The Journal of Bone & Joint Surgery

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

Scientific Articles | October 01, 2004

Uncemented Rotating-Platform Total Knee Replacement: A Five to Twelve-Year Follow-up Study

R. Barry Sorrells, MD¹; Paul E. Voorhorst, MS²; Jeffrey A. Murphy, MS²; Maryrose P. Bauschka, BA³; A. Seth Greenwald, DPhil(Oxon)³

¹ The Joint Replacement Clinic, 8907 Kanis Road, Suite 300, Little Rock, AR 72205
² DePuy Orthopaedics, P.O. Box 988, 700 Orthopaedic Drive, Warsaw, IN 46581
³ Orthopaedic Research Laboratories, Lutheran Hospital, Cleveland Clinic Health System, 1730 West 25th Street, Cleveland, OH 44113. E-mail address for A.S. Greenwald: seth@orl-inc.com

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In support of their research or preparation of this manuscript, one or more of the authors received grants or outside funding from DePuy, a division of Johnson and Johnson. In addition, one or more of the authors received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity (DePuy, Inc.). 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.

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Investigation performed at the Joint Replacement Clinic, Little Rock, Arkansas

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J Bone Joint Surg Am, 2004 Oct 01;86(10):2156-2162

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Abstract

Background: Mobile-bearing knee designs represent an alternative to conventional fixed-bearing total knee arthroplasty. We present the results of a prospective, intermediate-term clinical follow-up study of the bicruciate ligament-sacrificing porous-coated Low Contact Stress rotating-platform total knee design.

Methods: Between February 1984 and January 1994, 528 uncemented primary knee replacements were performed in 421 patients. All patellae were resurfaced with use of the Low Contact Stress rotating patellar component. The average age of the patients at the time of the index procedure was sixty-nine years. The study group included 261 women and 160 men. Patients were evaluated at three months, six months, and yearly thereafter with use of the 100-point New Jersey Orthopaedic Hospital knee-scoring system. In addition, a radiographic analysis of the tibial, femoral, and patellar components was performed at each interval.

Results: There were twenty-nine failures that resulted in revision. The Kaplan-Meier estimate of implant survival at twelve years was 89.5% (95% confidence interval, 83.4% to 95.6%). The total clinical scores improved significantly compared with the preoperative scores for the first twelve months postoperatively and then plateaued. Three hundred and twenty-one knees had adequate radiographic follow-up (average, 8.1 years; range, five to twelve years). Zonal radiographic analysis revealed ninety-three instances of radiolucent lines (eighty-two of which measured <1 mm in width), with the greatest number of radiolucent lines (thirty-nine) being located around the tibial tray stem. None of these lines were deemed to be progressive, and no knee with a radiolucent line that measured >2 mm was revised because of failure.

Conclusions: This first-generation uncemented, mobile-bearing, bicruciate ligament-sacrificing knee replacement was associated with a good survival rate and demonstrated clinical efficacy during the five to twelve-year follow-up interval.

Level of Evidence: Therapeutic study, Level IV (case series [no, or historical, control group]). See Instructions to Authors for a complete description of levels of evidence.

Figures in this Article

Adual surface articulation between a polyethylene insert and metallic femoral and tibial tray components is a defining characteristic of mobile-bearing total knee designs. These total knee replacements potentially offer a substantial increase in articulation conformity, with a beneficial distribution of the proximal and distal contact stresses and a decrease in the potential for polyethylene wear. Concurrently, through insert mobility, they minimize the constraint forces that are transferred to fixation interfaces^1-4. However, even with these apparent biomechanical advantages over fixed-bearing designs, the use of mobile-bearing knee implants has remained relatively rare in the United States, especially when compared with that in other countries. The issue of Food and Drug Administration regulation, the suspected technical difficulty of implantation, the sparse seminal reports from academic teaching centers, and the cost of the devices all have been factors that have impeded their use. While some early clinical reports described instances of bearing subluxation, dislocation, and breakage^5,6, recent efforts to incorporate careful collateral ligament balancing, appropriate bearing sizing, and polyethylene with good quality control have resulted in more effective constructs with better outcomes^7-10. The purpose of the present study was to prospectively evaluate the intermediate-term clinical results for a series of patients who were managed at a single center, by a single surgeon, with an uncemented bicruciate ligament-sacrificing porous-coated Low Contact Stress (LCS) rotating-platform knee replacement employing a rotating patellar component (DePuy, Warsaw, Indiana).

Materials and Methods

Materials and Methods | Results | Discussion | Appendix | References

Patient Demographics

The senior author (R.B.S.) implanted 528 primary, uncemented, tricompartmental, bicruciate ligament-sacrificing LCS rotating-platform total knee replacements in 421 patients between February 1984 and January 1994. The study group included 261 women and 160 men. The mean age of the patients at the time of the index procedure was sixty-nine years (range, twenty-nine to ninety-eight years). The patients had a mean weight of 79.2 kg (range, 42.7 to 127.1 kg) and a mean height of 1.7 m (range, 1.3 to 2.0 m). The mean body-mass index was 28.2 (range, 18.8 to 44.4). The diagnosis was osteoarthritis for 450 knees (85.2%), rheumatoid arthritis for forty-five (8.5%), and posttraumatic arthritis for thirty-three (6.3%). Fifty-four of the 528 knees had had a total of fifty-eight previous procedures, including meniscectomy (eleven knees; 2.1%), osteotomy (eight knees; 1.5%), and synovectomy (one knee; 0.2%).

At the time of database closure, in July 2000, 157 knees in 139 patients had not been followed for a minimum of five years because of death (eighty-eight knees), revision (nineteen knees), amputation (one knee), or loss to follow-up (forty-nine knees). With the exclusion of the forty-nine knees that had been lost to follow-up, the outcome was known for 90.7% (479) of the 528 knees at the end point of the study.

Three hundred and seventy-one knees had at least five years of clinical follow-up (Table I). Three hundred and twenty-one of these 371 knees had a minimum of five years of radiographic follow-up.

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TABLE I Data on the Patients Who Had at Least Five Years of Clinical Follow-up

Number of knees	371
Number of patients	282
Duration of follow-up* (mo)
Clinical	99 (60-180)
Radiographic†	97 (60-180)
Age* (yr)	68 (29-88)
Height* (m)	1.7 (1.3-2.0)
Weight* (kg)	80 (47-127)
Mean body-mass index	28.3
Gender (men/women) (number of knees)	137/234
Initial pathology (number of knees)
Osteoarthritis	316
Rheumatoid arthritis	29
Posttraumatic arthritis	26

The data are given as the mean, with the range in parentheses. †Three hundred and twenty-one knees had at least five years of radiographic follow-up.

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TABLE I Data on the Patients Who Had at Least Five Years of Clinical Follow-up

Number of knees	371
Number of patients	282
Duration of follow-up* (mo)
Clinical	99 (60-180)
Radiographic†	97 (60-180)
Age* (yr)	68 (29-88)
Height* (m)	1.7 (1.3-2.0)
Weight* (kg)	80 (47-127)
Mean body-mass index	28.3
Gender (men/women) (number of knees)	137/234
Initial pathology (number of knees)
Osteoarthritis	316
Rheumatoid arthritis	29
Posttraumatic arthritis	26

The data are given as the mean, with the range in parentheses. †Three hundred and twenty-one knees had at least five years of radiographic follow-up.

Surgical Approach

The surgical procedure employed a midline skin incision with initial resection of the proximal part of the tibia, which was performed perpendicular to the mechanical axis and was posteriorly inclined to mimic the slope of the tibia. Ligament and soft-tissue balancing in extension was done before any femoral cuts were made. Anterior and posterior femoral cuts were made to ensure a quadrilateral flexion gap, thereby balancing the collateral ligaments in flexion. Care was taken to ensure equal flexion and extension gaps. The proximal part of the tibia was prepared, and the rotating platform with its central cone was inserted. The femoral component was inserted, and the patella was prepared for a mobile polyethylene patellar component backed by a porous-coated baseplate with cruciform fixation runners. The knee was then taken through a range of motion while tracking of the patella was observed. The tourniquet was then deflated, hemostasis was established, and drains were placed.

Postoperatively, continuous passive motion was utilized for the duration of hospitalization. Twenty-five percent weight-bearing on the involved extremity was recommended for three weeks, followed by progression to full weight-bearing.

Clinical Evaluation

Clinical evaluations were performed preoperatively and postoperatively (at three months, six months, and yearly thereafter) with use of the New Jersey Orthopaedic Hospital scoring system¹¹. In this 100-point system, scores are assigned for pain (30 points), function (25 points), range of motion (15 points), deformity (12 points), stability (10 points), and strength (8 points). Pain is awarded the highest number of points and is considered the most important variable¹². The total score is classified as poor (=59 points), fair (60 to 69 points), good (70 to 84 points), or excellent (85 to 100 points).

Radiographic Evaluation

A zonal radiographic analysis of radiolucent lines was carried out at each follow-up interval. Standing anteroposterior radiographs of both knees as well as non-weight-bearing lateral and Merchant-view patellar radiographs were made. Careful attention was given to patient positioning, but fluoroscopy was not used for these evaluations. The radiographs were divided into sixteen zones with use of a modification of the Knee Society system⁸. Radiolucent lines were measured with use of a millimeter rule. All zonal measurements were corrected for magnification, and all radiolucent lines measuring <1 mm, 1 to 2 mm, and >2 mm were recorded. Implant-joint line and limb alignment were compared with those on the contralateral weight-bearing radiograph.

Statistical Analysis

Survivorship analysis was performed with use of the Kaplan-Meier method, with estimates carried out to twelve years^13,14. The end point for survival was revision of any component for any reason.

Results

Materials and Methods | Results | Discussion | Appendix | References

Clinical Results

In the group of 371 knees with at least five years of clinical follow-up, the mean preoperative New Jersey Orthopaedic Hospital total score was 62 points (range, 33 to 84 points). The mean postoperative score progressively increased to 91 points (range, 63 to 100 points) at twelve months and then stabilized for the remainder of the follow-up period (Fig. 1). This trend of an increase in the mean score followed by stabilization was consistent for the categories of pain, function, and range of motion. At the time of the most recent followup, the overall score was classified as excellent for 81.2% and good for 18.5% of the 298 knees for which a complete score had been recorded (Table II). The preoperative, five-year, ten-year, and twelve-year mean ranges of motion are presented in Table III.

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Fig. 1: Illustration showing the progressive yearly mean total clinical outcome score associated with 371 LCS rotating-platform knee replacements as determined with use of the 100-point New Jersey Orthopaedic Hospital scoring system.

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TABLE II New Jersey Orthopaedic Hospital Overall Rating at Time of the Most Recent Follow-up*

Rating	Score (points)	Number of Knees
Excellent	85-100	242 (81.2%)
Good	70-84	55 (18.5%)
Fair	60-69	1 (0.3%)
Poor	0-59	0 (0%)

Data are given for the 298 knees for which a complete score was calculated at the time of the most recent follow-up.

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TABLE II New Jersey Orthopaedic Hospital Overall Rating at Time of the Most Recent Follow-up*

Rating	Score (points)	Number of Knees
Excellent	85-100	242 (81.2%)
Good	70-84	55 (18.5%)
Fair	60-69	1 (0.3%)
Poor	0-59	0 (0%)

Data are given for the 298 knees for which a complete score was calculated at the time of the most recent follow-up.

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TABLE III Range of Motion for 371 LCS Rotating-Platform Knee Replacements

		Postoperative
	Preoperative	5 years	10 years	12 years
Range of motion*(deg)	95 (20-150)	112 (40-150)	112 (50-140)	105 (75-125)

The data are given as the mean, with the range in parentheses.

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TABLE III Range of Motion for 371 LCS Rotating-Platform Knee Replacements

		Postoperative
	Preoperative	5 years	10 years	12 years
Range of motion*(deg)	95 (20-150)	112 (40-150)	112 (50-140)	105 (75-125)

The data are given as the mean, with the range in parentheses.

Radiographic Results

Zonal radiographic analysis revealed ninety-three instances of radiolucent lines (eighty-two of which measured <1 mm, six of which measured 1 to 2 mm, and five of which measured >2 mm), with the greatest number of lines (thirty-nine) being observed around the tibial tray stem. None of these lines were deemed to be progressive at successive evaluations. Two knees showed a continuous radiolucent line beneath the tibial component on the lateral radiograph. In three knees, including one of the two knees with a continuous radiolucency, the radiolucent line measured >2 mm; none of these knees were revised.

Complications

Seventy-nine (15.0%) of the 528 knees had a complication. Fifty knees (9.5%) had a complication that did not require revision (Table IV), whereas twenty-nine (5.5%) had a complication that did require revision (Table V). Seven of the twenty-nine revision procedures involved an exchange of the polyethylene tibial and/or patellar component only. In addition, twelve of the twenty-nine revisions were performed for reasons that the surgeon believed to be due to a technical error that occurred during the primary procedure, including component malposition (eight knees), tibial component subsidence (two knees), and bearing malrotation (two knees). Nineteen of the twenty-nine revisions were performed before the time of the five-year clinical follow-up.

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TABLE IV Early Postoperative Complications That Did Not Necessitate Revision of the LCS Rotating-Platform Knee Replacement

Complication	Number of Knees (N = 528)
Effusion/hemarthrosis	16 (3.0%)
Deep venous thrombosis	6 (1.1%)
Pulmonary embolism	5 (0.9%)
Adhesions	4 (0.8%)
Periarticular fracture	4 (0.8%)
Superficial infection	3 (0.6%)
Synovitis	3 (0.6%)
Suction drain entrapment	2 (0.4%)
Hematoma	2 (0.4%)
Wound necrosis	2 (0.4%)
Patellar subluxation	1 (0.2%)
Peroneal palsy	1 (0.2%)
Tibial-femoral bearing malrotation ("spin-out")	1 (0.2%)

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TABLE IV Early Postoperative Complications That Did Not Necessitate Revision of the LCS Rotating-Platform Knee Replacement

Complication	Number of Knees (N = 528)
Effusion/hemarthrosis	16 (3.0%)
Deep venous thrombosis	6 (1.1%)
Pulmonary embolism	5 (0.9%)
Adhesions	4 (0.8%)
Periarticular fracture	4 (0.8%)
Superficial infection	3 (0.6%)
Synovitis	3 (0.6%)
Suction drain entrapment	2 (0.4%)
Hematoma	2 (0.4%)
Wound necrosis	2 (0.4%)
Patellar subluxation	1 (0.2%)
Peroneal palsy	1 (0.2%)
Tibial-femoral bearing malrotation ("spin-out")	1 (0.2%)

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TABLE V Postoperative Complications That Necessitated Revision of the LCS Rotating-Platform Knee Replacement

	Number of Knees (N = 528)
Complication	<5 Years Postop.	5 to 12 Years Postop.
Component malposition	5	3
Tibial component subsidence	4	—
Deep infection	3	—
Bearing malrotation	2	—
Ligament laxity	2	—
Cosmetic deformity	1	—
Patellar component baja	1	—
Patellar and/or tibial component polyethylene wear	1	4
Adhesions	—	1
Aseptic tibial loosening	—	1
Osteolysis	—	1

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TABLE V Postoperative Complications That Necessitated Revision of the LCS Rotating-Platform Knee Replacement

	Number of Knees (N = 528)
Complication	<5 Years Postop.	5 to 12 Years Postop.
Component malposition	5	3
Tibial component subsidence	4	—
Deep infection	3	—
Bearing malrotation	2	—
Ligament laxity	2	—
Cosmetic deformity	1	—
Patellar component baja	1	—
Patellar and/or tibial component polyethylene wear	1	4
Adhesions	—	1
Aseptic tibial loosening	—	1
Osteolysis	—	1

Survivorship

All 528 knees were available for survival analysis. Kaplan-Meier analysis revealed an estimated survival rate of 89.5% (95% confidence interval, 83.4% to 95.6%) at twelve years with revision for any reason as the end point (Fig. 2).

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Fig. 2: Kaplan-Meier survivorship curve (and 95% confidence intervals) for 528 cementless LCS rotating-platform total knee replacements that were followed for as long as twelve years, with revision for any reason as the end point.

Discussion

Materials and Methods | Results | Discussion | Appendix | References

The LCS total knee arthroplasty system, introduced in the late 1970s¹⁵, was designed to reduce polyethylene wear¹⁶ by distributing contact stresses over both the femorotibial and patellofemoral articulations while minimizing the prospect of component loosening through insert mobility. With these stated goals, dual surface articulation was developed, the efficacy of which depends on the particular distal displacements allowed in a given design¹⁷. The LCS rotating platform only allows rotatory displacement in this regard. As the femoral component articulates through the range of flexion beyond 20°, the contact area is progressively diminished, with a resulting increase in the stress profile. This increase is due to the particular J-curve of the femoral component, which is designed to maximize conformity during the stance phase of walking, during which high cyclic loading is most frequently encountered¹⁸. The bearing mobility that is realized with this design accommodates slight component positional variation while still allowing patellar tracking^19,20. In addition, such positional compliance allows these designs to function in patients with slightly aberrant gait patterns¹⁷ and contributes in part to the kinematic patterns observed in fluoroscopy studies^21-25.

Clinical Analysis

The clinical results for the subset of patients with five to twelve years of follow-up demonstrated a steady-state outcome with regard to pain, function, and range of motion according to the New Jersey Orthopaedic Hospital scoring system. This steady state was reflected in the total score as well, which also includes assessments of deformity, stability, and strength.

In the current study, the average range of motion after nine years of follow-up or more was 111° (range, 45° to 140°), which is comparable with that in other reports on LCS rotating-platform^7,8 and fixed-bearing implants^26-28. This finding suggests that this mobile-bearing design provides little, if any, advantage compared with fixed-bearing designs in terms of range of motion.

At the time of the most recent follow-up, the overall score was classified as excellent for 81.2% and good for 18.5% of the 298 knees for which a complete score had been recorded (Table II). These percentages are higher than those in previous reports in which this knee system has been evaluated with use of the New Jersey Orthopaedic Hospital scoring system⁸.

The value of body-mass index as a clinical parameter contributing to outcome was also assessed. In both the overall and subset populations, the mean body-mass index was determined to be 28.2. This value falls within the range considered as overweight²⁹. There were no instances in which obesity (defined as a body-mass index of =30) contributed to a compromised outcome.

Radiographic Analysis

Radiolucent lines measuring <1 mm occurred in eight of sixteen zones. Additionally, radiolucent lines measuring =1 mm were identified around the tibial baseplate on the anteroposterior radiograph (zones 5, 6, and 7), around the tibial baseplate on the lateral radiograph (zones 8, 9, and 10), and around the patellar component (zones 11 and 13). Within these zones, continuous radiolucent lines were observed in two patients in zones 8, 9, and 10. An apparent osteolytic process was observed in one patient who underwent revision. It is of note that in their study on the LCS rotating-platform knee implant, Callaghan et al. reported no revisions, minimal radiolucencies, and no evidence of osteolysis or loosening after an average of 9.7 years (range, nine to twelve years) of clinical and radiographic followup⁷. In the current study, there was only one case of aseptic loosening that resulted in revision. Perhaps the insert mobility provided by the LCS rotating platform provides some stress relief at the fixation interface and provides an argument for the use of either cemented or uncemented fixation with this design.

Survivorship Analysis

In the present study, the estimated survival rate (according to Kaplan-Meier analysis) was 89.5% at twelve years, with an overall revision rate of 5.5% (twenty-nine of 528). These results are in the range of those reported in other published studies for both fixed and mobile-bearing knees at twelve years following surgery (see Appendix)^{7,8,26-28,30-32}. This intermediate-term survival rate is achieved with 90.7% patient follow-up compliance, which is considerably above the 85% required by the Food and Drug Administration (FDA) for premarket medical device investigations. It is of note that, in the current study, no patellar fractures occurred and no patellar baseplates loosened in association with the rotating metal-backed component. This finding is in contrast with those that have been reported in studies of fixed metal-backed patellar components, which have been associated with complication rates of as high as 50% and therefore have been abandoned^33-37. The ability of the patella to track dynamically through the range of motion maintains component conformity within the femoral sulcus and may account for this observation.

Surgical technique is of paramount importance during the implantation of a mobile-bearing prosthesis. Instability arising from a failure to achieve soft-tissue balance in both flexion and extension, malalignment of components during insertion, and polyethylene quality and sterilization can be major contributors to early failure and osteolysis when it occurs. The findings of the present intermediateterm, prospective, clinical study suggest that this first-generation mobile-bearing total knee design performs comparably with fixed-bearing knee systems and is a viable option for the treatment of arthrosis of the knee.

Appendix

Materials and Methods | Results | Discussion | Appendix | References

A table presenting the results of other studies of fixed and mobile-bearing knee replacements is available with the electronic versions of this article, on our web site at (go to the article citation and click on "Supplementary Material") and on our quarterly CD-ROM (call our subscription department, at 781-449-9780, to order the CD-ROM).

References

Materials and Methods | Results | Discussion | Appendix | References

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Topics

follow-up ; knee region ; knee joint ; patella ; range of motion ; tibia ; knee replacement arthroplasty

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R. Barry Sorrells, Paul E. Voorhorst, Jeffrey A. Murphy, Maryrose P. Bauschka, A. Seth Greenwald; Uncemented Rotating-Platform Total Knee Replacement: A Five to Twelve-Year Follow-up Study. The Journal of Bone & Joint Surgery. 2004 Oct;86(10):2156-2162.

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