The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 86, Issue 10

Scientific Articles | October 01, 2004

The Influence of an Anterior-Posterior Gliding Mobile Bearing on Range of Motion After Total Knee Arthroplasty: A Prospective, Randomized, Double-Blinded Study

Christian Aigner, MD¹; Reinhard Windhager, MD¹; Michael Pechmann, MD¹; Peter Rehak, PhD¹; Klaus Engeleke, MD²

¹ Department of Orthopaedic Surgery (C.A., R.W., M.P.) and Division of Biomedical Engineering and Computing (P.R.), University of Graz Medical School, Auenbruggerplatz 5, 8036 Graz, Austria. E-mail address for C. Aigner: christian.aigner@uni-graz.at
² Orthopaedic Hospital Frohnleiten, Hauptplatz 3-5, 8130 Frohnleiten, Austria

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The authors did not receive grants or outside funding in support of their research or preparation of this manuscript. They did not receive payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.

Investigation performed at the University of Graz Medical School, Graz, Austria

The Journal of Bone and Joint Surgery, Incorporated

J Bone Joint Surg Am, 2004 Oct 01;86(10):2257-2262

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Abstract

Background: Range of motion is a crucial measure of outcome after total knee arthroplasty. In order for maximum flexion to occur, the femur must progressively shift posteriorly on the tibia, a movement that is known as femoral rollback. Mobile bearings with free anterior-posterior translation could improve knee flexion by allowing such motion. The purpose of the present study was to determine the influence of an anterior-posterior gliding mobile bearing on the postoperative range of knee motion in patients with an intact posterior cruciate ligament.

Methods: We performed a prospective, randomized clinical trial of fifty consecutive total knee arthroplasties that were performed with use of the LCS-Universal prosthesis. Participants were randomized to receive either a deep-dish rotating platform or a mobile bearing that allowed additional anterior-posterior translation, the latter of which requires an intact posterior cruciate ligament. The ranges of motion of the knees were assessed to detect a 15° difference in the active non-weight-bearing range of motion with a power (1 — ß) of 20% and with the level of significance (a) set at 0.05. The translation of the mobile bearing was measured with use of a standardized ultrasound technique and was correlated with maximum knee flexion. The participants and the assessor were blinded throughout the study.

Results: At the time of the one-year follow-up evaluation, forty-eight knees were available for an intention-to-treat analysis. The mean active non-weight-bearing range of motion at one year was 113° (95% confidence interval, 108° to 118°) in the twenty-six knees that had received a rotating platform and 111° (95% confidence interval, 115° to 125°) in the twenty-two knees that had received an anterior-posterior gliding bearing (p = 0.57). In the latter group, a continuous rollback occurred in two knees. There was no significant correlation between knee flexion and anterior-posterior translation (r² = 0.015).

Conclusions: The use of a mobile bearing that allowed free anterior-posterior translation did not regularly restore femoral rollback and did not improve range of motion after total knee arthroplasty compared with the findings seen in association with the use of a rotating platform.

Level of Evidence: Therapeutic study, Level I-1b (randomized controlled trial [no significant difference but narrow confidence intervals]). See Instructions to Authors for a complete description of levels of evidence.

Figures in this Article

Range of motion is an important determinant of the functional outcome after total knee arthroplasty^1,2. In order for maximum knee flexion to occur, progressive posterior translation of the femur on the tibia must occur with increasing flexion to allow the posterior rim of the tibia to clear the posterior aspects of the femoral condyles³. This movement, termed femoral rollback, has been inconsistently achieved with current knee arthroplasty designs^4-6. Mobile-bearing articular inserts have been introduced and are thought to reduce polyethylene wear. Certain types of mobile tibial inserts allow anterior-posterior translation of the tibial polyethylene⁷. In the presence of a functioning posterior cruciate ligament, such motion could improve femoral rollback and thereby allow greater knee flexion. To our knowledge, this hypothesis has not been adequately tested and has been evaluated in only nonrandomized studies thus far^8,9.

The purpose of the present study was to determine the influence of an anterior-posterior gliding mobile bearing on postoperative knee motion in patients with an intact posterior cruciate ligament.

Materials and Methods

Materials and Methods | Results | Discussion | References

Participants

In January 2001, we designed a prospective, randomized clinical trial that was performed in accordance with the International Conference on Harmonization (ICH 2000) and the revised CONSORT agreement¹⁰. We included patients who had been admitted for primary total knee replacement, who were between nineteen and eighty years old, who had an intact posterior cruciate ligament, and who had a deformity of =25°. We excluded knees with patella baja (as indicated by a Blackburne-Peel index¹¹ of <0.5), pregnant women, and the contralateral knees of previously enrolled patients. Decision by lot was used to select which knee would be included in cases of simultaneous bilateral procedures. Ethical approval was obtained from the internal review board of the university, and participants provided written informed consent.

Intervention

A unilateral total knee replacement with an LCS-Universal prosthesis (DePuy, a Johnson and Johnson company, Warsaw, Indiana) was performed with use of two different mobile bearings designed to fit the same tibial component. The deep-dish rotating platform compensates for the absent posterior cruciate ligament and has an anterior-posterior constraint and an elevated posterior rim, whereas the anteroposterior glide (AP Glide) bearing allows additional unrestricted anterior-posterior translation but requires an intact posterior cruciate ligament (Fig. 1). We used a lateral parapatellar approach in six knees with a fixed valgus deformity and a medial parapatellar approach in the remaining knees. A 7° posterior slope was created with the tibial cut, and femoral rotation was adjusted to the epicondylar line. A stepwise ligament release was performed^12-14 until balanced flexion and extension gaps and a properly functioning posterior cruciate ligament were observed with trial implants in place. Knees with a partially ruptured or elongated posterior cruciate ligament were excluded intraoperatively, as were knees that were treated with an intraoperative release of the posterior cruciate ligament. Only then was the surgeon informed of the allocation. The surgeon then resected the posterior cruciate ligament in knees that had been randomized to receive the rotating-platform prosthesis. On the day after surgery, the patients were mobilized and total weight-bearing was encouraged; after one week, they were transferred to a nursing hospital. Antibiotic therapy was continued for twenty-four hours, and enoxaparin was given for four weeks after surgery for prophylaxis against deep-vein thrombosis.

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Fig. 1: The rotating deep-dish platform (left) of the LCS-Universal system has an anterior-posterior constraint and an elevated posterior rim, whereas the AP Glide bearing (right) has a guide arm that rotates freely within the tray to allow anterior-posterior translation.

Objectives and Outcomes

We hypothesized that the AP Glide bearing would be associated with a 15° improvement in range of motion when compared with the rotating-platform prosthesis one year after the operation. The primary outcome measure was the active non-weight-bearing range of motion. The secondary outcome measures were the passive non-weight-bearing range of motion, the active and passive weight-bearing ranges of motion, and the Hospital for Special Surgery Score¹⁵. Data were collected preoperatively and at six weeks, three months, six months, and twelve months postoperatively by a blinded assessor with use of a goniometer. Non-weight-bearing values were obtained with the patient in the supine position on the table in order to allow free hip flexion. Unassisted squatting was done for the measurement of active weight-bearing⁶, and kneeling was done for the measurement of passive weight-bearing. Long-leg standing, lateral, and tangential patellar radiographs with the knee in 30° of flexion were made and were evaluated by the main investigator (C.A.). Permanent images of mobile-bearing translation were recorded with an 8-MHz linear ultrasound unit (with a precision of 0.7 mm and an accuracy of 0.2 mm¹⁶) at 30° intervals from extension to maximum flexion and were analyzed by a blinded investigator (M.P.).

Randomization, Blinding, and Statistical Analysis

The sample size was determined on the basis of values that were derived from a random sample of patients one year postoperatively. With mean values of 120° ± 23° for the AP Glide bearing and of 105° ± 9° for the rotating-platform prosthesis, it was determined that a total of forty-six knees would be needed to show a significant difference with a power (1 - ß) of 80% (a = 0.05, two-sided test). Therefore, fifty patients were randomized in order to compensate for dropouts.

The allocation sequence was stratified according to gender with a blockwise randomization, in groups of four. The allocation sequence was accomplished by a statistician (P.R.), was administered by an independent person, and was concealed until the surgeon detected a sufficient posterior cruciate ligament with use of appropriate trial components during the operation. The participants and the clinical assessor were blinded for the entire study period.

Statistical analysis was performed with NCSS 2001 (NCSS, Kaysville, Utah) and StatXact-4 (Cytel Software Corporation, Cambridge, Massachusetts) software. The two-sided t test and the Wilcoxon test were used to compare the means of numerical variables. The chi-square test and the Fisher exact test were used to compare differences in categorical variables. The level of significance was set at 0.05.

Results

Materials and Methods | Results | Discussion | References

Ninety-one patients were screened for eligibility during the recruitment period (Fig. 2). Twenty-three patients were excluded before the operation, three patients did not have the operation, and ten patients refused to participate. Four patients were excluded during the operation because of an insufficient posterior cruciate ligament. One patient was excluded after randomization because of a missing guide arm for the allocated AP Glide bearing. Fifty patients were therefore included in the study. The baseline demographic and clinical data were similar in both treatment groups (Table I).

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Fig. 2: CONSORT flow diagram of subject progress through the phases of this prospective, randomized clinical trial. APG = Anterior-posterior gliding, and RP = rotating platform.

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TABLE I Demographic and Clinical Data on Study Participants

	AP Glide (N = 23)	Rotating Platform (N = 27)	P Value
Female:male ratio	19:4	21:6	0.62
Age *(yr)	69.1 ± 7	70.0 ± 7	0.64
Weight *(kg)	77.4 ± 14	79.3 ± 11	0.61
Body-mass index *	28.8 ± 4.4	29.5 ± 2.6	0.48
Varus/valgus/no deformity (no. of knees)	19:4:0	18:5:4	0.71
Non-weight-bearing range of motion *
Active	101° ± 14.4°	99° ± 19.0°	0.60
Passive	104° ± 13.8°	103° ± 15.2°	0.80
Hospital for Special Surgery score *(points)	56 ± 9	53 ± 11	0.33

The values are given as the mean and the standard deviation.

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TABLE I Demographic and Clinical Data on Study Participants

	AP Glide (N = 23)	Rotating Platform (N = 27)	P Value
Female:male ratio	19:4	21:6	0.62
Age *(yr)	69.1 ± 7	70.0 ± 7	0.64
Weight *(kg)	77.4 ± 14	79.3 ± 11	0.61
Body-mass index *	28.8 ± 4.4	29.5 ± 2.6	0.48
Varus/valgus/no deformity (no. of knees)	19:4:0	18:5:4	0.71
Non-weight-bearing range of motion *
Active	101° ± 14.4°	99° ± 19.0°	0.60
Passive	104° ± 13.8°	103° ± 15.2°	0.80
Hospital for Special Surgery score *(points)	56 ± 9	53 ± 11	0.33

The values are given as the mean and the standard deviation.

After one year, the "intention-to-treat" analysis was completed with use of the data on forty-eight (96%) of the fifty participants; the remaining two patients (one from each group) had been lost to follow-up (Fig. 2). Two knees that had been treated with an AP Glide bearing were revised with a rotating-platform prosthesis, and the remaining forty-six knees (92%) were used for the per-protocol analysis.

There was no significant difference between the treatment groups with regard to the "intention-to-treat" analysis of the active (p = 0.57) and passive (p = 0.68) non-weight-bearing ranges of motion (Table II), and both of these values improved significantly postoperatively (p < 0.001). Active (p = 0.58) and passive (p = 0.26) weight-bearing flexion were not significantly different. Active flexion was significantly lower during weight-bearing than during non-weight-bearing (p < 0.001). The Hospital for Special Surgery score improved significantly until the time of the final follow-up (p < 0.001) but was not significantly different between groups (p = 0.33). In the per-protocol analysis, the mean active non-weight-bearing range of motion was 114° (95% confidence interval, 108° to 121°) for the knees with the AP Glide bearing and 113° (108° to 118°) for those with the rotating-platform prosthesis (p = 0.78).

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TABLE II Results of Intention-to-Treat Analysis One Year After Implantation

	AP Glide (N = 22)	Rotating Platform (N = 26)	P value	95% Confidence Interval for Differences
Non-weight-bearing range of motion*
Active	111° (103°-118°)	113° (108°-118°)	0.57	-11 to +6
Passive	118° (110°-127°)	120° (115°-125°)	0.68	-12 to +7
Weight-bearing flexion*
Active	92° (83°-101°)	95° (88°-102°)	0.58	-14 to +8
Passive	126° (120°-132°)	121° (116°-127°)	0.26	-3 to +12
Hospital for Special Surgery score*(points)	85 (79-92)	88 (85°-91°)	0.33
Mechanical axis†	1.3° ± 4°	1.9° ± 3°	0.78
Tibial reclination†	8.0° ± 3°	7.9° ± 3°	0.85

The values are given as the mean, with the 95% confidence interval in parentheses. †The values are given as the mean and the standard deviation.

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TABLE II Results of Intention-to-Treat Analysis One Year After Implantation

	AP Glide (N = 22)	Rotating Platform (N = 26)	P value	95% Confidence Interval for Differences
Non-weight-bearing range of motion*
Active	111° (103°-118°)	113° (108°-118°)	0.57	-11 to +6
Passive	118° (110°-127°)	120° (115°-125°)	0.68	-12 to +7
Weight-bearing flexion*
Active	92° (83°-101°)	95° (88°-102°)	0.58	-14 to +8
Passive	126° (120°-132°)	121° (116°-127°)	0.26	-3 to +12
Hospital for Special Surgery score*(points)	85 (79-92)	88 (85°-91°)	0.33
Mechanical axis†	1.3° ± 4°	1.9° ± 3°	0.78
Tibial reclination†	8.0° ± 3°	7.9° ± 3°	0.85

The values are given as the mean, with the 95% confidence interval in parentheses. †The values are given as the mean and the standard deviation.

The twenty AP Glide bearings had a mean forward shift of 1.8 ± 1.1 mm in the medial compartment and of 1.0 ± 0.8 mm in the lateral compartment. A continuous femoral rollback was found in two knees: in one knee the medial compartment demonstrated a total backward shift of 5.5 mm through 130° of flexion, and in the other knee the lateral compartment demonstrated a total backward shift of 3.2 mm through 125° of flexion. There was no significant correlation between the amount of translation and the maximum active flexion (r² = 0.015).

Five knees had a total of six additional interventions. Specifically, three knees with an AP Glide bearing were manipulated after implantation, and three knees were revised (with an AP Glide bearing being exchanged to a rotating-platform prosthesis in two of the three). In one woman who had had a previous Elmslie procedure, the knee was manipulated and a painful restriction of flexion to 70° subsequently developed. Impingement of the anterior rim of the AP Glide bearing into the patellar tendon was seen on the ultrasound investigation and was confirmed during revision to a rotating-platform prosthesis. The pain was notably reduced after the revision, but flexion remained restricted to 85°. Another woman had a staged revision because of an acute deep infection and had 90° of flexion (and a 75° range of motion) at the time of the final follow-up. A man with a rotating-platform prosthesis had development of a nonspecific synovitis after three months. The patient was managed with synovectomy and was pain-free at the time of the final follow-up, with a range of motion of 120°. The differences between the groups with regard to the rates of manipulation and revision were not significant (p = 0.22, Fisher exact test). Blinding of the assessor was confirmed at the time of the final follow-up (Cohen's kappa = 0.16; p = 0.37).

Discussion

Materials and Methods | Results | Discussion | References

Different methods of measurement of range of motion emphasize different demands. To describe the function of the knee after total knee replacement, it is desirable to report on all of them, but only one can be the primary outcome variable of a prospective study. In the present randomized clinical trial, we compared two different mobile bearings of the LCS-Universal prosthesis one year after implantation. The hypothesis was that a 15° increase in the mean active non-weight-bearing range of motion of the knee would be detected in association with the AP Glide bearing. However, no significant difference was found between the groups in either the intention-to-treat analysis or the per-protocol analysis. Both groups had a significant and clinically relevant improvement in the range of motion. The anterior-posterior translation was not correlated with maximum knee flexion, and only two knees exhibited physiological femoral rollback.

The primary characteristic of a mobile bearing is unconstrained rotational mobility, and the constraint forces in the transverse plane define different types of mobile bearings⁷. Studies of the LCS-Classic system suggested that there was a greater mean range of motion in association with anterior-posterior gliding mobile bearings. In a ten-year follow-up study, the reported mean range of motion was 107° for rotating-platform prostheses and 117° for anterior-posterior gliding bearings⁹. The mean preoperative range of motion in that study of primary arthroplasties, however, was greater for the anterior-posterior gliding bearings (106° compared with 93°). In a multicenter analysis, the mean range of motion was 120° for anterior-posterior gliding bearings and 108° for rotating-platform prostheses (p < 0.001) but the preoperative range of motion had been significantly greater in the anterior-posterior gliding group⁸. We believe that these nonrandomized studies were systemically influenced by a confounder as there is evidence of a direct relationship between preoperative and postoperative range of motion².

There have been a few prospective, randomized clinical trials that have compared fixed and mobile bearings^17,18, but we are not aware of any such trial that has compared different types of mobile bearings. In the present study, the interventions were identical except for the allocated bearing and the mandatory resection of the posterior cruciate ligament in the group that received the deep-dish rotating-platform prosthesis. A tight posterior cruciate ligament would narrow the flexion gap and consequently would reduce knee flexion. As there was no difference in total flexion between the groups, it is unlikely that the posterior cruciate ligament influenced the result.

The behavior of the anterior-posterior gliding mobile bearing in the present study was in accordance with the findings of previous kinematic studies, which have rarely shown physiologic femoral rollback in association with these designs^4-6. The lack of correlation between translation and knee flexion suggests that this type of bearing probably does not improve the postoperative range of motion¹⁹.

The present study was designed to detect a rather large difference in range of motion, which was suggested by the available literature and the result of our random sample. Although the study was not underpowered, the hypothesis was rejected in terms of the primary outcome variable. Smaller differences between the treatment groups, such as the 15° suggested in this study, will be found by a 95% probability within the confidence intervals of the differences in average range of motion. For the primary outcome variable, the active non-weight-bearing range of motion, the average value for the AP Glide bearings was as much as 11° worse than, or 6° better than, that for the rotating-platform prostheses (Table II). Additional studies designed to identify smaller differences between treatment groups are needed to address their implications with regard to the clinical outcome. Furthermore, the present study did not allow us to draw any conclusions regarding polyethylene wear or the rate of survival of these particular systems.

References

Materials and Methods | Results | Discussion | References

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NakagawaS, Kadoya Y, Todo S, Kobayashi A, Sakamoto H, Freeman MA, Yamano Y. Tibiofemoral movement 3: full flexion in the living knee studied by MRI. J Bone Joint Surg Br.2000;82: 1199-200.821199 2000 [PubMed][CrossRef]

KomistekRD, Scott RD, Dennis DA, Yasgur D, Anderson DT, Hajner ME. In vivo comparison of femorotibial contact positions for press-fit posterior stabilized and posterior cruciate-retaining total knee arthroplasties. J Arthroplasty.2002;17: 209-16.17209 2002 [CrossRef]

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AignerC, Radl R, Pechmann M, Rehak P, Stacher R, Windhager R. The accuracy of ultrasound for measurement of mobile-bearing motion. Clin Orthop.2004;421: 169-74.421169 2004 [PubMed][CrossRef]

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Topics

posterior cruciate ligament ; prosthesis implantation ; range of motion ; knee replacement arthroplasty

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Christian Aigner, Reinhard Windhager, Michael Pechmann, Peter Rehak, Klaus Engeleke; The Influence of an Anterior-Posterior Gliding Mobile Bearing on Range of Motion After Total Knee ArthroplastyA Prospective, Randomized, Double-Blinded Study. The Journal of Bone & Joint Surgery. 2004 Oct;86(10):2257-2262.

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