Professional Documents
Culture Documents
in Revision Arthroplasty
edited by
Christian DeIIoye
Universite Catholique de Louvain
Brussels, Belgium
Gordon Bannister
Southmead Hospital
Bristol, England
MARCEL
MARCELDEKKER,
INC. NEWYORK BASEL
DEKKER
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10 9 8 7 6 5 4 3 2 1
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
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
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
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
Sanne van der Donk University Medical Centre 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:
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
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.
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.
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.
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.
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.
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
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.
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 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
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.
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
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
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
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
process and structure. J Bone Joint Surg [Am] 1997; 79-A: 1 – 16.
45. Simonian PT, Conrad EU, Chapman JR, et al. Effect of sterilization and storage
treatments on screw pullout strength in human allograft bone. Clin Orthop 1994; 302:
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 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.
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
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.
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.
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
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
I. INTRODUCTION
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.
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.
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.
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 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 10 Lever-out forces recorded in the lever-out test. Highest forces were
found for the large, washed bone grafts.
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
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
REFERENCES
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
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
III. GRADING
Figure 2 Pyramid of spheres showing how specific smaller sizes can fill the gaps.
Figure 3 Particle size distribution for two theoretical ideals and the three test
mixtures.
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
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.
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
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.
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.
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.
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
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
22. Sommers JFA, Timperley AJ, Wendover N, Gie G, Ling RS. Impaction grafting in
cemented revision surgery of the acetabulum. J Bone Joint Surg (Br.) 1999; 81: 217.
23. Bonfiglio M, Jeter WS. Immunological responses to bone. Clin Orthop 1972; 87:
19 – 27.
24. Burchardt H, Enneking WF. Transplantation of bone. Surg Clin North Am 1978; 58:
403– 427.
25. Goldberg VM, Stevenson S. Natural history of autografts and allografts. Clin Orthop
1987; 225: 7 – 16.
26. Whiteside LA. Cementless fixation issues in revision total knee arthroplasty. Instr
Course Lect 1999; 48: 177–182.
27. Tagil M. The morselized and impacted bone graft. Animal experiments on proteins,
impaction and load. Acta Orthop Scand Suppl 2000; (290): 1 – 40.
28. Urist MR. Bone: formation by autoinduction. Science 1965; 12:698: 893– 899.
29. Burwell RG. Studies in the transplantation of bone: V. The capacity of fresh and
treated homografts of bone to evoke transplantation immunity. J Bone Joint Surg
(Am.) 1963; 65: 239– 246.
30. Burwell RG. Studies in the transplantion of bone: VII. The fresh composite
homograft-autograft of cancellous bone. An analysis of factors leading to osteo-
genesis in marrow transplants and in marrow-containing bone grafts. J Bone Joint
Surg (Br.) 1964; 46: 110– 140.
31. Ray RD. Vascularization of bone grafts and implants. Clin Orthop 1972; 87: 43– 48.
32. Goldberg VM, Powell A, Shaffer JW, Zika J, Bos GD, Heiple KG. Bone grafting:
role of histocompatibility in transplantation. J Orthop Res 1985; 3: 389– 404.
33. Dunlop DG, Griffon D, Howie CR, Madabhushi SP, Usmani AS, Gillespie WJ. An
ovine model to evaluate impacted pellets of new synthetic bone graft substitutes.
J Bone Joint Surg (Br.) 2000; 82(suppl 1): 65 –66.
34. Aspenberg P, Tagil M, Kristensson C, Lidin S. Bone graft proteins influence
osteoconduction. A titanium chamber study in rats. Acta Orthop Scand 1996; 67:
377– 382.
35. Horowitz MC, Friedlaender GE. Immunologic aspects of bone transplantation. A
rationale for future studies. Orthop Clin North Am 1987; 18: 227– 233.
36. Stevenson S, Li XG, Martin B. The fate of cancellous and cortical bone after
transplantation of fresh and frozen tissue-antigen matched and mismatched osteo-
chondral allografts in dogs. J Bone Joint Surg (Am.) 1991; 73: 1143– 1156.
37. Muscolo DL, Caletti E, Schajowicz F, Araujo ES, Makino A. Tissue typing in human
massive allografts of frozen bone. J Bone Joint Surg (Am.) 1987; 69: 583– 595.
38. van der Donk, S. Experimental and clinical data on the incorporation of impacted
morsellized bone grafts. Thesis/Dissertation, University of Nijmegen, Netherlands,
2002.
39. 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.
40. 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.
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
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
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.
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.
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 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.
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.
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
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
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.
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.
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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complications after one hundred and forty-four consecutive hip revisions with
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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.
94 Kuiper et al.
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?
Mean particle
Type of graft No. of particles size (mm2)
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.
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
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
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)
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
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.
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
I. INTRODUCTION
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.
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
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.
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.
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).
IV. DISCUSSION
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
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20. European Association of Musculo Skeletal Transplantation (EAMST) and European
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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
Biological/
Biological Biological Synthetic Synthetic synthetic
human nonhuman nonabsorbable absorbable combinations
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
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.
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.
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
Cortical bone 20 10
Cancellous bone 6–9 0.5
Porous calcium phosphate 1 – 10 0.36
Dense calcium phosphate 30 – 130 10 –28
Porosity (%)
5 30 45
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 4 Radiograph from an ovine study showing ceramic granules still clearly
visible 2 years after impaction grafting.
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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cancellous allografts and cement for revision total hip arthroplasty. J Bone Joint
Surg 1993; 75-B:14 –21.
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3. Madhok R, Lewellen DG, Wallrichs SL, et al. Trends in the utilisation of primary
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4. Galea G, Kopman D, Graham BJM. Supply and demand of bone allograft for
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virus. An estimate of risk of acquired immunodeficiency syndrome (AIDS). Clin
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6. Jofe MH, Gebhardt MC, Tomford WW, Mankin HJ. Reconstruction for defects of
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70-A:507 – 516.
Bone Graft Substitutes for Impaction Grafting 135
7. Lord CF, Gebhardt MC, Tomford WW, Mankin HJ. Infection in bone allografts.
J Bone Joint Surg 1988; 70-A:369 – 376.
8. Meding J, Ritter M, Keating E, Faris P. 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; 79-A:1834 –1841.
9. Galea G, Lumley S. SNBTS Strategic Review 1994/95: tissue banking services.
The “What” Phase 1995.
10. Friedlander GE, Strong DM, Sell KW. Studies on the antigenicity of bone. Freeze-
dried and deep-frozen bone allografts in rabbits. J Bone Joint Surg 1976;
58-A:854 – 858.
11. Friedlander GE, Strong DM, Sell KW. Studies on the antigenicity of bone. Donor
specific anti-HLA antibodies in human recipients of freeze-dried allografts. J Bone
Joint Surg 1984; 66-A:107 – 112.
12. Musculo DI, Caletti E, Schajowicz F, et al. Tissue typing in human massive
allografts of frozen bone. J Bone Joint Surg 1987; 69-A:583 – 595.
13. Simonds RJ, Holmberg SD, Hurwitz RL, et al. Transmission of human
immunodeficiency virus type 1 from a seronegative organ and tissue donor.
N Engl J Med 1992; 326:726 – 732.
14. Simonds RJ, Holmberg SD, Hurwitz RL, et al. Transmission of human
immunodeficiency virus type 1 from a seronegative organ and tissue donor.
N Engl J Med 1992; 326:726 – 732.
15. Heiple K, Kendrick R, Herndon C, Chase S. A critical evaluation of processed calf
bone. J Bone Joint Surg 1967; 49-A:1119 – 1127.
16. Levai J, Boigard S. Acetabular reconstruction in total hip revision using a bone graft
substitute. Clin Orthop 1996; 330:108 – 114.
17. Doherty M, Schlag G, Schwarz M, Mollan R, Nolan P, Wilson D. Bio and
compatability of xenogeneic bone, commercially available coral, a bioceramic and
tissue sealant for human osteoblasts. Biomaterials 1994; 15(8):601– 607.
18. Hubble M, Goodship A, Learmonth I. Xenograft bone for impaction grafting in
revision total hip arthroplasty. An in vivo pilot study. J Bone Joint Surg 1997; 79-B
(suppl IV):468.
19. Begley C, Doherty M, Mollan R, Wilson D. Comparative study of the
osseoinductive properties of bioceramic, coral and processed bone graft substitutes.
Biomaterials 1995; 16(15):1181 – 1185.
20. Porsson B, Ekelund L, Londaal R, et al. Favourable results of acrylic cementation
for giant cell tumours. Acta Orthop Scand 1984; 55:209 – 214.
21. Jones L, Hungerford D. Cement disease. Clin Orthop 1987; 225:192 – 206.
22. Hunter GA, Welsh RP, Cameron HU, Bailey WH. The results of revision of total
hip arthroplasty. J Bone Joint Surg 1979; 61-B:419 – 421.
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24. Pellici PM, Wilson PD, Sledge CB, et al. Long term results of revision total hip
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25. Amstutz HC, Ma SM, Jinnah RH, Mai L. Revision of aseptic loose total hip
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136 Blom and Learmonth
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31. Jonck L, Grobbelaar C. A glass ionomer for reconstructive surgery: Ionogran—an
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32. Eldridge J, Cunningham J, Samuels A, Lawes T, Learmonth I, Goodship A. Glass
ionomer as a potential osteoconductive expander of allograft in revision
arthroplasty of the hip. Key Eng Mat 2001; 192–195:951 – 954.
33. Gilding D, Reed A. Biodegradable polymers for use in surgery—polyglycolic/
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Bone Graft Substitutes for Impaction Grafting 137
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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
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.
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].
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
Shear strength
Interlocking Friction (kPa) at
(kPa) angle s ¼ 350 kPa
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.
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.
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
REFERENCES
48. Paterson M, Fulford P, Denham R. Loosening of the femoral component after total
hip replacement. The thin black line and the sinking hip. J Bone Joint Surg (Br) 1986;
68:392 – 397.
49. Haddad RJJ, Cook SD, Thomas KA. Biological fixation of porous-coated implants.
J Bone Joint Surg (Am) 1987; 69:1459– 1466.
50. 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
(Am) 1994; 76:95 – 103.
51. Harris WH, Mulroy RDJ, Maloney WJ, Burke DW, Chandler HP, Zalenski EB.
Intraoperative measurement of rotational stability of femoral components of total hip
arthroplasty. Clin Orthop 1991; 266:119 – 126.
52. Mjoberg B, Hansson LI, Selvik G. Instability of total hip prostheses at rotational
stress. A roentgen stereophotogrammetric study. Acta Orthop Scand 1984;
55:504 – 506.
53. 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.
54. 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
Surg (Br) 1989; 71:452– 455.
55. Brumby SA, Howie DW, Pearcy MJ, Wang AW, Nawana NS. Radiographic and
histologic analysis of cemented double tapered femoral stems. Clin Orthop 1998;
355:229 – 237.
56. Lanyon LE. The measurements of bone strain “in-vivo”. Acta Orthop Belg 1976;
42(suppl 1):98– 108.
57. Lanyon LE, Hampson WG, Goodship AE, Shah JS. Bone deformation recorded in
vivo from strain gauges attached to the human tibial shaft. Acta Orthop Scand 1975;
46:256 – 268.
58. Lanyon LE, Paul IL, Rubin CT, et al. In vivo strain measurements from bone and
prosthesis following total hip replacement. An experimental study in sheep. J Bone
Joint Surg (Am) 1981; 63:989 – 1001.
59. Lanyon LE, Smith RN. Measurements of bone strain in the walking animal. Res Vet
Sci 1969;10:93– 94.
60. Roszek B, Weinans H, van Loon P, Huiskes R. In vivo measurement
of the loading conditions on the tibia of the goat. Acta Anat (Basel) 1993;
146:188 – 92.
61. Buhler DW, Oxland TR, Nolte LP. Design and evaluation of a device for measuring
three-dimensional micromotions of press-fit femoral stem prostheses. Med Eng Phys
1997; 19:187 – 199.
62. Gilbert JL, Bloomfeld RS, Lautenschlager EP, Wixson RL. A computer-based
biomechanical analysis of the three-dimensional motion of cementless hip
prostheses. J Biomech 1992; 25:329 – 340.
63. Berzins A, Sumner DR, Andriacchi TP, Galante JO. Stem curvature and load angle
influence the initial relative bone-implant motion of cementless femoral stems.
J Orthop Res 1993; 11:758– 769.
Synthetic Bone Grafting Material 155
I. INTRODUCTION
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.
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.
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.
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)
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.
G. Definitions
The following definitions were used (Fig. 6):
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.
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.
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
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.
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.
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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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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prostheses. J Biomech 1989; 22:735– 744.
22. Schneider E, Kinast C, Eulenberger J, Wyder D, Eskilsson G, Perren SM. A
comparative study of the initial stability of cementless hip prostheses. Clin Orthop
1989; 248:200 –209.
23. Huiskes R, Verdonschot N, Nivbrant B. Migration, stem shape, and surface finish in
cemented total hip arthroplasty. Clin Orthop 1998; 355:103– 112.
24. Dall DM, Learmonth ID, Solomon MI, Miles AW, Davenport JM. Fracture and
loosening of Charnley femoral stems. Comparison between first-generation and
subsequent designs. J Bone Joint Surg 1993; 75-B:259 – 265.
25. Sochart DH, Hardinge K. Comparison of the Wrightington FC hip with the Charnley
low-friction arthroplasty. 10- to 15-year results and survival analysis. J Bone Joint
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26. Buhler DW, Oxland TR, Nolte LP. Design and evaluation of a device for measuring
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27. Larsson S, Elloy M, Hansson LI. Fixation of unstable trochanteric hip fractures. A
cadaver study comparing three different devices. Acta Orthop Scand 1988; 59:658–663.
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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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30. Phillips TW, Messieh SS, McDonald PD. Femoral stem fixation in hip replacement.
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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
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32. Sugiyama H, Whiteside LA, Kaiser AD. Examination of rotational fixation of the
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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
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35. Karrholm J, Malchau H, Snorrason F, Herberts P. Micromotion of femoral stems in
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39. Karrholm J, Hultmark P, Carlsson L, Malchau H. Subsidence of a non-polished stem
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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?
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.
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.
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
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).
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.
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
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
1. Brewster NT, Gillespie WJ, Howie CR, Madabhushi SP, Usmani SP, Fairbrain DR.
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
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.
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).
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.
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.
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.
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
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
Average shear
strength (tu )
Angle of (0.37 MPa
Cohesion (c) internal friction compressive
Group (MPa) (f) (rad) stress) (MPa)
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.
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 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
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.
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
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
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.
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.
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
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.
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.
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
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
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224 Tägil and Aspenberg
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.
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.
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.
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.
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.
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
X-ray
Histology,
months Subsid.
Pat No. Gender Age Prosth. p.o. Mm Trab. Bone def.
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 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 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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Histology After Bone Impaction 239
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240 Ullmark
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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.
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
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
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).
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
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.
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.
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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28. Thoren K, Aspenberg P, Thorngren KG. Lipid extraction decreases the specific
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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
[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.
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
Control
Postoperative mean+SD OP-1 mean+SD
week (sample size) (sample size) p-value
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.
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
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].
REFERENCES
1. Brady OH, Garbuz DS, Masri BA, Duncan CP. The treatment of periprosthetic
fractures of the femur using cortical onlay allograft struts. Orthop Clin North Am
1999; 30:249 – 257.
2. Emerson RH Jr, Malinin TI, Cuellar AD, Head WC, Peters PC. Cortical strut
allografts in the reconstruction of the femur in revision total hip arthroplasty. A basic
science and clinical study. Clin Orthop 1992; 285:35– 44.
Osteogenic Enhancement of Bone Graft 267
3. Head WC, Malinin TI, Mallory TH, Emerson RH Jr. Onlay cortical allografting for
the femur. Orthop Clin North Am 1998; 29:307 –312.
4. 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.
5. Hooten JP, Engh CA, Heekin RD, Vinh TN. Structural bulk allografts in acetabular
reconstruction: analysis of two grafts retrieved at post-mortem. J Bone Joint Surg
1996; 78B:270 – 275.
6. Pelker R, Friedlaender GE, Markham TC. Biomechanical properties of bone
allografts. Clin Orthop 1983; 174:54– 57.
7. Schwarz N, Schlag G, Thurnher M, Eshberger J, Dinges H, Redl H. Fresh autogenic,
frozen allogenic, and decalcified allogenic bone grafts in dogs. J Bone Joint Surg
1991; 73-B:787 – 790.
8. Burchardt H. The biology of bone graft repair. Clin Orthop 1983; 174:28 – 42.
9. Enneking WF, Burchardt H, Puhl JJ, Piotrowski G. Physical and biological
aspects of repair in dog cortical-bone transplants. J Bone Joint Surg 1975;
57-A:237 – 252.
10. Celeste AJ, Lannazzi JA, Taylor RC, Hewick, RM, Rosen V, Wang EA, Wozney JM.
Identification of transforming growth factor-beta superfamily members present in
bone inductive protein purified from bovine bone. Proc Natl Acad Sci USA 1990;
87:9843– 9847.
11. Ozkaynak E, Rueger DC, Drier EA, Corbett C, Ridge RJ, Sampath TK,
Oppermann H. OP-1 cDNA encodes an osteogenic protein in TGF-beta family.
EMBO J 1990; 9:2085 –2093.
12. Sampath TK, Coughlin JE, Whetstone RM, Banach D, Corbett C, Ridge RJ,
Ozkaynak E, Oppermann H, Rueger DC. Bovine osteogenic protein is composed of
dimers of OP-1 and BMP-2A, two members of the transforming growth factor-beta
superfamily. J Biol Chem 1990; 265:13198 – 13205.
13. Stevenson S, Cunningham N, Toth J, Davy D, Reddi AH. The effect of osteogenin
(a bone morphogenetic protein) on the formation of bone in orthotopic segmental
defects in rats. J Bone Joint Surg 1994; 76-A:1676 – 1687.
14. Urist MR. Bone formation by autoinduction. Science 1965; 150:893 – 899.
15. Urist MR, Mikulski A, Lietze A. A solubilized and insolubilized bone
morphogenetic protein. Proc Natl Acad Sci USA 1979; 76:1828 – 1832.
16. Wang EA, Rosen V, Cordes P. Purification and characterization of other distinct
bone inducing proteins. Proc Natl Acad Sci USA 1988; 87:9484– 9488.
17. Sampath TK, Maliakal JC, Hauschka PV, Jones WK, Sasak H, Tucker RF, White KH,
Coughin JE, Tucker MM, Pang RH. Recombinant human osteogenic protein-1 (hOP-
1) induces new bone formation in vivo with a specific activity comparable with
natural bovine osteogenic protein and stimulates osteoblast proliferation and
differentiation in vitro. J Biol Chem 1992; 267:20352 – 20362.
18. Urist MR, Delange RJ, Finerman GA. Bone cell differentiation and growth factors.
Science 1983; 220:680 – 686.
19. Wozney JM, Rosen V, Celeste AJ, Mitsock LM, Whitters MJ, Kriz RW, Hewick RM,
Wang EA. Novel regulators of bone formation: molecular clones and activities.
Science 1988; 242:1528 – 1534.
268 Cook and Barrack
20. Cook SD, Baffes GC, Wolfe MW, Sampath TK, Rueger DC. Recombinant human
bone morphogenetic protein-7 induces healing in canine long-bone segmental defect
model. Clin Orthop 1994; 301:302– 312.
21. Cook SD, Baffes GC, Wolfe MW, Sampath TK, Rueger DC. The effect of
recombinant human osteogenic protein-1 (rhOP-1) on healing of large segmental
bone defects. J Bone Joint Surg 1994; 76-A:827 –838.
22. Cook SD, Dalton JE, Tan EH, Whitecloud TS, Rueger DC. In vivo evaluation of
recombinant human osteogenic protein (rhOP-1) implants as a bone graft substitute
for spinal fusions. Spine 1994; 19:1655 –1663.
23. Cook SD, Rueger DC. Osteogenic protein-1. Biology and applications. Clin Orthop
1996; 324:29 – 38.
24. Cook SD, Wolfe MW, Salkeld SL, Rueger DC. Effect of recombinant human
osteogenic protein-1 on healing of segmental defects in non-human primates. J Bone
Joint Surg 1995; 77A:734 –750.
25. Gerhart T, Kirker-Head C, Kriz MJ, Schellin S, Wang E. Healing segmental defects
in sheep using recombinant human bone morphogenetic protein (BMP-2). Trans
Orthop Res Soc 1991; 16:172.
26. Friedlander GE, Perry CR, Cole JD, Cook SD, Cierny G, Muschler GE, Zych GA,
Calhoun JH, LaFore AJ, Yin S. Osteogenic protein-1 (bone morphogenetic
protein-7) in the treatment of tibial nonunions. J Bone Joint Surg 2001;
83-A(suppl 1):151 –158.
27. Sampath TK, Reddi AH. Dissociative extraction and reconstitution of extracellular
matrix components involved in local bone differentiation. Proc Natl Acad Sci USA
1981; 78:7599 – 7603.
28. Salkeld SL, Patron LP, Barrack RL, Cook SD. The effect of osteogenic protein-1 on
the healing of segmental bone defects treated with autograft and allograft bone.
J Bone Joint Surg 2001; 83-A:803 –816.
29. Cook SD, Barrack RL, Santman M, Patron LP, Salkeld SL, Whitcloud TS. Strut
healing to the femur with recombinant human osteogenic protein-1. Clin Orthop
2000; 350:50 – 60.
30. Cockin J. Autologous bone grafting-complications at the donor site. J Bone Joint
Surg 1973; 53-B:153.
31. Younger EM, Chapman MW. Morbidity at bone graft donor sites. J Orthop Trauma
1989; 3:192 – 195.
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.
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.
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
I. INTRODUCTION
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.
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).
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
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
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.
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
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.
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.
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%.
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.
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
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.
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Slooff TJJH. Favorable results of acetabular reconstruction with impacted morsellized
bone grafts in patients younger than 50 years. Acta Orthop Scand 2001; 72:120 – 126.
7. Bolder SB, Melenhorst J, Gardeniers JWM, Slooff TJJH, Veth RPH, Schreurs BW.
Cemented total hip arthroplasty with impacted morcellized bone-grafts to restore
acetabular bone defects in congenital hip dysplasia. J Arthroplasty 2001;
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8. Charnley J, Feagin JA. Low friction arthroplasty in congenital subluxation of the hip.
Clin Orthop 1973; 91:98 – 113.
9. Harris WH, Crothers O, Oh I. Total hip replacement and femoral head grafting for
severe acetabular deficiencies in adults. J Bone Joint Surg 1977; 59A:752– 759.
10. Enneking WF, Mindell ER. Observations in massive retrieved human allografts.
J Bone Joint Surg 1991; 73A:1123– 1142.
11. Hooten JP, Engh CA, Heekin RD, Vinh TN. Structural bulk allografts in acetabular
reconstruction: analysis of two grafts retrieved post-mortem. J Bone Joint Surg 1996;
78B:270 – 275.
12. 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.
304 Schreurs et al.
13. Schreurs BW, Slooff TJJH, Buma P, Gardeniers JWM, 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 1998; 80-
B:391 – 395.
14. Malchau H, Herberts P, Ahnfelt L. Prognosis of total hip replacement in Sweden:
follow-up of 92,675 operations performed 1978– 1990. Acta Orthop Scand 1993;
64:497 – 506.
15. Creighton MG, Callaghan JJ, Olejniczak JP, Johnston RC. Total hip arthroplasty in
patients who have rheumatoid arthritis. A minimum ten-years follow-up study.
J Bone Joint Surg 1998; 80-A:1439 –1446.
16. Lehtimaki MY, Kautiainen H, Lehto U, Hamalainen MM. Charnley low-friction
arthroplasty in rheumatoid patients: a survival study up to 20 years. J Arthroplasty
1999; 14:657 – 661.
17. Hastings DE, Parker SM. Protrusio acetabuli in rheumatoid arthritis. Clin Orthop
1975; 108:76 – 84.
18. Ranawat CS, Dorr LD, Inglis AE. Total hip replacement in protrusio acetabuli of
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19. Johnsson R, Ekelund L, Zygmunt S, Lidren L. Total hip replacement with spongious
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20. Gates HS, McCollum DE, Nunley JA. Bone grafting in total hip arthroplasty for
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21. Rosenberg WJ, Schreurs BW, Waal Malefijt MC de, Veth RPH, Slooff TJJH.
Impacted morsellized bone grafting and cemented primary total hip arthroplasty for
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24. Schreurs BW, Thien MT, de Waal Malefijt MC, Buma P, Veth RPH, Slooff THJJH.
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acetabular component without cement after total hip arthroplasty: a follow-up note at
7 to 11 years. J Bone Joint Surg 1996; 78A:1366– 1370.
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Long-Term Results of Acetabular Reconstruction 305
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acetabulum reconstruction with morsellized grafts is less surgical dependent when
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22
Impaction Bone Technique at the
Acetabular Side
E. Winter
BG Unfallklinik
Tübingen, Germany
I. INTRODUCTION
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.
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.
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
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
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
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
MR, Müller ring; BSR, Burch-Schneider ring; n.s., not specified; M.d.A., Merle d’Aubigne.
317
318 Winter
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Acetabular Bone Impaction 321
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.
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.
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.
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.
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.
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.
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).
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.
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
Figure 6 Alignment of instruments: The guide wire should point to the middle of
the popliteal fossa when viewed down its length.
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.
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.
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 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.
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.
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 16 Stem insertion: The stem is introduced into the neomedullary canal.
Impaction Bone Grafting on the Femoral Side 345
Figure 18 Trial reduction: Final trial reduction before closure of external rotators.
346 Timperley et al.
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.
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.
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
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.
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).
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
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.
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.
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.
REFERENCES
1. Slooff TJJH, Huiskes R, van Horn J, Lemmens AJ. Bone-grafting in total hip
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
immunodeficiency virus type 1 from a seronegative organ and tissue donor. N Engl J
Med 1992; 326:726 – 732.
19. Conrad EU, Ericksen DP, Tencer AF, Strong DM, Mackenzie AP. The effects of
freeze-drying and rehydration on cancellous bone. Clin Orthop 1993; 290:279 – 284.
20. Friedlander GE, Strong DM, Sell KW. Studies on the antigenicity of bone.
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.
22. Jones KC, Andrish J, Kuivila T, Gurd A. Radiographic outcomes using freeze-dried
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.
25. Mazhar 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.
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.
28. 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.
29. 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.
30. 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.
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
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
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 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.
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
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.
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
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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7. Dohmae Y, Betchold JE, Sherman RE, Puno RM, Gustilo RB. Reduction in cement-
bone interface shear strength between primary and revision arthroplasty. Clin Orthop
1988; 236:214 –220.
8. Hultmark P, Karrholm J, Stromberg C, Herberts P, Mose CH, Malchau H. Cemented
first-time revisions of the femoral component: prospective 7 to 13 years’ follow-up using
second-generation and third-generation technique. J Arthroplasty 2000; 15:551–561.
9. 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.
10. Migaud H, Jardin C, Fontaine C, Pierchon F, d’herbomez O, Duquennoy A. Femoral
reconstruction with endosteal bone allografts protected by a metallic mesh in
reoperation of total hip prosthesis. 19 cases with an average follow-up of 83 months.
Rev Chir Orthop 1997; 83:360 – 367.
11. Pierchon F, Migaud H, Duquennoy A. Reconstitution of femoral bone stock in
loosening of total hip prosthesis. Acta Orthop Belg 1993; 59:278– 286.
12. Gie GA, Linder L, Ling RSM, Simon JP, Sloof TJJH, Timperley AJ. Impacted
cancellous allografts and cement for revision total hip arthroplasty. J Bone Joint Surg
(Br) 1993; 75:14– 21.
13. 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.
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. 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.
16. Johnston RC, Fitzgerald RH Jr, Harris WH, Poss R, Muller ME, Sledge CB. Clinical
and radiographic evaluation of total hip replacement. A standard system of
terminology for reporting results. J Bone Joint Surg (Am) 1990; 72:161– 168.
17. 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.
18. 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.
19. Eldridge JD, Smith EJ, Hubble MJ, Whitehouse SL, Learmonth ID. Massive early
subsidence following femoral impaction grafting. J Arthroplasty 1997; 12:535 – 540.
20. 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 (Br) 1995; 77:862 – 864.
21. Gie GA. Impaction grafting is a treatment of choice in revision total hip arthroplasty.
Seventeenth Current Concepts in Joint Replacement, Orlando, FL, Dec 13 –16, 2000,
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22. De Thomasson E, Guinguand O, Mazel C. Modified Exeter technique for recons-
truction of femoral bone loss in revision total hip arthroplasty. Does prosthesis
stability affect remodeling of the graft? Eur J Orthop Surg Traumatol 2000; 10:35–42.
376 Migaud et al.
23. 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 (Am) 1999; 81:1080 – 1092.
24. Vives P. Descellement aseptique des prothèses totales de hanche repris par prothèse
cimentée. Rev Chir Orthop 1989; 75(suppl 1):23 –60.
25. 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.
26. 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.
27. 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(suppl 1):195– 202.
28. Ullmark G, Hallin G, Nilsson O. Impacted corticocancellous allografts and cement
for femoral revision of total hip arthroplasty using Lubinus and Charnley prostheses.
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29. 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.
30. Ullmark G, Nilsson O. Impacted corticocancellous allografts: recoil and strength.
J Arthroplasty 1999; 14:1019– 1023.
31. 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.
32. 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
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for femoral revision total hip arthroplasty. In vitro mechanical stability and effects of
cement pressurization. J Arthroplasty 1996; 11:500 – 506.
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results without cement. Orthop Clin North Am 1993; 24:635– 644.
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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
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.
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.
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.”
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.
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.
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
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
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].
VII. SUMMARY
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27
Revision of Total Knee Arthroplasty
by Impaction Bone Grafting
Gary W. Bradley
ALTA Orthopaedics
Santa Barbara, California, U.S.A.
I. INTRODUCTION
II. INDICATIONS
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
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
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
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
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.
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 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.
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
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.
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].)
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].)
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.
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.
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
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
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 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.
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
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.
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
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.
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.
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].
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.
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.
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
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