The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 87, Issue 3

Scientific Articles | March 01, 2005

Modular Fixed-Bearing Total Knee Arthroplasty with Retention of the Posterior Cruciate Ligament: A Study of Patients Followed for a Minimum of Fifteen Years

Michael C. Dixon, MBBS, FRACS(Orth)¹; Richard R. Brown, MA, FRCS(Orth)¹; Dominik Parsch, MD¹; Richard D. Scott, MD²

¹ Department of Orthopaedic Surgery, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115
² Harvard Medical School, 125 Parker Hill Avenue, Boston, MA 02120

View Disclosures and Other Information

In support of their research or preparation of this manuscript, one or more of the authors received grants or outside funding from the German Orthopaedic Society. 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-Johnson and Johnson). Also, a commercial entity (DePuy) paid or directed, or agreed to pay or direct, benefits to a research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.

Investigation performed at the Department of Orthopaedic Surgery, Brigham and Women's Hospital, and New England Baptist Hospital, Boston, Massachusetts

The Journal of Bone and Joint Surgery, Incorporated

J Bone Joint Surg Am, 2005 Mar 01;87(3):598-603. doi: 10.2106/JBJS.C.00591

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Abstract

Background: There have been a limited number of studies of total knee arthroplasties with durations of follow-up of fifteen years, but we are not aware of any involving modular fixed-bearing posterior cruciate-retaining prostheses.

Methods: A consecutive series of 139 total knee arthroplasties in 109 patients (average age, sixty-seven years), performed by one surgeon using a nonconforming posterior cruciate-retaining prosthesis, was followed for fifteen years or longer. Forty-five patients (fifty-nine knees) were examined at a minimum of fifteen years postoperatively, fifty-seven patients (seventy knees) had died, five patients (eight knees) were too ill to return for assessment, and two patients (two knees) were considered lost to follow-up. The patients were assessed clinically with use of the Knee Society clinical rating system, and the knees were assessed radiographically. Survivorship analysis was performed with use of worst-case-scenario analysis and with failure defined as a reoperation for any reason.

Results: There were five reoperations, four of which were performed because of wear of the polyethylene insert. In addition, one loose cemented femoral component was revised at fifteen years. The survival rate without revision or a need for any reoperation was 92.6% at fifteen years. The mean Knee Society score and functional score at fifteen years were 96 and 78 points, respectively. The prevalence of radiolucent lines was 13%, with 2% around the femur, 11% around the tibia, and none around the patella. None of these lines were clinically relevant. There was no evidence of progressive radiolucent lines, and there was one case of asymptomatic femoral osteolysis.

Conclusions: In this single-surgeon series, modular fixed-bearing posterior cruciate-retaining total knee arthroplasties had good clinical and radiographic results with excellent survivorship for up to fifteen years. These results are comparable with those in long-term studies of posterior stabilized implants and of prostheses with mobile-bearing and nonmodular tibial inserts.

Level of Evidence: Therapeutic Level IV. See Instructions to Authors for a complete description of levels of evidence.

Figures in this Article

Total knee arthroplasty has been found to have good survivorship results fifteen years after implantation in several large multicenter series^1,2. Although the results of a nonmodular total knee arthroplasty have been followed for a minimum of fifteen years³, to our knowledge we are the first to report the results of a modular fixed-bearing total knee arthroplasty after that duration of follow-up. Long-term follow-up of patients treated with knee arthroplasty provides valuable information for surgeons about the survivorship of the implant and the chances that a patient will need revision surgery in his or her lifetime. It also provides a benchmark with which future design systems can be compared.

Materials and Methods

Materials and Methods | Results | Discussion | Appendix | References

Between July 1985 and January 1988, a consecutive series of 139 primary posterior cruciate-retaining total knee arthroplasties without a metal-backed patella were performed by a single surgeon (R.D.S.). The prosthesis was implanted in sixty-seven right knees and seventy-two left knees, and thirty patients had a bilateral procedure. The average age of the 109 patients (seventy-six female and thirty-three male) at the time of the surgery was sixty-seven years (range, seventeen to eighty-nine years). The preoperative diagnosis was osteoarthritis in ninety-seven (70%) of the knees, rheumatoid arthritis in thirty-six (26%), juvenile rheumatoid arthritis in five (4%), and femoral osteonecrosis in one.

A modular fixed-bearing posterior cruciate-retaining prosthesis (PFC Total Knee Prosthesis, Johnson and Johnson Professional, Raynham, Massachusetts) was used in all patients. The tibial component was made of a titanium alloy and allowed insertion of a modular ultra-high molecular weight polyethylene tibial insert with a machined articulating surface, which is flat in the sagittal plane. Thus, there was a round-on-flat tibiofemoral articulation. The femoral component was made of a cobalt-chromium alloy, and the trochlear groove was contoured to allow nonresurfacing of the patella if clinically indicated. The patellar component was all-polyethylene and was oval in shape, with three pegs for cement fixation. The polyethylene was sterilized with gamma radiation in the presence of oxygen. The femoral cut was performed with use of an intramedullary guide system providing 3° of external rotation, with the posterior condyles used as a reference. An extramedullary system, with the midpoint of the talus as a reference and with 3° to 5° of posterior slope, was used to cut the proximal part of the tibia.

A porous-coated femoral component was used in 117 knees (84%) in which a good press-fit could be achieved, and a cemented tibial component was used in all knees. The patella was not resurfaced in twenty-two knees that had no eburnated bone or inflammatory synovitis and had congruent patellofemoral tracking. One patient had had a previous patellectomy. Patellar tracking was assessed with use of the so-called rule of no thumb⁴. A lateral release was performed in fifty-four knees (39%): in 46% of the knees with a resurfaced patella and in 5% of those without a resurfaced patella (Table I).

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TABLE I Component Sizes, Fixation Techniques, Lateral Release Rate

	Total No.	Percentage
Femoral component
Extra-large	21	15
Large	40	29
Standard	60	43
Small	18	13
Porous-coated	117	84
Non-porous-coated	22	16
Tibial component
Extra-large	16	12
Large	29	21
Standard	60	43
Small	34	24
Non-porous-coated	139	100
Size of tibial and femoral components
Equal size	99	71
Femoral larger than tibial	39	28
Tibial larger than femoral	1	1
Tibial insert thickness
8 mm	92	66
10 mm	40	29
12.5 mm	6	4
15 mm	1	1
Patellar component
All-polyethylene	116	83
Not resurfaced	22	16
Patellectomy	1	1
Lateral release
No	85	61
Yes	54	39

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TABLE I Component Sizes, Fixation Techniques, Lateral Release Rate

	Total No.	Percentage
Femoral component
Extra-large	21	15
Large	40	29
Standard	60	43
Small	18	13
Porous-coated	117	84
Non-porous-coated	22	16
Tibial component
Extra-large	16	12
Large	29	21
Standard	60	43
Small	34	24
Non-porous-coated	139	100
Size of tibial and femoral components
Equal size	99	71
Femoral larger than tibial	39	28
Tibial larger than femoral	1	1
Tibial insert thickness
8 mm	92	66
10 mm	40	29
12.5 mm	6	4
15 mm	1	1
Patellar component
All-polyethylene	116	83
Not resurfaced	22	16
Patellectomy	1	1
Lateral release
No	85	61
Yes	54	39

Of the 139 knees, fifty-nine in forty-five patients were evaluated clinically and radiographically at a minimum of fifteen years. Five of these knees had undergone a reoperation. Thus, fifty-four knees (39%) were included in the analysis of the clinical and radiographic results, at a mean of 15.5 years (range, 15.0 to 16.9 years) postoperatively. Fifty-seven patients (seventy knees, 50%) had died, and five patients (eight knees, 6%) were unable to return for an examination because of severe general illness. For the survivorship analysis, the primary care physician or the next of kin of the patients who had died or were seriously ill were contacted to confirm that no revision surgery had been performed or had been (or was) pending. This could not be confirmed for one patient who had died, and that patient was considered, in the worst-case-scenario analysis, to have had a revision following his last known examination. One other patient was lost to follow-up, and that patient also was considered to have had a revision after the last follow-up evaluation.

Clinical follow-up was performed with use of the Knee Society clinical rating system⁵, which includes a score for pain, range of motion, and stability as well as a functional score for activities such as walking and stair-climbing. The preoperative Knee Society scores were not available, as the index procedures were all performed prior to publication of the rating system⁵.

Radiographic analysis included weight-bearing anteroposterior, non-weight-bearing lateral, and skyline views of the knee. Each radiograph was assessed for evidence of loosening, implant position, radiolucencies, and osteolysis with use of the Knee Society evaluation and scoring system⁶. Fluoroscopy was not used to obtain orthogonal views of the prostheses.

Statistical analysis included unpaired two-tailed Student t tests, with the level of significance set at p = 0.05. The actuarial life-table method described by Armitage and Berry⁷ was used for survivorship analysis and for the worst-case-scenario analysis with calculation of the numbers at risk and the survival rates at annual intervals⁸. The method described by Rothman⁹ was used to calculate the 95% confidence intervals. The end point was a reoperation for any reason or circumferential radiolucency adjacent to any of the three components.

Results

Materials and Methods | Results | Discussion | Appendix | References

Survivorship, Life-Table Analysis, and Reoperations

In the worst-case-scenario analysis, for which it is assumed that all patients lost to follow-up had a failure of the prosthesis, the survivorship was 97.6% (95% confidence interval, 92% to 100%) at ten years and 92.6% (95% confidence interval, 86% to 98%) at fifteen years (Fig. 1). The results of the life-table survivorship analysis and confidence intervals are presented in the Appendix^7-10.

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Fig. 1: The results of the fifteen-year survivorship analysis and worst-case-scenario analysis of the PFC Total Knee Prosthesis. The vertical bars indicate the 95% confidence intervals.

No reoperation for any indication was performed within the first nine years after the index arthroplasty, and there were no reoperations due to either infection or periprosthetic fracture in the series.

There were five revisions. In the first, the components were well fixed and there was no radiographic evidence of osteolysis. There was anterior wear, both medially and laterally, of the articulating surface of the polyethylene insert. The patient remained asymptomatic seven years after a synovectomy with an exchange of the insert and prophylactic resurfacing of the unresurfaced patella. The second reoperation was performed because of asymptomatic lateral joint-space narrowing that was seen on radiographs. Intraoperatively, posterior wear of the articulating surface of the insert (more lateral than medial) was seen, with some delamination of the lateral portion of the well-fixed patellar component. The patient was asymptomatic four years after an insert exchange and revision of the patellar component. The third revision was done in a patient with juvenile rheumatoid arthritis who had painless persistent swelling and radiographic evidence of joint-space narrowing. All components were well fixed. Marked polyethylene wear of the tibial articulating surface and early delamination of the patellar component were noted intraoperatively. A synovectomy, a liner exchange, and a prophylactic exchange of the patellar component were performed. The fourth revision was performed because of painful swelling of the knee in a patient with juvenile rheumatoid arthritis. There was delamination of the polyethylene of the central-medial aspect of the tibial articulating surface. The fifth and most recent reoperation was done fifteen years after the initial surgery because of loosening of a cemented femoral component.

Clinical and Radiographic Results

At a minimum of fifteen years, the mean Knee Society and functional scores were 96 points (range, 83 to 100 points) and 78 points (range, 0 to 100 points), respectively. The mean Knee Society score was 97 points (range, 83 to 100 points) for the patients with osteoarthritis and 94 points (range, 85 to 100 points) for the patients with inflammatory arthritis. The mean functional score was 85 points (range, 70 to 100 points) for the patients with osteoarthritis, which was significantly different from the mean functional score of 61 points (range, 0 to 100 points) for those with inflammatory arthritis (p = 0.001). With the numbers available, there was no significant difference in the Knee Society score (p = 0.9) or functional score (p = 0.09) between patients who were younger than sixty-five years of age and those who were older at the time of the index arthroplasty. The Knee Society and functional scores after fifteen years of follow-up are shown in Figure 2 according to diagnosis, age, and whether the patella had been resurfaced.

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Fig. 2: The Knee Society scores (KSS) and functional scores (FS) at the fifteen-year follow-up evaluation. OA = osteoarthritis, RA = rheumatoid arthritis, JRA = juvenile rheumatoid arthritis, pat. = patella, and res = resurfaced.

The mean amount of flexion at fifteen years was 114° (range, 70° to 135°), which was similar to the intraoperative value of 113° (Fig. 3). Three patients had hyperextension of <5°. There were no fixed flexion contractures or extensor lags of >5°. The postoperative flexion in the patients with osteoarthritis (116°) was significantly greater than that in the patients with inflammatory arthritis (104°) (p = 0.014). There was no significant difference, with the numbers available, in the mean amount of flexion (p = 0.99) or extension (p = 0.53) between the patients younger than sixty-five years of age and the older patients.

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Fig. 3: A comparison between the intraoperative range of motion and that measured at the fifteen-year follow-up evaluation.

At fifteen years, the tibiofemoral angles on weight-bearing radiographs ranged from 4° to 8° of valgus, with a mean (and standard deviation) of 6.1° ± 1.07° of valgus. A radiolucent line was seen in seven knees (13%). Six knees had tibial radiolucencies, four of which involved a single zone and two of which involved two zones⁶. One patient had a 2-mm femoral radiolucency in zone 1⁶. No radiolucent lines were noted adjacent to the all-polyethylene patellar components. No radiolucency was progressive, was >2 mm, or extended beyond two zones. There was no radiographic evidence of component loosening. One asymptomatic patient had femoral osteolysis in zone 4 (Figs. 4-A and 4-B).

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Figs. 4-A and 4-B: Anteroposterior and lateral radiographs showing a radiolucent line adjacent to the tibial prosthesis and femoral osteolysis in zone 4.

Discussion

Materials and Methods | Results | Discussion | Appendix | References

The definition of failure of a total joint arthroplasty has not been consistent in the literature, but revision of the arthroplasty has been the most commonly used criterion^8,11,12. We included all reoperations for any indication to determine the absolute survivorship in our study. Despite this wider definition of failure, the fifteen-year survival rate was 92.6%, with a narrow 95% confidence interval of 86% to 98%.

Important issues related to survivorship analysis include the number and outcome of patients lost to follow-up and the number of subjects followed each year. Other key issues are the use of confidence intervals in order to validate the reliability of a survival curve and the fact that survival analysis should not be extrapolated beyond the end of the study^8,13. All of these issues, mentioned by Murray et al.⁸, were addressed in this study.

In a recent overview, Meding and Keating¹ found only a few good long-term reviews (with a follow-up of twelve to fifteen years or longer) in which the authors reported knee scores and the results of survival analysis with narrow confidence intervals. Very few papers have satisfied those criteria and have also included a minimum duration of follow-up of fifteen years of the results of a single surgeon.

It has been shown that good survivorship is associated with accurate reconstruction of the normal tibiofemoral angle¹⁴, which ranged from only 4° to 8° of anatomical valgus in our series. We also found a low prevalence of radiolucent lines, with no evidence of a radiolucent line of >2 mm or extending beyond two zones⁴. A circumferential radiolucency adjacent to a prosthetic component is used to define loosening radiographically¹⁵, whereas incomplete and nonprogressive radiolucent lines have been reported to have no clinical relevance¹⁶. However, the prevalence of radiolucencies may be underestimated because they may be difficult to detect on routine plain radiographs¹⁷. The accurate tibiofemoral angles, absence of postoperative infection and periprosthetic fractures, and paucity of radiolucent lines in our study were probably related to the surgical technique^11,18.

Two features of the design of this modular prosthesis may have contributed to the excellent survival that we observed. The all-polyethylene patellar component was phased into use by the senior author (R.D.S.) in July 1985, as a result of evidence of an increased failure rate with the use of a metal-backed patellar component^16,19. In a recent report on the PFC prosthesis with a metal-backed patellar component, the survivorship was 90% at a minimum of ten years¹⁶. Although there was no formal alteration in patient selection criteria between the times of these studies, the two components were never used concurrently to allow a direct comparison.

Another factor contributing to our good results could be the substantial difference in the conformity and constraint between the flat cruciate-retaining insert and the curved cruciate-substituting design with a post. A nonconforming articulating surface produces focal stress loading, with resultant polyethylene subsurface delamination and increased wear compared with that associated with a more conforming articulation^20-23. Thus the design rationale of many prostheses has moved away from a so-called flat-on-flat sagittal nonconforming articulation to a more conforming design, which has been shown to decrease the risk of topside polyethylene wear^22,24.

A nonconforming articulation, such as the one used in this series, does result in more anteroposterior sliding, with a theoretical increase in wear of the articulating surface of the insert²⁵. However, this may decrease the stress imparted on the locking mechanism of a fixed-bearing insert and at the prosthesis-cement interface, potentially resulting in less backside wear of the insert and less component loosening²⁶. Four of the five reoperations in our study were due to wear of the modular polyethylene insert, which can be addressed relatively easily during revision surgery, but these results should be compared with the long-term results of other prostheses, including those with a nonmodular tibial component³.

With the publication of increasing numbers of longer-term follow-up studies, the survivorship of the patients themselves at fifteen years after the surgery is of interest. Fifty-two percent of the patients, who were an average of sixty-seven years of age at the time of the surgery, had died by the time of the fifteen-year follow-up point from causes unrelated to the surgery. In an earlier ten-year follow-up study of a similar patient population, the rate of deaths unrelated to the surgery was 30% (3% per year)¹². Ranawat reported a rate of unrelated deaths of 46% at fourteen years (3.2% per year) and 72% at twenty years (3.6% per year)¹¹, which is similar to the rate of 52% at fifteen years (3.5% per year) in the present study.

This survivorship study, in which we used a worst-case-scenario analysis and a broad definition of prosthetic failure and which had a 1.4% loss-to-follow-up rate, showed that excellent clinical and radiographic results can be achieved with the modular fixed-bearing posterior cruciate-retaining total knee design.

Appendix

Materials and Methods | Results | Discussion | Appendix | References

A table showing the results of the life-table analysis of the 139 arthroplasties 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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Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop.1989;248: 13-4.24813 1989

Ewald FC. The Knee Society total knee arthroplasty roentgenographic evaluation and scoring system. Clin Orthop.1989;248: 9-12.2489 1989

Armitage P, Berry G. Statistical methods in medical research.3rd ed. Boston: Blackwell Scientific Publications; 1994. p 468-92.468 1994

Murray DW, Carr AJ, Bulstrode C. Survival analysis of joint replacements. J Bone Joint Surg Br.1993;75: 697-704.75697 1993 [PubMed]

Rothman KJ. Estimation of confidence limits for the cumulative probability of survival in life table analysis. J Chronic Dis.1978;31: 557-60.31557 1978 [PubMed][CrossRef]

Dobbs HS. Survivorship of total hip replacements. J Bone Joint Surg Br.1980;62: 168-73.62168 1980 [PubMed]

Ranawat CS, Flynn WF Jr, Saddler S, Hansraj KK, Maynard MJ. Long-term results of the total condylar knee arthroplasty. A 15-year survivorship study. Clin Orthop.1993;286: 94-102.28694 1993 [PubMed]

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Windsor RE, Scuderi GR, Moran MC, Insall JN. Mechanisms of failure of the femoral and tibial components in total knee arthroplasty. Clin Orthop.1989; 248: 15-20.24815 1989 [PubMed]

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Schai PA, Thornhill TS, Scott RD. Total knee arthroplasty with the PFC system. Results at a minimum of ten years and survivorship analysis. J Bone Joint Surg Br.1998;80: 850-8.80850 1998 [PubMed][CrossRef]

Lundberg-Jensen A, Kourakis AH, Rossen B, Kofoed H. Radiolucency adjacent to the tibial component in total knee arthroplasty. Orthopedics.2000;25: 49-51.2549 2000

Scuderi GR, Insall JN, Windsor RE, Moran MC. Survivorship of cemented knee replacements. J Bone Joint Surg Br.1989;71: 798-803.71798 1989

Bayley JC, Scott RD. Further observations on metal-backed patellar component failure. Clin Orthop.1988;236: 82-7.23682 1988

Kilgus DJ, Moreland JR, Finerman GA, Funahashi TT, Tipton JS. Catastrophic wear of tibial polyethylene inserts. Clin Orthop.1991;273: 223-31.273223 1991 [PubMed]

Bartel DL, Bicknell VL, Wright TM. The effect of conformity, thickness, and material on stresses in ultra-high molecular weight components for total joint replacement. J Bone Joint Surg Am.1986;68: 1041-51.681041 1986

Wright TM, Rimnac CM, Stulberg SD, Mintz L, Tsao AK, Klein RW, McCrae C. Wear of polyethylene in total joint replacements. Observations from retrieved PCA knee implants. Clin Orthop.1992;276: 126-34.276126 1992

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Topics

femur ; knee region ; knee joint ; osteolysis ; patella ; posterior cruciate ligament ; prostheses and implants ; prosthesis implantation ; repeat surgery ; tibia

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Michael C. Dixon, Richard R. Brown, Dominik Parsch, Richard D. Scott; Modular Fixed-Bearing Total Knee Arthroplasty with Retention of the Posterior Cruciate LigamentA Study of Patients Followed for a Minimum of Fifteen Years. The Journal of Bone & Joint Surgery. 2005 Mar;87(3):598-603.

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