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C OPYRIGHT  2016 BY T HE J OURNAL OF B ONE AND J OINT S URGERY, I NCORPORATED

No Difference in Implant Micromotion Between

Hybrid Fixation and Fully Cemented Revision
Total Knee Arthroplasty
A Randomized Controlled Trial with Radiostereometric Analysis of
Patients with Mild-to-Moderate Bone Loss
P.J.C. Heesterbeek, PhD, A.B. Wymenga, MD, PhD, and G.G. van Hellemondt, MD

Investigation performed at the Departments of Orthopaedics and Research, Sint Maartenskliniek, Nijmegen, the Netherlands

Background: In revision total knee arthroplasty (TKA), the femoral component and tibial baseplate are usually cemented.
However, stems can be fixed either with cement or with a press-fit technique, with the latter resulting in hybrid fixation.
There is no consensus on the preferred stem fixation technique. Therefore, we compared the stability of cemented
TKA implants with the stability of TKA implants fixed with the hybrid technique in a prospective randomized trial using
radiostereometric analysis (RSA).
Methods: Thirty-two patients with a Type-I or II bone defect who needed revision TKA and were randomly allocated at the
time of surgery into either the cemented or hybrid-fixation group were included in the study. The radiographs for the RSA
were obtained during hospitalization (baseline); at 6 weeks; and at 3, 6, 12, and 24 months. Migration of the femoral and
tibial implants was measured using model-based RSA and expressed along or around the 3 orthogonal axes and as total
translation (TT) and total rotation (TR). Clinical results were evaluated using the Knee Society Score (KSS), the Knee injury
and Osteoarthritis Outcome Score (KOOS), active flexion, and visual analog scale (VAS) scores for pain and satisfaction.
Mann-Whitney and chi-square tests were used to compare migration and clinical outcomes between the cement and
hybrid techniques.
Results: At 24 months, no difference in median migration or the number of migrating components was found between
the cemented and hybrid-fixation groups. In each group, approximately one-third of the tibial components had total rotation
of >1
. The clinical scores did not differ between the techniques.
Conclusions: At 24 months after revision TKAs, cemented and hybrid-fixation replacements were equally stable. Unex-
pectedly, both groups had implants with >1 mm or >1
of micromotion although there were no clinical or radiographic signs of
loosening. Whether these findings indicate the possibility of loosening with longer follow-up remains to be investigated.
Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Peer review: This article was reviewed by the Editor-in-Chief and one Deputy Editor, and it underwent blinded review by two or more outside experts. The Deputy Editor
reviewed each revision of the article, and it underwent a final review by the Editor-in-Chief prior to publication. Final corrections and clarifications occurred during one or
more exchanges between the author(s) and copyeditors.

A
chieving reliable implant fixation is critical to the suc- securing diaphyseal fixation, reducing proximal strain, im-
cess of revision total knee arthroplasty (TKA). Stems proving axial alignment, and permitting the use of augments
provide the possibility of bypassing damaged bone, and adjustment of component offset1-5. Numerous technical

Disclosure: The institution of the authors received funding for this study from Smith & Nephew (Memphis, Tennessee), the manufacturer of the device
used in this study. Smith & Nephew had no role in interpretation or reporting of the results of the study. On the Disclosure of Potential Conflicts of
Interest forms, which are provided with the online version of the article, one or more of the authors checked “yes” to indicate that the author had a relevant
financial relationship in the biomedical arena outside the submitted work; “yes” to indicate that the author had a patent and/or copyright, planned,
pending, or issued, broadly relevant to this work; and “yes” to indicate that the author had other relationships or activities that could be perceived to
influence, or have the potential to influence, what was written in this work.

J Bone Joint Surg Am. 2016;98:1359-69 d http://dx.doi.org/10.2106/JBJS.15.00909

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with the latter producing hybrid fixation. We are not aware of

TABLE I Precision (95% Confidence Interval) of Double any evidence indicating which construct provides better sta-
Examinations to Measure Migration of Femoral
and Tibial Components bility; several investigators have reported that both options are
at least clinically equivalent4,6-8.
Translation* (mm) Rotation* (deg) The pros and cons of cemented compared with hybrid
Tx Ty Tz Rx Ry Rz constructs have been reported in the literature. Hybrid fixation
has the potential for bone stock preservation and enables better
Femur 0.16 0.17 0.42 0.67 0.39 0.20 alignment of the intramedullary axis, whereas cemented stems
Tibia 0.20 0.11 0.44 0.64 0.54 0.27 allow more variability of component positioning to prevent
lateral oversizing and/or excessive length6,8-10, which can be
*See Fig. 3 for description of x, y, and z translation and rotation.
countered by using offset stems8,11,12. A disadvantage of hybrid
fixation is the potential for end-of-stem pain13, although this
options are available, but the main issue remains: how to fix the can be diminished by the use of slotted stems14. The ideal fix-
stem? The femoral component and tibial baseplate are usually ation of modular revision TKA remains unclear. Hybrid and
cemented whereas the stems are either cemented or press-fit, all-cement fixation techniques have been reported to provide

TABLE II Baseline Characteristics

Variable Cemented Hybrid P Value*

Age at time of surgery† (yr) 67 (6.5) 64.5 (2.8) 0.57

Sex (male:female) (no. of patients) 6:10 3:13 0.24
Side (left:right) (no. of patients) 6:10 6:10 1.00
KSS‡ (points)
Clinical 51 (29-78) (2) 49 (0-62) 0.23
Functional 50 (220-70) (2) 50 (25-60) 0.45
Total 100.5 (9-137) (2) 97.5 (0-121) 0.34
Active flexion of affected knee‡ (deg) 100 (60-130) (1) 87.5 (40-110) (2) 0.009
VAS pain score‡ (points) 64 (37-100) (3) 64.5 (0-89) 0.86
KOOS‡ (points)
Pain 36 (19-56) (2) 33 (0-56) (1) 0.83
Other symptoms 44.5 (32-75) (2) 43 (14-75) (1) 0.14
Activities of daily living 33 (13-56) (2) 31 (0-60) (2) 0.45
Sports and recreation function 0 (0-15) (3) 0 (0-20) (3) 0.49
Knee-related quality of life 6 (0-44) (2) 13 (0-31) (1) 0.91
Physical condition (excellent/good/moderate/poor/data missing) 2/10/3/0/1 0/7/7/0/2
(no. of patients)
AORI bone defect type (I/IIA [med.]/IIA [lat.]/IIA [med. 1 lat.]/IIB/
data missing) (no. of patients)
Femur 3/1/6/4/2/0 6/0/5/2/3/0
Tibia 11/1/0/3/0/1 11/1/1/2/1/0
Level of implant constraint (posterior stabilized/constrained) 14/2 12/4 0.65
(no. of patients)
Construct length (no. of patients)
Femur (150 mm with offset coupler/160 mm without offset coupler) 11/5 9/7 0.72
Tibia (120 mm with offset coupler/130 mm without offset coupler) 15/1 12/4 0.33
Stem diameter‡ (mm)
Femur 20 (16-20) (0) 20 (15-22) (0) 0.48
Tibia 16 (12-20) (0) 16 (12-20) (0) 0.19

*No significant differences between groups, except for active flexion of affected knee. †The values are given as the mean (standard deviation).
‡The values are given as the median (range) (number with missing data).
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19
equal stability, and experimental and clinical results (survival,
TABLE III Overview of Indications aseptic loosening, and clinical outcome) have been reported to
No. of Patients be comparable8,15. However, a need for high-quality research
on this topic persists because of the low levels of evidence in
Main Reason for Revision Total Cemented Hybrid
previous studies8,15.
Instability 8 5 3 We are not aware of any reports of a clinical comparison
Aseptic loosening 7 4 3 between hybrid fixation and all-cement techniques in revision
Component malposition/ 10 3 7
TKA in patients with (1) constructs of the same length, (2) the
malrotation same Anderson Orthopaedic Research Institute (AORI) type of
Patellar subluxation after 3 0 3 bone defect as well as an intact diaphysis and metaphysis, (3)
malrotation implants with the same level of constraint, and (4) 1 revision
Infection* 3 3 0 only (i.e., re-revisions were excluded). In addition, the litera-
Polyethylene wear 1 1 0 ture that we reviewed provided no precise outcome measures
and the levels of evidence were low8,15. Therefore, we performed
*Before infection became an exclusion criterion. a randomized controlled trial comparing cemented and hybrid
constructs in terms of implant stability and clinical outcome in

TABLE IV Migration of Femoral Component at Follow-up Intervals in Cemented and Hybrid Groups

Cemented Hybrid
6 Wk 3 Mo 6 Mo 12 Mo 24 Mo 6 Wk 3 Mo 6 Mo 12 Mo 24 Mo

Medial translation (Tx) (mm)

No. 16 16 16 14 15 15 15 15 15 14
Median 0.03 0.09 0.03 0.10 0.05 20.02 20.04 20.14 0.00 20.13
Min. 20.10 20.21 20.37 20.22 20.36 20.43 20.28 20.24 20.18 20.41
Max. 0.18 0.31 0.33 0.29 0.41 0.27 0.23 0.28 0.27 0.38
Proximal translation (Ty) (mm)
No. 16 16 16 14 15 15 15 15 15 14
Median 20.03 20.04 0.01 0.01 0.02 0.04 0.01 0.04 0.03 0.06
Min. 20.22 20.22 20.17 20.23 20.31 20.16 20.10 20.14 20.15 20.17
Max. 0.37 0.29 0.41 0.38 0.45 0.32 0.43 0.34 0.76 0.44
Anterior translation (Tz) (mm)
No. 16 16 16 14 15 15 15 15 15 15
Median 0.13 0.16 0.12 0.12 0.15 20.04 0.07 0.12 0.11 0.13
Min. 20.54 20.28 22.38 20.56 21.10 20.34 20.82 20.74 21.26 20.78
Max. 0.85 0.90 0.63 0.95 1.01 0.73 0.62 0.83 0.94 0.88
Flexion (Rx) (deg)
No. 15 16 16 14 15 15 15 15 15 14
Median 0.01 0.03 0.06 0.02 20.04 0.02 20.04 20.06 20.05 20.10
Min. 21.34 20.76 20.54 21.05 20.73 20.56 20.55 20.98 20.88 20.86
Max. 0.95 0.86 3.64 1.34 2.05 1.11 1.66 0.91 1.00 0.91
Internal rotation (Ry) (deg)
No. 15 16 16 14 15 15 15 15 15 14
Median 20.13 20.13 20.12 20.17 20.29 0.04 20.10 20.18 20.05 20.12
Min. 20.87 20.47 20.64 20.65 20.75 20.32 20.40 20.49 20.76 20.40
Max. 0.69 0.68 0.36 0.32 0.42 0.62 0.50 0.50 0.47 0.83
Varus (Rz) (deg)
No. 15 16 16 14 15 15 15 15 15 14
Median 0.00 0.02 0.12 20.01 20.04 20.01 20.04 20.05 20.03 20.10
Min. 20.19 20.27 20.61 20.30 20.40 20.56 20.35 20.35 20.32 20.53
Max. 0.27 0.31 0.47 0.37 0.42 0.28 0.14 0.26 0.24 0.26
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TABLE V Migration of Tibial Component at Follow-up Intervals in Cemented and Hybrid Groups

Cemented Hybrid
6 Wk 3 Mo 6 Mo 12 Mo 24 Mo 6 Wk 3 Mo 6 Mo 12 Mo 24 Mo

Medial translation
(Tx) (mm)
No. 15 15 14 13 14 14 14 14 13 14
Median 0.01 20.04 20.03 0.03 0.03 20.07 0.08 0.04 0.02 0.06
Min. 20.13 20.18 20.24 20.85 20.25 20.33 20.23 20.43 20.23 20.31
Max. 0.31 0.36 0.43 0.46 0.70 0.26 0.14 0.24 0.16 0.37
Proximal translation
(Ty) (mm)
No. 15 15 14 13 14 14 14 14 13 14
Median 0.02 0.03 0.09 0.06 0.07 20.00 0.05 0.04 0.05 0.12
Min. 20.06 20.07 20.07 20.05 20.14 20.21 20.41 20.40 20.45 20.35
Max. 0.14 0.20 0.22 0.29 0.25 0.13 0.15 0.22 0.28 0.32
Anterior translation
(Tz) (mm)
No. 15 15 14 13 14 14 14 14 13 14
Median 20.08 0.05 20.01 20.09 20.21 0.03 0.03 0.02 0.07 0.15
Min. 20.53 20.45 20.47 21.65 20.60 20.44 20.29 20.38 20.34 20.57
Max. 0.39 0.90 0.89 0.87 0.94 0.33 0.70 0.41 0.94 1.99
Anterior tilt (Rx) (deg)
No. 15 15 14 13 14 14 14 14 13 14
Median 20.04 0.06 0.08 20.05 20.27 20.04 0.02 0.01 0.03 0.30
Min. 20.69 20.67 20.71 22.13 20.80 20.84 20.91 21.05 20.92 20.97
Max. 0.66 1.25 1.23 1.15 1.09 0.61 0.91 0.35 1.11 2.85
Internal rotation
(Ry) (deg)
No. 15 15 14 13 14 14 14 14 13 14
Median 0.03 0.10 0.08 0.03 20.09 20.09 20.07 0.01 20.01 20.02
Min. 20.79 20.70 20.81 20.73 20.61 20.74 20.61 20.67 20.54 20.89
Max. 1.90 1.89 1.98 1.66 1.76 0.44 0.38 0.76 0.66 0.63
Valgus (Rz) (deg)
No. 15 15 14 13 14 14 14 14 13 14
Median 0.01 0.04 0.06 20.04 0.01 0.11 20.01 0.07 0.08 20.02
Min. 20.40 20.53 20.78 20.79 20.81 20.21 20.50 20.40 20.48 20.50
Max. 0.23 0.52 0.60 1.13 0.41 0.44 0.67 0.80 0.39 0.52

patients with revision TKA. The hypothesis that we tested was and research nurse enrolling and assessing participants. During surgery, on
that the use of either an all-cement or a hybrid fixation tech- preparation for implantation of the stems, the envelope was opened by the
nique would result in equal implant micromotion and func- surgical technician to reveal the allocation.
To detect a difference of 1 mm or 1
of micromotion at 1 year (which
tional outcomes.
was arbitrarily considered to be clinically relevant and feasible with regard
to the accuracy and precision) with a 2-sided 5% significance level and a
Materials and Methods power of 90%, a sample size of 16 patients per group was necessary; this
Trial Design took into account an anticipated number of missing data because of marker

T his single-center, patient-blinded, parallel-group study with an allocation

ratio of 1:1 was conducted from January 2008 to April 2010 at Sint
Maartenskliniek, Nijmegen, the Netherlands. Block randomization (block sizes
of 6, 4, and 4) was performed by a computer-generated random-number list
prepared by an independent investigator. The allocation sequence was con-
cealed, in sequentially numbered, opaque, sealed envelopes, from the surgeons
occlusion.
The study protocol was approved by the hospital’s investigational
review board and the Arnhem-Nijmegen Medical Ethical Review Board
(2007/083). The trial is registered at the Nederlands Trial Register (www.
trialregister.nl), identified with number NTR1315. This study was con-
ducted in accordance with the Declaration of Helsinki, CONSORT
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TABLE VI Postoperative (2-Year) Clinical Scores in Cemented and Hybrid Groups

Cemented* Hybrid*

KSS (points)
Clinical 89 (46-100), 15 81 (17-94), 14
Functional 60 (0-100), 15 60 (220-100), 15
Total 149 (46-200), 15 146 (18-188), 14
Active knee flexion (deg) 110 (90-140), 13 90 (30-130), 13
VAS (points)
Pain 28 (0-83), 15 53 (0-99), 15
Satisfaction 78 (13-100), 15 84 (3-100), 15
KOOS (points)
Pain 61 (31-100), 14 62.5 (0-81), 14
Other symptoms 64 (36-96), 14 57.5 (7-82), 14
Activities of daily living 46.5 (18-96), 14 62.5 (7-82), 14
Sports and recreation 10 (0-50), 13 6.3 (0-30), 7
function
Knee-related quality of life 25 (0-88), 14 38 (0-81), 14

*The values are given as the median (range), number of patients.

(Consolidated Standards of Reporting Trials) guidelines, and ISO (Inter- With the hybrid implantation technique (a cemented femoral component
national Organization for Standardization) 16087:2013 for radiostereo- or tibial baseplate with a press-fit stem), the diaphyseal fixation was obtained
metric analysis (RSA). Written informed consent was obtained from all using a canal-filling stem in order to provide a substantial length of diaphyseal
participating patients. cortical contact. The stem thickness was patient-specific, and was chosen either by
fitting the stem into the medullary canal with cement (with the cemented stems
Patients available in 2-mm increments) or by placement of a press-fit stem (available in
Eligible participants were adults on the waiting list for a total system re- 1-mm increments). A shorter stem length was chosen if an offset coupler (length,
vision of a primary TKA for whom either implantation technique (all- 30 mm) was used (in both cemented and hybrid constructs), and a longer stem
cement or hybrid) was indicated. Patients had to be in stable health and free
from, or under treatment for (with stabilization of their condition), car-
diac, pulmonary, hematological, or any other conditions that might pose an TABLE VII Serious Adverse Device-Related Effects in Cemented
excessive operative risk or affect compliance with the standard postoper- and Hybrid Groups During First 2 Years After Surgery
ative rehabilitation protocol. Exclusion criteria were radiographically or
perioperatively defined Type-III bone loss (deficient metaphyseal bone with Cemented Hybrid
bone loss compromising a major portion of the condyle or plateau, occasionally
Stiff knee* 1 3
with detachment of a collateral ligament or patellar tendon) according
16
to the Anderson Orthopaedic Research Institute (AORI) classification , Persistent or increasing pain 3 6
2
a body mass index (BMI) of >35 kg/m , or a known sensitivity to materials Effusion or suspicion of 2 3
in the device. infection
Extension deficit 1 2
Interventions
Insert exchange 1 0
All patients received the Legion revision TKA (Smith & Nephew). All surgical
procedures were performed by 2 experienced orthopaedic knee surgeons Secondary patellar 1 0
(A.B.W. and G.G.v.H.) who had >10 years’ experience using both the all- resurfacing
cement and hybrid techniques. All patients received spinal anesthesia or re- Total system revision: 0 1
gional femoral and sciatic nerve blocks. The femoral components and tibial arthrodesis
baseplates were cemented in all cases, whereas the patella was selectively re- Fracture of lateral 0 1
surfaced, with 14 patellae remaining unresurfaced. Instrumentation specific to epicondyle during surgery
both stem-fixation techniques was used as described in the surgical technique
brochure provided by the manufacturer (Smith & Nephew). Medial patellofemoral 1 0
The all-cement treatment involved fully cementing the stems of both ligament reconstruction
the tibia and the femoral component. A Weber PE (polyethylene) cement plug Total 10 16
(Zimmer) was placed, after which pulse lavage was performed, vacuum-mixed
Palacos R1G or COPAL cement (Heraeus Medical) was injected without a *The knee in the cemented group and 1 of the 3 in the hybrid
pressurizer and with a retrograde technique, and the femoral and tibial im- group were treated for the stiffness with manipulation under
plants were inserted; at least 1 cm of cement was placed between the cement anesthesia.
plug and the end of the stem.
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Fig. 1
Schematic illustration of the lengths of the femoral (A and B) and tibial (C and D) constructs with the use of an offset coupler (B and D) and without the
coupler (A and C). (Reproduced, in part, with permission from Smith & Nephew.)

length was chosen if no offset coupler was used. The total length of the construct
was 150 or 160 mm for the femur and 120 or 130 mm for the tibia, depending on
the use of an offset coupler (Fig. 1). All of the longer, press-fit stems (no offset
coupler) were slotted stems. Slotted shorter stems were not available.
All procedures were performed in 1 stage except in 3 patients with in-
fection as the indication for the revision, who were treated with a 2-stage revision.
All patients received the same preoperative, perioperative, and postoperative
standard care; they were allowed full weight-bearing using crutches immediately
postoperatively. After preparation of the bone and before placement of the im-
plants, 1-mm tantalum beads for RSA were placed in the femur and tibia (Fig. 2).
Outcome Measures
Implant Migration
The primary end point with respect to implant stability was micromotion,
measured with RSA using a uniplanar setup with ceiling-mounted x-ray tubes.
Patients were in a supine position, with standardized foot rotation to enable
marker visibility throughout the follow-up period. Migration was expressed
along or around the 3 orthogonal axes: longitudinal, transverse, and sagittal
(Fig. 3).
Laser-scanned, reverse-engineered models were used. Accuracy was
determined with a phantom study and, for the femoral component, was
±0.063, ±0.021, and ±0.167 mm for translation along the transverse, lon-
gitudinal, and sagittal axes, respectively, and ±0.127
, ±0.095
, and ±0.042

for rotation around these axes. For the tibial component, the accuracy was
±0.043, ±0.030, and ±0.075 mm for translation along the transverse, longi-
tudinal, and sagittal axes, respectively, and ±0.079
, ±0.122
, and ±0.072
for
rotation around these axes. Double examinations were carried out for all
subjects at the 6-week follow-up evaluations to assess precision. Precision was
calculated as the 95% confidence interval (1.96 · standard deviation [SD])
around the mean migration between the two examinations (Table I). Patients

Fig. 2
An analyzed MBRSA image of a revision TKA fixed with a hybrid technique (with a slotted stem in the tibia) showing the 3-dimensional (3-D) surface model of
the femoral (green) and tibial (red) components, with the implant contours (red outlines) detected on the radiographs, and the respective bone markers with
the corresponding 3-D model (pink for femur and blue for tibia). The yellow and green markers are the fiducial and control markers of the calibration box.
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were evaluated preoperatively and at 6 weeks (±1 week), 3 months (±2
weeks), 6 months (±3 weeks), 1 year (±1 month), and 2 years (±2 months)
postoperatively.
Model-based (MB) RSA measurements were performed with MBRSA
software (RSAcore). Migration of the femoral component was calculated with
NO DIFFERENCE IN IMPLANT MICROMOTION BETWEEN HYBRID
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Fig. 3
Orientation of the longitudinal, transverse, and
sagittal axes and the directions of positive
translation and rotation (in italics) for both the
femur and the tibia.
reference to the femoral bone, and migration of the tibial component was
calculated with reference to the tibial bone. Since the stem is firmly attached to
the femoral component or tibial baseplate, the two are considered to behave as
one rigid body. A cutoff level of <150 was used for the condition number. Total
translation (TT) was calculated as TT = O(Tx21Ty21Tz2) and total rotation
Fig. 4
Flow diagram of patient enrollment.
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17
(TR) was calculated as TR  O(Rx21Ry21Rz2) , with x, y, and z defined as
shown in Figure 3, and these were used as summarizing variables for the trans-
lation along and rotation around the 3 axes.
Clinical Outcome
During all follow-up visits, the research nurse collected data during a physical
examination. The clinical, functional, and total Knee Society Score (KSS) and
active flexion of the affected knee were assessed. The patients marked visual
analog scales (VASs) for pain and satisfaction and filled out the Knee injury and
18
Osteoarthritis Outcome Score (KOOS) . Mid-thigh or mid-shin pain was
scored as “yes” or “no” at 6, 12, and 24 months postoperatively and patients
were considered to have such pain when they answered “yes” at one or more
of the follow-up visits.
Statistical Methods
Statistically, all RSA data were assessed as not having a normal distribution; the
medians and interquartile ranges of the TT and TR are presented graphically.
The primary end points were the TT and TR values at 2 years. Additional
analyses were done to compare the number of migrating implants according to
different thresholds of TT and TR (0.5, 1.0, 1.5, and 2.0 mm or degrees)
between the cemented and hybrid fixation groups at the 2-year follow-up
assessment. Groups were compared using the Wilcoxon-Mann-Whitney test,
and categorical values were compared using the chi-square or Fisher exact test.
Medians and ranges are presented for the RSA results as well as for the clinical
outcome parameters. During the trial, no interim analyses were carried out.
P values of <0.05 were considered significant.
Results
he patient flow diagram is presented in Figure 4. Of the 34
T patients randomized, 1 did not receive the allocated in-
tervention and 1 (with a hybrid stem) was excluded from the
analysis because the size of this patient’s femoral component
was not available for MBRSA measurements. Of the 32 patients
included in the study, 30 (15 with cemented stems and 15 with
hybrid stems) completed the 2-year follow-up. There was no
statistically significant difference between the treatment groups
with regard to the baseline demographics, clinical character-
istics, or indications for revision surgery, except for active
flexion of the affected knee (Tables II and III19).
Implant Migration
At 2 years, the median TTfemur and TRfemur were 0.31 mm
(range, 0.15 to 1.14 mm) and 0.62
(range, 0.13
to 2.10
) for
the cemented constructs and 0.45 mm (range, 0.13 to 0.89 mm)
and 0.57
(range, 0.13
to 1.12
) for the hybrid group, with no
significant difference between the groups (p = 0.66 for both TT
and TR). The median TTtibia and TRtibia were 0.40 mm (range,
0.14 to 1.02 mm) and 0.86
(range, 0.24
to 1.88
) for the ce-
mented group and 0.44 mm (range, 0.16 to 2.05 mm) and 0.65

(range, 0.28
to 2.95
) for the hybrid group. Again, there was no
significant difference between the treatment groups (p = 0.68
and p = 0.89 for TTtibia and TRtibia, respectively).
The median translations and rotations at all follow-up
intervals for both groups (Tables IVand V) were at or below the
precision limits, indicating that there was not a significant
amount of implant migration on the group level.
The number of implants showing translation or rotation
of >1 mm or >1
was comparable between the groups at all
follow-up interval (p > 0.26 for the femoral implants and p > 0.32
for the tibial implants). At 2 years, 2 cemented femoral com-
ponents had translated >1 mm compared with 0 hybrid femoral
components and 3 cemented femoral components had rotated
>1
compared with 1 hybrid femoral component (Fig. 5). Two

Fig. 5
Migration (total translation and total rotation) of the femoral components at the follow-up intervals in the cemented and hybrid-fixation groups.
Top and bottom of box = 25th and 75th percentiles, horizontal line within box = median, whiskers = lower and upper adjacent values, and
markers = outside values.
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F I X AT I O N A N D F U L LY C E M E N T E D R E V I S I O N T KA

Fig. 6
Migration (total translation and total rotation) of the tibial components at the follow-up intervals in the cemented and hybrid-fixation groups. Top and bottom
of box = 25th and 75th percentiles, horizontal line within box = median, whiskers = lower and upper adjacent values, and markers = outside values.

tibial components (1 cemented and 1 hybrid) had translated
>1 mm at 2 years and 10 (5 cemented and 5 hybrid) had rotated
>1
(Fig. 6). Also, no differences between the groups were found
when the numbers of migrating components were compared on
the basis of different thresholds of TT and TR (0.5, 1.0, 1.5, and
2.0 mm or degrees) (Figs. 7 and 8).
Clinical Outcome
At 2 years, the clinical outcomes were comparable between the
all-cement and hybrid fixation techniques (Table VI). In the
cemented group, 8 patients reported mid-thigh or mid-shin
pain during at least 1 follow-up visit; in the hybrid group, 6
patients reported mid-thigh or mid-shin pain.
Complications
The occurrence and types of serious adverse device-related
effects are listed in Table VII. The most frequent was persistent
or increasing pain, with some patients referred to a pain clinic.
There was no difference in the occurrence of serious adverse
device-related effects between the 2 groups (p = 0.29).

Fig. 7 Fig. 8
Fig. 7 Scatterplot of total translation and rotation of the femoral components at 24 months in the cemented and hybrid-fixation groups. The reference
lines indicate migration thresholds at 0.5, 1.0, 1.5, and 2.0 mm or degrees. Fig. 8 Scatterplot of total translation and rotation of the tibial components
at 24 months in the cemented and hybrid-fixation groups. The reference lines indicate migration thresholds at 0.5, 1.0, 1.5, and 2.0 mm or degrees.
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Discussion
I n this randomized controlled trial, we compared implant
stability and clinical outcomes between fully cemented re-
vision TKAs and revision TKAs performed with a hybrid fix-
ation technique. The 2 procedures were done with the same
implant, the same length of construct, and the same level of
implant constraint in patients with a Type-I or II bone defect.
Implant migration was similar between the 2 groups at the 2-
year follow-up evaluation. The median translation and rotation
remained at or below the precision level in both groups, in-
dicating that the amount of implant migration was not sig-
nificant at the group level. In addition, the number of implants
showing >1 mm of translation or >1
of rotation was com-
parable between the groups. Our hypothesis that there was
equal implant stability could not be rejected.
By studying patients with the same length of construct,
same level of bone loss, and same level of implant constraint; by
excluding re-revisions; and by using a randomized design and a
precise measurement technique we were able to focus on the
optimal stem fixation strategy. We believe this to be the first and
only randomized controlled trial in which implant micromotion
of revision TKAs was measured with RSA and thus that there is
no literature with which to compare our results. However, this
topic has been investigated in some studies with a lower level of
evidence (III or IV), including a review and a recent meta-
analysis, which showed the implant survival rate, rate of aseptic
loosening, and clinical outcomes to be comparable between the
cemented and hybrid techniques8,15. The conclusions of our
study support those findings. However, we were surprised by
the high number of fully cemented constructs with micromotion
of >1 mm or >1
as we expected “rock solid” constructs. It is
unclear whether the relatively high number of components (in
both groups) that migrated >1 mm or >1
will eventually have
loosening, or whether the arbitrary choice of 1 mm or 1
to
indicate migration was too conservative. In a previous study of
primary tibial components, a maximal total point motion of
>1.6 mm indicated an unacceptable risk of revision at 5 and 10
years20. Extended follow-up of the patients in the current study
continues, with collection of 5 and 10-year results, to ascertain
whether the amounts of migration found in the present study
will lead to early re-revisions.
Clinical scores were comparable with those found in other
studies8, although some patients in the present study did have
substantially lower scores. Mid-thigh or mid-shin pain was
reported by almost half of the patients but was equally distrib-
uted between the groups and therefore not specific for the hy-
brid fixation. The prevalence was a bit higher than has been
reported in the literature21, but counting a patient as having mid-
thigh or shin pain when he/she reported it at one or more follow-
up visits might have resulted in an overestimation. Although one
explanation may be a low-threshold referral strategy to our own
pain clinic, the high prevalence, particularly in the group with
cemented constructs, warrants further investigation.
This study has some limitations. First, during the course
of the trial an additional exclusion criterion was added (the
need for a 2-stage revision). This change was made because the
NO DIFFERENCE IN IMPLANT MICROMOTION BETWEEN HYBRID
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surgeons became concerned that they might be cementing
stems in patients who had an infection at the site of the im-
plant. Since these patients were excluded before randomization
took place, we do not believe this affected the outcome at the
group level, but it is still a flaw. Second, the baseline RSA was
not always performed on the same postoperative day because of
logistic reasons, although it was always carried out after mo-
bilization and as late as possible during the hospital stay. There
were no differences between the groups in terms of the day of
the RSA, and we are confident that this did not introduce bias.
Third, the sample size in the present study was small, a problem
inherent to RSA studies. While the sample was sufficient for
investigation of micromotion, no conclusions can be drawn
regarding clinical outcomes. Fourth, this study was limited to
patients with Type-I, IIA, or IIB defects. We cannot predict the
results for patients with Type-III osseous defects, for those
undergoing re-revision, or for those treated with other stem
lengths or in whom hybrid fixation techniques with secondary
osseous ingrowth possibilities were used. The total length of the
construct was not the same for all patients; it differed by 10 mm
between those treated with and those treated without an offset
coupler. Although the stem lengths were equally distributed
between the randomization groups, theoretically this could have
led to bias as randomization took place before the decision to
use offset couplers. However, Wood et al. found results of
hybrid and cement fixation techniques to be comparable
irrespective of the degree of constraint, use of augments, or
length or thickness of the stems4.
The results of our study show that both stem fixation
techniques resulted in equally stable constructs. Recent de-
velopment of ingrowth metaphyseal sleeves and porous metal
cones has resulted in a trend toward using shorter stems
in combination with solid metaphyseal fixation22,23. Stability
of this type of construct compared with the ones that we
investigated will likely stimulate debate and will be a topic of
future investigations.
In conclusion, all-cement and hybrid fixation of revi-
sion TKAs resulted in equal stability at 24 months in patients
with a Type-I or II bone defect, the same length of construct,
and the same level of implant constraint. There were implants
with micromotion of >1 mm or >1
in both groups, but there
were no clinical or radiographic signs of loosening. Whether
the micromotion might result in loosening at a later follow-up
interval remains to be investigated. n
NOTE: The authors thank research nurse Saskia Susan for her efforts in patient recruitment and
data management.
P.J.C. Heesterbeek, PhD1
A.B. Wymenga, MD, PhD1
G.G. van Hellemondt, MD1
1Departments of Research (P.J.C.H.) and Orthopaedics (A.B.W. and
G.G.v.H.), Sint Maartenskliniek, Nijmegen, the Netherlands
E-mail address for P.J.C. Heesterbeek: p.heesterbeek@maartenskliniek.nl
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