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Dr. Callaghan is the Lawrence and Marilyn Dorr Chair in Hip Reconstruction and Research, Professor of Orthopaedics, Rehabilitation and Biomedical Engineering, University of Iowa, and Staff Orthopaedic Surgeon, Veterans Affairs Medical Center, Iowa City, IA. Dr. Cuckler is Orthopaedic Surgeon, Alabama Spine and Joint Center, PC, Birmingham, AL. Dr. Huddleston is Assistant Professor, Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, CA. Dr. Galante is The Grainger Director, Rush Arthritis and Orthopedic Institute, Rush-Presbyterian-St. Lukes Medical Center, and Professor of Orthopedic Surgery, Department of Orthopedic Surgery, Rush Medical College, Rush University Medical Center, Chicago, IL.
*The Implant Wear Symposium 2007 Clinical Work Group included John J. Callaghan, MD, John M. Cuckler, MD, Jorge O. Galante, MD, DMSc, Alejandro González Della Valle, MD, Stuart B. Goodman, MD, PhD, James I. Huddleston, MD, Lynne C. Jones, PhD, David G. Lewallen, MD, Henrik Malchau, MD, PhD, William Maloney, MD, Amanda Marshall, MD, Wayne Paprosky, MD, Hollis G. Potter, MD, Michael D. Ries, MD, Aaron Rosenberg, MD, Thomas P. Sculpco, MD, Bernard N. Stulberg, MD, Audrey K. Tsao, MD, and Timothy Wright, PhD.
Dr. Callaghan or a member of his immediate family has received research or institutional support, miscellaneous nonincome support, commercially derived honoraria, or other nonreseach-related funding and royalties from DePuy. Dr. Cuckler or a member of his immediate family has received royalties and miscellaneous nonincome support, commercially derived honoraria, or other nonreseach-related funding from Biomet and is a consultant for Biomet. Dr. Galante or a member of his immediate family has received research or institutional support and royalties from Zimmer. Neither Dr. Huddleston nor a member of his immediate family has received anything of value from or owns stock in a commercial company or institution related directly or indirectly to the subject of this article.
| Abstract |
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When considering whether a bearing surface couple is an improvement over previously used couples in a total joint arthroplasty, one must know the incidence and prevalence of osteolysis and its associated sequelae (eg, loosening) as well as its source (wear particulate debris). It must also be recognized that older-generation polyethylene-on-metal bearings were extremely durable and have performed well out to 20 or 30 years in the vast majority of patients in whom these bearing surfaces were implanted, especially when the hip or knee devices were of adequate design and the operation was technically well performed.1-4 (Older-generation polyethylene-on-metal bearings are those sterilized by gamma-irradiation in air and exposure to ethylene oxide.)
However, 20 to 35 years ago, surgeons were more conservative about performing these procedures in younger patients, and patient weights and expectations concerning any activity limitations were different from those today. In evaluating the 30-year data on total hip arthroplasty (THA) patients and the 15-year data on total knee arthroplasty (TKA) patients, average weight was often <170 lb (75 kg). In a recent minimum 25-year follow-up of a series of THAs with polyethylene that was gamma-irradiated in air and mated to a metallic femoral head bearing surface, the linear head penetration was 0.098 mm/yr for stable components and 0.213 mm/yr for revised components.3 The acetabular revision incidence was 5%, and the femoral component revision incidence was 2.8%. However, revision prevalence increases with implant longevity: of those patients still alive at 25-year follow-up, 23% were revised on the acetabular side and 10% on the femoral side. Of a mobile-bearing TKA construct followed for a minimum of 15 years, 3% had osteolytic lesions; in a modular cruciate-retaining knee, 6% required revision for wear and osteolysis.5,6 In contrast, in a more recent evaluation of a posterior-stabilized modular total knee with polyethylene gamma-irradiated in air, the incidence of osteolysis was 16% at only 5- to 8-year follow-up.7 Similar findings have been reported in other knee implant systems.8,9 Hence, osteolysis is a multifactorial process dependent on material and design factors, patient demographics, and surgical technique.
Following cementless fixation in THAs of adequate design at 15-year follow-up, incidence of acetabular revision for loosening ranges from 0% to 2% of patients <50 years of age.10-12 In the overall series, 5% had definite acetabular osteolysis, while 3% required revision. The mean femoral head penetration rate was 0.12 mm/yr.12 However, in patients <50 years of age, the penetration rate was 0.187 mm/yr.11 Using another acetabular component design with less optimal fixation matched to femoral components with 32-mm diameter heads, a 15% incidence of acetabular revision for loosening and wear was observed.13
On the femoral side of the cementless construct, when circumferential porous coating was used, revision for loosening occurred in 2% to 4% of cases at 15 years.14 Although minimal distal osteolysis was noted, proximal osteolysis was observed in up to 37% of cases. Therefore, with successful, cementless early-generation acetabular and femoral designs, durability of fixation is excellent out to 15 and 20 years. Wear-induced osteolysis, however, is the dominant problem.
Alternative bearing couples such as highly cross-linked polyethylene, metal-on-metal, and ceramic-on-ceramic are attractive because of the potential for reduced wear and anticipated reduced osteolysis and loosening. Clinical data exist to support the use of these materials.15-17 However, methods for detecting osteolysis for monitoring wear, and for measuring serum and urine ion levels now present more precise ways to evaluate the outcome of the modern alternative articular couples.18,19 These methods include computed tomography (CT) and magnetic resonance imaging (MRI) to detect osteolysis and radiostereometric analysis (RSA) and edge-detection techniques to monitor wear. Because of the sensitivity of these tools, direct comparisons with the results reported with first-generation bearings will be difficult; these tools either were unavailable or may be inappropriate for hard-on-hard bearings.
Data on the outcome of cross-linked polyethylene and its effect on the prevention of osteolysis are limited. Results of studies out to 5 years have been reported for many of the commonly used highly cross-linked polyethylenes. Using RSA evaluation, highly cross-linked polyethylene (irradiated at 100 kGy and remelted) demonstrated 62% lower proximal penetration and 31% lower total penetration at 3 years than did conventional inserts that had been gamma-sterilized in an inert atmosphere.20 At 3 years, no differences were found between highly cross-linked polyethylene and cobalt-chrome 28- and 36-mm heads, and no evidence of osteolysis or progressive radiolucencies was observed, using RSA.21 In another study with a minimum 5-year follow-up using manual radiographic techniques to measure wear, the highly cross-linked polyethylene linear wear rate was 0.029 mm/yr versus 0.065 mm/yr for conventional polyethylene.22 Using edge-detection techniques at 4 years, the rate for highly cross-linked polyethylene was 0.007 mm/yr versus 0.174 mm/yr for conventional material.23,24
Evaluating a highly cross-linked and annealed material, 2-year results demonstrated 42% reduction in wear versus conventional polyethylene; 5-year results in another study, a 72% reduction in wear (0.036 mm/yr versus 0.131 mm/yr, respectively, for the highly cross-linked polyethylene versus conventional polyethylene).25,26 Results with a randomized study of a 50-kGy remelt material at a minimum of 5 years was 0.01 mm/yr versus 0.19 mm/yr, a 95% reduction versus gas plasma–sterilized conventional polyethylene; in another study, the difference was 0.02 mm/yr versus 0.13 mm/yr, a 72% reduction in wear.27,28 In a study using CT analysis at nearly 6 years of follow-up, possible osteolysis was observed in 8% of THAs with highly cross-linked polyethylene, compared with 28% of THAs with gas plasma–sterilized polyethylene inserts; however, the absence of preoperative CT scans makes the interpretation of these results less conclusive.18 Furthermore, none of the patients in this study demonstrated evidence of loosening or pain, suggesting that osteolysis (at this early period of follow-up) may not necessarily correlate with implant failure.
First-generation cross-linked polyethylenes have documented reductions in fatigue, tensile, and toughness properties.29 Fractures of the highly cross-linked material have been reported in THA acetabular components. Concern exists regarding the locking mechanisms and the strength of cruciate-substituting and other constraint posts in TKA; this concern has tempered enthusiasm for use of cross-linked polyethylene materials in the knee.28,30 In the hip, polyethylene fractures have been associated with malpositioned acetabular components; edge loading has produced high contact stresses in the locking mechanism. Use of large heads with thin, highly cross-linked polyethylene liners is of concern in cases with malpositioned acetabular components because fracture of the cross-linked polyethylene insert has been observed.31-33
Although alumina ceramic-on-ceramic hip replacements have been used in France since 1970, few large-scale long-term studies exist. In the only long-term study to date of ceramic acetabular components mated with alumina ceramic femoral heads, 20-year survival was 85% for cemented cups and 61.2% for cementless cups. Only 3 of 118 cases demonstrated osteolysis, and none showed detectable wear. Failure of the ceramic acetabular components was related to design and fixation aspects of these implants.16
A 20-year follow-up study of cemented conventional polyethylene components (gamma-sterilized in air) articulating with 32-mm–diameter alumina femoral heads demonstrated a wear rate of only 0.03 mm/yr.34 A newer alumina-on-alumina cementless design followed for an average of 62 months demonstrated that 99.7% of cups were stable, 1.4% developed osteolysis, and there were no fractures.35 In another series, wear was related to positioning of the cup in <15° of anteversion.36
Concerns exist with ceramic-on-ceramic bearings. Squeaking from ceramic-on-ceramic THAs during walking, ascending stairs, or rising from sitting has been associated with ceramic acetabular bearings placed in excessive anteversion (>40°) and excessive lateral opening.37 Ceramic alumina wear particles are biologically active and can lead to osteolysis.38 Multiple retrievals have demonstrated rim chip fractures and cracks in the acetabular liners, especially when the components are malpositioned.37,39 Stripe wear damage to ceramic femoral heads and acetabular components has been noted, as has metal transfer to ceramic heads that have subluxated or dislocated; the long-term effects of damage to ceramic- on-ceramic, wear bearing surface couples is currently unknown.40,41 Unfortunately, the brittle nature of ceramic materials prevents the fabrication of extended wall liners, and a relatively small femoral head diameter is required because of the necessary thickness of the acetabular ceramic bearing.
Metal-on-metal cobalt-chromium bearing surfaces have been used since the early 1950s. The McKee-Farrar THA survivorship rates were 77% at 20 years, compared with 73% for the Charnley device over the same time span.42,43 In another study of the McKee-Farrar THA, the survivorship was 84% at 20 years and 74% at 28 years, with minimal osteolysis.44 The benefit of metal-on-metal is the ability to use the largest head diameter for a given acetabular diameter, which not only increases the range of motion and reduces the risk of dislocation, but also optimizes the tribology for decreased wear for this bearing couple.45,46
The concerns with these devices are the potential for increased serum ion concentrations and allergic response to the metals; production of pseudotumors, osteolysis, and runaway wear have been reported with malpositioned acetabular components.15,47-49 A recent 5- to 9-year follow-up of a contemporary design demonstrated a 6.5% revision rate for aseptic loosening thought to be associated with osteolysis; however, the metallurgy of the implant was probably suboptimal.50 In contrast, Grübl et al51 reported an extremely low prevalence of osteolysis in a series of patients followed at least 10 years with the Metasul (Centerpulse Orthopedics, Austin, TX) 28-mm prosthesis. Perhaps equally important, the distribution and extent of osteolysis were limited to very small areas of the proximal femur and did not appear to be progressive (Figure 1). In a 7-year follow-up of 154 Metasul 28-mm hips, Long et al52 reported nine cases in which minor calcar resorption was observed but no cases of extensive or progressive osteolysis.
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Osteolysis that results in loosening of the bone-implant interface and progressive loss of bone stock is the critical aspect affecting the long-term performance of arthroplasty materials. Substantial data exist to guide the surgeon toward early revision of implants demonstrating progressive osteolysis; thus far, the extent to which newer alternative wear bearing surface couples reduce the prevalence and severity of osteolysis may be a clinical advantage. However, longer-term follow-up from multiple centers will be necessary to confirm the early observational data. It is hoped that the next decade of follow-up will not produce observations of progressive and aggressive osteolysis.
The resurgence and reintroduction of alternative bearings, especially in THA, has been accompanied by carefully planned and closely followed cohort studies, many with randomized controls. In general, these have been performed in centers with high volume of revision total hip replacement. All three bearing couples (highly cross-linked polyethylene–on-metal, metal-on-metal, and ceramic-on-ceramic) have demonstrated early clinical success with minimal evidence of osteolysis and minimal wear. For all three bearing couples, proper acetabular component positioning (ie, avoiding excessive lateral opening and anteversion) prevents some of the complications associated with these alternative bearings: cross-linked polyethylene—fracture; ceramic-on-ceramic—squeaking, impingement wear; and metal-on-metal—runaway wear, osteolysis.
The effects of surgical technique, such as malposition, and the effects of minimally invasive surgery and third-body wear may produce significant alterations in the performance of these bearing surface couples.
| Future Directions for Research |
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