The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 86, Issue 3

Scientific Articles | March 01, 2004

The Rates of Osteolysis and Loosening Associated with a Modular Posterior Stabilized Knee Replacement: Results at Five to Fourteen Years

Paul F. Lachiewicz, MD¹; Elizabeth S. Soileau, BSN¹

¹ Department of Orthopaedics, University of North Carolina, Chapel Hill, 242 Burnett Womack Building, CB 7055, Chapel Hill, NC 27599

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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. A commercial entity (Zimmer to Total Joint Research Fund, Department of Orthopaedics, University of North Carolina, Chapel Hill) 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 Orthopaedics, University of North Carolina, Chapel Hill, Chapel Hill, North Carolina

The Journal of Bone and Joint Surgery, Incorporated

J Bone Joint Surg Am, 2004 Mar 01;86(3):525-530

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Abstract

Background: Osteolysis and increased polyethylene wear have been reported in association with several designs of modular total knee prostheses. The purpose of the present study was to evaluate a modular posterior stabilized prosthesis to determine its clinical performance as well as the rates of component loosening and osteolysis.

Methods: We performed a prospective, consecutive study of 193 knees in 131 patients who were managed with the modular Insall-Burstein II posterior stabilized total knee prosthesis by one surgeon. The mean age of the patients at the time of surgery was sixty-eight years, and the mean duration of follow-up was seven years (range, five to fourteen years). Clinical evaluation was performed with use of standard knee-scoring systems. Radiographs were evaluated for the presence of radiolucent lines, osteolysis, and loosening.

Results: The overall result (as determined with the Hospital for Special Surgery scoring system) was rated as excellent for 112 knees, good for sixty, fair for fifteen, and poor for six. The mean postoperative flexion was 112°. No clinical or radiographic loosening of the tibial component was noted. Eight knees had osteolytic lesions of the tibia. Thin, incomplete, nonprogressive radiolucent lines were noted around thirty tibial components (16%). There were three reoperations.

Conclusions: Despite previous reports of osteolysis, polyethylene wear, and loosening in association with some modular total knee implant designs, there was no loosening in this series of posterior stabilized total knee replacements and only eight knees had tibial osteolysis after a mean duration of follow-up of seven years. We believe that total knee arthroplasties that are performed with use of cemented modular posterior stabilized components can have a high rate of intermediate-term success.

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

Osteolysis associated with total knee arthroplasty has been described in isolated case reports since the late 1980s and early 1990s^1-8. Those reports typically involved rapid or catastrophic polyethylene wear in patients who had been managed with cementless components. To our knowledge, the first large study of osteolysis after total knee arthroplasty without cement was reported by Peters et al. in 1992⁹. Osteolysis after total knee arthroplasty with cement has been less frequently described as a clinical problem^10-12. Recently, Puloski et al.¹³ reported extensive wear of the polyethylene tibial post of a variety of retrieved cemented posterior stabilized total knee implants. However, the polyethylene damage score was greatest for knees that had been revised for osteolysis or recurrent effusions.

The Insall-Burstein posterior stabilized total knee prosthesis (Zimmer, Warsaw, Indiana) was introduced with an all-polyethylene tibial component in 1978¹⁴, which was followed by a metal-backed, nonmodular tibial component in 1981¹⁵. In 1989, a metal-backed, modular tibial component (Insall-Burstein II; Zimmer) was introduced to permit the addition of wedges, blocks, and stem extensions (Fig. 1). The tibial polyethylene spine was also lengthened by 2 mm and was moved anteriorly by 2 mm at that time. From 1989 through 1994, the polyethylene liner for the modular tibial component was fabricated from ram-extruded machined GUR 4150 that was sterilized with gamma irradiation in air. Sometime during 1995, the manufacturer made a so-called running change of the polyethylene liner to compression-molded GUR 1050 that was sterilized with gamma irradiation in nitrogen. The purpose of the present study was to determine the prevalence of osteolysis and loosening in association with the Insall-Burstein II prosthesis, which had both a modular tibial insert and a large tibial spine for posterior stabilization.

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Fig. 1: Frontal views of the Insall-Burstein II prosthesis, showing the side-entry of the polyethylene liner and the locking clip mechanism.

Materials and Methods

Materials and Methods | Results | Discussion | References

From March 1989 to May 1998, 245 consecutive Insall-Burstein II total knee arthroplasties were performed in 170 patients by one surgeon (P.F.L.) and were followed prospectively both clinically and radiographically. The Insall-Burstein II implant was the only knee prosthesis used for primary arthroplasty during this period. Twenty-three patients (thirty-three knees) died before the five-year follow-up, and sixteen patients (nineteen knees) were lost to follow-up, refused to return, or moved out of state. Thus, 193 knees in 131 patients with a minimum duration of follow-up of five years formed the basis of this study.

The mean age of the patients at the time of surgery was sixty-eight years (range, twenty-two to eighty-nine years). One hundred and thirty-eight knee prostheses were implanted in ninety-six women, and fifty-five knee prostheses were implanted in thirty-five men. The mean weight of the patients was 79 kg (range, 30 to 129 kg). The preoperative diagnosis was osteoarthritis for 154 knees, rheumatoid arthritis for thirty-three, and a variety of other diagnoses for six. The mean duration of follow-up was seven years (range, five to fourteen years).

The Insall-Burstein II total knee prosthesis had a symmetric cobalt-chromium femoral component and an all-polyethylene patellar dome. The tibial component had a modular titanium-alloy tray with four holes that were occluded with small polyethylene plugs that could be removed to fasten a wedge or block to the tray with screws. The polyethylene liner was inserted from the side and was held in place with a front-loaded locking clip. The stated thickness of the polyethylene liner (and minimum thickness at the center) was 8 mm (5.3 mm) in seventy-five knees, 10 mm (7.3 mm) in seventy-six knees, 12 mm (9.3 mm) in thirty-six knees, and 15 mm (12.3 mm) in six knees. The intraoperative technique included the use of spacer bars in both flexion and extension. Hyperextension (recurvatum) of the knee was carefully avoided by using an intramedullary alignment instrument for the femur and by placing the thickest polyethylene liner that the knee could accommodate in extension. All three components were implanted with Simplex P bone cement (Howmedica, Rutherford, New Jersey). Pulsatile lavage (Stryker, Kalamazoo, Michigan) was routinely used before cementing, and the tibial cement was placed with a syringe into the occluded metaphysis and onto the cut tibial surface. Full weight-bearing and range of motion were begun on the first postoperative day.

The knees were prospectively evaluated clinically with use of the Hospital for Special Surgery knee score¹⁶, both preoperatively and postoperatively. In addition, at the time of the most recent follow-up, the knees were evaluated for pain and function by a clinical research nurse with use of the rating system of the Knee Society¹⁷. Radiographic analysis included sequential standing anteroposterior radiographs, supine lateral radiographs, and tangential radiographs of the patella. The radiographic scoring system of the Knee Society¹⁸ was used to determine the overall alignment of the knee, the presence of radiolucent lines in zones adjacent to the cement mantle, and migration of the components. The alignment of the femoral and tibial components in the sagittal plane was not measured. Serial radiographs were reviewed for changes in the bone that were consistent with osteolysis (circular or oval lytic lesions) and for progression of radiolucent lines. Fluoroscopic positioning of the knee was not used. Polyethylene wear was not measured.

Results

Materials and Methods | Results | Discussion | References

Clinical Results

According to the rating system of the Hospital for Special Surgery, 112 knees (58%) had an excellent result, sixty knees (31%) had a good result, fifteen knees (8%) had a fair result, and six knees (3%) had a poor result at the time of the latest follow-up. According to the rating system of the Knee Society, the mean knee score was 89.3 points (range, 48 to 98 points) and the mean functional score was 52 points (range, 0 to 100 points). The mean postoperative maximum flexion was 112° (range, 75° to 130°).

There were three reoperations. One patient had a deep infection with Staphylococcus aureus at thirteen months and was managed with open débridement with polyethylene exchange and chronic suppressive antibiotics; the patient had a good result at five years. Another patient, a fifty-one-year-old woman with osteoarthritis who had had a bilateral knee arthroplasty, had development of flexion instability (femoral-tibial subluxation) at five years. The polyethylene liner was exchanged at six years, and the result was excellent at seven years. A third patient had a reoperation at 5.5 years because of severe painful synovitis. This patient was a fifty-nine-year-old woman with nail-patella syndrome and a renal transplant who had undergone knee arthroplasty (without patellar resurfacing) for the treatment of osteoarthritis. The patient had an excellent result for four years, at which time the renal transplant failed and hemodialysis was started. At 5.5 years, she presented with a large hemarthrosis and a 3.5-cm osteolytic lesion of the proximal part of the medial aspect of the tibia. After synovectomy and polyethylene exchange, the patient continued to have recurrent hemarthroses, presumably related to hemodialysis, and the result was rated as poor. Evaluation of the polyethylene liner at the Dartmouth Biomedical Engineering Center showed grade-2 (10% to 50%) wear of the articular surface and grade-1 (<10%) wear of the nonarticular surface¹⁹.

Radiographic Results

The overall femorotibial alignment was neutral (3° to 9° of valgus) in 189 knees and varus (range, 0° to 3° of varus) in four. The mean femorotibial angle was 5.2° of valgus. Forty-two nonprogressive tibial radiolucent lines measuring 1 to 2 mm in width were seen in thirty knees (16%). The most common locations were zone 1 as seen on anteroposterior radiographs (Fig. 2-A) and zone 1 as seen on lateral radiographs (Fig. 2-B). No tibial component was associated with a complete radiolucent line or migration. No tibial component had debonded or had a radiolucent line at the metal-cement interface.

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Figs. 2-A and 2-B: Distribution of tibial radiolucent lines on the most recent anteroposterior (Fig. 2-A) and lateral (Fig. 2-B) radiographs.

Osteolysis was seen in the proximal part of the tibia in eight knees in six patients. One patient with osteolysis of the proximal part of the medial aspect of the tibia was described above. The second patient was a sixty-four-year-old woman who had had a bilateral arthroplasty for the treatment of osteoarthritis (Figs. 3-A, 3-B, and 3-C). The one-year postoperative radiographs showed no radiolucent lines or osteolysis. However, at two years, there were asymptomatic osteolytic lesions of the central part of the medial aspect of the tibia bilaterally, measuring 1 and 1.5 cm. At five and six years, the lesions had not changed, the knees remained asymptomatic, and reoperation was not recommended. The third patient had a 2-mm radiolucent line in anteroposterior zone 1 of the tibial component at four years. At seven years, there was a <1-cm area of osteolysis distal to this radiolucent line. The patient was asymptomatic, and reoperation was not recommended. The fourth patient, who had had a bilateral arthroplasty for the treatment of osteoarthritis, had a 6-mm-diameter area of tibial osteolysis in zone 1 on the lateral radiograph, which was only noted at five years. There was no significant association, with the numbers available, between the presence of osteolysis and the use of a polyethylene liner with a stated thickness of 8 mm. Of the six patients with osteolysis, two patients (two knees) had received polyethylene that had been fabricated before 1995 and four patients (six knees) had received polyethylene that had been fabricated in 1996 or 1997. Statistical comparison of these groups was not possible with the small numbers available.

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Figs. 3-A, 3-B, and 3-C: Radiographs of the left knee of a woman who underwent a bilateral total knee replacement at the age of sixty-four years. Fig. 3-A Radiograph made six weeks postoperatively. Fig. 3-B Radiograph made two years postoperatively, showing an osteolytic lesion in the medial aspect of the tibia. The patient was asymptomatic.

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Fig. 3-C: Radiograph made five years postoperatively, showing no change in the lesion. The patient remained asymptomatic.

Discussion

Materials and Methods | Results | Discussion | References

Osteolysis associated with total knee arthroplasty has been ascribed to the use of cementless components^1,4,7, screw fixation^9,20, and thin modular polyethylene liners^2,3,21. When osteolysis occurs it is frequently seen early, with a mean onset of thirty-five months postoperatively in one study⁹. Osteolysis after total knee arthroplasty with cement is uncommon and has been associated with carbon-reinforced polyethylene¹¹ and dissociation of a nonmodular liner¹². Recently, investigators have suggested that backside wear of modular tibial components²² and wear of the tibial post of posterior stabilized components¹³ may contribute substantially to the polyethylene wear of the knee. However, in the report by Puloski et al.¹³, only one of the twenty-three knees that underwent revision had received an Insall-Burstein II prosthesis and that knee was revised because of infection (not wear) at 17.7 months. Theoretically, increased polyethylene wear will lead to a higher prevalence of osteolysis with resultant synovitis and component loosening¹⁰.

Colizza et al. reported on the long-term results associated with the cemented Insall-Burstein I posterior stabilized knee prosthesis with a nonmodular metal-backed tibial component¹⁵. In that study of 101 knees that were followed for a minimum of ten years, no knee was revised because of polyethylene wear or osteolysis and no knee had a chronic effusion. In three knees, small focal lesions measuring <1 cm were noted at one year and there was little progression. The Insall-Burstein II posterior stabilized knee prosthesis differs from the original metal-backed model in that it features a tibial tray that is made of titanium alloy (rather than cobalt-chromium alloy), it has four holes in the baseplate that are occluded by small polyethylene plugs, and it has a modular side-entry polyethylene tibial insert that is held by a front-loading locking clip. With this design, there is a potential for polyethylene wear in association with the tibial insert-baseplate interface, the locking clip, and the elongated tibial spine.

O'Rourke et al. reported the minimum five-year results of 143 arthroplasties that were performed with a modular Insall-Burstein II prosthesis²³. Although there was only one revision for osteolysis, osteolysis without loosening was seen in 13% of the knees. The authors hypothesized that this finding was related to recurvatum of the knee and tibial spine impingement. In the present study of 193 total knee arthroplasties that were performed with the same modular prosthesis, there was no loosening of the cemented components after a minimum duration of follow-up of five years (mean, seven years). There was one reoperation for severe synovitis at 5.5 years, and the analysis suggested that this synovitis was due to recurrent hemarthroses associated with chronic hemodialysis. Osteolytic lesions of the tibia were seen, however, in eight knees (4%). The etiology of osteolysis is not known but may be related to bearing wear, backside wear, or post impingement; retrieved specimens will be needed in order to make this determination. These lesions also may be related to migration or wear of the polyethylene plugs that are used to occlude the holes in the tibial baseplate (which permit the attachment of wedges with screws); in the present study, osteolytic lesions were located directly beneath these plugs in two knees.

The results of the present study are encouraging because they demonstrate that modular posterior stabilized components that are inserted with cement can have a high rate of success after intermediate-term follow-up (mean, seven years). The rate of osteolysis associated with the modular implants in the present study (4%) was similar to the rate associated with the nonmodular implants in the study by Colizza et al.¹⁵ (3%), but the duration of follow-up in the present study was shorter. However, there were differences between the studies with regard to the patient populations and the rates of revision (Table I). Posterior subluxation or dislocation did not occur in any knee in the present study, and wear of the tibial post was not a clinically important problem. However, the ligaments were carefully balanced in these knees and hyperextension was avoided by keeping the knee tight in extension at the time of surgery. In addition, loosening and articular surface wear were not notable clinical or radiographic problems after this duration of follow-up. A shortcoming of the present study was that polyethylene wear was not directly measured. It is also possible that the rate of osteolysis will increase with longer follow-up. The senior author (P.F.L.) continues to follow these patients and continues to use a modular posterior stabilized cemented total knee prosthesis.

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TABLE I Comparison of Studies of the Insall-Burstein I and Insall-Burstein II Posterior Stabilized Prostheses

	Insall-Burstein I (Colizza et al.¹⁵)*	Insall-Burstein II (Present Study)*
No. of knees	101	193
No. of patients	74	131
Female	59	96
Male	15	35
Mean age (yr)	64	68
Duration of follow-up†(yr)	10.7 (10-11.8)	7 (5-14)
Osteolysis‡	3 (3%)	8 (4%)
Radiolucent lines‡	11 (11%)	30 (16%)
Revision
Femoral loosening‡	2 (2%)	0
Hemarthrosis‡	1 (1%)	1 (0.5%)
Instability‡	1 (1%)	1 (0.5%)
Infection‡	0	1 (0.5%)

The Insall-Burstein I prosthesis features a nonmodular metal-backed tibial component, and the Insall Burstein-II prosthesis features a modular metal-backed tibial component. †The data are given as the mean, with the range in parentheses. ‡The data are given as the number of knees, with the percentage in parentheses.

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TABLE I Comparison of Studies of the Insall-Burstein I and Insall-Burstein II Posterior Stabilized Prostheses

	Insall-Burstein I (Colizza et al.¹⁵)*	Insall-Burstein II (Present Study)*
No. of knees	101	193
No. of patients	74	131
Female	59	96
Male	15	35
Mean age (yr)	64	68
Duration of follow-up†(yr)	10.7 (10-11.8)	7 (5-14)
Osteolysis‡	3 (3%)	8 (4%)
Radiolucent lines‡	11 (11%)	30 (16%)
Revision
Femoral loosening‡	2 (2%)	0
Hemarthrosis‡	1 (1%)	1 (0.5%)
Instability‡	1 (1%)	1 (0.5%)
Infection‡	0	1 (0.5%)

References

Materials and Methods | Results | Discussion | References

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Engh GA, Parks NL, Ammeen DJ. Tibial osteolysis in cementless total knee arthroplasty. A review of 25 cases treated with and without tibial component revision. Clin Orthop.1994;309: 33-43.30933 1994

Gross TP, Lennox DW. Osteolytic cyst-like area associated with polyethylene and metallic debris after total knee replacement with an uncemented vitallium prosthesis. A case report. J Bone Joint Surg Am.1992;74: 1096-101.741096 1992 [PubMed]

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O'Rourke MR, Callaghan JJ, Goetz DD, Sullivan PM, Johnston RC. Osteolysis associated with a cemented modular posterior-cruciate-substituting total knee design: five to eight-year follow-up. J Bone Joint Surg Am.2002; 84: 1362-71.841362 2002 [PubMed]

Topics

knee joint ; osteolysis ; tibia ; knee replacement arthroplasty ; polyethylene ; knee joint prosthesis ; knee prosthesis, total ; osteolytic lesion

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Paul F. Lachiewicz, Elizabeth S. Soileau; The Rates of Osteolysis and Loosening Associated with a Modular Posterior Stabilized Knee ReplacementResults at Five to Fourteen Years. The Journal of Bone & Joint Surgery. 2004 Mar;86(3):525-530.

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