J Am Acad Orthop Surg, Vol 16, No suppl_1, July 2008, S1-S6.
© 2008 the American Academy of Orthopaedic Surgeons
How prevalent are implant wear and osteolysis, and how has the scope of osteolysis changed since 2000?
Amanda Marshall, MD,
Michael D. Ries, MD and
Wayne Paprosky, MD
Dr. Marshall is Assistant Professor, University of Texas Health Science Center, San Antonio, TX. Dr. Ries is Professor and Vice Chairman, University of California–San Francisco Medical Center, San Francisco, CA. Dr. Paprosky is Associate Professor, 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. Sculco, MD, Bernard N. Stulberg, MD, Audrey K. Tsao, MD, and Timothy Wright, PhD.
Dr. Marshall or a member of her immediate family has received research support from DePuy. Dr. Ries or a member of his immediate family has received royalties from Smith & Nephew. Dr. Paprosky or a member of his immediate family has received royalties from Zimmer.
 |
Abstract
|
|---|
Although the incidence of failures resulting from wear-related osteolysis and associated severe bone defects are expected to diminish with important advances in polyethylene manufacturing and processing, alternative bearing surfaces, implant design, and revision techniques, current failures still reflect concerns regarding earlier ultra-high–molecular-weight polyethylene sterilization and degradation. Clinical experience before the year 2000 included rates of wear and osteolysis from 10% to as high as 70% at 7- to 14-year follow-up. With recent advances, early clinical results are encouraging, demonstrating 50% to 81% decreases in radiographic wear rates. These improvements should eventually reduce the burden of future revision hip and knee surgery. However, the long-term in vivo durability of total hip arthroplasties using these alternative materials and bearing couples has not yet been well established, and considerably fewer clinical data are available for other types of joint arthroplasties, such as total knee arthroplasty.
Total hip and knee arthroplasties are among the most successful operations in orthopaedic surgery for patients with disabling arthritis. However, late failure may occur as a result of mechanical loosening, mechanical failure, or wear of the bearing surfaces. Several evolutionary milestones have occurred in implant materials and design. Thirty years ago, for example, failures of cemented total hip arthroplasties (THAs) were misinterpreted as the result of "cement disease." To eliminate cement as a potential problem, porous ingrowth surfaces were developed for cementless fixation of implant components in the 1980s. Clinical experience with porous-coated implants has demonstrated reliable biologic fixation to bone. However, periprosthetic osteolytic lesions have remained a problem, demonstrating that particulate debris from other implant materials, most notably wear debris from bearing surfaces of materials such as ultra-high–molecular-weight polyethylene (UHMWPE), contribute to osteolysis.
Recent advances in surgical technique, implant materials, and designs have been directed at improving the wear performance of total joint arthroplasty components. Have these improvements decreased the prevalence of osteolysis? Are there fewer revisions for UHMWPE wear and osteolysis as a result of progress with wear reduction?
During the 1990s, wear-related osteolysis was considered to be the most common cause of late failure of THA.1-3 Many of these failures were related to the use of UHMWPE acetabular components that had been sterilized by gamma irradiation in air before implantation.4 This form of sterilization was abandoned by most implant manufacturers in the mid 1990s. Nonetheless, components sterilized in this manner and implanted before 1995 have continued to fail as a result of osteolysis. The clinical experience before the year 2000 included rates of wear and osteolysis from 10% to as high as 70% at 7 to 14 years of follow-up.5-9 The overall number of these earlier implants utilized prior to 1995 still in clinical use is decreasing as patients with functioning arthroplasties die and those with failed joint replacements undergo revision surgery. Offsetting this decrease in patient numbers, however, is the fact that the population of patients who underwent primary arthroplasties in the 1990s increased each consecutive year. Most implants fail after more than 10 years of in vivo use; thus, the current revision rate of implants that will fail because of osteolysis caused by wear of UHMWPE implants gamma-irradiated in air may be increasing.10
According to 2005 data from the Nationwide Inpatient Sample (a cross-sectional analysis of approximately 1,000 hospitals evaluating the causes for revision THAs),11 roughly 10% of current revisions are directly related to osteolysis. However, more than 40% of the revision THAs were attributed to mechanical loosening (18%), periprosthetic fracture (6%), implant failure (11%), and other mechanical problems (8%), which may well represent additional consequences of wear and osteolysis. Thus, for now, the clinical problem of wear-related osteolysis in THA does not appear to be decreasing.
Osteolytic defects as a sequela of wear debris from UHMWPE components gamma-irradiated in air can cause considerable bone loss (Figure 1). The severity of bone loss usually increases with time from the index arthroplasty, requiring more complex revision reconstructions with less predictable outcomes. Early treatment allows retention of the acetabular metallic shell with simple exchange of the particle generator (the UHMWPE insert) along with curettage and bone grafting of osteolytic cysts. However, delay in recognition and treatment of osteolytic defects often precludes retention of the shell, necessitating extensile exposures and structural augmentation with allograft or metallic augments to address bone deficiencies (Figure 2). Because clinical outcomes of such complex cases are inferior to those of primary THA, early failure of the revision can lead to additional bone loss, periprosthetic fractures, and pelvic discontinuities.
View larger version (92K):
[in this window]
[in a new window]
|
Figure 1 A 72-year-old man who did not return for routine postoperative follow-up developed left hip pain and left leg shortening 16 years after cementless primary THA. A, Anteroposterior radiograph demonstrating extensive osteolysis with displacement of the acetabular cup. B, Axial computed tomography scan demonstrating severe bone destruction and pelvic osteolysis. C, Revision THA required extensive reconstruction with allograft and cage construct.
|
|
View larger version (67K):
[in this window]
[in a new window]
|
Figure 2 A, Radiograph demonstrating severe osteolysis resulting in pelvic discontinuity. B, Intraoperative reconstruction with trabecular metal augment and shell. C, Postoperative reconstruction of pelvic discontinuity with distraction technique using trabecular metal augments cemented to the shell.
|
|
The distinction between less technically demanding and more complex revision procedures is not straightforward, and surgeons must recognize the limitations of revision surgery for osteolysis. Complex revision surgery for osteolysis may require an experienced surgeon who specializes in arthroplasty, and it may be best performed at a high-volume institution. With decreasing numbers of fellowship-trained arthroplasty surgeons to address the increased burden of complex revision THAs, this requirement will affect the entire orthopaedic community.
Even cases with less severe bone loss must be carefully scrutinized. Many stable, well-positioned acetabular metallic shells may not accept cemented liners because the shells are not hemispheric in shape, or they have walls that are too thick or inner diameters that are too small to accept a new UHMWPE liner (Figure 3). This is often the case with female patients, who can have metallic shells <51 mm in diameter. Therefore, even in cases with minimal periprosthetic bone loss, the surgeon must be prepared to remove a well-fixed acetabular metallic shell. Similarly, malpositioned acetabular components may not be amenable to simple revision to a constrained liner, thus requiring removal.
View larger version (87K):
[in this window]
[in a new window]
|
Figure 3 A, Radiograph demonstrating severe polyethylene wear and resultant osteolytic lesions. B, Intraoperative photograph of a stable metal shell with severe damage necessitating removal.
|
|
Implants sterilized by ethylene oxide, gas plasma, or gamma irradiation in an inert atmosphere have been used since the discontinuation in the mid 1990s of gamma sterilization in air. As a result, failures resulting from wear-related osteolysis have decreased, even though these components are now reaching 10 years of in vivo use.12
Highly cross-linked UHMWPE has demonstrated a similarly higher level of wear resistance. Hip simulator studies revealed a dose-dependent diminution in wear compared with the material gamma-irradiated in air. Clinically, radiographic wear rates have decreased from 50% to 81%.13-17 Geerdink et al14 compared the femoral head penetration of conventional and cross-linked UHMWPE acetabular components at 5 years and found that the cross-linked components had markedly less linear wear (0.083 mm/y) compared with conventional UHMWPE components (0.123 mm/y). Dorr et al15 compared 31 THAs using conventional UHMWPE acetabular liners to 35 THAs with cross-linked liners and demonstrated a 45% lower annual linear wear rate with the cross-linked liners. Digas et al16 performed a prospective randomized study showing 62% lower linear penetration of the femoral head into the liner at 2 years with highly cross-linked UHMWPE components. In a study directly addressing osteolysis, Leung et al17 found the average lytic lesion size, as measured with computed tomography, to be 7.5 cm3 for 40 THAs performed with conventional UHMWPE liners, compared with 1.2 cm3 for 36 THAs performed with highly cross-linked liners, at a minimum of 5 years of follow-up.
The scope of the wear problem can be better understood by recent advancements in our understanding of the biologic pathways associated with osteolysis. The biologic response to particulate debris is dependent on several factors: the number of wear debris particles, their size and surface morphology, and the rate at which they accumulate in the periprosthetic tissues. Wear particles generated in total knee arthroplasty (TKA) are generally larger than those generated in THA, and osteolysis appears less common after TKA than after THA.18-20 Nonetheless, osteolysis can occur after TKA, producing lesions similar to those in the hip, which in turn can compromise mechanical support for the implant components (Figures 4 and 5). Similar to the clinical experience in THA, wear-related osteolysis in TKA is more commonly associated with UHMWPE sterilized through gamma irradiation in air.21
View larger version (113K):
[in this window]
[in a new window]
|
Figure 4 A, Lateral radiograph demonstrating a large osteolytic tibial defect resulting from wear of heat-pressed ultra-high–molecular-weight polyethylene that was gamma- irradiated in air. B, Intraoperative view of the tibia demonstrating a contained cavitary defect. C, Intraoperative photograph illustrating particulate bone graft filling the tibial defect. D, Postoperative radiograph demonstrating a revision proximal cemented tibial component with a press-fit stem. The preoperative tibial defect is now occupied with particulate bone graft.
|
|
View larger version (65K):
[in this window]
[in a new window]
|
Figure 5 A, Anteroposterior radiograph illustrating a large, uncontained proximal tibial defect. B, Intraoperative photograph demonstrating a severe proximal tibial defect. C, Postoperative radiograph illustrating a large metal augment to reconstruct the uncontained proximal tibial defect.
|
|
Alternative bearing surfaces may also be attractive due to better wear resistance and, consequently, low prevalence of osteolysis.
Dorr et al22 investigated 70 THAs with metal-on-metal articulations from 1991 to 1994 and found no evidence of pelvic osteolysis at 5 years. Saito et al23 reported on 106 metal-on-metal THAs at 5-year follow-up. No patient exhibited signs of loosening, migration, or osteolysis. THAs with ceramic-on-ceramic bearings were reported by D’Antonio et al24 in a prospective, randomized US Food and Drug Administration Investigational Device Exemption study. The alumina ceramic bearings showed an osteolysis rate of 1.4% versus 14% for patients with metal-on-UHMWPE bearings. Kim et al25 measured a mean linear wear rate of 0.07 mm/y (range, 0.01 to 0.23 mm/y) at 7-year follow-up, with no evidence of osteolysis. However, Willert et al26 reported osteolysis in 7 of 19 metal-on-metal THAs that required revision. Park et al27 found osteolysis in 10 of 169 metal-on-metal THAs followed for a minimum of 2 years. Their findings suggest that early osteolysis with metal-on-metal THAs is associated with a type IV delayed hypersensitivity to metal.
Although the incidence of failures due to wear-related osteolysis and the associated severe bone defects is expected to diminish with the increased durability of newer bearing surfaces, current failures still reflect the biologic response to high volumes of wear particles from UHMWPE components that were sterilized by gamma irradiation in air. Early results with alternative UHMWPE sterilization techniques, with highly cross-linked UHMWPE, and with metal-on-metal and ceramic-on-ceramic bearing surfaces are encouraging. The long-term in vivo durability of THAs using these alternative materials and bearing couples has not yet been well-established; considerably less clinical data are available for other types of joint arthroplasties, such as TKA.
In summary, over the past several years a number of important advances have been made in polyethylene manufacturing and processing, alternative bearing surfaces, implant design, and revision techniques. These improvements can be expected to reduce the future burden of revision hip and knee arthroplasty. However, to rectify matters related to earlier UHMWPE sterilization and degradation, we will be encumbered with increased revisions for at least the next few years.
|
Future Directions for Research
|
|---|
Periprosthetic osteolysis is a "silent disease" that can progress without symptoms until catastrophic structural failure or mechanical loosening of the implant components occur. Therefore, an emphasis should be placed on routine patient follow-up. One currently proposed protocol adopted in Sweden is follow-up every 5 years, following the first postoperative year, for otherwise well-functioning and asymptomatic joint arthroplasties. Research into the clinical and economic impact of an earlier diagnosis of osteolysis under such protocols is warranted. Protocols such as the one proposed in Sweden are supported by data gathered from large joint registries. To ascertain the long-term prevalence of wear-related osteolysis, the orthopaedic community in the United States should support the creation of a national joint registry and should encourage collaboration with industry to assist in tracking pertinent material and design changes as they are introduced. Modification of the current ICD-9 codes to subcategorize modes of failure will also help delineate which revisions can be attributed to wear-related osteolysis. The collection of large-scale, valid clinical data provides the best means for answering important questions concerning the long-term efficacy of proposed solutions to the problem of osteolysis.
|
Figures
|
|---|
|
References
|
|---|
- Harris WH: The problem is osteolysis. Clin Orthop Relat Res 1995; 311:46-53. [Medline]
- Maloney WJ, Smith RL: Periprosthetic osteolysis in total hip arthroplasty: The role of particulate wear debris. Instr Course Lect 1996; 45:171-182. [Medline]
- Schmalzried TP, Callaghan JJ: Wear in total hip and knee replacements. J Bone Joint Surg Am 1999;81:115-136. [Medline]
- Sutula LC, Collier JP, Saum KA, et al: The Otto Aufranc Award: Impact of gamma sterilization on clinical performance of polyethylene in the hip. Clin Orthop Relat Res 1995; 319:28-40. [Medline]
- Dumbleton JH, Manley MT, Edidin AA: A literature review of the association between wear rate and osteolysis in total hip arthroplasty. J Arthroplasty 2002; 17:649-661. [ISI][Medline]
- Udomkiat P, Dorr LD, Wan Z: Cementless hemispheric porous coated sockets implanted with press-fit technique without screws: Average ten-year follow-up. J Bone Joint Surg Am 2002;84:1195-1200. [ISI][Medline]
- Soto MO, Rodriguez JA, Ranawat CS: Clinical and radiographic evaluation of the Harris-Galante cup: Incidence of wear and osteolysis at 7 to 9 years follow-up. J Arthroplasty 2000; 15:139-145. [ISI][Medline]
- Kawamura H, Dunbar MJ, Murray P, Bourne RB, Rorabeck CH: The porous coated anatomic total hip replacement: A ten to fourteen-year follow-up study of a cementless total hip arthroplasty. J Bone Joint Surg Am 2001; 83 :1333 -1338 . [Abstract/Free Full Text]
- Schmalzried TP, Jasty M, Harris WH: Periprosthetic bone loss in total hip arthroplasty: Polyethylene wear debris and the concept of the effective joint space. J Bone Joint Surg 1992; 74:849-863. [Abstract/Free Full Text]
- Kurtz S, Mowat F, Ong K, Chan N, Lau E, Halpern M: Prevalence of primary and revision total hip and knee arthroplasty in the United States from 1990 through 2002. J Bone Joint Surg Am 2005;87:1487-1497. [Abstract/Free Full Text]
- Agency for Healthcare Research and Quality: Healthcare Cost & Utilization Project (HCUP). Rockville, MD: US Department of Health and Human Services. Available at www.ahcpr.gov/data/hcup. Accessed February 19, 2008.
- Pieringer H, Auersperg V, Böhler N: Long-term results of the cementless ALLOCLASSIC hip arthroplasty system using a 28-mm ceramic head: With a retrospective comparison to a 32-mm head. J Arthroplasty 2006;21:967-974. [Abstract/Free Full Text]
- Heisel C, Silva M, Schmalzried TP: In vivo wear of bilateral total hip replacements: Conventional versus crosslinked polyethylene. Arch Orthop Trauma Surg 2005; 125:555-557. [ISI][Medline]
- Geerdink CH, Grimm B, Ramakrishnan R, Rondhuis J, Verburg AJ, Tonino AJ: Crosslinked polyethylene compared to conventional polyethylene in total hip replacement: Pre-clinical evaluation, in-vitro testing and prospective clinical follow-up study. Acta Orthop 2006; 77:719-725. [ISI][Medline]
- Dorr LD, Wan Z, Shahrdar C, Sirianni L, Boutary M, Yun A: Clinical performance of a Durasul highly cross-linked polyethylene acetabular liner for total hip arthroplasty at five years. J Bone Joint Surg Am 2005; 87:1816-1821. [Abstract/Free Full Text]
- Digas G, Kärrholm J, Thanner J, Malchau H, Herberts P: The Otto Aufranc Award: Highly cross-linked polyethylene in total hip arthroplasty. Randomized evaluation of penetration rate in cemented and uncemented sockets using radiostereometric analysis. Clin Orthop Relat Res 2004;429:6-16. [Abstract/Free Full Text]
- Leung SB, Egawa H, Stepniewski A, Beykirch S, Engh CA Jr, Engh CA Sr: Incidence and volume of pelvic osteolysis at early follow-up with highly cross-linked and noncross-linked polyethylene. J Arthroplasty 2007; 22(6 suppl 2):134-139.
- Shanbhag AS, Bailey HO, Hwang DS, Cha CW, Reror NG, Rubash HE: Quantitative analysis of ultrahigh molecular weight polyethylene (UHMWPE) wear debris associated with total knee replacements. J Biomed Mater Res 2000; 53:100-110. [ISI][Medline]
- Huang CH, Ho FY, Ma HM, et al: Particle size and morphology of UHMWPE wear debris in failed total knee arthroplasties: A comparison between mobile bearing and fixed bearing knees. J Orthop Res 2002; 20:1038-1041. [ISI][Medline]
- Beaulé PE, Campbell PA, Walker PS,et al: Polyethylene wear characteristics in vivo and in a knee stimulator. J Biomed Mater Res 2002;60:411-419. [ISI][Medline]
- Naudie DD, Ammeen DJ, Engh GA, Rorabeck CH: Wear and osteolysis around the total knee arthroplasty. J Am Acad Orthop Surg 2007; 15:53-64. [Abstract/Free Full Text]
- Dorr LD , Wan Z , Longjohn DB , Dubois B , Murken R : Total hip arthroplasty with use of the Metasul metal-on-metal articulation: Four to seven-year results. J Bone Joint Surg Am2000; 82:789-798. [Abstract/Free Full Text]
- Saito S, Ryu J, Watanabe M, Ishii T, Saigo K: Midterm results of Metasul metal-on-metal total hip arthroplasty. J Arthroplasty 2006; 21:1105-1110. [ISI][Medline]
- D’Antonio J, Capello W, Manley M, Naughton M, Sutton K: Alumina ceramic bearings for total hip arthroplasty: Five-year results of a prospective randomized study. Clin Orthop Relat Res 2005;436:164-171. [ISI][Medline]
- Kim SY, Kim DH, Oh CW, Kim PT, Ihn JC, Kim SY: Total hip arthroplasty with the use of nonmodular cementless acetabular component. J Arthroplasty 2005; 20:632-638. [ISI][Medline]
- Willert HG, Buchhorn GH, Fayyazi A, et al: Metal-on-metal bearings and hypersensitivity in patients with artificial hip joints: A clinical and histomorphological study. J Bone Joint Surg Am 2005; 87:28-36. [Abstract/Free Full Text]
- Park YS, Moon YW, Lim SJ, Yang JM, Ahn G, Choi YL: Early osteolysis following second-generation metal-on-metal hip replacement. J Bone Joint Surg Am 2005; 87:1515-1521. [Abstract/Free Full Text]
Top
Abstract
Future Directions for Research
