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JBJS 15 00909
JBJS 15 00909
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.
*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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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
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
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
(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 Patients were in a supine position, with standardized foot rotation to enable
was 150 or 160 mm for the femur and 120 or 130 mm for the tibia, depending on marker visibility throughout the follow-up period. Migration was expressed
the use of an offset coupler (Fig. 1). All of the longer, press-fit stems (no offset along or around the 3 orthogonal axes: longitudinal, transverse, and sagittal
coupler) were slotted stems. Slotted shorter stems were not available. (Fig. 3).
All procedures were performed in 1 stage except in 3 patients with in- Laser-scanned, reverse-engineered models were used. Accuracy was
fection as the indication for the revision, who were treated with a 2-stage revision. determined with a phantom study and, for the femoral component, was
All patients received the same preoperative, perioperative, and postoperative ±0.063, ±0.021, and ±0.167 mm for translation along the transverse, lon-
standard care; they were allowed full weight-bearing using crutches immediately gitudinal, and sagittal axes, respectively, and ±0.127, ±0.095, and ±0.042
postoperatively. After preparation of the bone and before placement of the im- for rotation around these axes. For the tibial component, the accuracy was
plants, 1-mm tantalum beads for RSA were placed in the femur and tibia (Fig. 2). ±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
Outcome Measures rotation around these axes. Double examinations were carried out for all
Implant Migration subjects at the 6-week follow-up evaluations to assess precision. Precision was
The primary end point with respect to implant stability was micromotion, calculated as the 95% confidence interval (1.96 · standard deviation [SD])
measured with RSA using a uniplanar setup with ceiling-mounted x-ray tubes. 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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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.
were evaluated preoperatively and at 6 weeks (±1 week), 3 months (±2 reference to the femoral bone, and migration of the tibial component was
weeks), 6 months (±3 weeks), 1 year (±1 month), and 2 years (±2 months) calculated with reference to the tibial bone. Since the stem is firmly attached to
postoperatively. the femoral component or tibial baseplate, the two are considered to behave as
Model-based (MB) RSA measurements were performed with MBRSA one rigid body. A cutoff level of <150 was used for the condition number. Total
software (RSAcore). Migration of the femoral component was calculated with translation (TT) was calculated as TT = O(Tx21Ty21Tz2) and total rotation
Fig. 4
Flow diagram of patient enrollment.
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(TR) was calculated as TR O(Rx21Ry21Rz2) , with x, y, and z defined as included in the study, 30 (15 with cemented stems and 15 with
shown in Figure 3, and these were used as summarizing variables for the trans- hybrid stems) completed the 2-year follow-up. There was no
lation along and rotation around the 3 axes.
statistically significant difference between the treatment groups
with regard to the baseline demographics, clinical character-
Clinical Outcome istics, or indications for revision surgery, except for active
During all follow-up visits, the research nurse collected data during a physical
examination. The clinical, functional, and total Knee Society Score (KSS) and
flexion of the affected knee (Tables II and III19).
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 Implant Migration
18
Osteoarthritis Outcome Score (KOOS) . Mid-thigh or mid-shin pain was At 2 years, the median TTfemur and TRfemur were 0.31 mm
scored as “yes” or “no” at 6, 12, and 24 months postoperatively and patients (range, 0.15 to 1.14 mm) and 0.62 (range, 0.13 to 2.10) for
were considered to have such pain when they answered “yes” at one or more the cemented constructs and 0.45 mm (range, 0.13 to 0.89 mm)
of the follow-up visits.
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
Statistical Methods and TR). The median TTtibia and TRtibia were 0.40 mm (range,
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.
0.14 to 1.02 mm) and 0.86 (range, 0.24 to 1.88) for the ce-
The primary end points were the TT and TR values at 2 years. Additional mented group and 0.44 mm (range, 0.16 to 2.05 mm) and 0.65
analyses were done to compare the number of migrating implants according to (range, 0.28 to 2.95) for the hybrid group. Again, there was no
different thresholds of TT and TR (0.5, 1.0, 1.5, and 2.0 mm or degrees) significant difference between the treatment groups (p = 0.68
between the cemented and hybrid fixation groups at the 2-year follow-up and p = 0.89 for TTtibia and TRtibia, respectively).
assessment. Groups were compared using the Wilcoxon-Mann-Whitney test, The median translations and rotations at all follow-up
and categorical values were compared using the chi-square or Fisher exact test.
intervals for both groups (Tables IVand V) were at or below the
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. precision limits, indicating that there was not a significant
P values of <0.05 were considered significant. amount of implant migration on the group level.
The number of implants showing translation or rotation
Results of >1 mm or >1 was comparable between the groups at all
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
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
analysis because the size of this patient’s femoral component components and 3 cemented femoral components had rotated
was not available for MBRSA measurements. Of the 32 patients >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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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 cemented group, 8 patients reported mid-thigh or mid-shin
>1 mm at 2 years and 10 (5 cemented and 5 hybrid) had rotated pain during at least 1 follow-up visit; in the hybrid group, 6
>1 (Fig. 6). Also, no differences between the groups were found patients reported mid-thigh or mid-shin pain.
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 Complications
2.0 mm or degrees) (Figs. 7 and 8). The occurrence and types of serious adverse device-related
effects are listed in Table VII. The most frequent was persistent
Clinical Outcome or increasing pain, with some patients referred to a pain clinic.
At 2 years, the clinical outcomes were comparable between the There was no difference in the occurrence of serious adverse
all-cement and hybrid fixation techniques (Table VI). In the 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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