible pitfalls should always be kept in
mind. Critical factors include:
1. Infection should be diagnosed or excluded before surgery by ESR, CRP,
WBC and differential WCC, hip aspiration during arthrography, and
IgG-scanning. If an infection exists, it should be treated before recon-
struction with impacted bone grafting used as a two-stage procedure.
2. Prediction of the acetabular bone loss on radiographs is difficult.
A radiograph is a black-and-white two-dimensional projection of a
three-dimensional structure. Large metal implants will hide the
existing defects, at least partially. Therefore, it is very difficult to
clearly classify the defects. A golden rule is that “radiographs only
show 50% of the true situation.” If this is kept in mind, preparation for
surgery becomes more reliable.
3. Close all segmental bone defects with meshes; the defects must be
contained before impaction. Tight impaction of the chips is only
possible in a contained defect and is essential for the primary stability
of the acetabular reconstruction. Stability is a prerequisite for ingrowth
of the graft and its final remodeling into lamellar bone.
4. If fractures of the acetabulum or pelvic bone do exist, they should be
treated appropriately with plates and screws. Wire mesh is too flexible
to stabilize such a lesion, and its use in this situation will result in
failure. One should be especially wary of pelvic discontinuity.
5. Use large-sized trabecular bone chips on the acetabular side. Our long-
term experience is based on trabecular chips of substantial size (7 –
10 mm) and made by hand using a rongeur. Impacted large trabecular
chips can be easily impacted, and they create immediately stability.
The initial cup stability is poorer after a reconstruction with smaller
bone chips. Remember that most commercial bone mills produce
rather small chips (2 – 4 mm).
6. Use the proper impaction technique. A solid impaction using
appropriate impactors and a hammer should be used. Impaction bone
286 Gardeniers et al.

grafting by reverse reaming is inadequate. Migration is two to three


times greater than in cups cemented on to graft impacted with the
traditional technique using a hammer and metal impactors.
7. Be aware of the variation among surgeons. The outcome of impaction
bone grafting, like every procedure, depends on surgical technique and
experience. The way the surgeon prepares for surgical procedures, the
knowledge of the exposure, the instruments and implants, preparation
of the operating theater staff, and the learning curve of the procedure
influence the outcome. Do not start this technique with the most
difficult case. Become familiar with the technique and start on the
simpler cavitary defect.

REFERENCES

1. Slooff TJ, van Horn J, Lemmens A, Huiskes R. Bone grafting for total hip replacement
in acetabular protrusion. Acta Orthop Scand 1984; 55:593 – 597.
2. Slooff TJ, Schimmel JW, Buma P. Cemented fixation with bone grafts. Orthop Clin
North Am 1993; 24:667 – 677.
3. Slooff T, Buma P, Gardeniers J, Schreurs B, Schimmel J-W, Huiskes R. Revision of
the acetabular component: bone packing. In: Callaghan JJ, ed. The Adult Hip.
Philadelphia: Lippincott-Raven Publishers, 1998:1449 – 1459.
4. D’Antonio JA, Capello WN, Borden LS, et al. Classification and management of
acetabular abnormalities in total hip arthroplasty. Clin Orthop 1989; 243:126– 137.
5. Engh GA, Glassman AH. Cementless revision of failed total hip replacement.
Instructional Course Lectures of the AAOS 1991:1189 – 1197.
6. Chandler HP, Penenberg BL, eds. Bone Stock Deficiency in Total Hip Replacement:
Classification and Management. Thorofare, NJ: Slack Inc., 1989.
7. Paprosky WG, Magnus RE. Principles of bone grafting in revision total hip
arthroplasty: acetabular technique. Clin Orthop 1994; 298:147 – 155.
8. Garbuz D, Morsi E, Mohamed N, Gross AE. Classification and reconstruction in
revision acetabular arthroplasty with bone stock deficiency. Clin Orthop 1996;
324:98 – 107.
9. Crowe JF, Massi I, Ranawat CJ. Total hip replacement in congenital dislocation and
dysplasia of the hip. J Bone Joint Surg 1979; 61A:15– 23.
21
Long-Term Results of Acetabular
Reconstruction Using Impaction
Bone Grafting and a Cemented Cup
B. Willem Schreurs, Jean W. M. Gardeniers, and
Tom J. J. H. Slooff
University Medical Centre Nijmegen
Nijmegen, The Netherlands

I. INTRODUCTION

Although total hip arthroplasty (THA) is one of the most innovative and successful
procedures in modern medicine, the number of patients who need a revision is
rapidly increasing. In the long-term, the main reason for failure of all types of total
hip implants is aseptic loosening. Aseptic loosening is influenced by a number of
factors but will result in osteolysis around the failed implant. In most patients
osteolysis is associated with progressive pain, especially when the implant is
unstable. However, in some cases there is radiological evidence of progressive
osteolysis in patients who are symptom-free. Revision hip replacement when there
is extensive bone loss is more demanding, and the greater the bone loss, the less
successful is the outcome. Therefore, regular follow-up radiographs, especially in
patients at high risk of revision, is mandatory after hip replacement. The most
frequent indication for revision of a failed hip arthroplasty is pain, progressive loss
of function, increasing physical disability, and in some cases progressive
osteolysis on radiographs. During revision surgery, removal of prostheses
frequently causes additional loss of bone stock. The loss of bone stock around the
prosthesis is therefore the key problem to be addressed in revision surgery.
On the acetabular side, loosening causes cavitary bone defects and, in more
serious cases, segmental ones with further loss of bone stock. Many acetabular
287
288 Schreurs et al.

reconstruction techniques have been described with both cemented and


uncemented cups, and there is little agreement about the best way of managing
bone defects.
We use tightly impacted morselized cancellous allografts in combination
with a cemented cup in all cases with acetabular bone loss, in both primary and
revision hip replacement. We think this is an attractive technique because it
allows biological repair of damaged bone so should there be a further revision,
which can be anticipated as all arthroplasties fail in time, the bone stock will be
better than the first one.
Our experience of this technique dates from 1979. The essentials of the
impaction grafting technique are:
1. Restoration of the lost bone stock
2. Reconstruction of the original center of rotation of the hip
3. Transformation of a medial or peripheral segmental bone defect into a
cavitary defect using metal mesh
4. Stabilizing the bone graft using impactors and vigorous impaction
technique
5. Use of a standard acetabular cup with bone cement.
On the acetabular side, we always use 7 – 10 mm diameter chips, preferably
of pure cancellous bone. We do not use this technique in combination with metal
reconstruction rings but rely on the stability of the cement graft reconstruction.
From the beginning in 1979, we used this technique in patients undergoing
primary total hip replacement who had preexisting bone loss as well as in
revisions of failed acetabular components. In our center, we now use it in all cases
of acetabular bone loss.
In a primary total hip replacement with simple protrusio, we use the
patient’s femoral head for bone chips, sometimes with cancellous bone from the
proximal femur. However, in primary cases with severe loss of bone stock (e.g.,
congenital hip dysplasia), we also use fresh frozen femoral head allograft in
combination with mesh to reconstruct defects and restore the original center of
rotation. Initially in revision cases, we used a combination of autologous human
bone from the iliac crest with fresh frozen human femoral head allografts.
However, for the last 15 years we have used femoral head allografts alone
obtained from our local bone bank. When there has been loss of bone stock loss
and a revision is planned, it is essential to distinguish septic from aseptic
loosening. If there is any suspicion of infection, technetium scanning, gamma-
immunoglobulin scintigraphy, if available, and preoperative aspiration of the hip
to obtain cultures should be undertaken.
When planning a revision, it is important to recognize that the bone loss and
disruption of acetabular anatomy encountered during surgery are frequently
much more severe than the preoperative radiographs suggest. Good quality
Long-Term Results of Acetabular Reconstruction 289

antero-posterior, lateral, and oblique plain radiographs are therefore necessary to


assess the severity of the anatomical distruption, the extent of bone lysis, and the
location of bone cement.
In this review we will present the outcome of several follow-up studies
performed recently. Readers should realize that the Orthopaedic Department of
the University Medical Centre, Nijmegen, is not a high-volume revision center.
However, since 1979 we have gained great experience with one revision
technique: bone impaction grafting. This is the only technique used in our center,
and we have used it for over 20 years. In that time we made only one major
modification to the technique. We no longer use metal mesh on top of impacted
bone. We used to insert it just before the bone cement in the early years to limit
the surface contact between bone cement and graft. At that time, metal-backed
cups were very popular, because it was felt that they reduced stress peaks on the
acetabulum. The hypothesis turned out to be incorrect, and we concluded that the
mesh, like the metal backing, probably had no function, so with the benefit of this
experience, we decided to cement directly onto impacted bone. During these 20
years we invested a lot of energy in both basic and clinical research into this bone
impaction grafting technique. It was the vision of Tom Slooff to extend the study
of impaction grafting from clinical to basic scientific research to examine
multiple aspects of the technique. Therefore, we developed the infrastructure
necessary to perform both biomechanical and histological research into this
technique in our center. Thus, in vitro and animal studies supported clinical
research in an attempt to understand the technique and define its limitations.
From the beginning, all patients had the same postoperative treatment. This
included anticoagulation, systemic antibiotics for 24 hours, and, immediately
after surgery, indomethacin for 7 days to prevent heterotopic ossification.
Initially after we started the technique, patients were kept in bed for 6 weeks and
on crutches for 3 months. Nowadays, mobilization of the patient depends on the
extent of the original defect. In simple cavitary defects, the patient is mobilized
within 2 days, partially weight bearing on crutches. We mobilize cases with more
extensive bone loss after 2 weeks partially weight bearing. Nowadays, only cases
with very extensive defects, particularly of the medial wall, have 6 weeks bed rest
followed by partial weight bearing of 50% of the body weight. Twelve weeks
after surgery full weight bearing is allowed.
Many of the results presented are long-term follow-up studies, as these are
the only proof of the true clinical value of a revision technique. None of the
studies presented are single surgeon series. We tried to prevent selection bias in
all these studies. All cases undergoing impaction grafting were prospectively
entered in a computer database. When we select a subset of these patients for
study, we enter all subsequent patients from this database. Our patient files are
nearly complete. We try to trace every patient because we think that loss to
follow-up influences long-term outcome studies. Therefore, in many of our
290 Schreurs et al.

studies we present a worst-case scenario, as suggested by Murray et al. [1]. We


think that this scenario should be included in every long-term outcome study of
hip implants so the reader has easy access to the information and can draw his or
her own conclusions as to its reliability. In all studies we used the AAOS scoring
system to classify the extent of the acetabular defect [2]. For radiological
loosening in all studies, we use the criteria described by DeLee and Charnley [3].

II. CLINICAL RESULTS

In 1984, we first reported our short-term results of bone impaction grafting in 40


patients with 43 acetabular reconstructions; 21 were primary cases and 22
revisions after failed total hip arthroplasty [4]. After a follow-up of 2 years there
had been no revisions, but radiolucent lines were visible in 5 cases.
However, as already explained, only long-term clinical follow-up can
prove the true clinical value of a technique. Therefore, we analyzed several
groups of patients with long-term follow-up after acetabular bone impaction
grafting. We first focused our clinical research on long-term results of primary
and revision total hip arthroplasty. Then we decided to study subsets of these
patient groups. We studied the outcome of this technique in patients who were
under 50 years at the time of surgery. We use this technique in congenitally
dysplastic hips. As total hip replacement in patients with rheumatoid arthritis is
associated with poorer results, we studied the outcome of this acetabular
reconstruction technique in both primary and revision arthroplasty.

A. Acetabular Reconstruction in Primary THA


We studied the outcome of acetabular reconstruction with morselized impacted
cancellous bone autograft in primary THA [5] after 10 – 17 years. Between 1979
and 1986, 69 acetabula were reconstructed in 63 patients with autologous bone
chips. At review, 10 patients (9 hips) had been lost to follow-up, leaving 54
patients with 59 hips for review. Unfortunately, the loss to follow-up was
relatively high in this study. There were 43 women and 11 men. The average age
at surgery was 56 years (range 20 –83 years). The preoperative diagnosis was
primary osteoarthritis in 42%, secondary osteoarthritis in 27%, and rheumatoid
arthritis in 31%. Eleven patients (12 hips) had died within 10 years of the
operation; none had undergone revision surgery. The follow-up was 10 years or
more (10 – 17 years, average 12.3 years) in 47 hips (43 patients). The average
HHS (Harris Hip Score) was 88 points at the last follow-up. No hip was very
painful. Radiologically the defects were classified according to D’Antonio et al.
[2] as cavitary in 78% and combined segmental and cavitary in 22% of the cases.
Radiographically, all grafts united. At an average of 12.3 years follow-up,
Long-Term Results of Acetabular Reconstruction 291

4 revisions had been performed: one for septic loosening (1.5 years after primary
surgery) and 3 for aseptic loosening (after 7, 12, and 17 years). There were 3
radiographic failures, but these patients were only mildly symptomatic at review.
We concluded that the survival rate for aseptic loosening of primary THA was
94% at 10 –17 years follow-up after bone impaction grafting. The survival rate
including both revision and radiological loosening as endpoint was 87% at 12.3
years. In a worst-case scenario, including patients lost to follow-up as failures, the
survival rate was 76%.

B. Follow-Up Study of Acetabular Reconstruction with


Bone Impaction Grafting in Patients Under 50 Years
The outcome of primary and revision total hip arthroplasty in young patients with
acetabular bone stock loss is poor. We report a long-term review of 41 acetabular
reconstructions using impacted morselized bone grafts and a cemented THA in
patients younger than 50 (22 –49; average 38) years [6]. Reconstruction was
performed in 23 primary THA (19 patients) and 18 revision THA (17 patients).
Three patients were lost to follow-up, and 3 (4 hips) died within 10 years of
surgery, none of which were revised. Thus, 34 hips (30 patients) were reviewed,
with an average follow-up of 13 (10 –18) years. Two hips were revised for aseptic
loosening of the acetabular component 7 and 11 years after surgery. One
additional cup was revised after 12 years during a femoral stem revision due to
wear and problems matching components, but was well fixed. The survival rate of
the acetabular reconstruction technique was 94% (95% CI 90 –98%), allowing
the conclusion that acetabular reconstruction with impacted morselized bone
graft and cement gives satisfactory long-term results, even in patients younger
than 50 years (Fig. 1).

C. Follow-Up Study of Acetabular Reconstruction with


Bone Impaction Grafting in Patients with Congenital
Hip Dysplasia
With increasing experience, we decided to use this method for all acetabular
reconstruction in patients with congenital hip dysplasia [7]. Congenital dysplasia
of the hip (CDH) is a relatively common problem, which frequently results in
secondary osteoarthritis. This can be treated by joint replacement, but as Charnley
and Feagin point out, total hip arthroplasty in patients with CDH is difficult due to
acetabular and femoral dysplasia, limb-length inequality, soft tissue contractures,
and muscle atrophy. They initially discouraged this procedure in CDH [8].The
main problem in joint replacement in CDH patients is how to restore the normal
anatomy and obtain a stable fixation of the prosthetic components. The use of
bone grafts to restore the normal anatomy is biologically attractive, and
292 Schreurs et al.

Figure 1 (A) Preoperative x-ray of a 22-year-old woman who had several


previous hip surgeries due to a secondary osteoarthritis after neonatal septic
arthritis of the left hip. She had a resurfacing hip prosthesis that failed. (B) X-ray
4 months after reconstruction of the hip with bone impaction grafting at age 23.
(C) After 21 years the reconstruction looks stable. Clinically the result was
excellent: no signs of wear with a complete incorporated bone graft. A beginning
osteolytic line is visible in zone 1 of DeLee and Charnley.
Long-Term Results of Acetabular Reconstruction 293

Figure 1 Continued.

conventional acetabular implants can be used. The restoration of bone stock also
anticipates future revision, which we consider very important because hips
replaced for CDH are usually in relatively young patients. Two types of bone
grafts can be used to restore the acetabular bone defects seen in CDH.
Harris et al. used solid, structural bone grafts [9]. These bone grafts
consisted of large segments of femoral head and neck fixed with screws to the
ilium. Many reviews of this technique in CDH have reported good clinical results
in primary and revision arthroplasty. However, the incorporation of large solid
bone grafts is unpredictable, and they may ultimately resorb. This can lead to
loosening of the acetabular component in the long term [10,11].
We reviewed the results of 27 acetabular reconstructions in 21 patients with
secondary osteoarthritis due to congenital dysplasia of the hip in which the
acetabular bone defects were restored with impacted morselized bone grafts in
combination with a cemented cup. No patient was lost to follow-up. The average
age at surgery was 49 years (range 26– 74). There were 20 females and 1 male.
Six patients had bilateral procedures. Using Crowe’s classification [12], the
degree of dislocation was stage I in 6 hips, stage II in 8 hips, stage III in 9 hips,
and stage IV in 4 hips. During surgery, peripheral segmental bone defects were
reconstructed with a metal mesh to support the cup superolaterally. After an
average follow-up of 7 years and 7 months (5 –15 years), two hips had been
revised. The HHS increased after surgery from 37 (range 9 – 72) preoperatively to
94 (range 70– 100) at follow-up ( p , 0.01 in a paired t-test). One cup was
294 Schreurs et al.

revised after 27 months for sciatic nerve problems and the other for aseptic
loosening of the cup after 12 years. Using the Kaplan-Meier method,
the cumulative survival of the acetabular reconstruction was 96.3% after 5 and
10 years. Two hips (7.7%) showed stable radiolucent lines in zone III
without migration of the cup. None of the cemented stems were revised. Bone
impaction grafting is a safe and attractive method of restoring bone defects in
dysplastic hips.

D. Acetabular Reconstruction in Revision THA


We carried out a long-term review of impaction grafting in acetabular revision
surgery in 1998 [13]. Between 1979 and 1986, 62 acetabular reconstructions
had been performed in 58 patients with failed hip prostheses. Two hips were
lost to follow-up, leaving data on 56 patients (60 hips). Fifteen patients had
died, but none had undergone a re-revision. The indication for revision was
aseptic loosening in 56 hips and septic in 4; 2 hips had been revised before—
once and twice, respectively. There were 13 men and 43 women with a mean
age at operation of 59.1 years (range 23 –82). Defects were recorded using the
D’Antonio classification as cavitary in 37 cases and combined cavitary/
segmental defects in 23 cases (10 central segmental and 13 peripheral wall
defects). At review after an average of 11.8 years (range 10 – 15 years), the
mean Harris Hip score was 85 (range 53– 100). Five cases were revised again:
two for culture-proven septic loosening after 3 and 6 years and three for aseptic
loosening after 6, 9, and 12 years. Radiological loosening was observed in 4
hips with progressive radiolucent lines in three zones according to DeLee and
Charnley [3]. However, most hips were radiologically very stable even in
young patients with a long follow-up (Fig. 2). The survival rate for aseptic
loosening with this technique for revision surgery was 94% at a mean follow-
up of nearly 12 years. The survival rate for revision due to aseptic loosening or
radiological losening was 85%. The worst-case scenario, considering all hips
lost to follow-up as having aseptic loosening, showed a survival rate for aseptic
loosening of 90%.
We have just updated this group of patients. At review in April 2001, 42
reconstructions in 38 patients were available for review with a minimum follow-
up period of 15 years. Nineteen patients with 20 reconstructions in the original
group of 62 patients died before the 15th postoperative year. None of these
patients had been re-revised, and the deaths were unrelated to hip surgery. Of the
original group of 60 hips, 11 had been revised again. The reason for re-revision
was septic loosening in 2 cases, aseptic loosening in 7, one for wear after
17 years, and one for problems matching components during a femoral revision.
The survival rate for aseptic loosening was 84% at a mean follow-up of
16.5 years.
Long-Term Results of Acetabular Reconstruction 295

Figure 2 (A) Six years after implantation the first hip arthroplasty had failed with
progressive acetabular bone stock loss and migration of the cup in a 54-year-old
woman with primary osteoarthrosis. (B) Reconstruction of the acetabulum with
bone impaction grafting and a cemented cup. A metal mesh was used on top of the
graft. This mesh is no longer used. Cementation is now performed directly on
the bone graft. (C) X-ray 11 years after the reconstruction. (D) X-ray 17 years after
the reconstruction. No signs of loosening, but a radiolucent line is visible in Zone 3
according to DeLee and Charnley in combination with progessive polyethylene
wear.
296 Schreurs et al.

Figure 2 Continued.
Long-Term Results of Acetabular Reconstruction 297

E. Acetabular Bone Impaction in Rheumatoid Arthritis


Approximately 5% of all hip arthroplasties are performed for rheumatoid arthritis
based on 92,675 cases in the Swedish national hip multicenter study [14]. Good
results can be expected from cemented hip prostheses, but loosening of the cup is
the main long-term problem [15,16]. In primary hips in patients with rheumatoid
arthritis, bone stock loss due to protrusio acetabuli is frequently observed.
Impaction morselized bone grafting in patients with rheumatoid arthritis has
proven successful for protrusio in the short and mid-term [17 –20]. We studied
the long-term outcome of this technique in rheumatoid arthritis [21]. We also
reviewed the outcome in patients with rheumatoid arthritis who had an acetabular
revision. Revisions in rheumatoid arthritis are difficult because bone quality is
poor and there is generally further loss of bone stock. Remarkably, there are few
reports in the literature on this group of patients.

F. Acetabular Bone Impaction in Rheumatoid Arthritis and


a Primary THA
Rosenberg et al. studied the outcome of 36 primary total hip arthroplasties
performed in 31 patients with rheumatoid arthritis and protrusio acetabuli who
were operated on between 1979 and 1989 [21]. The deficient acetabulum was
reconstructed with autologous morselized bone grafts from the femoral head.
Unfortunately, 3 patients were lost to follow-up. Twelve patients (13 hips) died
within 8 years of surgery, none of whom were revised. Sixteen patients (20 hips)
were reviewed at an average follow-up of 12 (range 8 – 18) years.
In 2 hips a revision was performed for aseptic loosening of the acetabular
component 6.5 and 8 years after primary surgery, respectively. The survival rate
of this acetabular reconstruction technique in rheumatoid patients with protrusio
acetabuli calculated by Kaplan-Meier analysis was 90% (CI 77– 100%). Using a
revision or radiographic failure as endpoint, this percentage remains 90%. In a
worst-case scenario, considering also loss to follow-up as failure, the survival rate
is 86%. We considered that impaction grafting can be of great value in cases with
protrusio acetabuli due to rheumatoid arthritis.

G. Acetabular Bone Impaction in Rheumatoid Arthritis and


a Revision THA
Revision of a failed total hip arthroplasty in a patient with rheumatoid arthritis
can be very demanding because of the poor quality of the bone stock.
Remarkably, only two reports exist in literature on the outcome of these
reconstructions. Raut et al. [22] reported satisfactory clinical results after
cemented revision of failed total hip arthroplasties in 41 patients (47 hips) with
298 Schreurs et al.

rheumatoid arthritis at an average follow-up of 7 years, but the radiographic


results of the socket revisions were not encouraging, with 36% (15 of 41)
showing radiological loosening. The loosening was associated with loss of
acetabular bone stock. Raut et al. stated that the preservation of acetabular bone
stock is the key to a good result from revision arthroplasty and that the use of
bone grafting should be considered when the acetabular bone stock is deficient.
Recently, the results of acetabular revisions with uncemented acetabular
components in patients with rheumatoid arthritis were presented [23]. This study
confirmed that revisions in rheumatoid patients are difficult. Cementless
acetabular revisions had a low rate of success in these patients. The survival rate
was 44% at 9 years using Kaplan-Meier analysis, with failure of the acetabular
component as the endpoint.
We studied the outcome of the clinical and radiological outcomes of
acetabular revisions using the bone impaction grafting technique and a cemented
polyethylene cup at midterm follow-up in rheumatoid arthritis [24]. Thirty-five
consecutive acetabular revisions were performed in 28 patients with rheumatoid
arthritis using bone impaction grafting and a cemented cup. The average age at
revision was 57 years (range 31– 73 years). Patients were reviewed at a minimal
follow-up of 3 years (range 3 –14 years; average follow-up 7.5 years). At review
no patient was lost to follow-up, but five patients (6 hips) had died. Acetabular
bone stock defects were classified by the AAOS method as cavitary (11 cases) or
combined segmental/cavitary (24 cases). Five deceased patients (6 hips) had
been doing well up to their latest follow-up. After an average follow-up of 7 years
and 6 months, six patients (6 hips) had a repeat revision. At review the average
Harris hip score was 82 (range 52 –97), hip pain was absent or mild in 21 of the 23
hips (91%). Radiographic analysis of all 29 hips that were not revised showed
loosening in one patient, and two other hips had a nonprogressive radiolucent line
in one zone.
Excluding the septic loosenings, the survival rate for aseptic loosening
using Kaplan-Meier analysis for this technique at a follow-up of 8 years is 90%
(95% CI 80 –100%). Therefore, acetabular revision with impaction bone grafting
and a cemented cup is promising in rheumatoid revision surgery (Fig. 3).

III. DISCUSSION AND RECOMMENDATIONS

Revision arthroplasty on the acetabular side is still a controversial issue among


orthopedic surgeons. A variety of reconstructive techniques has been suggested.
In revisions, the surgeon has to decide how best to deal with the loss of bone
stock, restore the original center of rotation, and stabilize the new implant.
Comparison of outcomes of different techniques is difficult because several
Long-Term Results of Acetabular Reconstruction 299

Figure 3 (a) Radiographs of a 35-year-old male with rheumatoid arthritis and


bilateral loosenings of cemented hip components. On the right side loosening of
both the cup and stem is evident; on the left side a complete protrusio of the cup into
the pelvis is seen and the stem has pivoted out. (b) Both hips were reconstructed
within one month using impaction bone grafting. On the right side a small metal
mesh was used to close a limited medial wall defect, the defect was impacted, and
the stem was recemented. On the left side the medial wall defect was closed with a
large metal meshes and a large reconstruction was performed. On top of the graft a
metal mesh was placed and a cup was cemented. (The use of this metal mesh on
top of the layer of grafts has been abandoned since 1990.) (c) Radiographs
obtained 12 years after the reconstructions demonstrate that the limited migration
of the left cup in the axial direction, noted in the initial months after the
reconstructions, had stabilized. Both hips were clinically well functioning. There
were no signs of radiological failure, and the grafts seemed to be incorporated
according to the used criteria.

methods have been used to classify the preoperative bone defect. More
uniformity in classification is therefore required.
Cemented fixation in revision is less effective when bone stock has been
lost and it is impossible to achieve adequate cement penetration into the sclerotic
300 Schreurs et al.

Figure 3 Continued.
Long-Term Results of Acetabular Reconstruction 301

host bone that remains. However, this method can be considered in very elderly
patients with limited life expectancy. In cases with large rim defects, several
types of reinforcement ring have been used in combination with bone grafting
and cement. We wish to stress that the use of morselized bone grafts in
combination with metal reinforcement rings is a totally different method from the
impaction grafting that we recommend. Reports showed good long-term results at
midterm follow-up. However, we are critical of this method for two reasons. In
our view it is essential that impacted bone grafts are loaded, and load protection
by a metal shell hampers the process of graft incorporation. The other point is that
in time the rigid metal reinforcement ring may fail because of the mismatch with
the more elastic pelvic bone. After failure of a metal ring, the defect is likely to be
larger than the original one. The quality of the bone graft will be inferior due to
the limited ingrowth, so the surgical problems at the second revision will be even
more challenging.
Structural femoral head auto- and allografts have been used to reconstruct
large acetabular rim defects. However, long-term results show failure in 29%
after a mean follow-up of 16.5 years [25]. The clinical outcome is not predictable,
and graft resorption occurs. Both the fixation technique and incomplete
incorporation of the structural grafts may account for this. Hooten et al. [11]
reported on two graft retrievals after structural bulk allografts had been used for
acetabular reconstruction. Although the patients performed well clinically and
the radiographs showed incorporation of graft to the host bone, microscopically
there was limited bony union. Revascularization extended no more than 2 mm
into the structural graft. Even after 48 months, allograft revascularization and
remodeling were minimal.
Some reports on cementless acetabular components showed excellent
short-term and intermediate results, whereas others were clearly inferior. These
cementless components were very often supplemented by bone grafts.
Morselized bone grafting successfully restored loss of bone stock in cavitary
and noncontained medial wall defects. In cavitary defects and in defects with
more than 80% of the acetabular rim intact, the results were excellent at midterm
follow-up [26,27]. The results of uncemented cups in combination with more
severe rim defects remain unclear. This gives rise to serious concern regarding
the long-term results of uncemented acetabular revision. Another problem is the
severe osteolysis seen in the longer term in uncemented cups used for primary hip
replacement. If osteolysis also occurs in revision cases, the outcome will
probably be disastrous. Very large uncemented implants have been used in cases
with extensive loss of bone stock. Although a large jumbo cup or a double bubble
cup can be used to restore the original center of rotation, long-term success rates
for these procedures has not been reported. However, should these big implants
fail, there will be extensive loss of bone stock.
302 Schreurs et al.

In our view, a biological technique should be used to reconstruct skeletal


defects, and we now have more than 20 years of experience with impaction bone
grafting in combination with cement. Long-term data are available for both
primary and revision total hip arthroplasty with preexisting bone stock loss.
Although the cup survival rate declines after 10– 15 years, the results are good.
The application of this technique to larger segmental defects is technically far
more demanding. In general, surgeon and surgically related factors play the
greatest role in the success or failure of a revision procedure. Therefore, before a
surgeon starts acetabular reconstruction with impaction grafting and cement, he
or she should become familiar as possible with the clinical, technical, and
scientific details of the method. It is important to be aware that a wide exposure
is essential to position the mesh to contain peripheral segmental defects.
Preparation of the bone graft material is also important. Our long-term experience
in revision surgery is solely based on the use of fresh-frozen femoral heads. The
size of the chips is a crucial factor. Almost all commercial mills produce chips
that are far too small for impaction grafting in the acetabulum (2 – 4 mm). We
always produced our chips by hand using a nibbler until a special type of bone
mill (Noviomagus bone mill) was developed that can produce chips of 7– 10 mm.
We never wash the bone graft after impaction. Although this may be possible
using a sieve to protect the bone graft and this may improve cement penetration
into the graft, a potential drawback is that potentially important biological factors
(e.g., BMP, growth factors) may be diluted or washed out.
We studied the stability of acetabular cups after reconstruction with
impaction bone grafting in fresh-frozen human pelvises [28]. In several
experiments the size of the bone chips had a significant effect on stability. Large
bone chips improve the initial stability of a cemented cup after bone impaction
grafting. When large bone chips were used, the outcome was more predictable,
more consistent, and less surgeon-dependent. Therefore, we strongly recommend
using 0.7 – 1.0 cm bone chips for acetabular reconstruction, because the outcome
is more predictable.
Concern has been expressed about cement coming into contact with
impacted morselized bone graft material. However, in 1982– 83, Roffman et al.
[29] showed that contact with bone cement did not impair incorporation of the
bone graft. We confirmed this in two goat models in which we studied the
outcome of bone impaction grafting on the acetabular and femoral sides [30 –32].
Heekin et al. reported incorporation in retrievals after morselized bone grafting
[33]. In 1996 our group reported on the histology of acetabular impaction grafting
in 8 THA cases performed at our center [34]. More recently, we have re-reviewed
all the biopsies obtained for histological investigation from acetabular
reconstructions [35]. This new series contains a number of larger biopsies.
Histology specimens were available on 25 biopsies from 20 patients. In general,
bone incorporation was more or less complete in all cases. A remarkable
Long-Term Results of Acetabular Reconstruction 303

observation was that remnants of cartilage were visible in the reconstruction,


even after longer follow-up. The remnants were almost always found in the
reconstructions with milled bone. All cartilage should be removed before milling
a head. This cartilage will not remodel into bone, but it will have an adverse
mechanical effect on the reconstruction [36].
Bone impaction grafting is very suitable for acetabular reconstruction in
primary and revision surgery. It provides a biological solution for loss of
acetabular bone stock. However, the method is technically highly demanding,
and great care must be taken to fully understand the principles of the technique.

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22
Impaction Bone Technique at the
Acetabular Side
E. Winter
BG Unfallklinik
Tübingen, Germany

I. INTRODUCTION

There is an ever-increasing number of failed hip arthroplasties displaying


massive deficiencies of acetabular bone stock combined with segmental and
cavitary defects [1 – 5]. Unfortunately, no single technique is likely to provide a
solution to span the full spectrum of possible acetabular defects. But contained
acetabular defects can generally be treated by grafting of the defects and
inserting a hemispherical acetabular component using screws and no cement
[6 – 9].
A valuable alternative to augmentation of the deficient acetabulum is the
placement of a hemispherical acetabular component. This is then secured, with
screws and not cement, onto the superior margin of the acetabular defect,
resulting in a standard hip center as described by Woolson and Adamson [10] or
in a high hip center as described by Dearborn and Harris [11]. Another option is
to fill the superior acetabular defect with metal in the form of an oblong
acetabular component [12]. As a result, the superior hemisphere of this implant
remains securely in contact with the host bone above, allowing the establishment
of a normal hip center. When using an oblong cup, it is necessary to remove
additional bone in order to accommodate the shape of this implant. Still another
alternative treatment is the use of bulk allografts, whose failure rate has been
shown to increase over time [13,14]. Because of the tendency of bulk allografts to
collapse or dissolve over time, some authors have instead advocated the usage of
acetabular reinforcement rings.
307
308 Winter

In the early 1980s, the Schneider-Burch [15] ring was introduced. This
device came equipped with peripheral flanges, which were screwed onto the
periacetabular pelvic bone in order to provide additional stability. Originally it
was common practice to fill the bone defects with bone cement. But this
technique frequently led to early complications with further loss of bone stock
and secondary loosening of the antiprotrusio ring [1,16 – 21]. Today, the majority
of authors are convinced that massive acetabular bone deficiencies should be
filled with bone grafts. The use of either autograft or allograft in combination
with reinforcement rings has been proven to be successful in long-term follow-up
studies [1,22 – 25]. However, it has been questioned whether transplanted
cryopreserved allogenic bone grafts can lead to vital acetabular bone stock.
While several authors have reported failure of acetabular reconstruction with
cryopreserved allogenic bone grafts [26,27], other clinical investigations have
described cryopreserved allogenic cancellous grafts as being successful in
clinical use [1,25,28– 32]. We present a study that was undertaken to evaluate the
long-term results, clinically and radiologically, using cryopreserved allogenic
morselized bone graft and a Schneider-Burch antiprotrusio cage to manage Type
III and IV acetabular deficiencies (AAOS Classification) in revision hip
arthroplasty.

II. MATERIALS AND METHODS


A. Patient Study Group
During the period from January 1, 1988, to January 1, 1994, 41 patients (41 hips)
with acetabular defects (Type III and IV [33]) after hip arthroplasty due to
coxarthrosis were operated on consecutively. The type and extent of the
acetabular deficiencies had been determined from preoperative radiographs and
intraoperative assessments. Failed arthroplasties were diagnosed to be aseptic in
all cases. Of the 41 patients, 2 died of unrelated causes 4 and 6 years after surgery,
and one patient was unavailable for the follow-up examination. The remaining 38
patients were assessed clinically and radiologically before the operation and, on
average, 7.3 years (range 4.2 –9.4 years) after their operation.
There were 21 right and 17 left hips operated on in 38 patients. These
patients included 24 women and 14 men with an average age at the time of the
operation of 76 (range 49 –83) years. Thirty-four patients had a Type III
deficiency, and four patients had a Type IV deficiency [33]. In 27 patients,
femoral stem revision had to be performed as well because of aseptic loosening. In
10 instances, the cemented stem was replaced with another cemented stem, while
in the remaining 17 patients the cemented stem had to be removed and a revision
stem was inserted using a cementless technique.
Acetabular Bone Impaction 309

B. Operative Technique
Arthroplasty was performed in a vertical laminar-flow operating room. The
lateral transgluteal approach was used in all cases. First, the failed acetabular
component was exposed and removed. The full extent of the defect became
apparent only after the entire acetabulum had been debrided of cement and
scarred capsular tissue. This was performed with curettes, osteotomes, and
hemispherical reamers in order to achieve a well-vascularized recipient bed. Care
was taken to avoid extending the size of the existing defect. Then, allogenic
cancellous frozen bone from the bone bank was morselized (chip size
approximately 1 cm3). Bone grafts were obtained from femoral heads stored at
2808C according to standard bone bank guidelines. Depending on the size of the
defect, cancellous bone of up to three femoral heads was used. The cancellous
chips were pressed into the acetabular cavity and carefully condensed. The
flanges of the Schneider-Burch reinforcement ring (Protek AG, Berne,
Switzerland) were bent into shape in order to comply with the specific anatomy
of the acetabular region. The ring was then positioned by buttressing its inferior
flange into the ischium, preferably with screws. The superior flange of the metal
ring was fixed to the ilium with cancellous bone screws. This should result in a
stable composite (composed of the load bearing host bone, allograft, and implant)
with a compressed bone graft located beneath the ring. A polyethylene cup was
then cemented into the metal cage in a correct position with a thin film of cement
(2 – 3 mm). In order to avoid too much penetration of cement through the porous
ring, the bone graft had to be well compressed.

C. Rehabilitation Program
Patients were maintained at bedrest postoperatively for one week if only the
changing of the acetabular component or a proximal femur approach became
necessary. Patients were maintained at bedrest for 2 weeks if a transfemoral
approach was used. Intensive physical therapy began when patients were at
bedrest from the first postoperative day on. The patients had been carefully
advised to avoid bending the affected hip joint more than 908 and to avoid forced
rotation, especially forced internal rotation. Slight abduction was ensured for 14
days using a wedged pillow. Partial weight bearing with 20 kg was recommended
for 6 weeks, and in the case of a transfemoral approach for up to 12 weeks.
Clinical and radiological follow-up examinations were performed 3 months,
6 months, and one year after the operation and, then, once a year.

D. Clinical Follow-Up Examination


Thirty-eight patients (38 hips) were assessed clinically and radiologically before
and after their operation. Clinical follow-up studies had been performed on
310 Winter

average 7.3 years (range 4.2 –9.4 years) after surgery according to Johnston et al.
[34]. These guidelines consist of a comprehensive list of questions and exami-
nations covering the following categories: degree of pain, level of activity, ability
of putting on shoes and socks, ability of ascending and descending stairs, ability
of changing position from sitting to standing, patient’s walking capacity, ability to
walk without support, and ability to walk with support. Additionally, the Harris
hip score [35] was used to grade the clinical results. The patients expressed their
subjective impression of the surgical result as “very satisfied,” “satisfied,” or
“dissatisfied.”
The physical examination included assessing the range of hip motion
before the operation and at the time of the follow-up. In addition, the difference in
leg length was recorded at the time of the follow-up examination. Preoperative
data (patient’s records and questionnaires) were compared with the parameters
evaluated at the time of the follow-up examination.

E. Radiographic Evaluation
In all 38 cases a detailed radiographic analysis was performed at the time of the
clinical follow-up, which involved the determination of the migration of
the acetabular implants as well as the assessment of the grafted area. Immediate
postoperative and final follow-up radiographs were performed. The following
parameters were measured according to Peters et al. [25]: acetabular index (AI),
horizontal migration (HM), and vertical migration (VM) (Fig. 1) on immediate
postoperative and final follow-up radiographs. The bone/implant interface was
also examined for the presence of complete or partial radiolucencies. Based on
the appearance of trabecular remodeling, the bone graft was determined as either
incorporated or not incorporated. Trabecular remodeling within the grafted area
was assumed in the case of equal radiomorphological appearance (graft density
and architecture) of the grafted area and the surrounding native bone, as
described earlier [36 –38]. The three zones delineated by De Lee and Charnley
[39] were used to report the location of the radiolucency and to give some
indication of its extent. Furthermore, we analyzed whether the reinforcement ring
underwent tilting and compared the x-rays of the shape of the ring shortly after
the operation and at the time of the follow-up.

F. Statistical Methods
Continuous paired observations, for example, range of hip motion, were analyzed
before and after treatment using the paired t-test. Ordinal data (for example
degree of pain) were tested for homogeneity of the marginal distributions of the
corresponding transition matrices according to the Mann-Whitney test for ordinal
independent observations as generalized by Agresti [40]. This involved
Acetabular Bone Impaction 311

Figure 1 Diagram of a bilateral acetabular reconstruction showing the


radiographic parameters with which migration is analyzed. Line A: reference
line through the teardrop figure. Line B: perpendicular reference line through the
teardrop figure. Line C: line through the axis of the antiprotrusio cage.
HM ¼ horizontal migration; VM ¼ vertical migration; AI ¼ acetabular index.

generating contingency tables and evaluating whether the differences in the


marginal distributions of these tables significantly differed from zero. This
method estimates the probability of how extensively the preoperative and
postoperative severity of a condition differs.

III. RESULTS
A. Clinical Results
The patient’s opinion of the surgical results yielded the following: Fourteen
patients were “very satisfied,” 22 were “satisfied,” and 2 were “dissatisfied.” We
compared all the individual parameters preoperatively and at the time of the
follow-up examination as described by Johnston et al. [34]: degree of pain, level
of activity, ability to put on shoes and socks, ability to ascend, and descend stairs,
ability to change position from sitting to standing, patients walking capacity, and
ability to walk with and without support. The results showed that all of these
312 Winter

parameters had significantly improved at the time of the follow-up examination


( p , 0.0001), even in the two patients who were “dissatisfied.”
The range of motion of the affected hip had significantly improved
( p , 0.005) at the time of the follow-up examination in all patients compared to
the joint motion prior to surgery. Only operated legs showed an increase in
length. The average measured increase at the time of the follow-up examination
was 0.8 cm (range 0.5 –3.0 cm). The average Harris hip score [35] was 82.6
(range 58.2– 94.9) at the last follow-up examination. This included 11 (29%)
patients who had an excellent score (90 –100 points), 14 (37%) who had a good
score (80 – 89 points), 9 (24%) with a fair score (70 – 79 points), and 4 (10%) who
had a poor score (,70 points).

B. Radiographic Results
Evaluating the migration of the acetabular implants was crucial in the analysis
of the radiographs. No significant differences between the immediate
postoperative and follow-up values were detected with respect to the acetabular
index, horizontal migration, and vertical migration (Fig. 1). No tilting of
the reinforcement ring was found. These findings indicate that no significant
migration occurred in any patient ( p , 0.0005). Complete trabeculation and
integration of the bony structures of the area in which the graft was implanted
were observed at the time of the follow-up examination in the three acetabular
zones defined by De Lee and Charnley [39]. The radiographic morphology of
the graft appeared to match that of the surrounding native bone. According to the
described criteria [4,30,35], this was interpreted as a sign of mature woven bone
formation within the region of the graft.

C. Complications
Few perioperative complications were observed. In one case the loosened
acetabulur cup dislocated deeply into the lesser pelvis during the revision
operation. Despite this, we were able to remove the cup using the lateral
approach. In another case, an intraoperative fracture of a cancellous bone screw
in the ilium occurred. General postoperative complications included a total of 11
successfully treated conditions caused by nonsurgical complications: 2 cases of
bronchitis, 2 gastritis, 5 urinary infections, and despite low-dose heparinization, 2
cases of deep venous thrombosis without severe sequelae. Local postoperative
complications included 6 hematoma, of which 3 were surgically drained, and 2
subcutaneous inflammatory reactions were treated conservatively. Revision
surgery was required in one patient with a deep infection, but it was possible
to preserve the implant. One early postoperative dislocation occurred. After
Acetabular Bone Impaction 313

Figure 2 (A) Anteroposterior and axial radiograph of the hip of a 68-year-old


woman, made 9 years after a total hip arthroplasty performed with cement, showing
a type III combined defect [33]. (B) Radiograph made 6 months after a revision hip
arthroplasty was performed with use of a morselized, cryopreserved, cancellous
allograft bone, a Schneider-Burch reinforcement ring, and a cup inserted into the
ring with cement. (C) Radiograph made 5 years after revision hip arthroplasty,
showing un-changed position of the implants and a complete trabeculation of the
bony structures of the area in which the graft was implanted.
314 Winter

reposition followed by conservative treatment (2 weeks of bed rest and an


“antirotation” cast), no further dislocation took place.

IV. DISCUSSION

The majority of published studies we are aware of have concurred that the
presence of severe multisegmental acetabular defects is an indication that an
acetabular reconstruction procedure coupled with a metal reinforcement ring and
bone graft should be used [23,25,41 –43]. A large number of authors have
recommended using the Schneider-Burch reinforcement ring with a cranial and
caudal flange, which can be secured to the ilium and ischium [21,23,25,44,45].
This method provides a high degree of initial stability and allows early weight
bearing in the patient. The ring also protects the graft implanted beneath from
mechanical irritation as well as promotes the bone remodeling process. The close
fit between the graft and the acetabulum together with mechanical immobility
and stability are regarded as a crucial precondition for the remodeling of the
allograft [1,28,29,46].
The studies performed by Haentjens et al. [47], Schatzker et al. [21], and
Zehntner and Ganz [43] illustrated the limits of utilizing the smaller Müller
support ring in cases of extensive acetabular defects. In series ranging in size
from 25 to 56 cases, they reported a high rate of implant migration with up to 44%
(25 of 56 cases) after an average follow-up period ranging between 7.2 and 8
years postoperatively. The authors attributed this to the design limitations of the
smaller Müller support ring. Since the Müller device is only fixated to the ilium
and is not buttressed by the inferior pelvic bone, its use should not be extended
beyond smaller defects in the acetabular roof, anterior or posterior column, or
isolated cavitary defects. Therefore, careful preoperative and intraoperative
analysis of the defect using a classification system becomes essential as well
as the correct evaluation and implant selection of the specific acetabular
pathoanatomy.
A comparison of the complications encountered in hip reconstruction using
an acetabular support ring is extremely difficult because similar studies list
intraoperative and postoperative complications either incompletely, unsystema-
tically, or not at all. In our study, no patient experienced any neurovascular
complications, and none of the general postoperative complications encountered
led to any permanent damage. Regarding the local postoperative complications
that took place in our patients, infection, in particular, warrants mention. One
patient experienced a serious infection, which was fortunately treated without
removal of the implant. Only one dislocation was observed in 38 cases. We
attribute the low dislocation rate to our usage of the lateral approach and a strict
rehabilitation program. Nevertheless, we were concerned by the occurrence of six
Acetabular Bone Impaction 315

hematomas, three of which required surgical drainage. Although we consider this


a rather high rate, we need to take into consideration the rather extensive
procedures which we are dealing with.
None of the patients showed any significant measurable migration or
displacement of the acetabular component. A comparison of the literature
revealed rates of Schneider-Burch support ring loosening of up to 12% with an
average follow-up period of 5 years [1,21,23]. In all patients within our study
group, bony consolidation, according to the criteria described by Azuma et al.
[36], Kondo and Nagaya [37], and Morsi et al. [38], occurred entirely within the
grafted area. Rosson and Schatzker [44] pointed out the importance of bone
grafting over bone cementing after analyzing 66 acetabular reconstructions
performed with either the Müller ring (n ¼ 46) or the Schneider-Burch ring
(n ¼ 20). Peters et al. [25] reported impressive restoration of the acetabulum in a
group of 28 patients who underwent acetabular reconstruction with a Schneider-
Burch ring and allogenic cancellous bone graft. They noted that the average
medial wall bone stock improved significantly from 1.9 mm before surgery to
10.1 mm postrevision ( p , 0.01, two-sample Student’s t-test, assuming
unequal sample variances). The average follow-up period for this study was
2.8 years.
In 1999, Paprosky and Sekundiak [18] stated that the role of the acetabular
reconstruction cages should, at present, only be defined as a short-term treatment
and that follow-up studies still need to be performed in order to determine the
worthiness of this procedure. Surprisingly, they only listed three references to
support their view. At least 17 studies were published between 1984 and 2001
concerning the role of the acetabular rings with an average follow-up time period
of 9.4 years [1,20 –25,28,30,31,41– 44,47 – 49,50] (Table 1). Furthermore, they
proposed that the use of an acetabular reconstruction ring should be considered
not as an alternative but rather as an adjunctive procedure. Contrarily, our results
[50] and results of the other mentioned similar studies indicate that the use of
an acetabular reconstruction ring with morselized cryopreserved allograft
cancellous bone can be considered as a reliable, established procedure that is able
to handle massive acetabular deficiencies.
Paprosky and Sekundiak [18] concluded that allogenic bone grafts provide
only osteoconductive potential. Several authors [21,23 – 25,30] have stated that
the autograft and morselized cryopreserved allograft are of equal value in
reconstructing acetabular defects. Even Slooff et al. [32], who have a different
approach in restoring deficient acetabulae, noted that autograft and deep-frozen
allograft bone chips are equally effective. They were among the first to use this
method and popularize it. Gross et al. [29] reported successful results using
morselized, deep-frozen, and irradiated allograft bone in the treatment of
acetabular defects. Herr et al. [51] were able to show in their experimental studies
that the cryopreservation of cancellous allografts at 2808C preserved the
316

Table 1 Comparison of Literature on Acetabular Reconstruction with Reinforcement Rings, 1984–2001

Support Follow-up X-ray/


Year ring Number Cancellous graft Complications period Score bonegraft Ref.

1984 MR 20 Only a few 1 M-ring 1 – 3 yr Harris All grafts 21


BSR 5 allografts loosened integrated
1986 Kerboull 18 All allograft No infection, no 1 – 7 yr n.s. All grafts 30
ring loosening (avg. 30 mo) integrated
1988 Freeman 37 All allograft 2 asymptomatic Avg. 1.5 yr n.s. All grafts 20
ring loosening integrated
1989 MR 145 Allograft in 61 4.8% infection, Avg. 7.7 yr n.s. “Good experience” 28
patients 0.7% loosening (n.s.)
1989 Gross ring 5 All allograft No infection, no — Harris All grafts 31
loosening integrated
1991 BSR 24 Autograft þ bone 2 infections, 1 Avg. 19 mo n.s. “Positive 41
substitutes loosened ring experience” (n.s.)
1992 BSR 42 20 allografts 12% infection, Avg. 5 yr n.s. All grafts 1
12% loosening integrated
1992 MR 30 n.s. No infection, no Avg. 30 mo Mayo Clinic “Very positive” 24
loosening (n.s.)
1992 MR 46 33 allografts, 8 No infection, 5 Avg. 5 yr Harris All grafts 44
Winter

BSR 20 autografts MR loosened integrated


1993 MR 150 67 allografts 7.3% infection, Avg. 7 yr M.d.A. All grafts 49
9% loosening integrated
1993 MR 43 No BTx 3 loosened rings Avg. 8 yr M.d.A. 25 increasing 47
radio-lucencies
1994 MR 56 All allografts 14% infection, Avg. 7.2 yr Modif. — 43
44% migration M.d.A.
1995 BSR 28 All allografts No infection, no Avg. 33 mo n.s. “Bone stock 25
loosening improved” (n.s.)
1996 BSR 16 All morselized — Avg. 6.8 yr — “Overall success 42
allograft rate of morselized
Acetabular Bone Impaction

grafting was 90%”


1998 MR 87 42 autografts 6% infection, Avg. 9.4 yr IDES 4 “All bone grafts 22
3% loosening had fully healed”
1998 BSR 63 38 allografts 1% infection, 3% Avg. 8.5 yr IDES 4 “37 of 38 allograft 23
loosening, 2% had radiological
migration evidence of full
incorp.”
2001 BSR 38 All allografts 1 infection, no Avg. 7.3 yr Johnston [34] All allografts 50
loosening and Harris successful

MR, Müller ring; BSR, Burch-Schneider ring; n.s., not specified; M.d.A., Merle d’Aubigne.
317
318 Winter

osteoinductive bone morphogenic protein isotypes. Recently, a [18F]fluoride


ion positron-emission tomography (PET) study conducted at our institution
verified the presence of bone metabolism in areas of allogenic cryopreserved
morselized bone grafts even years after hip revision arthroplasty, which clearly
indicated intact bone perfusion and vitality in allografted areas [52,53].
In summary, acetabular reconstruction using allogenic morselized
cryopreserved cancellous bone grafts and an acetabular support ring with
fixation at the ilium and ischium appears to be an important method in managing
massive acetabular deficiencies and can be highly successful in restoring vital
bone stock. It is clear that longer-term evaluation will need to take place in order
to obtain a better assessment of this procedure.

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23
Impaction Bone Grafting on
the Femoral Side
A. J. Timperley, P. Kenny, and G. A. Gie
Princess Elizabeth Orthopaedic Centre, Royal Devon and Exeter Hospital
Exeter, United Kingdom

I. THE EXETER TECHNIQUE—INDICATIONS

Femoral impaction grafting may be indicated in any patient with pain and
functional disability or asymptomatic bone loss secondary to a loose total hip
arthroplasty. The technique is most useful in the younger patient, especially in
those cases where bone stock is significantly compromised or where the host
bone surface interface will not allow satisfactory mechanical fixation of an
implant. It may not be indicated in the very old or in medically unfit patients
where it is possible to achieve distal fixation, especially if extensive proximal
reconstruction of the femur would be required for the impaction grafting
technique.

II. PREOPERATIVE PLANNING


A. Exclusion of Infection
Screening of patients for infection is carried out along conventional lines. Patients
have inflammatory markers tested such as CRP and ESR. Where there is a clinical
suspicion of infection, aspiration of the joint is carried out prior to the definitive
surgery. If the infection is proven, or where there remains a high index of
suspicion for infection, then a two-stage procedure is carried out with appropriate
use of high-dosage antibiotics in cement spacers at the first stage. Antibiotics are
added to the graft at the subsequent impaction grafting procedure [1].
323
324 Timperley et al.

B. Analysis of Bone Deficiencies


The preoperative x-rays should be analyzed in order to estimate the amount of
bone stock loss in the femur. In addition to an A-P view showing the whole length
of the existing implant, lateral x-rays are also required to detect anterior and
posterior femoral deficiencies. An estimation of the amount of bone necessary for
the procedure is made and a number of femoral heads or strut grafts booked with
a bone bank accordingly.
It is usually possible to predict if any of the X-change wire meshes will be
necessary to reconstruct the femoral tube, although these meshes should be
readily available in the operating theatre in case they are unexpectedly required
intraoperatively.

C. Templating
A-P and lateral films should include the whole of the femoral component and should
extend distally (down to normal femur) beyond the femoral defects. From these
films we determine the position and size of the distal plug. The plug will be placed at
least 2 cm beyond the stem tip or 2 cm below the most distal lytic area in the femur,
whichever is the more distal. The X-change plug template is used to confirm the
position of the plug and to determine the distance of the plug from the tip of the
greater trochanter. This will ensure that the plug is placed at the correct position
during the surgery by use of the corresponding calibrations on the guide wire.
The stem length, the offset, and the stem size of the Exeter femoral
component to be implanted are estimated by using the preoperative template. The
system of X-change instruments allows for implants ranging in offset from 30 to
44 mm. In addition it is possible to implant the smaller 50 offset stems into the
neo-medullary canal created by the 44 mm offset phantoms. Stem lengths up to
260 mm are available (Fig. 1). The final stem offset and size is decided upon
intraoperatively.
Long stems should be considered in cases where a fracture is present, where
there is poor quality bone stock in the femur at a level corresponding to the stem
tip of a conventional length stem, or for the reasons discussed in Sec. X in cases
of Endoklinik 3 and 4 bone stock loss.

III. POSITIONING THE PATIENT

The patient is positioned by the operating surgeon on his or her side in the lateral
decubitus position. This position will allow, if necessary, exposure of the
posterior, lateral, and anterior aspects of the hip joint and pelvis by modifications
to the approach. The patient is supported securely with a sacral pad and support
pads on the anterior superior iliac spines (Figs. 2, 3). The patient is draped so that
Impaction Bone Grafting on the Femoral Side 325

Figure 1 Stem range: Longer stems up to 260 mm in length are available with
instruments to facilitate graft packing.

the incision can be extended up to the posterior superior iliac spine and down as
far as the knee when necessary.

IV. SURGICAL APPROACH


A. Incision
We use a long postero-lateral incision incorporating or excising the previous scar,
if possible. However, if the patient has previously had an antero-lateral approach
or the old scar is unsuitable, then a new incision is made.
326 Timperley et al.

Figure 2 Positioning: The patient is positioned securely on the operating table.

B. Fascial Incision
The incision should begin through an area of fascia lata that has not been involved
in previous exposures. This allows the development of the subfascial plane and
the identification of a good fascial layer, which is important for closure. The
tendinous part of the gluteus maximus is exposed at its insertion, and
approximately two thirds of this divided.

C. Identification of the Sciatic Nerve


The sciatic nerve is identified, although we do not find it necessary to expose the
nerve throughout the surgical field unless the posterior column of the pelvis is
Impaction Bone Grafting on the Femoral Side 327

Figure 3 View of pelvis clamps.

deficient and requires augmentation. The nerve is protected by a flap of capsular


tissue, which is retracted posteriorly.

D. Identification of Landmarks
The ischium, sciatic notch, gluteus medius tendon, the posterior border of gluteus
minimus, and the ilium superior and posterior to the socket should be identified.

E. Aspiration of the Hip


At this stage a needle is passed through the capsule into the hip joint and fluid is
sent routinely for Gram stain and microscopy. Should there be an excessive
328 Timperley et al.

number of neutrophils or if organisms are identified, the procedure should


be abandoned in favor of a two-stage procedure. Frozen section of multiple tissue
samples may be useful if there remains any doubt about the possibility of the joint
being infected [2].

F. Capsular Exposure and Incision


The capsule and remnants of the external rotators are incised with cutting
diathermy along their attachments to the posterior aspects of the trochanter and
the trochanteric ridge. They are reflected as a flap backwards from the femur, the
proximal margin of the flap running along the lower border of gluteus minimus to
the posterior margin of the acetabulum, and the distal margin being the posterior
inferior aspect of the capsule extending down towards the transverse ligament.
Stay sutures are then placed in these tissues, and these can be used to hold the
capsular flap posteriorly also protecting the nerve. Where the capsule is very
thick and scarred, it is partially excised. At the end of the procedure, the capsular
flap is reattached to the posterior aspect of the femur. The psoas tendon is usually
released from the lesser trochanter, and, using sharp dissection or diathermy, the
anterior capsule is released from the anterior aspect of the femur on the femoral
neck. It is important to carry out this release before the leg is significantly flexed
and internally rotated since the anterior wall of the femur is often flimsy and may
fracture and tear off during dislocation of the joint.

G. Dislocation
After mobilization of the posterior capsule, the head of the prosthesis is visible
and a bone hook is passed around the neck of the prosthesis to aid dislocation.
The femur should not be rotated during dislocation as this may cause fracture.
Further scar tissue is released from the anterior femoral neck as necessary.

H. Removal of the Femoral Component


Considerable soft tissue dissection may be needed to remove the femoral
component safely. Cement is removed from over the shoulder of the prosthesis
using a high-speed burr. The tissue and cement around the proximal part of the
femoral component should be released and removed. The femoral component is
then knocked out gently. Vigorous attempts to extract the component may
fracture the femur. If the femoral component cannot be removed without the use
of excessive force then an extended trochanteric osteotomy is performed [3]. This
maneuver does not preclude the impaction grafting. When the time comes for
reconstruction of the femur an X-change femoral phantom that bypasses the
Impaction Bone Grafting on the Femoral Side 329

distal osteotomy cut is seated down the femur to the correct level and the
osteotomy is reduced and held with Dall-Miles cables. It is usually necessary to
excavate some of the bone from the greater trochanter to allow the osteotomized
fragment to be reduced adequately (see below).

I. Further Mobilization of the Femur


It is essential to achieve adequate mobilization and delivery of the proximal
femur. The proximal part of the greater trochanter must be exposed sufficiently to
allow insertion of the guide wire down the medullary canal in the midline axis of
the canal so that the neo-medullary canal that is subsequently formed by the use
of the femoral phantoms is in neutral alignment down the femur, and not in either
varus or valgus. The width of these instruments dictates that the proximal aspect
of the trochanter must be opened approximately 1 cm lateral to the midline axis
of the canal (Fig. 4). The lateral margin of the proximal opening lies anterior to
the gluteus medius tendon and posterior to gluteus minimus and may extend over
the lateral side of the tip of the trochanter.

V. PREPARATION OF THE GRAFT

In Exeter we use almost exclusively allograft from fresh frozen femoral heads
from our own bone bank, but, if available, distal femoral condyles are an
excellent source of cancellous bone. The Exeter Bone Bank complies with the
standards and procedures as required by the British Association for Tissue
Banking [4]. ABO compatibility between graft donor and recipient is not
necessary. Rhesus compatibility is important when the patient is a rhesus-
negative woman of child-bearing age. Donors are screened for transmissible
diseases and are rescreened 6 months after donation. Should all tests remain
negative, then the femoral head is released for use as allograft.
The allograft chips are prepared by passing the femoral heads through a
bone mill. All cartilage and soft tissue must be removed from the femoral heads
prior to milling. The mill allows two sizes of chips to be made. The smaller chips,
2 –4 mm in size, are used in the distal canal. Larger chips are used in the proximal
femur. In canals that are very capacious proximally, hand-made croutons 10 mm
in size will be mixed with smaller chips and are packed in around the seated
phantom.
Bone slurry is not a suitable material for adequate compaction. The ideal
material is pure cancellous fragments or cortico-cancellous chips; thick cortical
fragments from the calcar area of the head should be removed. At least two
330 Timperley et al.

Figure 4 Guide wire in place: The trochanter must be opened laterally far enough
to allow the guide wire to lie in a neutral position.

femoral heads should be available for each case—more if this is predetermined


by the preoperative x-ray examination or if the acetabulum also requires grafting.

VI. PREPARATION OF THE FEMUR


A. Removal of Cement from Previous Prosthesis
Cement removal must be complete in the area for impaction grafting. However, if
the distal cement plug is greater than 2 cm beyond the most distal lytic area of the
femur, is solidly fixed, and if there is definitely no infection, it may be left in
position and used to occlude the distal canal.
Impaction Bone Grafting on the Femoral Side 331

B. Removal of All Granulomatous Tissue and


Fibrous Membrane
This material should also be thoroughly removed, followed by copious irrigation
of the canal. Six separate specimens of tissue and membrane from the interfaces
are routinely sent for microbiological examination.

C. Repair of Diaphyseal Defects in the Femur


The success of impaction grafting as a revision technique depends on adequate
physical constraint for the graft. Therefore, defects in the femur must be
reconstructed prior to impaction grafting. In Exeter we use malleable meshes
(Stryker Howmedica, Benoist-Girard, France) and monofilament cerclage wires
to reconstruct diaphyseal defects after reflecting vastus lateralis anteriorly to
expose the femur. More proximal defects are reconstructed later in the procedure
(see below).

D. Prophylactic Cerclage Wire of the Femur


Prophylactic cerclage wiring is recommended where there is poor-quality bone in
the proximal femur or if there is any evidence of splitting of cortical bone.
Vigorous packing during impaction grafting may cause intraoperative femoral
fracture or extension of a crack if wiring has not been carried out.

E. Distal Occlusion of the Femur


Prior to grafting, the distal femur must be occluded in order to constrain the graft.
Most often a new threaded intramedullary X-change plug is used. The threaded
intramedullary plug is screwed onto a guide rod, and the plug-introducer sleeve is
passed over this rod. The guide rod introducer is then assembled onto the slap-
hammer assembly and the plug is impacted to the level previously templated. The
depth of the plug should be at least 2 cm distal to the implant that has been chosen.
For example, with the standard implant the plug must be to a depth of at least
19.5 cm from the tip of the trochanter, and with a 220 mm implant the plug must be
at least 240 mm. Occasionally there is a suitable cement plug, which may be left in
situ. If this cement plug is to be used, then the largest distal impactor that will fit
down the canal is introduced down to the level of the plug, and this acts as a drill
centraliser. The intra-medullary drill is passed through the impactor and the
cement drilled to a depth of approximately 6 mm. The guide rod can then be passed
through the impactor and screwed into the predrilled hole in the cement plug.
If lysis extends beyond the isthmus and there is no suitable preexisting
plug, then the canal may be occluded with bone cement. This is achieved by using
332 Timperley et al.

a small bolus of viscous cement delivered to the correct level. When the cement
has polymerized, the largest plug that will pass through the isthmus should be
placed on top of the newly formed distal cement plug. An alternative method is to
introduce the largest plug that passes through the isthmus down to the correct
depth and then prevent it from migrating distally by introducing one or two
K-wires percutaneously at a level just below the plug. The instruments now used
to pack the graft in the distal femur and in the proximal femur are cannulated and
pass over the guide wire (Fig. 5).

Figure 5 Distal packers and proximal phantom: The instruments used to pack the
graft are all cannulated and pass over the guide wire.
Impaction Bone Grafting on the Femoral Side 333

F. Aligning the Instruments in a Neutral Position


The impactor sleeve is removed, and the proximal impactor or phantom of the
size previously templated is passed over the rod to ensure that it will fit down to
the appropriate level to restore leg length. The correct size of phantom is decided
at this point. The proximal packer chosen should pass easily down the guide wire
without hitch to a depth well below the level required to restore the correct leg
length.
Care should be taken that the rod is not driven into varus as the impactor is
inserted. If this occurs, further development of the postero-lateral slot in the
trochanter is necessary until neutral alignment of the proximal impactor can
be achieved. Neutral alignment is best checked by reference to the middle of the
popliteal space. The guide wire should lie freely in the canal proximally, and it
should point to the midpoint of the popliteal fossa when viewed from its proximal
end (Fig. 6).

VII. IMPACTION OF THE GRAFT


A. Distal Packing
Before using the distal impactors to impact the bone chips, it is important to
establish the distance down the canal that each size of impactor can be passed
without jamming in the canal. Any attempt to hammer the impactor further than
this point will inevitably lead to a fracture. The impactor that corresponds to one
size smaller than the intramedullary plug should pass over the guide wire down to
the plug without obstruction. Each larger-diameter impactor in turn is introduced
as far down the canal as it will pass, and a small rubber ring is snapped onto its
shaft at the level of the tip of the greater trochanter (Fig. 7). Subsequently, when
impacting the bone chips, do not drive the impactor beyond this depth.
Ensure that the plug is tight and not migrating down the canal; if the plug
migrates, the calibration on the guide wire opposite the tip of the trochanter will
move. The assistant should be given the task of checking the mark after each
instrument is passed. If the plug is migrating, it can be transfixed at the correct
depth with a K-wire.
The allograft chips are introduced around the guide rod using a 10 mL
syringe which has had the end sawn off. The chips are then pushed down the canal
using the larger impactors. The impactor that corresponds to the diameter that
will pass right down to the plug is then introduced over the guide rod and chips
are compacted down onto the distal plug. A depth of 10 –15 mm is established by
hand-packing. The impactor should then be connected to the slap hammer for
further impaction.
334 Timperley et al.

Figure 6 Alignment of instruments: The guide wire should point to the middle of
the popliteal fossa when viewed down its length.

The impaction process is continued by introducing and impacting more


chips and using progressively larger impactors. The distal impaction is continued
until the level of the chips is up to the level of the distal impaction line. This
corresponds to the depth down the femur of the proximal phantom and is
indicated by the beginning of an area of polishing on the shaft of the distal
packers (Fig. 7). At this point the proximal impactors or phantoms should be
used. It is important not to pack chips beyond the distal impaction line or it may
prove impossible to introduce the phantom. If this occurs it may be possible to
introduce a smaller phantom to cut into the distal bone plug, although more often
Impaction Bone Grafting on the Femoral Side 335

Figure 7 Markers on distal packers: An indicator is snapped onto each distal


packer to indicate how far down the canal it can be used.

some of the distal graft will have to be removed—either with the use of a long
curette or by using the corer from the long-stem instruments.

B. Packing with the Proximal Phantoms


The appropriate proximal impactor or phantom is mounted on the slap hammer
assembly and threaded over the guide rod. Using the slap hammer, the phantom is
driven into the distal bone plug. This forces the distal graft against the wall of the
canal. The handle is used to ensure that the neo-medullary canal so formed is in
336 Timperley et al.

the correct amount of anteversion—usually 10 –15 degrees. More graft is


introduced (approximately 5 cc at a time), and the distal packers are used by hand
to compact the chips onto the graft distally. The proximal impactor is repetitively
driven into the distal impacted graft using the slap hammer in a vigorous fashion.
When the canal has been filled almost to the top, a trial reduction of the
femur may be carried out, leaving the guide rod in position (Fig. 8). The level to
which the femoral component should be inserted can be determined from this trial
reduction and an appropriate mark made on the femoral neck to indicate the depth
of insertion of the implant (Fig. 9).

Figure 8 Trial reduction: A trial reduction is carried out, leaving the guide wire in
place.
Impaction Bone Grafting on the Femoral Side 337

Figure 9 Leg length mark: A mark is made on the surface of the femoral neck
adjacent to one of the marks on the stem.

An assessment of stability and the range of movement can also be


established. If there is impingement, then further excision of soft tissue or bone
may be required. A stem of larger offset may occasionally be indicated.

C. Proximal Reconstruction of the Femur


One should also at this stage assess the need for reconstruction of the proximal
femur. If there is deficient bone in the proximal femur, reconstruction should now
be carried out with the phantom seated to the correct depth. The femur requires
338 Timperley et al.

augmentation if there is loss of bone below the level of the lesser trochanter on
any aspect. The reconstruction should be up to a level that corresponds to one of
the three marks on the phantom (and therefore on the implant). The stem must be
supported up to this level in order that it is torsionally stable within the femur.
Proximal reconstruction is achieved with the use of malleable wire mesh
and monofilament wires. If the loss of proximal bone in the calcar area is modest,
the “acetabular rim meshes” are very useful and may be applied over the deficient
area and held with monofilament wires (Fig. 10). The preferred method to apply
these wires is as follows: a drill hole is made through the trochanter as far
laterally as possible halfway between the tip of the greater trochanter and the
level of the lesser trochanter. Both cortices are drilled and the wire passed
through the anterior edge of the wire mesh. The wire is further threaded through

Figure 10 Rim mesh: The “acetabular rim mesh” can be wrapped around the
proximal femur to reconstruct the calcar region.
Impaction Bone Grafting on the Femoral Side 339

the posterior edge of the mesh and then tightened to itself. This fixed wire
prevents the mesh moving up or down on the femur. A second wire is passed
around the femur beneath vastus lateralis just below the lesser trochanter,
threaded through a hole in the mesh, and tightened to itself. Occasionally a third
wire is necessary. For larger defects an anatomical “calcar mesh” is available
(Figs. 11, 12). This is applied in a similar fashion to the smaller mesh. Cables may

Figure 11 Calcar mesh: An anatomic shaped calcar mesh can be used to


reconstruct larger deficiencies in the proximal femur.
340 Timperley et al.

Figure 12 X-rays of calcar mesh: Calcar mesh applied with monofilament wires
proximally and Dall-Miles cables distally.

be used around this mesh distally. These are usually avoided more proximally
because of a fear of the cable fretting as it passes through the mesh.

D. Proximal Packing of Graft


Having reconstructed the proximal femur, the phantom is withdrawn from over the
guide rod, more bone chips are inserted, and then they are impacted, initially using
Impaction Bone Grafting on the Femoral Side 341

the hand-held distal impactors and then using the proximal phantom impactor. The
proximal impactor should now be getting tight within the canal. From now on,
alternate the proximal phantom impactor and the distal impactors, packing in more
bone chips at each stage. With the proximal phantom impactor partially
withdrawn, a final proximal packing is achieved using the hand-held impactors
(Fig. 13). The proximal impactor is again used to impact this proximal bone. If
the graft is so tight that the proximal impactor cannot be introduced fully, use one
size smaller for final impaction. Select the stem size on the basis of the size of the
proximal phantom impactor that is used for the final packing. Absolute axial and

Figure 13 Hand-packing of graft: Larger bone chips are packed around the
seated femoral phantom.
342 Timperley et al.

torsional stability of the phantom should be evident at the conclusion of impaction.


It should be very difficult to withdraw the phantom at the end of impaction grafting
and impossible to achieve removal without the use of the slap-hammer.

E. Cementation and Stem Insertion


At this stage the graft is ready for insertion of the definitive prosthesis. The guide
wire is unscrewed, leaving the phantom in position until just before cement

Figure 14 Neomedullary canal: Removal of the stem phantom reveals the


“neomedullary canal.”
Impaction Bone Grafting on the Femoral Side 343

insertion. This keeps the graft compressed, and the canal can be sucked dry by
placing a catheter down the lumen of the phantom. After removal of the phantom
(Fig. 14), antibiotic Simplex cement is introduced in retrograde fashion using the
revision cement gun with a tapered gun spout. Once the canal has been filled, the
nozzle is cut flush with the femoral seal and the cement is then pressurized into
the graft (Fig. 15).
Pressurization is maintained until the viscosity of the cement is appropriate
for stem insertion—normally about 5 minutes after mixing if the operating room
temperature is 208C. A wingless Exeter stem centralizer is fitted to the end of the

Figure 15 Cement pressurization: Cement is injected with a gun through the


proximal femoral seal to pressurize the cement into the graft.
344 Timperley et al.

prosthesis prior to insertion. The stem is then inserted to its predetermined


position. Attention must be paid to the alignment of the stem during insertion.
The surgeon uses his thumb to occlude the exit from the medullary canal and thus
maintain pressure on the medial cement throughout insertion (Fig. 16). When the
desired position of the prosthesis is achieved, the stem introducer is removed and
a proximal seal is applied around the proximal stem in order to maintain pressure
on the cement and graft while the cement polymerizes (Fig. 17). Trial reduction is
then carried out using one or more of the þ4 mm, 0, or 24 mm heads, and the
appropriate one selected after testing for leg length, range of motion, and stability
(Fig. 18).

Figure 16 Stem insertion: The stem is introduced into the neomedullary canal.
Impaction Bone Grafting on the Femoral Side 345

Figure 17 Horsecollar: The sorbothane “horsecollar” is applied around the


implant and pressure applied onto the graft and cement.

Figure 18 Trial reduction: Final trial reduction before closure of external rotators.
346 Timperley et al.

VIII. REDUCTION AND CLOSURE

The hip is reduced. The posterior capsule is reattached via drill holes to the
posterior aspect of the femur. The wound is closed over a single deep drain.

IX. POSTOPERATIVE MANAGEMENT

The drain is removed and patients are mobilized on the first or second day post-
operatively. Touch weight bearing is advised in most patients for at least the first
6 weeks, at which point they are re-x-rayed. If there is less than 1 mm of
migration of the stem within the cement mantle, they are allowed to take more
weight through the limb building up to full weight bearing by 12 weeks. In the
elderly, full weight bearing is permitted.

X. LESSONS WE HAVE LEARNED DURING EVOLUTION


OF THE TECHNIQUE

The results of impaction grafting at our center have generally been good with
regard to the clinical outcome scores for patients, survivorship of the implants,
and the radiological feature of restoration of bone stock. As a result of the
optimistic results in the early group of patients who underwent this procedure [5],
dedicated instruments were developed to help make the procedure more
reproducible and to facilitate graft compaction. A greater number of patients with
severe bone stock loss have been operated on since the original group, and the
risk factors for the two principal complications for the impaction grafting
procedure—femoral fracture and significant subsidence of the stem within the
cement mantle—have become evident.
In a series of 225 consecutive cases of femoral impaction grafting carried
out by multiple surgeons at the Orthopaedic Hospital in Exeter, there were 10
cases of femoral shaft fracture, in 5 of which an unrecognized fracture had
occurred during the operation. It is therefore important to recognize and
adequately fix a fracture that occurs intraoperatively, and a long stem to bypass
the area is generally advocated. We now also use longer stems to bypass
weakened or defective areas of bone since they are at increased risk of
postoperative fracture. Occasionally, strut grafts or plates are used in addition to
the longer stem. Dedicated instruments have been developed to allow bone to be
packed around these long stems.
The other complication that has been reported in the literature is that of
massive subsidence of the stem within the canal [6 –10]. Subsidence of the stem
within the cement mantle over 10 mm occurred in 14 cases in our series.
Impaction Bone Grafting on the Femoral Side 347

Subsidence of this degree did not lead to a deterioration in the clinical scores of
these patients, but movement of this degree is best avoided if possible. We found
that the patients most at risk for significant subsidence were those with severe
bone stock loss (Endoklinik 3 and 4).
The incidence of significant subsidence has now been reduced by a number
of measures, including the use of larger bone chips in capacious canals, a better
distribution of particle size [11,12], tighter compaction of these chips within the
femoral canal [11,13 –16], and, in the case of severe bone stock loss, the use of
longer stems.
In revision surgery the technique of impaction grafting has an advantage
over other forms of femoral reconstruction in that it holds the potential for
augmentation of bone stock in deficient femora as the compacted allograft chips
are incorporated and subsequently remodeled in the host skeleton. The potential
problems associated with the technique are becoming clearer, as are the
indications for its use (see above). Most of the complications reported from centers
that have used this technique, including our own, have resulted from inappropriate
surgical technique. Application of the methods described in this chapter should
further improve the results possible using the impaction grafting method.

REFERENCES

1. English H, Timperley A, Dunlop D, Gie G. Impaction grafting of the femur in


two-stage revision for infected total hip replacement. J Bone Joint Surg Br 2002;
84:700– 705.
2. Athanasou NA, Pandey R, de Steiger R, Crook D, Smith PM. Diagnosis of infection
by frozen section during revision arthroplasty. J Bone Joint Surg Br 1995; 77:28– 33.
3. Younger TI, Bradford MS, Magnus RE, Paprosky WG. Extended proximal femoral
osteotomy. A new technique for femoral revision arthroplasty. J Arthroplasty 1995;
10:329– 338.
4. A code of practice for tissue banks providing tissues of human origin for therapeutic
purposes. London: UK Department of Health, 2001.
5. Gie GA, Linder L, Ling RS, Simon JP, Slooff TJ, Timperley AJ. Impacted cancellous
allografts and cement for revision total hip arthroplasty. J Bone Joint Surg Br 1993;
75:14– 21.
6. Eldridge JD, Smith EJ, Hubble MJ, Whitehouse SL, Learmonth ID. Massive early
subsidence following femoral impaction grafting. J Arthroplasty 1997; 12:535 – 540.
7. Masterson EL, Masri BA, Duncan CP. The cement mantle in the Exeter impaction
allografting technique. A cause for concern. J Arthroplasty 1997; 12:759 –764.
8. Jazrawi LM, Della Valle CJ, Kummer FJ, Adler EM, Di Cesare PE. Catastrophic
failure of a cemented, collarless, polished, tapered cobalt-chromium femoral stem
used with impaction bone-grafting. A report of two cases. J Bone Joint Surg Am
1999; 81:844 –847.
348 Timperley et al.

9. Meding JB, Ritter MA, Keating EM, Faris PM. Impaction bone-grafting before
insertion of a femoral stem with cement in revision total hip arthroplasty. A
minimum two-year follow-up study. J Bone Joint Surg Am 1997; 79:1834 – 1841.
10. Pekkarinen J, Alho A, Lepisto J, Ylikoski M, Ylinen P, Paavilainen T. Impaction
bone grafting in revision hip surgery. A high incidence of complications. J Bone
Joint Surg Br 2000; 82:103 –107.
11. Brewster NT, Gillespie WJ, Howie CR, Madabhushi SP, Usmani AS, Fairbairn DR.
Mechanical considerations in impaction bone grafting. J Bone Joint Surg Br 1999;
81:118 – 124.
12. Ullmark G, Nilsson O. Impacted corticocancellous allografts: recoil and strength.
J Arthroplasty 1999; 14:1019– 1023.
13. Karrholm J, Hultmark P, Carlsson L, Malchau H. Subsidence of a non-polished stem
in revisions of the hip using impaction allograft. Evaluation with radiostereometry
and dual-energy x-ray absorptiometry. J Bone Joint Surg Br 1999; 81:135– 142.
14. Giesen EB, Lamerigts NM, Verdonschot N, Buma P, Schreurs BW, Huiskes R.
Mechanical characteristics of impacted morsellised bone grafts used in revision of
total hip arthroplasty. J Bone Joint Surg Br 1999; 81:1052– 1057.
15. Malkani AL, Voor MJ, Fee KA, Bates CS. Femoral component revision using
impacted morsellised cancellous graft. A biomechanical study of implant stability.
J Bone Joint Surg Br 1996; 78:973 – 978.
16. Hostner J, Hultmark P, Karrholm J, Malchau H, Tveit M. Impaction technique and
graft treatment in revisions of the femoral component: laboratory studies and clinical
validation. J Arthroplasty 2001; 16:76 – 82.
24
Impaction Grafting of the Proximal
Femur with Freeze-Dried Bone in
Revision Arthroplasty
A. Mazhar Tokgözoğlu, Bülent Atilla, and Egemen Turhan
Hacettepe University Faculty of Medicine
Hacettepe, Ankara, Turkey

I. INTRODUCTION

From the beginning of total hip replacement there has always been a need for
revision for loosening. Loosening causes a significant amount of bone loss, which
must be replaced if the revision hip replacement is to survive over the long term.
Restoration of bone stock is a challenge, and various approaches have been
suggested. Of these, impaction grafting has been one of the most innovative.
Impaction grafting has been used for restoring bone defects in revision total hip
arthroplasty since 1979. In 1979 Slooff et al. introduced it for reconstructing
contained cavitary bone defects of the acetabulum during revision hip
replacement [1]. They used morselized fresh frozen femoral head allografts
from their bone bank, which collected femoral heads harvested during primary
total hip arthroplasties. The technique proved satisfactory when the acetabular
bone defect was cavitary and vigorous impaction was used. Later they were able
to extend their indications to segmental defects when the rim was reconstructed
with wire mesh. Their 10-year results proved that this biological approach to the
management of bone defects caused by acetabular loosening was sound [2].
This experience encouraged Ling and Gie to try impaction grafting for
femoral loosening in 1987 [3]. They impacted morselized allograft in the femur
after removing the loose stem and interface membrane. Their initial indication
was cavitary defects of the proximal femur in revision total hip arthroplasty.
Fresh frozen femoral heads from primary total hip arthroplasties were their
349
350 Tokgözoğlu et al.

source of cancellous bone. An average of four to six femoral heads were


morselized and impacted into the proximal femur. After impaction, a collar-
less polished double-tapered stem (Exeter, Howmedica, Rutherford, NJ) was
implanted using third-generation cementing techniques. The stability achieved in
the early stage and early clinical results encouraged them to extend the
indications for its use [4] and develop an instrumentation system (X-Change
System, Howmedica, Rutherford, NJ) to improve the consistency of their results.
Excellent results of this procedure have been reported in the literature
[5 –12]. Biopsies show that the impacted allograft incorporates and reconstitutes
the proximal femur [13 –16]. However, the supply of allograft is limited, and
disease transmission is a major issue despite rigorous testing [17,18]. Several
femoral heads are required for satisfactory impaction, and despite bone from
organ donors and routine harvesting of femoral heads, the supply of fresh femoral
head allografts does not match the demand of increasing numbers of revisions.
There are national and cultural variations in obtaining consent for bone donation.
Storage and transport of fresh frozen allograft increases its cost and decreases its
availability.
To overcome the problems storing and transportating fresh frozen grafts,
freeze-drying (lyophilization), widely used in the food industry, was introduced
to bone banking. During freeze-drying, water is removed by sublimation from the
material after it has been frozen. The bone is then vacuum-packed under sterile
conditions and can be stored at room temperature for up to 5 years. Freeze-drying
also prevents bacterial growth [19 –21]. Although the shelf life can be increased
significantly, some properties of stored bone change with freeze-drying [19,21].
Freeze-drying does not affect the limited osteoinductive properties of allograft
bone and decreases its antigenity. While the osteoprogenitor cells are destroyed,
the osteoconductive properties of the cancellous and cortical bone are largely
retained. The deeply bound, limited osteoinductive material present in the graft
may be only partially retained. Moreover, freeze-drying can decrease the
mechanical properties of allograft bone with loss of hoop and compressive
strength on rehydration [19]. Initially, these concerns prevented the use of freeze-
dried graft for impaction grafting since mechanical strength of the impacted bone
is a prerequisite to the technique. However, freeze-dried allografts have been in
used in orthopedic surgery with satisfactory results [19,23].

II. SURGICAL TECHNIQUE

On admission to the hospital for impaction grafting, radiographs of the patient are
examined for preoperative planning. Using the templates of the Exeter X-Change
Hip Revision System (Howmedica, Rutherford, NJ), the site of the distal
restrictor is determined and the approximate volume to be filled with bone is
Revision Arthroplasty 351

estimated. Once the patient is brought in to the operating theater, the estimated
amount of freeze-dried allograft is delivered. After surgical exposure and frozen
section to exclude infection, the bone is reconstituted in 0.9% physiological
saline. This takes between 30 minutes and an hour, during which time the
prostheses, cement, and fibrous membrane are removed. After complete removal
of the cement and surrounding osteolytic membrane, a polyethylene bone plug
with a guide wire attached is placed in the femoral medullary canal. The
estimated amount of allograft needed is checked once more to ensure that the
required amount of bone is available. Cortical defects are reconstructed with
allograft struts or metal mesh fixed with cerclage wire. After insertion of the bone
plug, the freeze-dried allograft is impacted into the femoral canal [3]. We
recommend impacting the graft as densely as possible to make sure it is really
solid. The graft is initially impacted with graft impactors chosen to fit the
canal diameter. These impactors work over the guide wire attached to the
distal restrictor. After the isthmus is filled with graft, tamps shaped like the
femoral stem are used. These tamps come in different sizes that match the femoral
component. The tamp used is chosen during the preoperative planning with
templates. The canal is filled with bone again, and the graft is impacted into the
proximal femur. The tamps work over the central guide wire (Fig. 1). Additional

Figure 1 The final temp is impacted into the proximal femur over the guide wire.
The anterior rim of the femoral neck is reconstructed with a metallic mesh.
352 Tokgözoğlu et al.

bone is packed around the tamp until the proximal femur is completely filled with
impacted graft. Then the handle of tamp is twisted with a wrench to ensure
rotational stability. If the tamp does not move with twisting, the graft is con-
sidered adequate. The tamp also can accommodate provisional femoral heads to
carry out a trial reduction and check the stability of the graft. After grafting
is complete and trial reduction is satisfactory, an Exeter polished stem
(Howmedica, Rutherford, NJ) is cemented in the gap created by the
instrumentation using third-generation cementing techniques (Fig. 2).

III. THE HACETTEPE EXPERIENCE

Since October 1996, we have performed 42 impaction graftings during revision


total hip arthroplasty. Of these 42 hips, 33 hips in 32 patients had a complete
clinical and radiological follow-up [24]. Our indication for performing these
procedures was aseptic loosening of a total hip arthroplasty in patients with
cavitary defects of their femora that could not be managed with a fully porous

Figure 2 The final temp and guide wire are removed from the canal prior to
cementation. The quality of bone impaction is visible resembling the cancellous
bone of the proximal femur. As the graft is firmly impacted, the position of impacted
bones does not change despite removal of the temp.
Revision Arthroplasty 353

coated long cementless femoral component. Using the AAOS classification of


femoral defects, 23 of these hips were type 2, and 12 of them were type 3. We
followed these patients prospectively, and all of them are currently under review.
As of May 2002, our average follow-up is 53 (range 42 – 68) months (Fig. 3).
Only one patient required a revision for deep sepsis following removal of a

Figure 3 One of our cases 3 years after impaction grafting. The reconstitution of
bone is visible. There are no subsidence or radiolucent lines at the cement bone
interface. Ectatic lateral cortex of the femur has started to heal.
354 Tokgözoğlu et al.

broken trochanteric wire after 48 months. Other than this, none of our cases are
being considered for revision. We impacted either morselized or cancellous
cubes of freeze-dried allograft. When the available graft was cancellous cubes,
they were morselized with a bone mill. The average amount of bone graft needed
was 145 (range 60 –270) cc. Cortical defects requiring reconstruction with metal
mesh were present in 9 hips. In 4 of the hips, cortical freeze-dried allograft was
used to reconstruct cortical defects. Cable wires were used in 15 hips to either fix
the metal mesh and cortical grafts or to protect the femur from fracturing during
and after graft impaction (Fig. 4). In three cases the wires were used to prevent
fissure fractures from propagating distally.
After surgery the patients were allowed to bear weight within limits of
comfort the following day and were encouraged to fully weight bear with
crutches before discharge on the seventh postoperative day. All cases were
followed up after 6 weeks and 6 months postoperatively and thereafter yearly. All
patients were assessed with Harris Hip Scores and radiographs at their latest
follow-up. Radiographs were examined for radiolucent lines, subsidence, cement
fracture, and cortical and trabecular remodeling of the impacted graft.
At the latest follow-up examination, all cases except the infected one had
significantly higher Harris Hip Scores (average preoperative score 55, post-
operative 89; p ¼ 0.043). Only three patients needed canes to walk because of
weak abductors. All patients except the infected one, whose prosthesis had been
removed, were free of pain. Five patients had a slight limp. None sustained a
postoperative fracture.
There was incorporation and remodeling of the impacted freeze-dried
allograft in all cases including the infected one. Cortical remodeling took place in
ectatic femora. The femoral component subsided in the cement mantle in five
cases by an average of 2 mm (range 1 – 4 mm). One patient with 3 mm of
subsidence also had the only cement mantle fracture. Follow-up radiographs
revealed that this cement fracture was stable and the implant was not loose.
There were radiolucent lines about 1 mm thick in 17 patients mostly in
Gruen zones 1 and 7. Trabecular remodeling was seen to some extent in all
patients (Fig. 5).
A patient with severe rheumatoid arthritis was revised for a painful
hemiarthroplasty with protrusio. During the revision with impaction grafting, a
trochanteric osteotomy was needed to expose the centrally displaced femoral
head. This was fixed with a cable grip, the wire of which broke 24 months
postoperatively, causing a painful trochanteric bursitis. After removal of the wire,
the patient developed a wound infection that was initially treated with antibiotics.
However, the infection became deep, an initial attempt at antibiotic suppression
with retention of the prosthesis failed, and 50 months after the impaction grafting
the prosthesis was removed and an antibiotic impregnated cement spacer
inserted.
Revision Arthroplasty 355

Figure 4 One of the cases that needed metallic mesh and cable wire fixation.
This case is 54 months after the impaction grafting. There is evidence of radiolucent
lines, or subsidence. The impacted graft has remodeled.

IV. SCINTIGRAPHIC STUDY

As none of our patients other than the infected case required revision, we
wished to assess the biological activity in the bone mass after impaction
grafting and tried bone scintigraphy in a group of patients. To overcome the
356 Tokgözoğlu et al.

Figure 5 New trabeculae formation and reconstitution of the cortex are clearly
visible 48 months after impaction grafting.

problem of superimposition of the anterior and posterior aspects of the stem,


we used the single photon emission computed tomography (SPECT) technique
to determine revascularization and new bone formation in the impacted bone
graft surrounding the femoral stem. Nine patients who underwent impaction
grafting with at least 1- to 2-year follow-up were included in this study [25].
Revision Arthroplasty 357

These patients underwent a Tc-99m MDP bone scintigraphy using SPECT, and
all demonstrated increased uptake indicating new bone formation in the
impacted freeze-dried graft. This indicated that significant revascularization,
remodeling, and new bone formation were still occurring up to 2 years after
impaction grafting (Fig. 6).

Figure 6 One of the patients in the group that was examined with scintigraphy.
The area corresponding to the impacted graft demonstrates a significant uptake of
radioisotope both in the coronal and transverse slices of the SPECT study. This
indicates the intense new bone formation within the graft mass.
358 Tokgözoğlu et al.

V. DISCUSSION

When revising a loosened total hip arthroplasty, the aim is to reconstruct the
artificial joint. This can be done with either an implant or bone. As soon as a new
hip replacement is implanted, the loosening process and loss of bone stock starts
again, so the loose joint replacement should preferably be reconstructed with
bone. By restoring bone stock with impaction grafting, further revisions should
be easier. Impaction grafting is a proven method of reconstructing defective
femoral bone stock after removal of an aseptically loose total hip arthroplasty.
Impacting cavitary defects with bone graft is traditional practice in benign
tumors and trauma. In impaction grafting the same principle is applied; the
defective femur is grafted with bone and the graft is internally fixed with a
cemented femoral stem. The stem recommended for this purpose is the Exeter
(Howmedica, Rutherford, NJ). It has a double taper with a polished surface that
subsides within the cement mantle, compressing the remodeling bone. As the
cement mantle expands with creep, the stem can subside within the cement
mantle maintaining the integrity of the cement bone interface [26,27].
Freeze-dried allografts have been used for different indications in
orthopedic surgery [22,23]. Freeze-dried allografts are effective fillers and a
good scaffold for osteoconduction [21]. However, because freeze-drying impairs
the compressive strength of bone, it was considered unsuitable for impaction
grafting. A major advantage of freeze-dried allograft is its availability and the
much lower risk of disease transmission. Fresh frozen grafts obtained from
femoral heads are easy to collect but difficult to test for safety and store. Fresh
frozen femoral heads collected during total hip arthroplasty vary in quality,
quantity, and shape [28,30]. Femoral heads are usually collected from patients
with osteoarthritis, which reduces the amount of cancellous bone and conse-
quently their osteoinductive and osteoconductive properties. Because of this,
we decided to try freeze-dried cancellous allograft for impaction grafting as
it was readily available and is reliable in terms of disease transmission and
quantity.
Three major problems following impaction grafting have been reported and
are major concerns in impaction grafting. The first is femoral fracture [9,11],
usually caused by stems that are too short to bypass lytic lesions. We addressed
this problem by filling the cavity with bone and bypassing the lowest defect by
3 cm or supporting the cortex with strut allografts. There have been no
postoperative femoral fractures. However, we had three intraoperative femoral
fractures during graft impaction. These were managed with cerclage wiring, and
whenever we suspected that the underlying bone was weak, we prophylactically
fixed the femur with wires.
The second problem has been rapid loosening and significant subsidence of
the femoral component [11]. Initially when the instrumentation was designed, the
Revision Arthroplasty 359

tamps were designed to create a void just large enough for the femoral
component. This did not allow sufficient space for an adequate cement mantle,
and rapid failure ensued [30,31]. We overcame this by using a 2 mm oversized
tamp before cementing. The new instrumentation is oversized by 2 mm to
address this.
The third problem is inadequate graft impaction. If grafts are not impacted
adequately, the final construct fails early. We addressed this by impacting the
tamps into the graft until we could no longer twist them with a wrench attached to
the tamp handle. For consistent results the instrumentation should include a
torque wrench to measure the stability of the tamp, and research should be
undertaken to determine the amount of impaction required. In our series we had
no early loss of fixation and satisfactory results overall probably because we
learned from the experience of others.
Using freeze-dried allograft, we obtained good clinical and radiographic
results [24] that compare with larger series of fresh frozen allograft. Only one
patient required a revision for infection. This suggests that freeze-dried
morselized cancellous allograft is suitable for impaction grafting of the
femur. Although it does not have the biological properties of fresh frozen
allograft, both our clinical and scintigraphic results indicate that this is
not a disadvantage. The main disadvantage of freeze-dried allograft is its
impaired mechanical strength. However, this can be overcome by vigorous
impaction.
There have been several retrieval studies of patients after impaction
grafting [13 – 16]. These demonstrated that the impacted allograft resorbs and that
new bone forms on the impacted graft. Fresh frozen allograft has better biological
potential to stimulate bone formation and therefore is a better material for
impaction grafting. We did not retrieve any specimens to assess the biological
activity in the impacted freeze-dried graft mass, but the SPECT bone scintigraphy
recorded activity similar to previous studies [25]. Indirectly, this suggests that
similar events occur in freeze-dried allograft despite its potential biological
limitations. It may be that the blood and bone debris of the patient that gets
mixed into the graft mass during impaction is osteoinductive. This, with the
stability provided by satisfactory impaction and stem fixation, seems to create the
conditions necessary for bone healing.
Impaction grafting with freeze-dried cancellous allograft gave satisfactory
results in our hands despite its biological disadvantages. Surgeons performing
impaction grafting should accept that surgical technique is more important than
material grafted. Longer-term follow-up and further research on this material
will explain our results. If we can demonstrate that impaction grafting
with freeze-dried cancellous allograft works after 5 years, an alternative
method of biological reconstruction after loose total hip arthroplasty may be
established.
360 Tokgözoğlu et al.

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replacement for acetabular protrusio. Acta Orthop Scand 1984; 55:593 – 596.
2. Schreurs BW, Slooff TJ, Buma P, Gardeniers JW, Huiskes R. Acetabular
reconstruction with impacted morsellised cancellous bone graft and cement.
A 10- to 15-year follow-up of 60 revision arthroplasties. J Bone Joint Surg Br 1998;
80:391 – 395.
3. Gie GA, Linder L, Ling RSM, Simon J-P, Slooff TJJH, Timperley AJ. Impacted
cancellous allografts and cement for revision total hip arthroplasty. J Bone Joint
Surg Br 1993; 75-B:14 – 21.
4. Tsiridis E, Gie GA. Mal-united femoral fractures adjacent to loose total hip
arthroplasties. Salvage with impaction grafting. A case report. Injury 2002;
33:81 – 83.
5. Elting JJ, Mikhail WE, Zicat BA, Hubbell JC, Lane LE, House B. Preliminary report
of impaction grafting for exchange femoral arthroplasty. Clin Orthop 1995;
319:159 – 167.
6. Flugsrud GB, Ovre S, Grgaard B, Nordsletten L. Cemented femoral impaction bone
grafting for severe osteolysis in revision hip arthroplasty. Good results at 4-year
follow-up of 10 patients. Arch Orthop Trauma Surg 2000; 120(7 – 8):386– 389.
7. van Biezen FC, ten Have BL, Verhaar JA. Impaction bone-grafting of severely
defective femora in revision total hip surgery: 21 hips followed for 41 – 85 months.
Acta Orthop Scand 2000; 71:135 – 142.
8. Knight JL, Helming C. Collarless polished tapered impaction grafting of the femur
during revision total hip arthroplasty: pitfalls of the surgical technique and follow-up
in 31 cases. J Arthroplasty 2000; 15:159– 165.
9. Jazrawi LM, Della Valle CJ, Kummer FJ, Adler EM, Di Cesare PE. Catastrophic
failure of a cemented, collarless, polished, tapered cobalt-chromium femoral stem
used with impaction bone-grafting. A report of two cases. J Bone Joint Surg Am
1999; 81:844 – 847.
10. Meding JB, Ritter MA, Keating EM, Faris PM. Impaction bone-grafting before
insertion of a femoral stem with cement in revision total hip arthroplasty. A minimum
two-year follow-up study. J Bone Joint Surg Am 1997; 79:1834 – 1841.
11. Eldridge JD, Smith EJ, Hubble MJ, Whitehouse SL, Learmonth ID. Massive
early subsidence following femoral impaction grafting. J Arthroplasty 1997;
12:535 – 540.
12. Pekkarinen J, Alho A, Lepistö J, Ylikoski M, Ylinen P, Paavilainen T. Impaction
bone grafting in revision hip surgery. A high incidence of complications. J Bone
Joint Surg Br 2000; 82:103 –107.
13. Linder L. Cancellous impaction grafting in the human femur: histological and
radiographic observations in 6 autopsy femurs and 8 biopsies. Acta Orthop Scand
2000; 71:543 – 552.
14. Mikhail WE, Weidenhielm LR, Wretenberg P, Mikhail N, Bauer TW. Femoral bone
regeneration subsequent to impaction grafting during hip revision: histologic
analysis of a human biopsy specimen. J Arthroplasty 1999; 14:849– 853.
Revision Arthroplasty 361

15. Nelissen RG, Bauer TW, Weidenhielm LR, LeGolvan DP, Mikhail WE. Revision
hip arthroplasty with the use of cement and impaction grafting. Histological analysis
of four cases. J Bone Joint Surg Am 1995; 77:412 – 422.
16. Ling RS, Timperley AJ, Linder L. Histology of cancellous impaction grafting in the
femur. A case report. J Bone Joint Surg Br 1993; 75:693 – 696.
17. Galea G, Kopman D, Graham BJ. Supply and demand of bone allograft for revision
hip surgery in Scotland. J Bone Joint Surg Br 1998; 80:595– 599.
18. Simonds RJ, Holmberg SD, Hurwitz RL, Coleman TR, Bottenfield S, Conley LJ,
Kohlenberg SH, Castro KG, Dahan BA, Schable CA, et al. Transmission of human
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freeze-drying and rehydration on cancellous bone. Clin Orthop 1993; 290:279 – 284.
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I. Freeze-dried and deep-frozen allografts in rabbits. J Bone Joint Surg Am 1976;
58A:854– 858.
21. Gazdag AR, Lane JM, Glaser D, Forster RA. Alternatives to autogenous bone graft:
efficacy and indications. J Am Acad Orthop Surg 1995; 3:1– 8.
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cancellous allograft bone for spinal fusion in pediatric idiopathic scoliosis. J Pediatr
Orthop 2002; 22:285 – 289.
23. Yazici M, Asher MA. Freeze-dried allograft for posterior spinal fusion in patients
with neuromuscular spinal deformities. Spine 1997; 22:1467 – 1471.
24. Tokgözoğlu M, Senaran H, Atilla B, Alpaslan AM. Does freeze dried allograft work
in impaction grafting of the femur in revision hip arthroplasty? J Bone Joint Surg Br
2001; 83-B(suppl I):74.
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impaction grafting for total hip arthroplasty revision. Arch Orthop Trauma Surg
2000; 120:416 –419.
26. Timperley AJ, Gie GA, Lee AJC, Ling RSM. The femoral component as a taper in
cemented total hip arthroplasty. J Bone Joint Surg Br 1993; 75-B(suppl 1):33.
27. Gie GA, Fowler JL, Lee AJC, Ling RSM. The long-term behaviour of a totally
collarless, polished femoral component in cemented total hip arthroplasty. J Bone
Joint Surg (Br) 1990; 72-B:935.
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use of frozen bone-graft for impaction grafting. J Arthroplasty 2000; 15:368 –371.
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Mechanical considerations in impaction bone grafting. J Bone Joint Surg Br 1999;
81:118– 124.
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allografting technique. A cause for concern. J Arthroplasty 1997; 12:759 –764.
31. Masterson EL, Masri BA, Duncan CP, Rosenberg A, Cabanela M, Gross M. The
cement mantle in femoral impaction allografting. A comparison of three systems
from four centres. J Bone Joint Surg Br 1997; 79:908– 913.
25
Enmeshed Impacted Bone Allograft
at the Femoral Side
Henri Migaud, Christophe Chantelot, François Giraud,
Christophe Jardin, and Antoine Duquennoy
University Hospital of Lille
Lille, France

I. INTRODUCTION

Even with the so-called second- or third-generation cementing technique,


cemented femoral revision is a problem [1,2]. The greater the number of revi-
sions, the lower is the survival rate [3 –5]. This is because bone stock does not
recover spontaneously without grafting as cement occupies the areas of bone loss
[6] and the cement/bone interface is weak as there is little cancellous bone into
which cement can penetrate [7]. In cemented femoral revision without bone
grafting, radiolucent lines at the cement/bone interface are often seen on the
immediate postoperative x-ray, indicating that the new implant is loose and has
limited prospects of long-term survival (Fig. 1) [8]. To avoid these problems of
cemented femoral revision, we introduced the new technique of bone grafting in
the mid-1980s. The aim was to improve bone stock, particularly in young
patients, to make any subsequent revision easier and to improve cement/bone
fixation to decrease the rate of loosening.
Slooff et al. [9] had impaction-grafted acetabular bone defects, and we
introduced it for femoral revision in 1986. The two specific features we adopted
were obtaining stable fixation with long femoral stems and protecting the graft
from cement penetration with metal mesh [10,11]. This was one of a number of
new techniques of bone grafting, and in all of them there was a tremendous
improvement in bone stock never seen previously with conventional cemented
revisions [12 –15]. However, with the Exeter technique, a high rate of stem
363
364

Figure 1 Repeated aseptic loosening of a cemented femoral revision with rapid appearance of radiolucencies after revision.
(A) Loosening at 4 years follow-up of a primary hip replacement performed for femoral neck fracture. There was cement mantle
breakage (arrow) and subsidence (double arrow). (B) A bone cement radiolucency occurred in all zones 6 months after revision
surgery performed with a calcar cemented stem without grafting (second-generation cementation technique). The repeated loosening
required a new revision one year later. (C) Aspect of the calcar revision stem after retrieval. Loosening was located at bone/cement
Migaud et al.

interface. There was no macrointerlock between the cement and the smooth revised femoral canal.
Enmeshed Impacted Bone Allograft at the Femoral Side 365

subsidence was reported. If prostheses subsided 5 mm, they were described as


definitely loose in many classifications [16]. Femoral stem subsidence was not
regarded as loosening by the Exeter group. The Exeter procedure became very
popular, but there was a high rate of femoral subsidence, particularly when the
cement mantle was incomplete [17,18]. Femoral shaft fracture occurred post-
operatively when there was severe bone loss extending to the shaft [19,20]. In
contrast with the original Exeter technique, we try to obtain strong distal fixation
in healthy femur to achieve primary stability, facilitate bone graft incorporation,
and prevent stem subsidence (Fig. 2G). Following our principles, Gie [21] and
De Thomasson et al. [22] modified their impaction bone grafting technique by
using longer stems for severe and extensive femoral defects.
The aim of this chapter was to report our original technique of femoral
reconstruction and to emphasize the points of technique that make it a safe and
reproducible method.

II. THE TECHNIQUE


A. Preoperative Planning
Precise preoperative planning with templates is necessary to assess the stem
length necessary to bypass the lytic lesion any potential difficulty removing the
previous prosthetic material and any indication for a distal cortical window. The
stem should be cemented in the distal femur at least 3 –5 cm distal to the femoral
defect. A long stem should be used to bridge any cortical window (Fig. 2).
Straight calcar reconstruction stems are inserted usually because they simplify
the reconstruction and primary stability by their proximal shape. We used many
calcar stem types without any difference in outcome (LandangerTM/Johnson and
JohnsonTM, CeraverTM, Astel-ZimmerTM) (Figs. 3, 4, 5).
We used metal mesh placed in the femoral medullary canal at the cement/
graft interface to avoid excessive cement penetration into the graft, reinforce the
cement, and achieve an even cement mantle. The mesh alloy was compatible with
that of the stem. We used titanium mesh (CeraverTM) with a titanium stem and
strong stainless steel mesh from the X-change system (Stryker/HowmedicaTM)
with stainless steel stems (Fig. 3).

B. Surgical Procedure
1. Stage 1: Femoral Preparation
Although our technique can be performed through any surgical approach to the
hip, there must be adequate exposure of the femoral medullary canal, which can
be extended if required. An extended trochanteric osteotomy is preferred to a
366 Migaud et al.
Enmeshed Impacted Bone Allograft at the Femoral Side 367

conventional one to reduce the risk of nonunion, which is high when bone stock is
severely impaired [23]. The trochanteric osteotomy should not be extended so far
as to compromise the capacity of the femur to contain bone graft. In fact, this
technique needs an intact femoral canal, and we do not recommend it if the femur
is fractured before surgery. A segmental cortical defect is not a contraindication,
but we prefer to reconstruct with a bulk graft instead of mesh around the femur
because it devitalizes the cortex (Fig. 3). Likewise, an intraoperative femoral
fracture is not a contraindication if primary stability can be achieved and the graft
contained. To avoid the long extended trochanteric osteotomy sometimes
required to remove distal cement, we frequently use a distal cortical window that
does not compromise graft containment (Figs. 4, 5). After complete removal of
cement and granuloma, a sturdy distal polyethylene nonabsorbable plug
(CeraverTM, Roissy, France) (Fig. 2A) is placed 3 –5 cm below the distal end of
the lytic lesion loss or 5 cm distal to any cortical window.

Figure 2 Surgical steps of the enmeshed impacted bone allografting technique.


(A) After removal of the previous stem and cement, a distal plugging is performed.
The stability of the plug should be adequate, as the reconstruction will be based on
it. Its position should be determined on preoperative planning. Then a metallic
cylinder is introduced in the femoral canal. The diameter of this cylinder
corresponds to the diameter of the mid-part of the stem that is selected in
preoperative planning. The distal end of the cylinder is larger than the distal revision
stem and must fit the distal femoral canal in order to avoid graft penetration into the
distal healthy femur. (B) Once the femoral rod in place, the reconstruction with
morselized allograft is performed. The grafts are introduced from the proximal
opening of the femoral canal. When performed, a cortical window could also be
used for graft packing. (C) The metallic mesh is molded around the trial stem. The
length of the mesh is determined during preoperative planning and adjusted during
surgery to be equal to the length of bone grafting. Few absorbable sutures can be
used to maintain the mesh molded around the trial stem. (D) After femoral metallic
rod removal, the trial stem and the mesh are both introduced into the reconstructed
femoral canal (white zone with black dots) and firmly impacted. (E) The trial stem is
removed leaving the mesh in the femoral canal. At this stage a complementary
femoral reconstruction can be performed by packing morselized allograft around
the mesh at the proximal aspect of the femur. (F) The cement (black zone with white
dots) is introduced in the femur. A second- or third-generation cementing technique
is required according to the extended length of revision stems and in order to obtain
distal fixation. (G) Final aspect of the procedure. The reconstruction is achieved by
graft packing around the mesh. The grafts are protected from excessive cement
penetration by the mesh, which also reinforces the cement mantle and make it
regular. Distal cementation in the healthy area of the femur achieves stable initial
fixation.
368

Figure 3 Reconstruction with enmeshed of a femoral loosening grade 2 according to French Orthopaedic Society score. (A)
There was segmental defect of the distal lateral cortex and loss in thickness of proximal medial and lateral cortex. (B)
Postoperative AP view. The segmental defect was treated by bulk allograft fixed by cerclage. The proximal reconstruction was
performed with impacted morselized allograft. The mesh (X-Change system) is placed in front of the graft. (C) Six years later there
Migaud et al.

was favorable bone reconstruction and no stem subsidence.


Enmeshed Impacted Bone Allograft at the Femoral Side

Figure 4 Long-term result of a reconstruction with enmeshed grafting applied to a femoral loosening grade 3 according to
French Orthopaedic Society score. (A) Severe osteolysis extended to the diaphyseal area. (B) AP view 2 years after femoral
reconstruction (the cup liner was changed). There was reappearance of the medial and lateral cortex and trabeculations in the
369

grafts. The mesh and the stem were made of titanium alloy. A distal cortical window, performed to remove previous distal cement
was united. Note adequate distal cementation and the absence of stem subsidence. (C) AP view 13 years after revision. The
cortical thickness remains fully corrected. There was no recurrence of osteolysis despite wear of the cup liner.
370

Figure 5 Reconstruction of a severe femoral bone loss (grade 4) with enmeshed impacted allograft. (A) Severe osteolysis and
destruction of the femoral cortex extended to the diaphyseal area with stem subsidence. (B) AP postoperative view. A distal cortical
window was performed to remove distal cement because of the weakness of the proximal femur. The reconstruction was performed
with a titanium mesh and calcar revision stem. This last one had diaphyseal fixation and the mesh was extended in front of the graft.
(C) Nine years later there was satisfactory reconstruction of the femoral cortex and reappearance of trabeculations in the graft area.
Migaud et al.

There was no subsidence of the stem nor recurrence of osteolysis (the cup liner was changed during femoral revision).
Enmeshed Impacted Bone Allograft at the Femoral Side 371

2. Stage 2: Bone Graft Preparation


Morselized allografts are obtained from fresh frozen femoral heads with all the
cartilage removed in all cases. Until 1991 the bone was morselized by hand, and
after that a bone mill was used for greater consistency (Figs. 3, 5).

3. Stage 3: Femoral Bone Grafting


There is no manufactured instrumentation for this stage. We tried some prop-
rietary devices [X-Change (Strycker/HowmedicaTM), Elite (DePuy/Johnson and
JohnsonTM)], but none were suitable for long stems. The only special instrument
we use is a straight metal cylinder, around which we impact morselized allograft.
The diameter of the cylinder corresponds to that of the mid-part of the stem and is
determined during preoperative planning (Fig. 2A). The distal end of the cylinder
is larger than the distal revision stem to stop graft from entering the normal distal
femur and interfering with distal fixation and stem stability. Once the guide is
positioned, morselized grafts are introduced and impacted around it in areas of
bone loss (Fig. 2B) creating a new femoral canal shaped for stem and mesh
insertion. Graft can be introduced through the distal window if one has to be
made. Segmental defects must be contained with bulk allograft (Fig. 3). If the
shaft fractures during the operation, it must be reduced and fixed before
impaction. The next step is grafting the proximal 3 –5 cm of the femoral canal. If
a cortical window or proximal trochanteric osteotomy is performed, it should be
fixed with metal wires just before or during graft impaction.

4. Stage 4: Mesh Preparation


The metallic mesh is moulded around a trial stem and fixed with some
circumferential absorbable sutures (Fig. 2C). The length of the mesh is adapted to
fit the bone loss reconstructed by allograft (Figs. 2G, 4). After removal of the
metal cylinder, a composite of the trial stem and mesh is then introduced into the
reconstructed canal and appropriately positioned to restore leg length and femoral
offset (Fig. 2D). If the femur is severely defective, cerclage wiring can be
performed to prevent intraoperative fracture before insertion of the definitive
stem. Then the trial stem is removed, leaving the mesh in the femoral canal
(Fig. 2E). At this point, if necessary, further proximal graft can be impacted
around the mesh.

5. Stage 5: Cement Insertion and Fixation of the Definitive Stem


Whether cement is inserted prograde or retrograde, the aim is to obtain an
adequate cement fixation into the virgin distal femur (Figs. 2F, G). A vacuum
venting tube should be placed in the distal femur to improve filling if cement
is inserted prograde. All the stems were cemented with high-viscosity,
372 Migaud et al.

gentamicin-loaded cement (Palacos GentaTM, Schering-Plough). The final aim is


satisfactory fixation to the virgin distal femur, adequate proximal femoral
reconstruction by impaction grafting protected by metal mesh, reinforcement of
cement with mesh, and a collared stem to prevent subsidence (Fig. 2G).

C. Postoperative Management
When femoral bone loss defect was limited and there was satisfactory distal
fixation, weight bearing was permitted after 3 days when the drains had been
removed. Otherwise it was delayed for 6 weeks.

III. CLINICAL DATA

Between 1986 and 1995, we revised 435 total hip replacements for femoral
loosening, 36 of which were performed using the technique described above. The
technique was employed in selected cases of aseptic femoral loosening with
severe bone loss but a contained or limited cortical defect and no preoperative
periprosthetic fracture.
Eight of these 36 hips undergone previous revision surgery. There were
30 patients with a mean age of 61+14 years (SD) (16 men, 14 women). The
mean follow-up was 10 years. No patient was lost to follow-up, but two died after
8 years of follow-up with their prosthesis in place at the time of death. Only one
stem, in an active 48-year-old patient, had recurrent loosening and required
further revision after 10 years. There was loosening at the cement/bone interface,
which related to progressive proximal osteolysis and massive cup wear. There
was no evidence that it was related to the mesh as the stem and cement were
mobile and easily removed in one piece. No other stem revision was required.
Subsidence was assessed on x-rays with a digitizer (OrthographicsTM) with a
significant threshold of 4 mm. After 4 years of follow-up, one stem had subsided
4.4 mm. The subsidence was not progressive, and the hip was asymptomatic.
There were no postoperative fractures.
Using the French Orthopaedic Society scoring system [24], bone loss was
grade 2 in three hips. Grade 2 bone loss is destruction of the lateral femoral cortex
and slightly impairment of the medial (Fig. 3). Twenty-six hips had grade 3 bone
loss, which was severe destruction of the medial and lateral femoral cortex
(Fig. 4). Seven hips were grade 4, in which the medial and lateral femoral cortex
were thin and ballooned (Fig. 5). The remainder were rated grade 1, which
involved slight destruction of the femoral cortex or grade 0 with no bone loss.
Bone loss always improved at follow-up with reappearance of the femoral cortex
and normal trabecular bone (Fig. 5). Except for the case that loosened, there was
no bone lysis or stress shielding. The Merle d’Aubigné hip score improved
Enmeshed Impacted Bone Allograft at the Femoral Side 373

from 9.8 preoperative to 16.5 at follow-up, and 85% of the hips had no pain or
slight pain at follow-up.

IV. DISCUSSION

Currently, impaction bone grafting is restricted by availability of allograft and


risk of viral transmission. The procedure is technically demanding with a high
complication rate. Complications such as shaft fracture prevent satisfactory
recovery of bone stock. Pekkarinen et al. [25] experienced with the Exeter
technique complications in 34 out of 68 cases (50%). Knight and Helming [26]
had a 16% incidence of femoral fracture and 16% subsided over 5 mm. Our
original technique obtained strong distal fixation and bridged the bone defect. We
were able to prevent postoperative fracture, even in severely defective femora,
and the long stems never caused stress-shielding in our experience. Adequate
distal fixation may also prevent subsidence, which is frequent after impaction
bone grafting. Only 2% of our cases subsided always less than 5 mm. The
collared stem may have contributed to this result, as suggested by Fetzer et al.
[27], who reported only 3.8% subsidence (all less than 5 mm) with a similarly
collared femoral component. Likewise, Ullmark et al. [28] reported no subsidence
exceeding 5 mm in cases with severe bone destruction (Endoklinik grade 3 and 4)
when using long-collared stems with impaction grafting. The removal of
cartilage before milling was investigated by Bavadekar et al. [29], who concluded
that it improved the stiffness of the impacted graft. This probably also helped to
prevent subsidence in our series. Ullmark and Nilsson [30] and Karrholm et al.
[31] reported that the size of bone chips and force of impaction influence in vitro
graft compactness and possibly subsidence. However, this work has to be
confirmed, and even if it is, poor graft quality may still cause subsidence. It
therefore seems reasonable to prevent subsidence by a long-collared stem rather
than relying on the variable strength of impacted graft.
An inadequate cement mantle can fracture and has been associated
with severe subsidence after impaction bone grafting [18,32]. In our technique,
mesh reinforced the cement and prevented cement fracture over follow-up of 10
years. The mesh also contributed to an even cement mantle of at least 2 – 3 mm
and prevented excessive cement penetration into the graft. Excessive cement
penetration does not improve fixation in vitro [33] and may impair graft
incorporation.
Impaction bone grafting is a time-consuming technique [34], and locked
or unlocked cementless stems have become very popular in Europe for femoral
revision. Spontaneous bone repair often occurs with cementless stems [6,35,36]
without difficult and time-consuming bone grafting. However, we do not know
how to improve spontaneous bone repair around cementless stems. There is now
374 Migaud et al.

10-year follow-up of impaction bone grafting, and the technique has stood the
test of time. All series of impaction bone grafting have restored bone stock,
and remodeling has been demonstrated histologically [37]. However, the
complication rate of the original Exeter technique makes its reproducibility
questionable. Our original technique was reproducible and had a low
complication rate. Longer stem may cause problems in further revision, but
this only occurred in 2% in our series after follow-up of 10 years. The indications
for enmeshed impacted allograft are: (1) bone loss with a contained defect in a
femur that is not fractured, (2) aseptic loosening, and (3) severe distal bone loss
that risks perioperative fracture or prevents adequate fixation of a standard
cemented stem. In our experience, impaction bone grafting is best suited to
patients under 75 years old. Older patients usually have severe osteoporosis that
risks intraoperative fracture. Impaction bone grafting is better than cementless
revision when the femoral canal is ectatic (.15– 19 mm). In ectatic femora, large
cementless stems have to be used and may produce severe stress shielding. Two
situations are not suited for impaction bone grafting: severe femoral bone loss
with extensive segmental defects and minor bone loss. Extensive femoral defects
are best treated with a bulk allograft or cementless hydroxyapatite (HA)-coated
stem and minor bone loss [38] with a cementless revision stem, which is a simple
and effective way of restoring bone stock [6,35]. Our original technique is
successful in the long term, and our modification of the Exeter technique has
had no adverse effect on results after 3 [11], 6 [10], and 10 years of follow-up
(Fig. 4).

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of impacted morselized grafts. Rev Chir Orthop 2000; 86(suppl 1):77– 80.
26
Impaction Bone Grafting at the Hip:
A Clinical Review
Mickey S. Cho and Michael T. Casnellie
William Beaumont Army Medical Center
El Paso, Texas, U.S.A.

Seth S. Leopold
University of Washington Medical Center
Seattle, Washington, U.S.A.

I. INTRODUCTION

Loosening of the femoral component after total hip arthroplasty is often


associated with loss of proximal femoral bone stock. A variety of techniques have
been described for revision of the femoral component in a failed total hip
arthroplasty (THA) with severe bone stock deficiency. Cemented [1,2] and
cementless [3 – 5] (Fig. 1) methods of fixation have been successful over both
intermediate- and long-term follow-up; however, these techniques are not always
suitable when there is massive bone stock loss (Fig. 2). The goal of these
techniques is to provide a stable and durable reconstruction despite the loss of
bone [1 –5]. In the most severe cases, allograft-prosthetic composites [6 –9] and
proximal femoral replacement “megaprostheses” [10 – 12] offer salvage options
but are associated with high rates of severe complication, including dislocation,
deep infection, and nonunion of allograft-prosthesis composites.
The technique of cancellous impaction allografting with cement, unlike the
other femoral revision techniques previously mentioned, attempts to reconstitute


The views expressed in this article are those of the authors and do not reflect the official policy of the
Department of Defense or the United States Government.

377
378 Cho et al.

Figure 1 Anteroposterior hip radiograph of an extensively porous-coated,


cementless, revision femoral component. While this is a durable revision
technique, it is occasionally associated with severe proximal stress shielding, as
seen in this radiograph. (Figure courtesy of Aaron G. Rosenberg, M.D.)
Impaction Bone Grafting at the Hip 379

Figure 2 Anteroposterior hip radiograph showing severe bone loss around a


failed femoral component. This case would be difficult to revise using standard
cementless or cemented techniques, and might be a suitable case for impaction
allografting. (Figure courtesy of Aaron G. Rosenberg, M.D.)
380 Cho et al.

bone defects in the proximal femur while at the same time gaining stable fixation
[6,8,13 –16]. This approach consists of cementing a femoral stem into a “neo-
endosteum” created within the deficient femur by containing and tightly packing
morselized cancellous bone graft. One potential advantage of impaction
allografting is the reconstitution of bone stock [15,17], which may be desirable
for future revision operations, should they be necessary. The purpose of this
chapter is to review the history, indications, surgical techniques, complications,
and published clinical results associated with femoral impaction allografting.

II. HISTORY OF IMPACTION ALLOGRAFTING

Impaction allografting with morselized cancellous bone was first described as a


technique for hip reconstruction in protrusio acetabuli [18]. Gie et al. later
adapted the technique for use on the femoral side of a failed THA [15]. It was first
used in England, without cement, for femoral reconstruction in 1985 [19]. Two
years later, the originators of the technique, Gie et al., performed the proce-
dure with cement using the Exeter stem (Stryker-Howmedica-Osteonics,
Rutherford, NJ) [15]. Numerous studies since have reported clinical results
using this technique or one of its variants [6,13,14,16,20 –34].
A major controversy that continues to surround this surgical approach is
whether it should be considered a “system” or a “surgical technique.” Early
advocates of impaction allografting [15,19] as well as some more recent
proponents [13,14,16,17] have maintained that success with this approach
depends not just on a high level of surgical performance, but also on a femoral
component of a particular design and surface finish. Many of these investigators
have indicated that the properties of the Exeter stem (Stryker-Howmedica-
Osteonics, Rutherford, NJ) [15] or the very similar CPT stem (Collarless Polished
Taper stem by Zimmer, Warsaw, IN) [13,14,16,17,21,31]—both of which
are highly polished, double-tapered, noncollared implants—are required to
achieve controlled subsidence and properly load the cancellous bone graft. These
investigators have indicated that subsidence of the wedge-shaped stem provides a
beneficial level of compression to the graft and encourages graft remodeling and
reconstitution of deficient bone stock.
Other published reports have highlighted the numerous variables intrinsic to
impaction allografting and have attempted to determine whether the benefits of
bone stock reconstitution could be achieved without the disadvantages associated
with stem subsidence [13,20,25], including fracture, dislocation, and limb length
inequality. In essence, these investigators and others have posed the question of
whether impaction allografting is a surgical technique, with numerous modifiable
variables whose adjustment might lead to higher or lower success rates, or a system
that consists of a particular stem design, instrumentation, graft type, and surgical
Impaction Bone Grafting at the Hip 381

approach. This line of inquiry has led to the exploration of other implant designs
[20,22,23,29,35,36], different means of graft packing and insertion [30], stem-
rasp mismatches [37], use of extended trochanteric osteotomies with impaction
grafting [38,46], and even performance of the technique (generally unsuccessfully)
without cement [29]. The alternative stem designs have covered the full range of
available implant geometries and surface finishes, including a Charnley-type stem
[5,32,36], a proximally roughened design (Spectron EF; Richards, Memphis, TN)
[22,23]; a roughened, precoated and normalized design (Harris Precoat; Zimmer,
Warsaw, IN) [20]; and a collared, proximally porous coated, titanium-alloy
implant (Bi-Metric and Head-Neck stems; Biomet, Warsaw, IN) [29]. Longer
follow-up will be needed to definitively ascertain whether cancellous impaction
allografting should be considered a “system” or a “technique.”

III. ALGORITHM FOR FEMORAL RECONSTRUCTION

The following is an algorithm that can be used to guide surgical decision making
in a failed femoral component (Fig. 3). Once infection is ruled out, both
metaphyseal and diaphyseal bone stock are assessed.
If the diaphysis is intact and there is minimal metaphyseal bone stock
disruption, conventional cemented or cementless fixation may be appropriate.
Such minimally damaged femurs would be expected to do well with most
revision techniques [1 – 6]. If there is more severe bone loss, but the femoral canal
diameter is less than or equal to 18 mm and intra-operatively at least 4– 6 cm of
intact diaphyseal bone is available to provide solid, cementless fixation with good
rotational stability, then a 6– 8 inch extensively porous-coated stem has proven
very successful [3,4,39]. Proximally coated cementless stems have not been
satisfactory over the long term in such situations [40]. When the femoral
diaphyseal canal is greater than 18 mm, the cortices have thinned to the point
where cementless fixation poses an undue risk of fracture and there is less than
4 cm of distal diaphysis available for press-fit fixation, revision options include:
proximal femoral replacement (Fig. 4), allograft-prosthetic composite, and
impaction allografting [3,6,8,10]. Impaction allografting may be considered in
this setting when priority is given to the restoration of proximal bone stock, such
as in a younger or more active patient.

IV. SURGICAL APPROACHES AND TECHNICAL


“PEARLS”

Gie et al. originally published results using femoral impaction allografting with
cement in 1993 [15]. The original stem used by that group was the highly
382 Cho et al.

Figure 3 Algorithm for revising a failed femoral component in total hip


arthroplasty.

polished, collarless, double-tapered Exeter stem (Stryker-Howmedica-Osteonics,


Rutherford, NJ). Controversy exists over the significance of implant shape and
surface finish [13,16,25,35], but no randomized, controlled clinical trials have
addressed these issues.
Regardless of the stem type used, it is agreed that uniform and consistent
insertion of bone graft should be achieved, that the neo-endosteum is fashioned
in a shape similar to the prosthesis to be inserted, and that the final rasp should
be larger in all dimensions than the actual implant in order to improve the quality
of the cement mantle [37]. To this end, several manufacturers have designed
Impaction Bone Grafting at the Hip 383

Figure 4 Anteroposterior radiograph of a proximal femoral replacement


prosthesis or “megaprosthesis.” A megaprosthesis may be used in cases of
severe femoral bone loss; however, they are associated with high rates of infection
and dislocation.
384 Cho et al.

systems, including instrumentation, that simplify delivery of morselized


cancellous graft chips, in addition to size- and shape-matched impaction tamps
[23,25,30,35,41].
It is imperative that the surgeon perform meticulous preoperative planning
prior to undertaking femoral impaction allografting. Deep infection must be ruled
out using necessary blood work, imaging studies, and, when indicated, hip
aspiration. Intraoperative frozen sections may also be useful to help exclude
infection [42,43]. Preoperative radiographs should include an AP pelvis and an
AP and lateral radiograph of the affected hip, which include several inches
of femur beyond the anticipated revision stem tip. Radiographs and physical
examination together can be used to determine appropriate limb length;
several approaches have been proposed to guide these measurements [44,45].
Abnormal femoral morphology, including bowing and angular deformity, should
be noted. Varus deformities of the proximal metaphyseal-diaphyseal junction are
frequently seen in femurs with long-standing aseptically loose stems. Since the
most common major complication of femoral impaction allografting is intra- and
postoperative fracture, it is critical to locate cavitary and segmental defects in the
femur, as well as areas of ectatic cortex that might require reinforcement with
strut allografts or wire mesh [14 – 16,20,23 –25,29].
Particular attention also needs to be paid to implant templating. Early
studies with femoral impaction allografting used prostheses that were similar in
length to primary reconstruction implants [13 –17].
Because of the concern about predisposing patients to a higher fracture risk
by using stems that did not extend past significant femoral defects, longer
implants have been used to bypass particularly severe areas of cortical
attenuation or damage [5,25]. For cases where significant femoral neck erosion
has occurred, calcar-replacement implants are sometimes used (Smith-Nephew-
Richards, Memphis, TN; Stryker-Howmedica-Osteonics, Rutherford, NJ); how-
ever, some proponents of impaction allografting prefer reconstructing the calcar
and femoral neck bone stock with impaction allografting along with mesh,
cortical allografts, and cerclage wires [15]. Either calcar-replacement stems or
proximal bone grafting is necessary to achieve equal leg length and to minimize
the likelihood of dislocation.
Regardless of the implant and graft-insertion system used, impaction
allografting begins with an adequate surgical exposure. Numerous approaches have
been used, including anterolateral, posterior, lateral transtrochanteric, and lateral
with extended trochanteric osteotomy [13,14,20,23,30,35,46]. While a trochanteric
osteotomy may improve exposure and facilitate failed component removal,
nonunion rates from 33 to 50% have been reported using this approach in impaction
allografting cases [16,20]. Likewise, extended trochanteric osteotomies have been
shown to be biomechanically and clinically inferior for impaction allografting
[38,46]. Therefore, it is best to avoid femoral osteotomies whenever possible.
Impaction Bone Grafting at the Hip 385

Once adequate exposure is achieved, the loose or failed femoral implant is


removed and the entire cement mantle extracted. Any debris or fibrous material
remaining in the femoral canal is removed as well. While removal of canal debris
may be tedious, extreme caution must be exercised while removing retained
cement. This is the part of the procedure where femoral perforation is most likely
to occur. Rates of femoral perforation with impaction allografting have ranged
from 5 to 24% in published series [14 –16,20,21,34,35].
Adequate suction devices, instruments specifically designed for cement
removal, and flexible fiberoptic illumination help minimize this danger. Once the
canal is debrided, cavitary defects and regions of ectatic cortex must be reinforced
with either wire mesh or cortical strut allografts and cerclage wire. This step is
critical to decrease the possibility of iatrogenic fracture during stem impaction.
Next, a canal-restricting plug is inserted approximately 2 cm distal to the
expected site of the tip of the revision prosthesis. Any cement distal to the plug
may be left in place to minimize the likelihood of causing a distal perforation. In
fact, a well-bonded, occlusive, distal cement plug may be left in situ to act as a
canal restrictor, provided that it is at an appropriate level, and the graft insertion
system does not depend on a centralizing rod that threads into a distal plastic plug.
Before inserting the morselized bone graft, it is imperative that the
impactors used to sculpt the neo-endosteum can be correctly aligned within the
femoral canal. Malalignment of the neo-endosteum created by poorly aligned
tamps or impactors will cause a malaligned implant. Some systems centralize
the neo-endosteum using cannulated tamps or impactors that pass over a threaded
rod, which itself inserts into the distal canal-restricting plug or into the retained
distal cement plug itself.
Insertion of the bone graft may be accomplished by hand or by using any
number of commercially available delivery systems. Stryker-Howmedica-
Osteonics (Rutherford, NJ) manufactures a bone graft – injecting “gun” (similar
to a cement gun), which attaches to tubes sized to the native endosteum in order
to fill the femoral canal with cancellous bone in a uniform fashion [41]. The
Smith-Nephew-Richards (Memphis, TN) system uses a hand-powered syringe,
with or without radial reaming impactors [23,30]; other devices are also
commercially available. It is imperative that regardless of which system is used,
the neo-endosteum and final implant be neutrally aligned. The most common
malalignment error is to place the neo-endosteum and final implant in varus,
which would be expected to compromise long-term results.
Although controlled trials comparing allograft types (fresh-frozen,
irradiated, freeze-dried) or bone graft substitutes have not been performed, the
procedure is most commonly performed using fresh-frozen cancellous bone
chips. Fresh-frozen allograft has better compliance for purposes of impaction
than does freeze-dried allograft, which tends to crumble or pulverize. In addition,
the osteoinductive properties of freeze-dried allograft are not clear, and adequate
386 Cho et al.

graft incorporation have only been shown in several small series [26,42]. A series
using freeze-dried allograft by Tokgözoglu et al. challenged this view, but the
small sample size and short-term follow-up presented in that report limits its
ability to draw firm conclusions on the topic [26]. Another recent series using
freeze-dried impacted allograft for acetabular revisions showed promising
intermediate results, but conclusions about the series may not be directly
transferable to femoral impaction allografting [42]. Cancellous allograft may be
prepared from allograft femoral heads that are morsellized to 2– 4 mm chips
using a bone mill (Lere Bonemill, DePuy Inc., Allendale, NJ). Premorselized
fresh-frozen cancellous allograft also is commercially available (Allosource,
Denver, CO), which can save time in the operating room. Some investigators
have specifically advocated nonirradiated fresh frozen allograft [15,41] because
of the potentially improved mechanical properties compared to allograft that has
been irradiated; again, this belief has not been clinically validated with
biomechanical or randomized, controlled trials.
Once the endosteum has been debrided and the distal canal restrictor has
been placed, approximately 2 cm of graft is impacted against the canal restrictor,
leaving enough length proximal to that graft to permit stem insertion. Graft is
then further inserted to fill the canal and a neo-endosteum is fashioned using hand-
held tamps [41], cannulated impactors or tamps [20,41], or reamers [30]. The graft
impaction process is necessarily vigorous, creating significant hoop stresses in the
femur. Intraoperative fractures occur most commonly during this step in the
procedure, and the importance of reinforcing femoral defects with wire mesh or
strut allografts and cerclage wires prior to impaction cannot be overstated.
The instruments used to fashion the neo-endosteum are contoured to match
the final prosthesis used. Ideally, the tamps are 1– 2 mm larger than the final
implant so that there is suitably thick cement mantle surrounding the stem [35].
This was not the case with some early impaction grafting systems where some
tamps were actually smaller than the final implant; the result was inconsis-
tent cement mantles [35]. Cement mantle quality may be difficult to assess
radiographically because of the presence of overlying bone graft, implant,
cortical struts, wire mesh, and other hardware. Nevertheless, even with properly
oversized tamps, poor cement mantles (Harris grade C and D [48]) are common
in series reporting on impaction allografting [20,35]. Since loss of femoral neck
bone stock to the level of the lesser trochanter is common in these cases, it is
important that the surgeon be prepared to use other landmarks to establish correct
femoral anteversion in order to avoid postoperative dislocation, such as the distal
femoral condyles or the linea aspera.
Once the neo-endosteum has been created, the final tamp in most systems
may be used to perform a trial reduction to evaluate the stability of the recon-
struction (Fig. 5). At this time supplemental bone graft may also be packed around
the trial stem in the upper end of the femur using a hand-held bone punch.
Impaction Bone Grafting at the Hip 387

Figure 5 Intraoperative photograph demonstrating the final tamp during an


impaction allografting procedure. This photograph was taken after the bone
graft had been inserted and tightly packed. In these cases, the final tamp may be
used as a trial to evaluate stability prior to cementing. (Figure courtesy of Aaron
G. Rosenberg, M.D.)
388 Cho et al.

If the impaction grafting procedure is performed properly, an impressive


amount of both axial and rotational stability can be achieved with the final tamp
(Fig. 6). One system even recommends verifying rotational stability using a
torque wrench to 9– 11 N-m (80 – 100 in-lb) [23]. No visible rotation of the tamp
should be observed when this torque is applied. Once acceptable stability has
been achieved, the trial tamp is removed and the final implant is cemented in the
standard fashion. One notable difference from routine cementing is that the
cement should be injected in a less viscous state than usual so that better cement
penetration into the packed cancellous graft of the neo-endosteum can be
achieved.

V. PROBLEMS AND COMPLICATIONS OF IMPACTION


ALLOGRAFTING
A. General Complications
Femoral impaction allografting is one of the most technically challenging
techniques used for femoral reconstruction; therefore, many investigators limit its
use to the more difficult revisions. As a result, the complication rate can be high,
especially in cases with more severe bone stock deficiency [16,20,24,25,29]. The
most common complication is intra- and post-operative femur fracture (Fig. 7),
which will be discussed separately. As expected, the dislocation rate is higher
than in primary total hip arthroplasty and has been reported to range from 0 to
14%. Postoperative infection is usually reported at a rate of 3– 6% which is also
considerably higher than in primary total hip arthroplasty. As mentioned
previously, femoral osteotomies are not recommended in femoral impaction
allografting. Nonunion of greater trochanteric osteotomies has been reported in
33 – 50% of cases [16,20]. Similarly, extended trochanteric osteotomies are
discouraged after both clinical and biomechanical studies reported problems with
that approach when combined with impaction allografting [38,46].
Osteotomies are suspected to do poorly because of compromised bone
stock and cement interposition within the osteotomy site itself. Other reported
complications include deep venous thrombosis, pulmonary embolus, postoperative
myocardial infarction, pneumonia, heterotopic ossification, hardware-related
trochanteric bursitis, and catastrophic stem failure [14–16,20,24,29,49].

B. Femoral Fracture and Perforation


The incidence of intra- and postoperative femur fracture ranges from 5 to 34%
and has been a reported complication in nearly every series on this technique
[14 –16,20,21,24,25,27,29,31 –34]. As anticipated, fracture is more likely in
Impaction Bone Grafting at the Hip 389

Figure 6 When impaction allografting is correctly performed, a significant amount


of axial and rotational stability should be obtained when trialing with the final tamp.
390 Cho et al.

Figure 7 Intraoperative, antero-posterior radiograph taken during a case of


impaction allografting, which shows an intraoperative femur fracture. This is the
most common complication of impaction allografting. Femoral fracture or perforation
is reported in 5–34% of published series on impaction allografting. (Figure courtesy
of Aaron G. Rosenberg, M.D.)
Impaction Bone Grafting at the Hip 391

cases with more significant bone stock deficiency [14 –16,20,24,25,29].


Intraoperative fractures generally occur during the impaction process when
large hoop stresses are generated [16]. Cortical strut allografts [14,16] or mesh
[15] should be used to reinforce femoral defects prior to impaction to reduce
the risk of fracture. Postoperative femur fracture may occur proximally [16] or
more distally near the stem tip [14]. It is suspected that many “postoperative”
femoral fractures are, in fact, undisplaced, intraoperative fractures that were
not appreciated during the surgery or on postoperative radiographs, as those
radiographs can be difficult to interpret in the presence of overlying densities from
cement, graft, stem, mesh, wires, and other hardware. Fractures have been
associated with failure of the reconstruction [15,16] and with reoperation
[14–16,24,25,29].
Femoral perforation usually occurs intraoperatively while removing
retained cement from the femoral canal. It can be treated successfully with
cortical strut allografts [50].
Good exposure, lighting, and cement-removal instruments help decrease
the likelihood of femoral perforation.

C. Subsidence
Considerable controversy exists regarding stem subsidence in femoral impaction
allografting. Gie et al. in their initial reports claimed that the wedge-shaped stem
geometry may improve bone graft incorporation and healing by the compressive
load produced by the subsiding stem [19]. It has therefore been suggested that
subsidence of wedge-shaped stems does not necessarily indicate failure
[14,15,51], in contrast to THAs designs that use roughened or precoated femoral
stems [50,52,53]. What remains to be answered from these reports about the
Exeter stem (Stryker-Howmedica-Osteonics, Rutherford, NJ) or ones similar to it
is the amount of subsidence that can reasonably be considered efficacious.
Eldridge et al. defined minimal subsidence less than 5 mm migration and
moderate subsidence 10 mm [13]. While subsidence with roughened or precoated
stems clearly indicates failure [20], subsidence of polished taper stems may not
be the entirely benign or beneficial process that early proponents of impaction
allografting suggested [15].
Originally, it was felt that subsidence was a result of “cold flow” of the
cement, and, as a result, the stem would self-tighten as it subsided. More recent
studies indicate that this does not always happen. Masterson et al. reported
high rates of cement fractures in stems that subsided [25]. This evidence suggests
that “cold flow” of cement is not the mechanism of all cases of subsidence.
A similar conclusion was reached in a study that used radiostereometric
analysis [54]. Additionally, subsidence has been associated with thigh pain [13]
392

Table 1 Results of Femoral Impaction Allografting

Failed/
a
Min/mean Femur Subsidence, revised for
follow-up fracture, % (n) and/or loosening, Dislocation,
Series Stem n (months) % (n) mean mm % (n) % (n)

Polished tapered
stems
Eldridge [13] Exeter, CPT 79 6/13 NA 23 (18/79)b 10 (8/79) NA
Elting [14] CPT 67 24/31 5 (3/60) 48 (27/56) 5 (3/60) 3 (2/60)
Flugsrud [21] Exeter-2, 10 36/52 0 (0/10) 80 (8/10) 2.1 0 (0/10) NA
CPT-8
Gie [15] Exeter 58 18/30 7 (4/58) 79 (44/56) 5 (3/58) 5 (3/58)
Knight [24] CPT 31 7/31 16 (5/31) 50 (15/30) 2.3 0 (0/31) 13 (4/31)
Lind [34] Exeter 87 12/42 2 (2/87) 2 (2/87)b 0 (0/87) 6 (5/87)
Masterson [25] Exeter 35 NA 17 (6/35) 20 (7/35)c NA 6 (2/35)
Tokgözoglu [26] Exeter 9 12/14 NA 0 (0/9) 0 (0/9) NA
Meding [16] CPT 34 24/30 24 (8/34) 44 (15/34) 6 (2/34) 3 (1/34)
Mikhail [55] CPT 43 min 60 5 (2/43) 86 (37/43) 3 (1/38) 8 (3/38)
Ornstein [28] Exeter 18 24/24 NA 2.5 NA NA
Pekkarinen [29] Exeter 36 1/(1– 72) 25 (9/36) 86 (31/36) 2.7 6 (2/36) 3 (1/36)
Bi-Metricd 21 33 (7/21) 90 (19/21) 2.7 5 (1/21) 14 (3/21)
Head-Neckd 11 64 (7/11) 100 (11/11) 5.6 9 (1/11) 0 (0/11)
van Biezen [31] Exeter 21 41/60 10 (2/21) 81 (17/21) 7.2 0 (0/21) 5 (1/21)
Cho et al.
Matte-finished,
small-collared
stems
Boldt [32] Charnley 79 ,20/48 1.2 (1/79) 9 (7/79)e 1.2 (1/79) 10 (8/79)
Elite Plus 3 (2/79)f
Collared stems
(varied surface
finishes)
Fetzer [33] Iowa 13 30/67 12 (3/26) 4 (1/26)g 0 (0/26) 12 (3/26)
Triumph 6
Heritage 4
Harris 3
Roughened,
Impaction Bone Grafting at the Hip

collared stems
Hostner [22] Spectron EF 24 3/3 NA 0.19 NA NA
Karrholm [23] Spectron 22 24/30 NA 0.4 0 (0/22) NA
Leopold [20] Harris 29 48/63 24 (6/25) 8 (2/25) 12 (3/25) 4 (1/25)
a
Defined as greater than or equal to 1 mm except as otherwise indicated.
b
Greater than 5 mm.
c
Greater than 10 mm.
d
Proximally porous-coated, collared, titanium alloy stems using uncemented fixation.
e
Greater than 4 mm, less than 6 mm.
f
Greater than or equal to 6 mm, less than or equal to 8 mm.
g
Less than 5 mm.
393
394 Cho et al.

and later dislocation [25]. Therefore, the assertion that stems may subside an
unrestricted distance, over any period of time, at any of several interfaces
(cement/bone, stem/cement, or both), without meeting criteria for failure cannot
be substantiated by studies that do not offer standardized functional or outcomes
scores [15].
The length of time a stem may subside without failure is controversial [16].
One recent study used radiostereometric analysis to determine that most
migration occurs during the first 2 weeks and that some stems become stable after
5 weeks [27]. In addition, other recent clinical trials have reported smaller
magnitudes of subsidence [32 –34]. A possible explanation for these apparently
improved results may involve the steps taken in preparation of the
neo-endosteum [22,26], by better impaction technique [22], or graft material
[26]. The reasons for stem subsidence in femoral impaction allografting are
complex, but based on the good short- to intermediate-term results of recent
series using an assortment of femoral prostheses, it seems that a firm impacted
allograft is more important than stem design [32 – 34].

VI. CLINICAL RESULTS OF IMPACTION ALLOGRAFTING

Results of femoral impaction allografting with short- to intermediate-term


follow-up have been reported using an assortment of femoral prostheses by
a number of different centers [13 –16,20 – 26,28,29,31 –34,55]. Table 1 summa-
rizes pertinent endpoints from these clinical series.

VII. SUMMARY

Femoral impaction allografting is an accepted alternative for revision of a failed


femoral component with severe bone stock deficiency. This procedure has a
considerable learning curve, is technically demanding, and has numerous
variables that need to be controlled in order to have a reasonable hope of clinical
success. To date there have been no published reports from randomized,
controlled clinical trials comparing different femoral stems or grafts for femoral
impaction allografting. Investigators have shown equally good short- to
intermediate-term results with a variety of femoral stems by a number of
different centers. Until there are data available to compare the many variables in
femoral impaction allografting—including graft type, impaction system, femoral
stem type, and others—the question will remain: Is femoral impaction
allografting a “system” or a “technique”?
Impaction Bone Grafting at the Hip 395

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7. Blackley HR, Davis AM, Hutchison CR, Gross AE. Proximal femoral allografts for
reconstruction of bone stock in revision arthroplasty of the hip. A nine to fifteen-year
follow-up. J Bone Joint Surg 2001; 83-A:346 – 354.
8. Chandler H, Clark J, Murphy S, McCarthy J, Penenberg B, Danylchuk K, Roehr
B. Reconstruction of major segmental loss of the proximal femur in revision total hip
arthroplasty. Clin Orthop 1994; 298:67 –74.
9. McGoveran BM, Davis AM, Gross AE, Bell RS. Evaluation of the allograft-prosthesis
composite technique for proximal femoral reconstruction after resection of a primary
bone tumour. Can J Surg 1999; 42:37–45.
10. Malkani AL, Sim FH, Chao EY. Custom-made segmental femoral replacement
prosthesis in revision total hip arthroplasty. Orthop Clin North Am 1993;
24:727– 733.
11. Malkani AL, Settecerri JJ, Sim FH, Chao EY, Wallrichs SL. Long-term results of
proximal femoral replacement for non-neoplastic disorders. J Bone Joint Surg Br
1995; 77:351 –356.
12. Malkani AL, Paiso JM, Sim FH. Proximal femoral replacement with megaprosthesis.
Instr Course Lect 2000; 49:141 – 146.
13. Eldridge JD, Smith EJ, Hubble MJ, Whitehouse SL, Learmonth ID. Massive early
subsidence following femoral impaction grafting. J Arthroplasty 1997; 12:535 – 540.
14. Elting JJ, Mikhail WE, Zicat BA, Hubbell JC, Lane LE, House B. Preliminary report
of impaction grafting for exchange femoral arthroplasty. Clin Orthop 1995;
319:159– 167.
15. Gie GA, Linder L, Ling RS, Simon JP, Slooff TJ, Timperley AJ. Impacted cancellous
allografts and cement for revision total hip arthroplasty. J Bone Joint Surg 1993;
75B:14 – 21.
16. Meding JB, Ritter MA, Keating EM, Faris PM. Impaction bone-grafting before
insertion of a femoral stem with cement in revision total hip arthroplasty. A
minimum two-year follow-up study. J Bone Joint Surg 1997; 79A:1834 – 1841.
396 Cho et al.

17. Nelissen RG, Bauer TW, Weidenhielm LR, LeGolvan DP, Mikhail WE. Revision
hip arthroplasty with the use of cement and impaction grafting. Histological analysis
of four cases. J Bone Joint Surg 1995; 77A:412– 422.
18. Slooff TJ, Huiskes R, van Horn J, Lemmens AJ. Bone grafting in total hip replacement
for acetabular protrusion. Acta Orthop Scand 1984; 55:593–596.
19. Ling RS, Timperley AJ, Linder L. Histology of cancellous impaction grafting in the
femur. A case report. J Bone Joint Surg 1993; 75B:693 – 696.
20. Leopold SS, Berger RA, Rosenberg AG, Jacobs JJ, Quigley LR, Galante JO.
Impaction allografting with cement for revision of the femoral component. A
minimum four-year follow-up study with use of a precoated femoral stem. J Bone
Joint Surg 1999; 81A:1080 – 1092.
21. Flugsrud GB, Ovre S, Grogaard B, Nordsletten L. Cemented femoral impaction bone
grafting for severe osteolysis in revision hip arthroplasty. Good results at 4-year
follow-up of 10 patients. Arch Orthop Trauma Surg 2000; 120:386 – 389.
22. Hostner J, Hultmark P, Karrhölm J, Malchau H, Tveit M. Impaction technique and
graft treatment in revisions of the femoral component: laboratory studies and clinical
validation. J Arthroplasty 2001; 16:76 – 82.
23. Karrhölm J, Hultmark P, Carlsson L, Malchau H. Subsidence of a non-polished stem
in revisions of the hip using impaction allograft. Evaluation with radiostereometry
and dual-energy x-ray absorptiometry. J Bone Joint Surg 1999; 81B:135 – 142.
24. Knight JL, Helming C. Collarless polished tapered impaction grafting of the femur
during revision total hip arthroplasty: pitfalls of the surgical technique and follow-up
in 31 cases. J Arthroplasty 2000; 15:159– 165.
25. Masterson EL, Masri BA, Duncan CP. The cement mantle in the Exeter impaction
allografting technique. A cause for concern. J Arthroplasty 1997; 12:759 – 764.
26. Tokgözoglu MA, Aydin M, Atilla B, Caner B. Scintigraphic evaluation of impaction
grafting for total hip arthroplasty revision. Arch Orthop Trauma Surg 2000;
120:416 – 419.
27. Ornstein E, Franzen H, Johnsson R, Sundberg M. Radiostereometric analysis in hip
revision surgery – optimal time for index examination: 6 patients revised with
impacted allografts and cement followed weekly for 6 weeks. Acta Orthop Scand
2000; 71:360 – 364.
28. Ornstein E, Atroshi I, Franzen H, Johnsson R, Sandquist P, Sundberg M. Results of
hip revision using the Exeter stem, impacted allograft bone, and cement. Clin Orthop
2001; 401:126 – 133.
29. Pekkarinen J, Alho A, Lepisto J, Ylikoski M, Ylinen P, Paavilainen T. Impaction
bone grafting in revision hip surgery. A high incidence of complications. J Bone
Joint Surg 2000; 82B:103 – 107.
30. Stulberg SD. Radial impaction grafting in revision total hip arthroplasty: a new
technique and results using femoral stems of variable lengths and neck off-sets.
Presented at American Association of Hip and Knee Surgeons, Dallas, TX, Oct
18 – 20, 1999.
31. van Biezen FC, ten Have BL, Verhaar JA. Impaction bone-grafting of severely
defective femora in revision total hip surgery: 21 hips followed for 41 – 85 months.
Acta Orthop Scand 2000; 71:135 – 142.
Impaction Bone Grafting at the Hip 397

32. Boldt JG, Dilawari P, Agarwal S, Drabu KJ. Revision total hip arthroplasty using
impaction bone grafting with cemented nonpolished stems and Charnley cups.
J Arthroplasty 2001; 16:943 – 952.
33. Fetzer GB, Callaghan JJ, Templeton JE, Goetz DD, Sullivan PM, Johnston RC.
Impaction allografting with cement for extensive femoral bone loss in revision hip
surgery. A 4-to 8-year follow-up study. J Arthroplasty 2001; 16:195 – 202.
34. Lind M, Krarup N, Mikkelsen S, Horlyck E. Exchange impaction allografting for
femoral revision hip arthroplasty. Results in 87 cases after 3.6 years’ follow-up.
J Arthroplasty 2002; 17:158 – 164.
35. Masterson EL, Busch CA, Duncan CP, Drabu K. Impaction allografting of the
proximal femur using a Charnley-type stem: a cement mantle analysis. J Arthroplasty
1999; 14:59– 63.
36. Ullmark G, Linder L. Histology of the femur after cancellous impaction grafting
using a Charnley prosthesis. Arch Orthop Trauma Surg 1998; 117:170 – 172.
37. Masterson EL, Masri BA, Duncan CP, Rosenberg A, Cabanela M, Gross M. The
cement mantle in femoral impaction allografting. A comparison of three systems
from four centres. J Bone Joint Surg 1997; 79B:908-913.
38. Chassin EP, Silverton CD, Berzins A, Rosenberg AG. Implant stability in revision
total hip arthroplasty: allograft bone packing following extended proximal femoral
osteotomy. J Arthroplasty 1997; 12:863– 868.
39. Aribindi R, Barba M, Solomon MI, Arp P, Paprosky W. Bypass fixation. Orthop Clin
North Am 1998; 29:319 –329.
40. Peters CL, Rivero DP, Kull LR, Jacobs JJ, Rosenberg AG, Galante JO. Revision total
hip arthroplasty without cement: subsidence of proximally porous-coated femoral
components. J Bone Joint Surg 1995; 77A:1217– 1226.
41. Capello WN. Impaction grafting plus cement for femoral component fixation in
revision hip arthroplasty. Orthopedics 1994; 17:878 – 879.
42. Della Valle CJ, Bogner E, Desai P, Lonner JH, Adler E, Zuckerman JD, Di Cesare
PE. Analysis of frozen sections of intraoperative specimens obtained at the time of
reoperation after hip or knee resection arthroplasty for the treatment of infection.
J Bone Joint Surg 1999; 81A:684– 689.
43. Feldman DS, Lonner JH, Desai P, Zuckerman JD. The role of intraoperative frozen
sections in revision total joint arthroplasty. J Bone Joint Surg 1995; 77A:1807– 1813.
44. Goodman SB, Huene DS, Imrie S. Preoperative templating for the equalization of leg
lengths in total hip arthroplasty. Contemp Orthop 1992; 24:703 – 710.
45. Woolson ST. Leg length equalization during total hip replacement. Orthopedics
1990; 13:17– 21.
46. Hellman EJ, Capello WN, Feinberg JR. Nonunion of extended trochanteric osteo-
tomies in impaction grafting femoral revisions. J Arthroplasty 1998; 13:945–049.
47. Thien TM, Welten MLM, Verdonschot N, Buma P, Yong P, Schreurs W. Acetabular
revision with impacted freeze-dried cancellous bone chips and cemented cup.
J Arthroplasty 2001; 16:666 – 670.
48. Harris WH, McCarthy JC Jr, O’Neill DA. Femoral component loosening using
contemporary techniques of femoral cement fixation. J Bone Joint Surg 1982;
64:1063– 1067.
398 Cho et al.

49. Jazrawi LM, Della Valle CJ, Kummer FJ, Adler EM, Di Cesare PE. Catastrophic
failure of a cemented, collarless, polished, tapered cobalt-chromium femoral stem
used with impaction bone-grafting. A report of two cases. J Bone Joint Surg 1999;
81A:844– 847.
50. Duncan CP, Masterson EL, Masri BA. Impaction allografting with cement for the
management of femoral bone loss. Orthop Clin North Am 1998; 29:297– 305.
51. Fowler JL, Gie GA, Lee AJ, Ling RS. Experience with the Exeter total hip
replacement since 1970. Orthop Clin North Am 1988; 19:477 – 489.
52. Berger RA, Kull LR, Rosenberg AG, Galante JO. Hybrid total hip arthroplasty: 7- to
10-year results. Clin Orthop 1996; 333:134– 146.
53. Oishi CS, Walker RH, Colwell CW Jr. The femoral component in total hip
arthroplasty. Six to eight-year follow-up of one hundred consecutive patients after
use of a third-generation cementing technique. J Bone Joint Surg 1994; 76A:
1130– 1136.
54. Franzen H, Toksvig-Larsen S, Lidgren L, Onnerfalt R. Early migration of femoral
components revised with impacted cancellous allografts and cement. A preliminary
report of five patients. J Bone Joint Surg 1995; 77B:862 – 864.
55. Mikhail WE, Wretenberg PF, Weidenhielm LR, Mikhail MN. Complex cemented
revision using polished stem and morselized allograft. Minimum 5-years follow-up.
Arch Orthop Trauma Surg 1999; 119:288– 291.
27
Revision of Total Knee Arthroplasty
by Impaction Bone Grafting
Gary W. Bradley
ALTA Orthopaedics
Santa Barbara, California, U.S.A.

I. INTRODUCTION

Revision total knee arthroplasty can be technically challenging. Invariably there


is bone loss, which at times is significant, and the remaining bone is often
extremely osteoporotic. Frequently, the bone loss is worse than had been
anticipated before surgery.
Relatively small, contained defects can be managed with a primary prosthesis.
Larger defects can be filled with large amounts of cement. Cement with screw
augmentation is an old technique, which is still indicated in certain circumstances.
In North America, the most common method of replacing bone loss has
been by metal wedges or blocks secured to special long-stemmed revision
prostheses. These implants are designed to be cemented, and do not replace bone
but actually, in most instances, remove more of it. The results of revision total
knee arthroplasty are less predictable than primary knee replacement, and the
technique of metal and cement augmentation creates a cycle of continued and
ongoing bone loss.
Custom implants have also been used for significant bone loss, but lost
bone is not replaced by bone but by implant so that in the event of failure yet
further bone is lost. Thus, it is logical to replace bone loss with bone graft.
Invariably bone loss is too great to be adequately replaced by autograft, so
cadaveric allograft from bone banks is used. This can be as whole bone, parts of
whole bones or impacted morselized allograft. Bone grafts can be used with
polymethylmethacrylate (PMMA) cement [1 – 17].
399
400 Bradley

In revision total joint arthroplasty, bone grafting for protrusioacetabuli or


medial wall defects was first used and reported in the 1970s [18]. This technique
has been most extensively studied and developed by Tom Slooff in Nijmegen, the
Netherlands [19 – 21]. Slooff has also studied the basic science of morselized
bone grafting and has vast and long-term clinical experience that reinforces the
effectiveness of the technique. Professor Slooff can well be called the father of
impaction allografting.
The technique of impaction bone grafting was later adopted by Gie, Linder,
and Ling on the femoral side of failed total hip arthroplasty [22]. Morselized bone
grafting was first used in the knee, to this author’s knowledge, in the early 1980s.
It was first reported by Samuelson in 1988 [11] and then Whiteside in 1993 [15],
and later, more definitively [16,17]. Both these authors used minimally impacted
morselized graft without poly-methylmethacrylate cement. The early reports of
morselized allograft consistently described satisfactory clinical results with good
pain relief and function.
In revision knee replacement, complications specific to bone grafting are
minimal. As with other series of revision arthroplasties, the usual wound
complications, patellar problems, and delayed fracture are reported. None of
these are related to allografting. At five-year follow-up, the percentage of
successful revisions has generally been 90% or more [2 –4,7,11,14,16,17].
Human histology has shown evidence of active new bone formation as
early as 3 weeks. By 3 months extensive vascular infiltration, osteoclastic
resorption of dead graft bone and new osteoid with osteoblasts are evident.
Extensive bone remodeling, resorption and new bone formation continues for
between one and two years; histology after 37 months has shown continuing
resorption and new bone formation [16,21,23,25].

II. INDICATIONS

The immediate appeal of this technique is replacement of lost bone. With


minimal bone loss, traditional modifications of primary arthroplasty techniques
can be used with conventional, primary components, minimal bone graft, and/or
PMMA cement.
In the elderly, frail, and low-demand individuals with moderate to even
extensive bone loss, conventional revision techniques using metal wedges and
blocks and cement can also be employed. Thus, small amounts of even
autogenous impacted morselized bone graft can be used in any revision or
primary knee arthroplasty with more than usual bone loss or extremely weak or
porotic bone [24,26,27]. However, the technique has the most to offer when there
is significant bone loss, especially in a young or active individual in whom the
Revision of Total Knee Arthroplasty 401

surgeon wishes to avoid the potential cycle of repeated revision and ever-
increasing bone loss.
The technique of impacted morselized bone grafting can be used in
infection [2]. Appropriate antibiotics can be placed in bone cement and graft.
I have not found combining bone graft and cement useful but have used impacted
morselized bone graft impregnated by appropriate antibiotics to salvage an
infected knee arthroplasty. The recommended technique is two-stage revision.
The first stage involves removal of all implants and cement, extensive
debridement of soft tissues and closure over antibiotic impregnated cement
beads, spacers, or Prostalac-type implants. The second stage takes place after a
delay of 4 –6 weeks with subsequent debridement and reimplantation of
cementless components utilizing antibiotic impregnated morselized bone graft.
There is concern that antibiotics on bone graft may not be effective, as bone graft
is dead. However, clinical results have been satisfactory with this technique.
There is a paucity of delayed histology on infected cases.

III. TECHNIQUE

The aim of revision total knee arthroplasty is a solid and stable construct and
satisfactory range of movement. Prerequisites to this are alignment, recreating the
joint line, stability, and restoration of lost bone. In revision total knee arthroplasty
alignment, position of joint line, stability, and replacement of lost bone are inter-
related. If these are not adequately addressed, the revision is destined for a poor
result and possibly early failure.
Alignment is a complex issue and often difficult to achieve whether
intramedullary or extramedullary guide systems are used. In revision knee
arthroplasty with significant bone loss, intramedullary alignment will be obtained
from stemmed implants. Instability in revision knee arthroplasty is invariably
related to bone loss or malposition of the joint line.
True ligamentous insufficiency is unusual in either primary or revision knee
arthroplasty. Clinically, malposition of the joint line manifest by patella alta is
associated with an increased incidence of diffuse radiolucent lines in primary
knee replacement [29]. Elevation of the joint line by more than 8 mm is
associated with decreased movement and functional knee scores and increased
pain and incidence of manipulation. Ultimately, revision is associated with to
malposition of the joint line. Another study found that the best knee scores were
when the joint line was within 3 mm of the anatomical normal [30].
In cadavers, elevation of the joint line by 5 mm causes mid flexion laxity
whereas lowering the joint line by 5 mm results in mid-flexion tightening. Any
change in joint line by 5 mm also caused, in these cadaver studies, varus/
valgus instability [33]. Restoration of joint line by replacing lost bone is
402 Bradley

important as a malposition causes instability or poor movement and function and,


ultimately, arthroplasty failure.
Bone loss manifest by malposition of the joint line is a real clinical
problem. In a series of over 100 knee replacements performed by elite surgeons
with extensive revision experience, the joint line was changed by .5 mm in
nearly 80% of cases [34].
The location of the joint line in a “normal” knee has been variably reported
to be between 20 and 40 mm proximal to the tibial tubercle, between 10 and
20 mm proximal to the fibular head, and 25 –33 mm distal to the medial femoral
epicondyle. There is an even more variable relationship to the lateral femoral
condyle. The medial femoral epicondyle is the most consistent landmark, being
most easily located and having the least variation among individuals. This
distance is slightly greater in large or male patients and relatively smaller in
small or female patients. The distance to the posterior femoral condyle from the
medial femoral epicondyle is generally greater than the distance to the distal
femoral condyle. This distance is, on average, between 25 and 30 mm [31 –33].
These observations can be translated to surgical technique in the revision knee
arthroplasty. Preoperative templating and measurements of removed implants
are helpful in determining revision implant size. A common error in revision
knee arthroplasty is downsizing the femoral component to obtain a better fit on
the distal femur deformed by significant bone loss.
The recommended surgical technique is to prepare the tibia first, then to
stabilize the distal femur by using a trial component with intramedullary
alignment rod and pins to restore proper femoral size and rotation. Only after
achieving flexion balance is extension balance addressed.
Flexion balance relates to femoral component size and tibial height, both of
which affect the position of the joint line and are, in turn, influenced by
replacement of lost bone. Flexion balance is also related to rotation and tibial
alignment. Extension balance is related to alignment of both components and
position of the joint line.
Technical performance of revision surgery can be divided into ten steps:

1. Surgical approach
2. Soft tissue debridement
3. Implant removal
4. Bone preparation
5. Graft preparation
6. Graft placement
7. Implant placement
8. Graft augmentation
9. Final impaction of components
10. Closure
Revision of Total Knee Arthroplasty 403

Surgical approach is dictated by surgeon preference and unique problems such as


contracture or deformity and previous surgical approaches. Soft tissue
debridement varies from highly extensive in infection to minimal in straight-
forward revisions without significant polyethylene wear or metallosis. There is,
invariably, in revision knee arthroplasty, extensive scarring in the suprapatellar
region, the medial and lateral gutters, and behind the patellar tendon. There are a
variety of techniques for implant removal.
Requirements for bone preparation are equally variable, but the principal is
to remove all soft tissue from the bone bed to be grafted. Even a sclerotic bone
bed is well vascularized and will contribute to bone healing [12,21]. It is not
necessary to remove sclerotic bone down to cancellous. Attempts to remove all
sclerotic bone just create an even more daunting defect to reconstruct.
The aim of graft preparation is to cancellous or cortico-cancellous bone
chips of between 3 and 5 mm. Most experience is with cleaned and fresh frozen
bone obtained from reputable bone banks. In the United States the American
Association of Tissue Banking has rigid requirements. It is recommended that all
bone be obtained from regulated bone banks.
Donor bone comes in various forms usually as femoral heads or 5 – 10 mm
cancellous and cortico-cancellous pieces. In either case, any of a variety of bone
mills can be used to obtain the 3– 5 mm pieces of bone to be impacted. The frozen
bone should be thawed before milling. Soaking the graft in antibiotic solution has
no adverse effect on ultimate graft viability. It is important to obtain an adequate
amount of bone graft. In most knee revisions two to three morselized femoral
heads or two to three 90 cc bags of cortico-cancellous blocks will be used. Graft
preparation can be performed on the back table by an assistant or technician while
the revision is going on.
Initial graft placement consists of filling all contained defects with
impacted bone. As with many orthopedic surgical techniques, the amount of
impaction can be described as “just enough,” i.e., enough to firmly impact the
graft and create a sound construct without fracturing the underlying bone. If a
sclerotic shell is present, it often is quite thin and fractures easily. If there is no
shell, cancellous bone will be exposed. This merely requires firm impaction of
more bone.
The original impaction techniques for revision knee arthroplasty, described
by Samuelson and Whiteside [11,15 –17], relied on minimal impaction but used
larger pieces of bone. From the extensive work of Slooff it is apparent that greater
impaction will result in better structural stability without impairing graft
incorporation [21].
Conventional tamps and a small to mid-size mallet can be used for
impacting graft. A one-handed auto impaction device (Finsbury Instruments, Ltd.
Leatherhead, Surrey, United Kingdom) improves the consistency of impaction
grafting. This device, originally developed for cement removal in revision hip
404 Bradley

arthroplasty, greatly facilitates the operative technique by freeing up the


surgeon’s other hand to place the morselized graft accurately. It also provides a
consistent and predictable amount of force to the graft (Fig. 1).
Uncontained or open defects can be controlled by using wire mesh or,
rarely, fracture plates [2,6]. After all contained defects have been filled, either
cutting guides or trial implants, depending upon the surgeons’ preference and
experience, can be positioned. If there is a large endosteal defect, it should be
grafted using tapered stems as tamps as in the proximal femur as described by Gie
et al., before cutting guides or trial implants are inserted. It is imperative that
the guides or trials be accurately aligned and reasonably well fixed. At this time,
stability and range of motion can be tested and the distance from the medial
femoral epicondyle to the joint line can be measured as described above. It is
recommended that intraoperative x-rays be obtained once a satisfactory construct
has been created. If there is significant bone loss in a relative capacious canal, the
construct may appear satisfactory individual component may be malaligned. This
seems to be a bigger problem in the lateral or flexion/extension than in the AP
view. Thus, both an AP and lateral x-ray should be obtained intraoperatively at
this stage (Fig. 2). Once the components are positioned accurately, uncontained
defects can be filled with morselized bone. At this point the actual implants are

Figure 1 One-handed automatic impaction device and selection of attachments.


Various tamps, cernent removing chisels, and a pin holder are shown.
Revision of Total Knee Arthroplasty 405

Figure 2 Intraoperative photos and follow-up x-rays. (A, B) The distal femoral
defect. The tibia bas already been reconstructed. (C) Placing bone endosteally to
stabilize the short stem. An intramedullary rad is shown being used to control bone
graft placement. (D) Trial component in position after contained defects have been
filled with impacted ball. The remaining defect is seen. (E) Final position of actual
implant with impacted bone seen to fill the previous defect. Additional bone is being
placed and impacted beneath the flange superiorly. (F) Six-year postoperative
lateral x-ray showing final position in slight flexion. Nonetheless, continued good
function (Knee Society Knee Score 155). (G) Six-year postoperative A-P x-ray.
406 Bradley

Figure 2 Continued.
Revision of Total Knee Arthroplasty 407

Figure 2 Continued.
408 Bradley

Figure 2 Continued.

placed but not fully seated. The bone is firmly impacted, completely filling all
defects. The most difficult area to fill is the posterior femoral condyle. The final
3 – 5 mm of graft impaction is achieved when the definitive prosthesis is finally
implanted.
Range of motion and stability are now tested. If there is instability or poor
mobility, alignment and position of the joint line should be remeasured. Repeat
intraoperative x-rays might be indicated. Routine wound closure with or without
drains and splinting or placement in a continuous passive motion device ensues.
Minimal weight bearing with two sticks or crutches is allowed for the first month.
During the second month, weight bearing, still with two sticks or crutches, is
allowed up to a maximum of 50%. During the third month, weight bearing with
Revision of Total Knee Arthroplasty 409

two sticks or crutches is allowed as tolerated. Depending upon the extent of


grafting, this time might be shorter but is more often longer, to a total of 4 months
using two sticks or crutches.

IV. CLINICAL EXPERIENCE

Morselized impaction bone grafting was first used by this author in 1992 for
revision of a chronically infected hinge arthroplasty in an 85-year-old woman.
She had been on long-term suppressive antibiotics for 10 years with progressive
bone loss. Although the infection appeared to be controlled, the bone loss was
not, and she faced either an amputation or a major reconstructive procedure.
Because of extensive bone loss, the usual (for that time) custom devices were not
deemed appropriate. Reconstruction was undertaken with a distal femoral
allograft, and the morselized impacted bone grafting was used for the proximal
tibia. This was treated as a chronically infected arthroplasty in three stages, with
interval debridement between implant removal and reconstruction. Postoperative
treatment was as described above. She made satisfactory progress and was living
independently 9 years later with a satisfactory construct and a satisfactorily
functioning knee (Fig. 3).
Initially this technique was used only in significant bone loss and further
bone loss had to be avoided. It has evolved so that it is now my preferred technique
for all but the most straightforward knee revisions. A standard LCS revision
component (DePuy, Warsaw, IN) was used in all but three knees. This revision
implant has a fixed stem that is proportional between sizes. The femoral
component stem varies from 9.5 to 10.5 cm in length with a base diameter of two
centimeters. The tibial component also has a fixed stem varying between 8.5 and
10.5 cm long with a base diameter between 2 and 2.5 cm. The tibial component
has two platform thicknesses of 5 and 15 mm. Both components are porous coated
on their undersurface and on the proximal portion of the stem only. The stems
taper slightly, forming an elongated cone. In all instances, a rotating platform
polyethylene insert was used with either standard or deep dish configuration.
In four patients the standard LCS revision components were not used. In one
of these patients, described above, a custom LCS femoral component with a longer
femoral stem was used to stabilize a whole distal femoral allograft in the knee in
which the proximal tibia was replaced using impacted graft. In two patients
Coordinate (DePuy) long-stemmed femoral revision components were used with
impacted allograft to reconstruct the distal femur, which had failed secondary to
supracondylar fracture. In a fourth patient an AMK prosthesis (DePuy) was left in
situ as the distal femur was grafted with 150 cc of morselized impacted bone.
Failed patellar components were handled differently, and this technique
was not used on any patella. Thirty-nine knees have been revised using this
410

Figure 3 Preoperative and postoperative x-rays of 85-year-old having reconstruction for chronically infected
hinged prosthesis: (A) preoperative A-P; (B) preoperative lateral; (C) 7-year postoperative A-P; (D) 7-year
Bradley

postoperative lateral.
Revision of Total Knee Arthroplasty 411

Figure 3 Continued.
412 Bradley

technique. All knees received at least 90 cc of morselized impacted bone graft,


roughly equivalent to one femoral head. Three knees were lost and two died
before one-year follow-up. Four knees in this series are known to have failed. In
two knees a partial femoral head without polymethylmethacrylate cement was
used for structural augmentation in conjunction with impacted morselized graft.
One whole distal femur was used (with PMMA) in a knee in which morselized
impacted graft was used on the tibial side. In five knees PMMA augmentation
was used in conjunction with morselized bone graft. All patients were advised,
preoperatively, that a large bone graft was to be used, that this was a biological
process, and that some graft resorption might be expected. They were
furthermore advised that the purpose of the procedure was to rebuild lost bone and
that a subsequent, even early, re-revision might be necessary. The average age of
these patients was 72 years (range 39– 92 years).
Six knee replacements had been infected. The index procedure was the
second or, in one case, the third stage of a staged reconstruction. One failure was
by aseptic loosening. This was in a knee in which the morselized graft was
augmented with bone cement. The loose component was converted to a
conventional long-stem semi-constrained cemented prosthesis. This is the only
known instance of loosening in this series. The second failure was following
reconstruction for a supra-condylar femur fracture. This failure mode was non-
union. Exploration at the time of repair of non-union showed, histologically
confirmed, impressive incorporation of impacted bone graft. The two other
failures were by tibial rotating polyethylene “spin-out.” These both required open
reduction but have ultimately achieved satisfactory function.
All patients followed for more than one year have benefited from the
procedure. The four patients requiring reoperation have achieved satisfactory
function in the revised knee. The Knee Society clinical rating system was used.
This divides knee and patient function scores [37]. These scores were tabulated
separately with their deductions and then added to form a final score. Without
deductions the maximum obtainable score was 200 points. With deductions it is
possible to obtain a negative score. All negative scores were recorded as 0 points.
Using this application of the Knee Society rating system, the preoperative knee
scores ranged from 0 to140 points (average 60 points). Postoperatively, the scores
ranged from 102 to 198 points (average 147 points). The average improvement
was 87 points. All patients had a minimum improvement of over 20 points.
Patients were categorized, applying Charnley’s hip classification of general
disease to the knee: Category A, unilateral knee involvement only; Category B,
unilateral knee involvement with a symptomatic opposite knee or other joint; and
Category C, multiple joint arthritis or significant medical infirmity [38].
According to these groups the patients in Category A benefited most from the
procedure, showing an average improvement in Knee Society knee scores of over
90 points. Follow-up radiographs have demonstrated no further significant bone
Revision of Total Knee Arthroplasty 413

loss. Several knees have measurable tibial subsidence of ,1 cm. Femoral


subsidence is difficult if not impossible to assess accurately. Sclerotic lines
around uncemented femoral and tibial stems are relatively common but do not
progress with time. Mild cortical hypertrophy has been seen occasionally in tibiae
and femurs but was not clinically significant.

V. CONCLUSIONS

Bone loss is inevitable in patients undergoing revision total joint surgery. This
bone loss is often found intra-operatively to be greater than anticipated
preoperatively and can be quite significant in total knee revision surgery.
Morselized impacted bone grafting has been used in a variety of contexts
and justifies considerable confidence. Incorporation of bone graft has been
substantiated by several radiographic methods, histology, and radiostereophoto-
metric analysis [9,12,20,21,25,39]. Histology provides the only absolute
evidence of graft viability. It is not feasible to assess an entire graft histo-
logically, so it is possible that significant portions of these grafts remain dead and
are not replaced with host bone. Nonetheless, in this and other series, significant
benefit has been obtained from bone grafting: bone has revascularized and
incorporated and midterm clinical results are more than satisfactory. There
appears to be some longevity and stability to these constructs.
This author’s experience and the experience of others supports the
continuing use of impacted morselized bone grafting techniques in patients with
large bone defects undergoing total knee revision arthroplasty. The basic principles
of knee revision surgery must be scrupulously adhered to if a satisfactory result is
to be expected. Alignment, placement of joint line, stability, and replacement of
bone loss are imperative to achieve structural stability and satisfactory kinematics.
Revision total knee arthroplasty can be divided into 10 steps:
1. Surgical approach
2. Soft tissue debridement
3. Implant removal
4. Bone preparation
5. Bone graft preparation
6. Initial graft placement, filling contained defects
7. Preliminary implant placement
8. Final graft placement, augmentation of uncontained defects
9. Final implant placement/impaction
10. Wound closure
If these 10 steps are meticulously followed, a satisfactory and long-lasting
construct can be anticipated.
414 Bradley

REFERENCES

1. Aglietti D, Buzzi R, Scrobe F. Autologous bone grafting for medial tibial defects in
total knee arthroplasty. J Arthroplasty 1991; 6:287 – 294.
2. Bradley, GW. Revision total knee arthroplasty by impaction bone grafting. Clin
Orthop 2000; 371:113– 118.
3. Chandler HP. Structural bone grafting about the knee. Orthopedics 1998;
21:1044 – 1047.
4. Dorr LD, Ranawat CS, Sculco TP, et al. Bone graft for tibial defects in total knee
arthroplasty. Clin Orthop 1986; 205:153 – 159.
5. Elia EA, Lotke PA. Results of revision total knee arthroplasty associated with
significant bone loss. Clin Orthop 1991; 271:114 – 121.
6. Garino JP. The use of impaction grafting in revision total knee arthroplasty.
J Arthroplasty 2002; 17:94– 97.
7. Heyligers IC, Van Haaren EH, Whisman PIJM. Revision knee
arthroplasty using impaction grafting and primary implants. J Arthroplasty 2001;
16:533 – 537.
8. Laskin RS. Total knee arthroplasty in the presence of large bony defects of the tibia
and marked knee instability. Clin Orthop 1989; 248:66– 69.
9. Lindstrand A, Hansson U, Toksvig-Larsen S, Ryd L. Major bone transplantation in
total knee arthroplasty. J Arthroplasty 1999; 14:144 – 148.
10. Lotke PA, Garino JP, Lonner JH, Nelson CL. Impaction grafting in revision total
knee arthroplasty: use of wire mesh for containment. AAOS Annual Meeting,
Orlando, FL, Scientific Exhibit No. SE033, 2000.
11. Samuelson KM. Bone grafting and non-cemented revision arthroplasty of the knee.
Clin Orthop 1988; 226:93– 101.
12. Ullmark G. Morselized impacted cortico-cancellous bone allografts in revision
surgery for endoprosthetic loosening with osteolysis. Acta Universitatis Upsaliensis,
Uppsala, Sweden, 2001.
13. Van Loun CMH, de Waal Malefijit MC, Buma P, et al. Autologous morselized bone
grafting restores uncontained femoral bone defects in knee arthroplasty. J Bone Joint
Surg 2000; 82-B:436 –444.
14. Van Zyl AA, Botha PJ. Bone impaction grafting in the total knee replacement. J Bone
Joint Surg 2002; 82-B(suppl 11):152.
15. Whiteside LA. Cementless revision total knee arthroplasty. Clin Orthop 1993;
286:160 – 167.
16. Whiteside LA. Results of cementless revision total knee arthroplasty. In: Engh G,
Rorabeck C, eds. Revision Total Knee Arthroplasty. Baltimore: Williams and
Wilkins, 1997.
17. Whiteside LA. Morselized allografting in revision total knee arthroplasty.
Orthopedics 1998; 21:1041 –1043.
18. McCollum DE, Nunley JA, Harrelson JM. Bone grafting in total hip replacement for
acetabular protrusion: J Bone Joint Surg 1980; 72A:248 – 252.
19. Sloof TJJH, Schimmel J, Buma P. Cemented fixation with bone grafts. Orthop Clin
North Am 1993; 24:667 – 672.
Revision of Total Knee Arthroplasty 415

20. Sloof TJJH, Huiskes R, Van Horn J, Lemmens AJ. Bone grafting in total hip
replacement for acetabular protrusion. Acta Orthop Scan 1984; 55:593– 596.
21. Sloof TJJH. Viability of acetabular bone bed. In: The Incorporation Process of
Morselized Bone Graft. CIP-Gegevens Koninklijke Bibliotheek, Den Haag, The
Netherlands, 1998.
22. Gie GA, Linder L, Ling RSM, et al. Impacted cancellous allograft and cement for
revision total hip arthroplasty. J Bone Joint Surg 1993; 75B:14 – 21.
23. Ullmark G, Obrant KJ. Histology of impacted bone-graft incorporation.
J Arthroplasty 2002; 17:150 – 157.
24. Altchek D, Sculco TP, Ralins B. Autogenous bone grafting for severe angular
deformity in total knee arthroplasty. J. Arthroplasty 1989; 4:151– 157.
25. Van der Donk S. Incorporation of morselized balle grafts: a study of 24 acetabular
biospy specimens. Clin Orthop 2002; 396:131 –141.
26. Franceschina MJ, Swienckowski JJ. Correction of varus deformity with tibial flip
autograft technique in total knee arthroplasty. J. Arthroplasty 1999; 14:172 – 174.
27. Windsor RE, Insall JN, Sculco TP. Bone grafting of tibial defects in primary and
revision total knee arthroplasty. Clin Orthop 1986; 205:132 – 136.
28. Scuderi GR, Insall JN, Haas SB, et al. Inlay autogenic bonegrafting of tibial defect in
primary total knee arthroplasty. Clin Orthop 1989; 248:93– 97.
29. Meding JB, Keating EM, Ritter MA, Farris PM. Total knee arthroplasty after high
tibial osteotomy. Clin Orthop 2000; 375:175 – 184.
30. Lyons ST, Hofmann AA, Camargo M, et al. Restoration of the joint line based on the
distal femur in revision total knee arthroplasty. AAOS Annual Meeting, Scientific
Exhibit No. SE032, 2000.
31. Clarke HD, Scott WN. Instability after major joint replacement. Orthop Clin North
Am 2001; 32(4).
32. Grelsamer RP. Patella baja after total knee arthroplasty: is it really patella baja?
J Arthroplasty 2002; 17:66 – 69.
33. Martin JW, Whiteside. The influence of joint line position on knee stability after
condylar arthroplasty. Clin Orthop 1990; 259:146 – 156.
34. Partington PF, Sawhney J, Rorabeck CH, Barra RL, Thoore J. Joint line restoration
after revision total knee arthroplasty. Clin Orthop 1999; 367:165 – 171.
35. Griffin FM, Math K, Scuderi GR, et al. Anatomy of the epicondyles of the distal
femur. J Arthroplasty 2000; 15:354 – 359.
36. Robbins GM, Masri BA, Garbuz DS, Duncan CF. Instability after major joint
replacement. Orthop Clin North Am 2001; 32(4).
37. Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical
rating system. Clin Orthop 1989; 248:13 – 15.
38. Charnley J. The long-term results of low-friction arthroplasty of the hip performed as
a primary intervention. J Bone Surgery 1972; 54B: 61 – 76.
39. Tokgozoglu A, Aydin M, Atilla B, Caner B. Scintigraphic evaluation of impaction
grafting for total hip arthroplasty revision. Arch Orthop Trauma Surg 2000;
120:416– 419.
28
Revision Knee Arthroplasty with
Impaction Bone Grafting
Gösta Ullmark
Centre for Research and Development
Länssjukhuset, Gävle, Sweden

I. BIOMECHANICAL ASPECT

The same principles apply to the knee as to the hip. Large bone chips with the fat
washed out and a very firm impaction is recommended.
Stable metal mesh must safely cover any defect before impaction grafting.
Only long-stemmed prostheses are recommended with impaction grafting. There
have to be dedicated instruments for any impaction grafting except in small
contained areas.

II. SURGICAL METHOD

A method is described using a dedicated instrument set adapted to the Link


Rotation Knee (Waldemar Link GmbH & Co, Hamburg, Germany) (Fig. 1). The
loose prosthesis, any cement, fibrous membrane, and debris are completely
removed. The cavitatory bone defects are reamed to achieve continuity with the
femoral and tibial medullary canals. The sclerotic inner surfaces are roughened
with a cutter. Starting with the tibia, the medullary canal is occluded with a firm-
fitting acrylic plug (Mitab, Scandimed, Sjöbo, Sweden). The centralizing device
screwed into the plug is left in place during the impaction grafting. The
morselized bone graft close to the plastic plug is packed with a distal impactor
and more proximally only lightly packed with this impactor. The tibial impactor
on the centralizer down is used to pack bone into the cavity to produce a firm
417
418 Ullmark

Figure 1 Impaction instruments for knee bone grafting dedicated to Link rotation
knee.

impaction grafting (Fig. 2). Proximally, additional graft is impacted around the
end of the tibial impactor using the end impactor. The centralizing rod is now
detached. The tibial impactor is pulled out and a small suction catheter is placed
at the bottom of the impacted medullary canal. A cement gun with a conical end is
used to fill the cavity retrograde. The tibial prosthesis component is inserted with
the cement at low viscosity.
The cavity in the distal femur is prepared in the same way. A femoral
impactor is used over the same centralizer as in the tibia. The distal end of the
femur can be prophylactically wired before hard impaction. The intracondylar
area of the femur is impacted by the condylar impactor followed by end
impaction. Before cementation of the femoral stem, alignment and appropriate
ligament tension is assessed by trial reduction of the femoral impactor against the
already cemented tibial component.
In cases when only partial bone grafting is needed, often in one of the tibial
condyles, a tibial titanium mesh is screwed through its flanges to the inside of the
defective tibial condyle (Fig. 3). After cutting the mesh to the appropriate height,
the tibial medullary cavity is reamed to fit the tibial impactor. This impactor is
inserted to the appropriate level followed by impaction morselized bone grafting
Revision Knee Arthroplasty with Impaction Bone Grafting 419

Figure 2 Tibia impaction instrument, impacted in a tibia graft bed.

Figure 3 Tibia titanium mesh to convert noncontained proximal tibia bone defect WEB COLOR
to a contained defect, followed by impaction grafting.
420 Ullmark

between the titanium mesh and the tibial impactor using the end impactor. This
impaction procedure is followed by a routine cementing of the prosthetic tibial
component. Partial knee impaction has been described in the literature [1].

III. RESULTS

We have been impaction grafting revision total knee arthroplasties (TKA) since
1993 [2] and have results from cementing prostheses into completely grafted
knees in nine cases (Fig. 4). Partial bone grafting was performed in 11 cases. The
follow-up period for these cases is 1 – 8 years. One was revised. The reason for
revision was fracture of the femoral component. On exploration, there was
metallosis and newly formed scalloping around the proximal lateral aspect of the
femoral component. In other areas the prosthesis and cement was well fixed to
bleeding bone in areas that had been grafted. The revision was carried out by
further impaction grafting. The clinical results in all other cases are good or
excellent. There are no radiographic or clinical signs of prosthetic loosening or
subsidence.
Two cases have been histologically assessed. There was evidence of bone
healing in both.

Figure 4 (Left) Major osteolysis and a loose Guepar prosthesis. (Right) 28


months after revision TKA including impaction grafting.
Revision Knee Arthroplasty with Impaction Bone Grafting 421

When a stemmed TKA is mechanically loose with severe bone loss, even
arthrodesis may be unreliable. In such cases, revision TKA with impaction
grafting of fresh frozen morselized and fat-reduced bone allograft is a demanding
but successful method. However, it is necessary to use stemmed knee prostheses
and dedicated knee impaction instruments. Furthermore, there is a learning curve
for this kind of revision surgery. At our center we are happy with the method and
continue to practice it whenever there is mechanical loosening of a knee
replacement with severe osteolysis.

REFERENCES

1. Benjamin J, Engh G, Parsley B, Donaldson T, Coon T. Morselized bone grafting of


defects in revision total knee arthroplasty. Clin Orthop 2001; 392:62 – 67.
2. Ullmark G, Hovelius L. Impacted morsellized allograft and cement for revision total
knee arthroplasty. Acta Orthop Scand 1996; 67:10 –12.
29
Revision Knee Arthroplasty
with Impaction
I. C. Heyligers , E. H. van Haaren, and
P. I. J. M. Wuisman
Vrije Universiteit Medical Center
Amsterdam, The Netherlands

I. INTRODUCTION

Loss of bone stock around loose total joint replacement is a serious problem in
revision surgery. It can be addressed by different techniques. Combinations of
metal and cement can be used to replace the lost bone, but this makes subsequent
revision much more difficult as there will be even greater loss of bone stock loss.
Replacement of the bone lost by bone solves this problem. In revision hip
arthroplasty, good clinical results have been reported when impacted bone particles
have been used to treat bone loss [1–3]. These particles are firmly impacted layer by
layer with special instruments, and a primary stem and cup are cemented into this
bed of impacted bone. Segmental defects are contained with metal mesh with
cerclage wires and screw fixation to restore the anatomy. Bone graft is impacted
against the metal mesh. Following good results with this procedure in revision hip
surgery, we adapted the technique to treat bone loss around loose knee implants [4].
Special instruments were designed and manufactured to impact the bone particles
layer by layer. Primary knee replacement prostheses (Kinemax, Stryker-
Howmedica-Osteonics) were cemented into this bone bed. In this chapter we
describe the technique and clinical results.


Current affiliation: Atrium Medical Center, Herleen, The Netherlands

423
424 Heyligers et al.

II. MATERIAL AND METHODS


A. Bone Banking Procedures
We use donor bone from our bone bank. This contains femoral heads processed to
the standards of the American Association of Tissue Banks (AATB) [5] and the
European Association of Musculo Skeletal Transplantation (EAMST) [6]. All
donors give informed consent.
They are first screened by questionnaire about their medical, social, and
sexual history and are subsequently interviewed by a medical doctor. The
questionnaire in the donor’s own language followed the guidelines of the AATB
and EAMST. After the questionnaire, a thorough physical examination is
performed and routine blood tests carried out. Donors are screened for syphilis,
HBV1 and 2, and HTLV type 1 and excluded if the erythrocyte sedimentation
rate (ESR) is raised (normal values: 0 – 15, males ,50 years; 0 –20, males .50
years and females ,50 years; 0– 30, females .50 years). All donors are screened
again for HIV1 and 2, syphilis, HBV, HCV, and HTLV1 6 months after the first
test to exclude any seroconvertors. Bacterial contamination of the femoral head is
assessed by culture and histopathology. Swabs from the corticocancellous bone
and a part of the capsule are taken for aerobic and anaerobic culture. Swabs are
incubated in Stuart’s medium and subcultured onto blood agar and culture broth
for at least 5 days. A 1 cm3 core biopsy from the femoral head and a sample of
synovium is examined histologically.

B. Surgical Technique
All implants, cement, and interfaces are removed and a thorough debridement is
performed. As much host bone as possible is saved. Preoperatively all necessary
diagnostic investigations are used to rule out infection. During surgery, frozen
sections, Gram stains, and cultures are also performed to exclude infection. If
there is an infection, we always perform a two-stage procedure. The bone of the
distal femur, the patella, and the proximal tibia are cleaned and carefully
inspected to assess bone loss, cracks, fractures, and bone quality. When bone can
be harvested from the same knee joint without interfering with the planned
surgery, for example, when a unicompartmental prosthesis is revised, we mix
autograft with donor bone.
The cancellous bone is cut with a large nibbler into pieces of about 7 mm
diameter. When a segmental defect needs to be treated, we use the same
technique as in revision hip arthroplasty. Metal mesh is cut to size and fixed with
self-tapping screws or cerclage wires. The bone is then impacted against the
metal mesh. In revision hip surgery we have a great deal of experience with this
technique, but in revision knee surgery we have used mesh only once so far. A
restrictor is fixed firmly into the medullary canal of the femur and the tibia. With
Revision Knee Arthroplasty with Impaction 425

special instruments we measure the diameter of this restrictor into which a central
guide wire is fixed. Cannulated tamps are inserted over this guide wire (Fig. 1).
The instruments used to impact the bone particles go up in increasing sizes to
finish with a final implant resembling the cemented prosthesis. The size of the
implants is based on radiographic measurements and the trial fitted during
the operation. The shape of the implants is based on the design of the definitive
prostheses and impacts the bone particles tightly. The femoral impactors have a
valgus angle of 78. The tibial component is placed in neutral in the coronal plane
with a posterior slope of about 38 (Figs. 2, 3). The bone particles are impacted
layer by layer with enough force to produce a dense mass of well-compressed
bone. The last impactor leaves the bone bed in the desired shape for the definitive
cemented prosthesis. The impactors are designed to allow an extra 2 mm for
the cement mantle. Joint line landmarks are identified to restore the joint line
as close as possible to the anatomical position. Primary knee prostheses without
long stems (Kinemax, Stryker-Howmedica-Osteonics, Limerick, Ireland) are
implanted. All implants are fixed with gentamicin bone cement (Simplex, Stryker-
Howmedica-Osteonics, Limerick, Ireland). In primary knee replacements, we do

Figure 1 Special instruments that were designed for impaction of the femur and
the tibia. Over a central rod, which is fixed to a plug in the femoral and tibial canal,
impactors with decreasing dimensions are used to impact the bone particles layer
by layer. (From Ref. [4].)
426 Heyligers et al.

Figure 2 Impaction of the femur. A sliding hammer is used to impact the donor
bone with impactors which are designed in such a way that the desired form is
created with an extra 2 mm into account for cement fixation of the final femoral
implant. (From Ref. [4].)

not resurface the patella and rarely do so in revisions. We always debride


degenerate cartilage and remove all osteophytes from the patella.
Every effort is made to centralize the patella in the trochlea, and we often
perform a lateral retinacular release. Depending on the primary stability and
extent of bone loss grafted, the knee is immobilized in a cast for up to 3 months,
during which isometric quadriceps exercises are performed. Knee movement is
started after this. Depending on the initial bone loss and the amount of donor bone
grafted, we do not permit full weight bearing for a minimum of 3 months after
surgery.

C. Patients
Eleven knee revisions were performed in nine patients (Table 1). The mean age
was 75 years, with a range of between 62 and 87 years. There were seven women
and two men. Six unicompartmental knee prostheses were removed, five from the
medial side and one from the lateral. Four total knee replacements were revised,
including one with long intramedullary stems in a patient who already had
undergone two knee revisions before on the same side (patient No. 1). In one
case, the femoral component alone was revised. Because of suspicion of
Revision Knee Arthroplasty with Impaction 427

Figure 3 Impaction of the tibia. A sliding hammer is used to impact the donor
bone layer by layer with canulated impactors for cement fixation of the tibial implant.
(From Ref. [4].)

infection, a two-stage procedure was performed in three cases. A medial


parapatellar approach was used in all operations. In one case, osteotomy of the
tibial tuberosity was performed. Bone defects of the distal femur and the
proximal tibia were described using the classification of the Anderson
Orthopaedic Research Institute [7] (Table 2). During the revision operations all
patients had a primary total knee prosthesis implanted with standard stems
(Kinemax, Stryker-Howmedica-Osteonics, Limerick, Ireland) into impaction
grafted donor bone. A posterior stabilized insert was used four times and a
conventional posterior cruciate retaining seven. A patellar component was
428

Table 1 Overview of Patients Treated with Impacted Bone Grafting in Revision Knee Arthroplasty
Bone loss Implanted Bone graft

Patient
no.,
sex,
age F.U. Removed Femur Tibia Femur Tibia Patella Insert Femur Tibia

1: F, 73 y 21⁄2 Y Revision TKP right F3 T2b Posterior Extra small No 21 mm 2 femoral head 2 femoral head
(long stems) stabilized
small
2: M, 62 y 3Y Cemented TKP F2b T2b Posterior Large Medium 21 mm 1/2 femur head 1/2 femur head
right and patella stablilized
component large
3: M, 87 y 31⁄2 Y Unicompartmental F2a T2b Medium Large No 10 mm Auto- and Auto- and
medial left allograft allograft 1/2
1/2 femur femur head
head
4: F, 78 y 31⁄2 Y Unicompartmental F2a T2a Primary TKP Small natural No 12 mm Autograft 1 femur head
medial left small
41⁄2 Y Unicompartmental F1a T2a Cemented Medium natural No 10 mm Autograft Autograft
Heyligers et al.

medial right medium


5: F, 77 y 41⁄2 Y Unicompartmental F2a T2a Medium Medium natural No 15 mm Autograft Autograft
lateral right
6: F, 82 y 5Y TKP right F2b T2b Medium Small No 18 mm 1/2 condylblock 1/2 condylblock
posterior
stabilized
7: F, 72 y 6Y Unicompartmental F1 T2a Medium Medium No 10 mm 1/2 femur head 1/2 femur head
medial left under
8: F, 78 y 61⁄2 Y TKP left F2a T1 Extra small Extra small with No 15 mm 1/2 femur head 1/2 femur head
wedge lateral
side
3Y Femur component F2b Small Stayed in situ No 25 mm 1 femur head No
þ insert posterior
Kinemax stabilized
9: F, 70 y 61⁄2 Y Unicompartmental F2a T2a Small Small No 15 mm Auto- and Auto and
medial right allograft (1/2 allograft (1/2
femur head) femur head)

Note: The amount of bone loss has been classified according to the Anderson Orthopaedic Research Institute (AORI). Y ¼ years; M ¼ months.
Revision Knee Arthroplasty with Impaction
429
430 Heyligers et al.

Table 2 Anderson Orthopaedic Research Institute Bone Defect Classificationa

Type 1 Defect: Intact metaphyseal bone


Minor bone defects of distal femur (F1) or proximal tibia (T1) that do not compromise the
stablility of the component. On preoperative radiographs:
No component subsidence or osteolysis
Femur: normal joint line with full condylar profile
Tibia: component above the fibular head and a full metaphyseal segment
Type 2 Defect: Damaged metaphyseal bone
Loss of cancellous bone in the methaphyseal segment that necessitates restoration. Type 2
defects can occur in one femoral condyle (F2A) or tibial plateau (T2A), or in both
condyles (F2B) or plateaus (T2B). On preoperative radiographs:
Femur: joint line elevation and a reduced condylar profile
Tibia: component is at or below the tip of the fibular head and the tibial flare is reduced
Type 3 Defect: Deficient metaphyseal segment
Bone loss that compromises a major portion of either femoral condyle (F3) or tibial plateau
(T3). On preoperative radiographs:
A deficient metaphyseal segment of the femur or tibia
a
The bone defect classification is applied separately to the femur (F) and the tibia (T).

implanted in one case alone. When unicompartmental prostheses were removed,


autograft was mixed with allograft in almost all cases.
In most cases no autograft bone was available and only allograft bank bone
could be used. All bone was cut in chips and firmly impacted layer by layer with
the specially developed instruments described above. Gentamicin PMMA bone
cement (Simplex, Stryker-Howmedica-Osteonics, Limerick, Ireland) was used in
all cases.

III. RESULTS

All defects of tibia and femur were type 2 except one type 1 and one type 3.
Autograft bone alone was used in two knees, a combination of autograft and
allograft in three, and allograft alone in six. The total amount of allograft used
consisted of eight femoral heads and one condyle. The postoperative treatment,
mobility, and clinical follow-up data are presented in Table 3. Five cases were
immobilized in a cast for between 6 and 12 weeks. The period of immobilization
depended on the extent of bone loss and stability of the joint at surgery. These
factors also determined the amount of weight bearing allowed. Weight bearing
after surgery was not restricted in four cases, partial for up to 6 weeks in two, and
delayed for 3 months in five. All knees were fully weight bearing 3 months
postoperatively. Follow-up ranged from 21⁄2 to 61⁄2 years with a mean of 4 years
Revision Knee Arthroplasty with Impaction 431

Table 3 Clinical Data

Patient no., Full Follow-up


sex, age Cast loading Mobility (yr)

1 F, 73 y 3M 3M 90/0/0 21⁄2
2 M, 62 y No Direct 70/0/0 3
3 M, 87 y No 3M 90/0/0 31⁄2
4 F, 78 y 6W Direct 100/0/5 31⁄2
5 left right No Direct 120/0/10 41⁄2
6 F, 77 y No Direct 120/0/20 41⁄2
7 F, 82 y 6W 3M 120/0/5 5
8 F, 72 y No 6W 90/0/0 6
9 F, 78 y 6W 6W 90/0/0 3
10 left right 6W 3M 130/0/5 61⁄2
11 F, 70 y No 3M 120/0/5 61⁄2

Y ¼ years; M ¼ months; mobility is in degrees flexion/0/extension.

and 3 months. One femoral component loosened within 21⁄2 years of surgery. This
patient (Table 1, patient No. 1) had undergone two previous revision procedures
in the same knee for infection. In this case metal mesh and massive bone grafts
were used to reconstruct a type 3 femoral segmental defect. The clinical
presentation and technetium and labeled leukocyte scans suggested recurrent
septic loosening 21⁄2 years after this procedure, although intraoperative specimens
were sterile. Biopsies of the femur showed no incorporation of donor bone.
During this re-revision, the tibial component was also revised. It was well fixed
and histology of samples from the graft site showed incorporation by
predominantly new woven bone. These biopsies gave the same appearances of
new bone formation as in revision hip arthroplasties after impaction grafting.
Clinical and radiographic examination indicated that all other implants
were well fixed. There was no radiographic evidence of graft resorption,
radiolucent lines, or subsidence (Figs. 4, 5). At follow-up examination, all knees
were fully weight bearing. One patient (Table 1, patient No. 2) was revised for
septic loosening of a cemented total knee, including the patellar component,
6 months after surgery. With a two-stage procedure including osteotomy of the
tibial tuberosity, revision surgery was finally carried out with a posterior
stabilized implant and patellar button. One patient with Type 2b defects of femur
and tibia were treated with impaction grafting of half a femoral head on each side
and postoperatively walked fully weight bearing without a cast. After 9 months
there was 1008 of flexion and full extension, but there were clinical signs of
infection again. Cultures were negative and the patient was treated conservatively
432 Heyligers et al.

Figure 4 (A) Radiograph before revision of an infected total knee implant. (B) A
two-stage procedure was performed with the use of gentamicin loaded PMMA beats.
Reimplantation with impacted cancellous grafting of the knee with the use of primary
implants was performed. (C) Radiograph 4 years after the operation. (From Ref. [4].)
Revision Knee Arthroplasty with Impaction 433

Figure 4 Continued.

with intravenous and oral antibiotics to which the organisms isolated before were
sensitive. After this, there was clinical improvement and the inflammatory markers
returned to normal. There were no clinical or radiographic signs of loosening or
infection. However, after this flexion decreased to 708, although extension
remained full and nearly 3 years later the patient is walking well without a stick.

IV. DISCUSSION

Because we had had good results from impaction grafting bone defects in
cemented hip revisions, we used the same technique in revision knee arthroplasty.
Special instruments were designed to impact the graft layer by layer, allowing us
to cement primary knee prostheses onto this donor bone bed. In revision hip
surgery, this technique provides good prosthetic fixation and new bone forms in
the graft [1 – 3]. Lost bone is replaced by new and prostheses used in primary
arthroplasty can be implanted. Impacted, morselized bone grafts have described
in cementless [8,9] and cemented [10 – 12] revision knee arthroplasty with long
stems. In revision knee arthroplasty, the treatment of bone loss with allograft has
been described [13]. In primary total knee arthroplasty impacted cancellous
434 Heyligers et al.

Figure 5 Radiograph of a cemented medial unicompartimental prosthesis:


(A) before revision; (B) 41⁄2 years after revision surgery with use of impaction
grafting and a primary total knee implant. (C) Especially at the proximal medial tibia,
trabecular bone can be seen in the area where cement was before.
Revision Knee Arthroplasty with Impaction 435

Figure 5 Continued.

autograft bone has been used [14] with a cemented tibial base plate and a long
press-fit modular stem. The bone quality in primary cases is, however, better than
revisions, in which it is often thin and sclerotic. Autograft in primary knee
replacement is more likely to be successful than allograft in revisions. Long
stems were used in primary knee replacement to prevent tilting of the tibial
component and promote loading of the graft in compression. With this technique,
the stem itself is usually not cemented [15]. We chose not to use long stems, but
to cement primary prostheses directly onto the donor bone to enhance load
transfer onto the graft. This is similar to the technique in hip revision where
the femoral stem is entirely surrounded by cement and transfers load onto the
bone graft. We think that diaphyseal fixation is unnecessary because well-
impacted bone will prevent tilting of the component and long stems may
decrease load transfer onto the bone graft. With our technique, primary stability
may more difficult to achieve. We think that inadequate primary stability was
responsible in our failed femoral component. Segmental femoral defects treated
with two pieces of femoral head and graft impacted onto metal mesh were
unstable after 21⁄2 years. With large bone defects, longer stems may afford better
primary fixation.
436 Heyligers et al.

The theory of our technique is that primary stability is created on firmly


impacted bone, which is loaded and eventually incorporates. This has been
demonstrated in hip arthroplasty in a number of reports of new bone formation in
graft biopsies [16 – 18]. This can be seen as trabeculation and cortical repair
radiographically. At present we have limited experience of impaction grafting in
revision knee arthroplasty, but trabeculation is seen on radiographs. The new
bone formation seen in the biopsies from the fixed tibial component in our
revision case suggests that the same process described after hip revisions happens
in impaction grafting in the knee. Stiffness 9 months after revision for infection is
unlikely to be related to impaction grafting. Based on the Knee Society
Roentgenographic Evaluation and Scoring System [19], there were no signs of
loosening in our patients except the one femoral component described above [20]
and no clinical or radiographic signs of failure as described by Lonner et al. [21].
The instruments developed make it possible to standardize the technique of
impaction grafting with cemented primary prostheses. The length of follow-up in
this group, however, is short and the numbers small, and it is difficult to draw
definitive conclusions. However, based on our encouraging experience, we feel
that the technique is suitable for cavitary defects in revision knee arthroplasties.
We plan to extend our indications gradually and to adapt the technique to
segmental defects. We believe that it is possible with our standardized technique
of impaction grafting to use cemented primary implants without long stems in
cases with bone loss and convert a revision situation to one more like a primary.
This creates bone stock for the future. This technique is relatively new. Greater
numbers with longer follow-up are needed to draw more definitive conclusions as
to its indications. It is important that the surgeon understands the principles of
impaction grafting and has experience with the technique.

REFERENCES

1. Gie GA, Linder L, Ling RS, Simon JP, Slooff TJ, Timperley AJ. Impacted
cancellous allografts and cement for revision total hip arthroplasty. J Bone Joint Surg
Br 1993; 75:14– 21.
2. Buma P, Lamerigts N, Schreurs BW, Gardeniers J, Versleyen D, Slooff TJ. Impacted
graft incorporation after cemented acetabular revision. Histological evaluation in 8
patients. Acta Orthop Scand 1996; 67:536– 540.
3. Slooff TJ, Buma P, Schreurs BW, Schimmel JW, Huiskes R, Gardeniers J. Acetabular
and femoral reconstruction with impacted graft and cement. Clin Orthop 1996;
324:108 – 115.
4. Heyligers IC, van Haaren EH, Wuisman PI. Revision knee arthroplasty using
impaction grafting and primary implants. J Arthroplasty 2001; 16:533– 537.
5. Standards for Tissue Banking [editorial]. American Association of Tissue Banks, 1996.
Revision Knee Arthroplasty with Impaction 437

6. Common Standards for Musculoskeletal Tissue Banking [editorial]. European


Association for Musculo Skeletal Transplantation, 1997.
7. Engh GA. Bone defect classification. In: Engh GA, Rorabeck CH, eds. Revision
Total Knee Arthroplasty. Baltimore: Williams and Wilkins, 1997:63– 121.
8. Whiteside LA. Cementless reconstruction of massive tibial bone loss in revision total
knee arthroplasty. Clin Orthop 1989; 248:80 – 86.
9. Whiteside LA. Cementless revision total knee arthroplasty. Clin Orthop 1993;
286:160– 167.
10. Bradley GW. Revision total knee arthroplasty by impaction bone grafting. Clin
Orthop 2000; 371:113 – 118.
11. Ullmark G, Hovelius L. Impacted morsellized allograft and cement for revision
total knee arthroplasty: a preliminary report of 3 cases. Acta Orthop Scand 1996;
67:10– 12.
12. Whiteside LA, Bicalho PS. Radiologic and histologic analysis of morselized
allograft in revision total knee replacement. Clin Orthop 1998; 357:149– 156.
13. de Waal M, van Kampen A, Slooff TJ. Bone grafting in cemented knee replacement.
45 primary and secondary cases followed for 2 – 5 years. Acta Orthop Scand 1995;
66:325– 328.
14. Ries MD. Impacted cancellous autograft for contained bone defects in total knee
arthroplasty. Am J Knee Surg 1996; 9:51– 54.
15. Bertin KC, Freeman MA, Samuelson KM, Ratcliffe SS, Todd RC. Stemmed revision
arthroplasty for aseptic loosening of total knee replacement. J Bone Joint Surg (Br)
1985; 67:242 –248.
16. van Biezen FC, ten Have BL, Verhaar JA. Impaction bone-grafting of severely
defective femora in revision total hip surgery: 21 hips followed for 41 – 85 months.
Acta Orthop Scand 2000; 71:135 – 142.
17. Schreurs BW, van Tienen TG, Buma P, Verdonschot N, Gardeniers JW, Slooff TJ.
Favorable results of acetabular reconstruction with impacted morsellized bone grafts
in patients younger than 50 years: a 10- to 18-year follow-up study of 34 cemented
total hip arthroplasties. Acta Orthop Scand 2001; 72:120– 126.
18. van der Donk S, Buma P, Slooff TJ, Gardeniers JW, Schreurs BW. Incorporation of
morselized bone grafts: a study of 24 acetabular biopsy specimens. Clin Orthop
2002; 396:131 –141.
19. Ewald FC. The Knee Society total knee arthroplasty roentgenographic evaluation
and scoring system. Clin Orthop 1989; 248:9 –12.
20. Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical
rating system. Clin Orthop 1989; 248:13 – 14.
21. Lonner JH, Siliski JM, Scott RD. Prodromes of failure in total knee arthroplasty.
J Arthroplasty 1999; 14:488 – 492.
30
Different Types of Biomechanical
Tests on Morselized Grafts

Xavier Banse
Université Catholique de Louvain
Brussels, Belgium

Many biomechanical tests are presented in the first half of the book. At
completion of the book, it appeared that a short note describing the various tests
would be useful. Its aim is to present in a single figure the different types of
mechanical testing. Each type of test is presented with a proposed name. Under
each test the chapters in which the test appears in the book are listed.

I. CONTAINED COMPRESSION TEST

This is a simple compression. Grafts are placed in a container, impacted and


compressed. Verdonshot et al. (Chapter 5), Bavadekar and Cornu et al. (Chapters
8, 9, and 13), and Kobayashi et al. (Chapter 14) report using this type of test.
Different impaction procedures are performed to obtain the pallets (cyclic
compaction or real hammer impaction) and different types of grafts are tested
(human femoral head bone or bone from the sternum of goat). The main resulting
parameter is the compressive modulus (or stiffness, MPa).

II. BIAXIAL SHEAR TEST

Such test is presented by Dunlop et al. (Chapters 6 and 11) and Kobayashi et al.
(Chapter 14). Similar procedure had been proposed by Brewster et al. [1]. The
principle of the test (derived from the soil mechanics) is to “gently” compress a
439
440 Banse

Figure 1 Biomechanical tests at a glance.


Different Types of Biomechanical Tests on Morselized Grafts 441

volume of material while shifting the two halves of the container. This produces a
shear failure within the material. A shear modulus and a shear strength (MPa) are
obtained. Note that shear properties are always recorded while compressing the
grafts.

III. TRIAXIAL SHEAR TEST

This test is only mentioned in Chapter 6 [2]. Grafts are placed in a cylinder with a
soft membrane around it. The upper plate moves toward the lower plate. Lateral
containment is obtained by pressurizing the liquid around the membrane.

IV. AXIAL COMPRESSION ON CUP

An acetabular reconstruction is performed either on a human hemipelvis or on a


plastic model (Verdonschot et al., Chapter 5). A defect is filled with grafts, grafts
are impacted, and a cup is cemented in the impacted grafts. The test is performed
applying an axial load on the cup. The resulting stress on the graft layer is
essentially compression which is applied repeatedly (i.e., 3000 cycles). The
implant migration is measured.

V. SHEAR ON CUP

This test is also called the “lever out test” by Verdonschot et al. in Chapter 5. A
handle is fixed to the cup. Applying a lateral movement to this joystick will cause
the cup to slip within the layer of grafts, creating a pure shear failure. The force
needed to rotate the cup is recorded. A similar test is reported by Ullmark [3].

VI. AXIAL COMPRESSION ON STEM

This type of test is presented by Verdonschot et al. (Chapter 5) and Dunlop et al.
(Chapter 11) using goat femurs. Kuiper et al. (Chapter 7) and Kobayashi et al.
(Chapter 14) used plastic models of femur (Glass-epoxy or Sawbonew). A
femoral defect is created, and reconstruction is simulated with impacted grafts.
Many parameters can have been tested: type of stem, cementation, type of
grafting material, type of impaction, etc. Usually, between 100 and 1000 cyclic
loading are performed. Load is applied on the head of the prosthesis, and the
displacement of the stem (or its varus rotation) is measured.
442 Banse

As grafts are contained between the femur and the implant, axial
displacement of the stem will create a combination of compression and shear
within the graft layer. To imagine how it works, take the two first figures
(contained compression and biaxial shear), turn them 908 and you will have a
better idea of what happens within the graft mantle when the stem is loaded.

VII. TORSION ON STEM

Using the same set-up as described above, the stem can be rotated (Kobayashi
et al., Chapter 14). Shear failure happens within the graft mantle.

VIII. WALKING SIMULATION

Godts et al. (Chapter 12) use pairs of human femurs, create a significant defect,
and perform reconstruction with impacted bone grafts. The stem is then axially
loaded during 10 days (about one million cycles). Axial subsidence and
micromotion of the implant can be measured.
Although not presented in the figure, Kuiper et al. (Chapter 7) also present a
model of knee revision using plastic tibial models. Their test is similar to axial
compression on stem, even if the load was selectively applied on the medial or
lateral side of the implant.

REFERENCES

1. Brewster NT, Gillespie WJ, Howie CR, Madabhushi SP, Usmani AS, Fairbairn DR.
Mechanical consideration in impaction bone grafting. J Bone Joint Surg 1999; 81-
B:118 – 124.
2. Brodt MD, Swan CC, Brown TD. Mechanical behavior of human morselized
cancellous bone in triaxial compression testing. J Orthop Res 1998; 16:43 –49.
3. Ullmark G. Bigger size and defatting of bone chips will increase cup stability. Arch
Orthop Trauma Surg 2000; 120:445 –447.
INDEX

Acetabular bone defect (clinical): structural bone graft, 293, 301, 307
AAOS classification, 277– 280, 308 surgical approach, 281–282, 309
classification systems, 276 surgical technique
ethiology, 275 ring, 309
Acetabular reconstruction (clinical): X-change, 281–286
adding ceramics, 132 Acetabular reconstruction (experimental):
aim of the technique, 278, 288 animal model, 261
alternative to impaction grafting, 275, axial compression tests, 45
307, 377 impaction technique, 45 – 48
complications, 312 shear test (lever-out), 49
for congenital hip displasia, 280– 281, American Association of Tissue Banks
291 (AATB), 12, 403, 424
impactor, 227, 284 Anderson Orthopaedic Research Institute
mesh, 228, 282– 284, 289, 293 bone defect classification, 430
patient’s installation, 281 Animal models (in vivo):
pelvic discontinuity, 279, 308 dog acetabular defect
post-operative care, 284, 289, 309 dog onlay cortical graft, 259
preparation of the morselized grafts, 284, dog segmental defect, 259
288, 309 goat bone conduction chamber, 243
reinforcement rings, 301, 308, 314 ovine defect, 144
results, 70, 227, 290– 294, 312 ovine femoral, 51, 131, 145
primary THA, 290 rabbit knee prosthesis, 215
patients under 50 y, 291 rat bone conduction chamber, 208
revision arthroplasty, 294, 311– 314
rheumatoid arthritis, 298 Bacterial contamination:
reverse reaming, 48, 285 post-mortem blood culture, 25
review of the published series, 229, 316 rifampicine immersion, 14, 27

443
444 Index

risk of, 15, 24, 26, 35, 122 Congenital hip dysplasia (CHD), 291
sample culture, 13, 25 Consent for tissue retrieval:
screening, 16, 24, 35, 424 law regulations, 13
swab culture, 25, 424 Cortical (structural) allograft (see Strut
Biological properties of ceramics, 130 graft)
Biological properties of the morselized Creutzfeldt-Jakob disease (see Prions)
grafts (experimental): Cyclic loading in simulations, 45, 77, 148,
effect of washing, 71, 245, 249– 251 158– 174
effect of impaction, 91, 208– 211,
249– 251
enhancement with OP-1, 257– 266, 270 Density of the compacted graft, 83, 85, 88,
immunogenicity, 211 101, 116, 173
ingrowth distance, 208– 212, 249– 251 Disease transmission (see also Bacterial
remodeling of the grafts, 207, 214, 245, transmission or Viral transmission),
247 12, 24
response to load, 214 Donor selection and screening, 12, 17, 24,
Biphosphonate, 271 34
Bone conduction chamber (BCC), 210, 243 Donor type:
Bone morphogenetic proteins or BMP’s deceased donors, 13, 24, 35
(see Growth factors) living donors, 13, 15, 23, 34, 36
organ donors, 13, 15, 24

Cartilage inclusions: Ethylene oxide, 17, 27


in biopsies, 248, 252 European Association of Musculoskeletal
effect on mechanical behavior, 100 Transplantation (EAMST), 12, 24,
in femoral impaction, 329 424
Cement: European Association of Tissue Banks
in acetabular reconstruction, 284, 302 (EATB), 12, 24
creep, 172, 358, 391
in femoral reconstruction, 342
mantle fracture, 354, 373, 391 Femoral reconstruction (clinical):
mantle thickness, 172, 382, 386 alternative to impaction grafting, 381
penetration in graft mantle, 92 with BMP, 264, 270
removal during revision, 309, 328, 351, cement, 342, 352, 371
367, 385 cerclage wire or cables, 331, 351, 354,
Ceramics (absorbable), 126 371, 384
biological properties, 130, 145 complications, 346, 354, 358, 365,
manufacture, 126 372– 373, 388
mechanical properties, 127, 142– 143 extended trochanteric osteotomy, 328,
mechanical strength, 127– 128 365, 384, 388
mixed with allograft, 128, 130– 133, with freeze-dried grafts, 349, 385
143– 151 impactors (packers, phantoms),
resorption and dissolution, 129 332– 341, 351, 371, 386
Compaction curve, 85, 87, 114 meshes, 324, 321, 338– 339, 351, 365
Compaction protocol, 43, 64, 97, 112, 190, patient’s installation, 324, 326
243 post-operative care, 346, 354, 372
Index 445

pre-operative planning, 324, 350, 365, sample weight loss, 110, 162
384 under hip simulator, 161
preparation of the morselized grafts, 329, Frequency or revision arthroplasty, 11, 141
351, 371, 386 Fuller curve (particle size), 59 – 60
results, 207, 227, 346, 352, 372, 394
review of the published series, 230,
392– 393 Growth factors (see Osteogenic factors)
stem type, 325, 365, 380– 381
strut graft, 346, 351, 354, 371, 384 Harris hip score (HSS), 290–298, 309, 312,
subsidence, 75, 346, 359, 372 354
surgical approach, 325, 384 Heat treatment, 28
surgical technique Hepatitis B, 12, 15, 24
enmeshed, 367 Hepatitis C, 12, 14 – 17, 24, 121
X-change, 324, 331, 350 Histology of impacted grafts:
torque wrench, 388 clinical cases, 218, 233– 237, 245– 249,
Femoral reconstruction (experimental): 251, 431
assessing degree of compaction, 80 – 82 experimental, 129, 209, 213, 216
cavitary defect, 160, 195 History (of impaction bone grafting):
cement mantle, 41 hip revision, 1 – 9, 205– 208, 289, 380
hip simulator, 148, 158– 174 knee revision, 400
impaction procedure, 163, 195 HIV, 12, 14 – 17, 24, 26, 121, 424
impaction set, 80 –82, 86 Hydroxyapatite (see Ceramics)
implant positioning/reproducibility, 159
influence of compaction, 80, 84
influence of stem design, 77 – 79 Impaction bone grafting (see Acetabulum,
initial stability, 41, 79, 90, 164– 166, 197 Femur, or Knee)
in vivo model, 51, 145 Indications:
mesh (metal) in, 51 – 53 for hip revision, 287, 323, 372
micromotion, 146– 150, 164– 174, 196 for knee revision, 400
push out test, 168 Infection:
rotation of the implant, 163, 197 exclusion before revision, 275, 282, 285,
segmental defect, 51 288, 323, 327, 424
strut grafts in, 51 – 53 in impaction bone grafting, 24
subsidence, 41, 51, 75 – 82, 146, in massive allografts, 24
164– 174, 197 treatment with impaction bone, 401
Follow-up study: Instrumentation (for clinical use):
quality, 289 acetabular impactor, 227, 284
Fracture of the host bone, 90, 279 Schneider-Burch ring, 309
femur 90, 331, 346, 365, 388 Irradiation, 17, 27, 315
pelvic discontinuity, 279, 285 bacteria and, 17, 27
Freeze-dried bone particles, 16, 349 effect on biological properties, 27
implant stability and, 173 effect on mechanical properties, 17, 27,
protocol, 111, 350 110
reconstitution or rehydration, 19, 112, low dose, 27
161, 351 prions and, 17
remodeling (clinical), 355– 357 virus and, 17, 27
446 Index

Knee arthroplasty revision (clinical): particle grading, 67


aim of the technique, 401 particle size (see Particle size)
alternative to impaction grafting, recoil, 43
399– 400 shear test, 64, 143, 192–195
cement, 418, 425, 435 viscoelastic behavior, 43
complications, 412, 431, 436 washing, 47 – 51, 67, 70, 117
flexion balance, 402 Mechanical stimulation and remodeling,
impactor, 403, 417, 425 214– 219
indications, 400 Merle d’Aubigné hip score, 372
joint line postion, 401– 402, 425 Mesh (use of metal):
mesh, 404, 418, 424 in acetabular defect, 227, 282– 284
post-operative care, 408, 426, 430 as metal back of acetabular implant, 289
preparation of morselized grafts, 403, in segmental femur defect, 51 – 53
417, 424 Micromotion (see Femoral side)
results, 409, 420, 430 Mohr-Coulomb failure law (shear test), 61,
surgical approach, 403, 427 67, 194
surgical technique (LCS), 401– 409
subsidence, 413, 420, 431
surgical technique Order schedule of allograft, 38
Kinemax, 424– 426 Osseointegration (or osteointegration):
Link, 417 of ceramics, 130
Knee arthroplasty revision (experimental): and microporosity, 130
influence of compaction, 83 Osteoarthritic femoral head, 36 – 37, 160,
in vivo rabbit model, 215 188
graft mantle densitometry, 83 – 84 density, 38
proximal tibial model, 82 Osteogenic factors, 257– 266, 269– 272
Knee Society score, 412 BMP’s, 213, 219, 259, 270
endogenous release, 212
exogenous addition, 213, 214, 219
Mechanical properites of absorbable OP-1, 214, 219, 258– 256, 272
ceramics, 127, 142– 143 TGF-b, 242
Mechanical properties of the allograft: Osteoinductive capacity, 15
effect of freeze-drying, 16 Osteoporotic femoral head, 36, 88, 188
effect of irradiation, 17
Mechanical properties of the morselized
particles: Particle shape, 70, 182
in acetabular reconstructions, 45, 49 Particle size, 45 – 50, 117– 185, 201, 329
compaction protocol (see Compaction in acetabular test, 45 – 51
protocol) in compression test, 103, 184
compression tests, 42, 85, 88, 97 – 99, distribution, 60, 192, 347
111– 113, 184 grading (theory), 58 – 62
during impaction blow, 86, 117, 189 in vivo defect model, 145
effect of cartilage inclusions, 101 measurement, 63, 180, 188
effect of compaction, 72, 85, 87, rongeur or bone mill, 45, 68, 179, 188,
100– 104, 173 242, 285, 288, 309
in femoral reconstruction, 167, 173 in shear test, 64, 68, 192– 195
Index 447

Polymerase chain reaction (PCR), 12, 14, studied by SPECT, 355


24, 35 Rhesus factor, 13, 329
Positron emission tomography (PET) and Rheumatoid arthritis, 298
healing of the graft bed, 231, 318 Ring (use of metal), 227
Preparation of the morselized grafts Rinsing the grafts (see Washing grafts)
for acetabular reconstruction (clinical), Roentgen stereophotogrammic analysis
284, 288, 309 (RSA), 146
for acetabular side test, 45 – 50
in the bone bank, 18
cartilage removal, 97, 105 Sieving particles, 63
for compression test, 96, 110 Soil engineering, 57, 80
cortical bone removal, 97, 105 Sterilization, 17, 26
for femoral reconstruction (clinical), Strut (cortical) graft:
329, 350, 371, 394 clinical practice, 258, 354, 384
freeze-drying and irradiation, 111 clinical use with OP-1, 265– 266
loss of material, 100, 102, 105, 114, 182 onlay animal model, 259
for shear test, 62– 63, 188 segmental defect animal model, 51 –53,
washing, 47 – 51, 67, 70, 117 259
Preservation (of the allograft), 16, 28 Subsidence:
deep-freezing, 16, 28 along with time, 394
freeze-drying, 16, 28, 350 of femoral stem, 41, 51, 75, 346, 354,
packaging, 18 – 19 372, 391
reconstitution, 18 – 19 influence of stem design, 77 – 79
Prions: in knee revision, 413
donor selection, 12 in soil mechanics, 58
graft chemical treatment, 16 Substitute (to bone allograft), 121, 141
graft irradiation, 17 absorbable ceramics (see Ceramics),
xenograft and, 123, 126 126
Processing (of the allograft), 15, 25 classification, 123
chemical treatment, 16, 27 commercially available products (list),
shaping and cutting, 15, 26 124
supercritical CO2, 16, 28 corraline hydroxyapatite, 126, 142
water jet lavage, 16, 26 xenograft, 122
Supply of bone allografts:
amount of bone per procedure, 33, 37,
Quarantine, 15, 35, 117 109, 167, 242, 350, 354, 403
bone bank regulation, 34, 403
Recombinant human proteins (see cost of the allograft, 34, 36, 122
Osteogenic factors) demand (shortfall) and, 33, 109, 121,
Record keeping, 18 350
Remodeling of the impacted bone grafts issue by weight, 37
(clinical) leaving cortical bone, 106
histology, 233– 237, 245– 249, 431 number of grafting procedures, 33
radiological, 292, 299, 312, 354– 356, Surgical technique (see the corresponding
372, 436 anatomical site)
studied by PET scan, 231, 318 Symmetrical (left-right) models, 173
448 Index

Transmissible spongiform encephalopathy risk of, 14 – 15, 24, 109, 358


or TSE (see Prions) seronegative window, 14
Tricalcium Phosphate or TCP (see
Ceramics) Washing the grafts, 47 – 51, 67, 70, 117,
Tumor transmission (by graft), 35 188, 243, 249– 251
Washing technique, 63
Viral contamination: Weight used to order allografts, 38

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