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The Bone & Joint Journal
Vol. 101-B, Issue 11 | Pages 1423 - 1430
1 Nov 2019
Wiik AV Lambkin R Cobb JP

Aims. The aim of this study was to assess the functional gain achieved following hip resurfacing arthroplasty (HRA). Patients and Methods. A total of 28 patients (23 male, five female; mean age, 56 years (25 to 73)) awaiting Birmingham HRA volunteered for this prospective gait study, with an age-matched control group of 26 healthy adults (16 male, ten female; mean age, 56 years (33 to 84)). The Oxford Hip Score (OHS) and gait analysis using an instrumented treadmill were used preoperatively and more than two years postoperatively to measure the functional change attributable to the intervention. Results. The mean OHS improved significantly from 27 to 46 points (p < 0.001) at a mean of 29 months (12 to 60) after HRA. The mean metal ion levels at a mean 32 months (13 to 60) postoperatively were 1.71 (0.77 to 4.83) µg/l (ppb) and 1.77 (0.68 to 4.16) µg/l (ppb) for cobalt and chromium, respectively. When compared with healthy controls, preoperative patients overloaded the contralateral good hip, limping significantly. After HRA, patients walked at high speeds, with symmetrical gait, statistically indistinguishable from healthy controls over almost all characteristics. The control group could only be distinguished by an increased push-off force at higher speeds, which may reflect the operative approach. Conclusion. Patients undergoing HRA improved their preoperative gait pattern of a significant limp to a symmetrical gait at high speeds and on inclines, almost indistinguishable from normal controls. HRA with an approved device offers substantial functional gains, almost indistinguishable from healthy controls. Cite this article: Bone Joint J 2019;101-B:1423–1430


The Bone & Joint Journal
Vol. 98-B, Issue 11 | Pages 1455 - 1462
1 Nov 2016
Matharu GS Berryman F Brash L Pynsent PB Dunlop DJ Treacy RBC

Aims. We investigated whether blood metal ion levels could effectively identify patients with bilateral Birmingham Hip Resurfacing (BHR) implants who have adverse reactions to metal debris (ARMD). Patients and Methods. Metal ion levels in whole blood were measured in 185 patients with bilateral BHRs. Patients were divided into those with ARMD who either had undergone a revision for ARMD or had ARMD on imaging (n = 30), and those without ARMD (n = 155). Receiver operating characteristic analysis was used to determine the optimal thresholds of blood metal ion levels for identifying patients with ARMD. Results. The maximum level of cobalt or chromium ions in the blood was the parameter which produced the highest area under the curve (91.0%). The optimal threshold for distinguishing between patients with and without ARMD was 5.5 µg/l (83.3% sensitivity, 88.4% specificity, 58.1% positive and 96.5% negative predictive values). Similar results were obtained in a subgroup of 111 patients who all underwent cross-sectional imaging. Between 3.2% and 4.3% of patients with ARMD were missed if United Kingdom (7 µg/l) and United States (10 µg/l) authority thresholds were used respectively, compared with 2.7% if our implant specific threshold was used, though these differences did not reach statistical significance (p ≥ 0.248). Conclusion. Patients with bilateral BHRs who have blood metal ion levels below our implant specific threshold were at low-risk of having ARMD. Cite this article: Bone Joint J 2016;98-B:1455–62


Bone & Joint Open
Vol. 5, Issue 6 | Pages 514 - 523
24 Jun 2024
Fishley W Nandra R Carluke I Partington PF Reed MR Kramer DJ Wilson MJ Hubble MJW Howell JR Whitehouse SL Petheram TG Kassam AM

Aims. In metal-on-metal (MoM) hip arthroplasties and resurfacings, mechanically induced corrosion can lead to elevated serum metal ions, a local inflammatory response, and formation of pseudotumours, ultimately requiring revision. The size and diametral clearance of anatomical (ADM) and modular (MDM) dual-mobility polyethylene bearings match those of Birmingham hip MoM components. If the acetabular component is satisfactorily positioned, well integrated into the bone, and has no surface damage, this presents the opportunity for revision with exchange of the metal head for ADM/MDM polyethylene bearings without removal of the acetabular component. Methods. Between 2012 and 2020, across two centres, 94 patients underwent revision of Birmingham MoM hip arthroplasties or resurfacings. Mean age was 65.5 years (33 to 87). In 53 patients (56.4%), the acetabular component was retained and dual-mobility bearings were used (DM); in 41 (43.6%) the acetabulum was revised (AR). Patients underwent follow-up of minimum two-years (mean 4.6 (2.1 to 8.5) years). Results. In the DM group, two (3.8%) patients underwent further surgery: one (1.9%) for dislocation and one (1.9%) for infection. In the AR group, four (9.8%) underwent further procedures: two (4.9%) for loosening of the acetabular component and two (4.9%) following dislocations. There were no other dislocations in either group. In the DM group, operating time (68.4 vs 101.5 mins, p < 0.001), postoperative drop in haemoglobin (16.6 vs 27.8 g/L, p < 0.001), and length of stay (1.8 vs 2.4 days, p < 0.001) were significantly lower. There was a significant reduction in serum metal ions postoperatively in both groups (p < 0.001), although there was no difference between groups for this reduction (p = 0.674 (cobalt); p = 0.186 (chromium)). Conclusion. In selected patients with Birmingham MoM hips, where the acetabular component is well-fixed and in a satisfactory position with no surface damage, the metal head can be exchanged for polyethylene ADM/MDM bearings with retention of the acetabular prosthesis. This presents significant benefits, with a shorter procedure and a lower risk of complications. Cite this article: Bone Jt Open 2024;5(6):514–523


Bone & Joint Open
Vol. 4, Issue 11 | Pages 853 - 858
10 Nov 2023
Subbiah Ponniah H Logishetty K Edwards TC Singer GC

Aims. Metal-on-metal hip resurfacing (MoM-HR) has seen decreased usage due to safety and longevity concerns. Joint registries have highlighted the risks in females, smaller hips, and hip dysplasia. This study aimed to identify if reported risk factors are linked to revision in a long-term follow-up of MoM-HR performed by a non-designer surgeon. Methods. A retrospective review of consecutive MoM hip arthroplasties (MoM-HRAs) using Birmingham Hip Resurfacing was conducted. Data on procedure side, indication, implant sizes and orientation, highest blood cobalt and chromium ion concentrations, and all-cause revision were collected from local and UK National Joint Registry records. Results. A total of 243 hips (205 patients (163 male, 80 female; mean age at surgery 55.3 years (range 25.7 to 75.3)) with MoM-HRA performed between April 2003 and October 2020 were included. Mean follow-up was 11.2 years (range 0.3 to 17.8). Osteoarthritis was the most common indication (93.8%), and 13 hips (5.3%; 7M:6F) showed dysplasia (lateral centre-edge angle < 25°). Acetabular cups were implanted at a median of 45.4° abduction (interquartile range 41.9° - 48.3°) and stems neutral or valgus to the native neck-shaft angle. In all, 11 hips (4.5%; one male, ten females) in ten patients underwent revision surgery at a mean of 7.4 years (range 2.8 to 14.2), giving a cumulative survival rate of 94.8% (95% confidence interval (CI) 91.6% to 98.0%) at ten years, and 93.4% (95% CI 89.3% to 97.6%) at 17 years. For aseptic revision, male survivorship was 100% at 17 years, and 89.6% (95% CI 83.1% to 96.7%) at ten and 17 years for females. Increased metal ion levels were implicated in 50% of female revisions, with the remaining being revised for unexplained pain or avascular necrosis. Conclusion. The Birmingham MoM-HR showed 100% survivorship in males, exceeding the National Institute for Health and Care Excellence ‘5% at ten years’ threshold. Female sex and small component sizes are independent risk factors. Dysplasia alone is not a contraindication to resurfacing. Cite this article: Bone Jt Open 2023;4(11):853–858


Bone & Joint Research
Vol. 10, Issue 10 | Pages 639 - 649
19 Oct 2021
Bergiers S Hothi H Henckel J Di Laura A Belzunce M Skinner J Hart A

Aims. Acetabular edge-loading was a cause of increased wear rates in metal-on-metal hip arthroplasties, ultimately contributing to their failure. Although such wear patterns have been regularly reported in retrieval analyses, this study aimed to determine their in vivo location and investigate their relationship with acetabular component positioning. Methods. 3D CT imaging was combined with a recently validated method of mapping bearing surface wear in retrieved hip implants. The asymmetrical stabilizing fins of Birmingham hip replacements (BHRs) allowed the co-registration of their acetabular wear maps and their computational models, segmented from CT scans. The in vivo location of edge-wear was measured within a standardized coordinate system, defined using the anterior pelvic plane. Results. Edge-wear was found predominantly along the superior acetabular edge in all cases, while its median location was 8° (interquartile range (IQR) -59° to 25°) within the anterosuperior quadrant. The deepest point of these scars had a median location of 16° (IQR -58° to 26°), which was statistically comparable to their centres (p = 0.496). Edge-wear was in closer proximity to the superior apex of the cups with greater angles of acetabular inclination, while a greater degree of anteversion influenced a more anteriorly centred scar. Conclusion. The anterosuperior location of edge-wear was comparable to the degradation patterns observed in acetabular cartilage, supporting previous findings that hip joint forces are directed anteriorly during a greater portion of walking gait. The further application of this novel method could improve the current definition of optimal and safe acetabular component positioning. Cite this article: Bone Joint Res 2021;10(10):639–649


Bone & Joint Open
Vol. 4, Issue 3 | Pages 182 - 187
14 Mar 2023
Sheridan GA Hanlon M Welch-Phillips A Spratt K Hagan R O'Byrne JM Kenny PJ Kurmis AP Masri BA Garbuz DS Hurson CJ

Aims

Hip resurfacing remains a potentially valuable surgical procedure for appropriately-selected patients with optimised implant choices. However, concern regarding high early failure rates continues to undermine confidence in use. A large contributor to failure is adverse local tissue reactions around metal-on-metal (MoM) bearing surfaces. Such phenomena have been well-explored around MoM total hip arthroplasties, but comparable data in equivalent hip resurfacing procedures is lacking. In order to define genetic predisposition, we performed a case-control study investigating the role of human leucocyte antigen (HLA) genotype in the development of pseudotumours around MoM hip resurfacings.

Methods

A matched case-control study was performed using the prospectively-collected database at the host institution. In all, 16 MoM hip resurfacing 'cases' were identified as having symptomatic periprosthetic pseudotumours on preoperative metal artefact reduction sequence (MARS) MRI, and were subsequently histologically confirmed as high-grade aseptic lymphocyte-dominated vasculitis-associated lesions (ALVALs) at revision surgery. ‘Controls’ were matched by implant type in the absence of evidence of pseudotumour. Blood samples from all cases and controls were collected prospectively for high resolution genetic a nalysis targeting 11 separate HLA loci. Statistical significance was set at 0.10 a priori to determine the association between HLA genotype and pseudotumour formation, given the small sample size.


Bone & Joint Open
Vol. 4, Issue 6 | Pages 408 - 415
1 Jun 2023
Ramkumar PN Shaikh HJF Woo JJ Haeberle HS Pang M Brooks PJ

Aims

The aims of the study were to report for a cohort aged younger than 40 years: 1) indications for HRA; 2) patient-reported outcomes in terms of the modified Harris Hip Score (HHS); 3) dislocation rate; and 4) revision rate.

Methods

This retrospective analysis identified 267 hips from 224 patients who underwent an hip resurfacing arthroplasty (HRA) from a single fellowship-trained surgeon using the direct lateral approach between 2007 and 2019. Inclusion criteria was minimum two-year follow-up, and age younger than 40 years. Patients were followed using a prospectively maintained institutional database.


Bone & Joint Research
Vol. 3, Issue 5 | Pages 150 - 154
1 May 2014
M. Takamura K Maher P Nath T Su EP

Objectives. Metal-on-metal hip resurfacing (MOMHR) is available as an alternative option for younger, more active patients. There are failure modes that are unique to MOMHR, which include loosening of the femoral head and fractures of the femoral neck. Previous studies have speculated that changes in the vascularity of the femoral head may contribute to these failure modes. This study compares the survivorship between the standard posterior approach (SPA) and modified posterior approach (MPA) in MOMHR. . Methods. A retrospective clinical outcomes study was performed examining 351 hips (279 male, 72 female) replaced with Birmingham Hip Resurfacing (BHR, Smith and Nephew, Memphis, Tennessee) in 313 patients with a pre-operative diagnosis of osteoarthritis. The mean follow-up period for the SPA group was 2.8 years (0.1 to 6.1) and for the MPA, 2.2 years (0.03 to 5.2); this difference in follow-up period was statistically significant (p < 0.01). Survival analysis was completed using the Kaplan–Meier method. . Results. At four years, the Kaplan–Meier survival curve for the SPA was 97.2% and 99.4% for the MPA; this was statistically significant (log-rank; p = 0.036). There were eight failures in the SPA and two in the MPA. There was a 3.5% incidence of femoral head collapse or loosening in the SPA and 0.4% in the MPA, which represented a significant difference (p = 0.041). There was a 1.7% incidence of fractures of the femoral neck in the SPA and none in the MPA (p = 0.108). . Conclusion. This study found a significant difference in survivorship at four years between the SPA and the MPA (p = 0.036). The clinical outcomes of this study suggest that preserving the vascularity of the femoral neck by using the MPA results in fewer vascular-related failures in MOMHRs. Cite this article: Bone Joint Res 2014;3:150–4


Bone & Joint 360
Vol. 3, Issue 1 | Pages 40 - 41
1 Feb 2014
Ivory J

Metal-on-metal (MoM) hip resurfacing was developed in the 1990s by surgeons in Birmingham, UK, as a surgical solution to the problem of osteoarthritis in younger, more active patients. Early results were promising and the procedure gained in popularity. However, adverse reports of soft-tissue reaction and failure started to appear from 2008 onwards. Surgeons may be asked to write medico-legal reports on the surgical aspects of an individual case for claimant lawyers or in defence for the NHSLA or indemnity insurers. The purpose of this article is to cover some of the aspects of the operation that may be considered in such medico-legal reports


Aims

To establish the survivorship, function, and metal ion levels in an unselected series of metal-on-metal hip resurfacing arthroplasties (HRAs) performed by a non-designer surgeon.

Methods

We reviewed 105 consecutive HRAs in 83 patients, performed by a single surgeon, at a mean follow-up of 14.9 years (9.3 to 19.1). The cohort included 45 male and 38 female patients, with a mean age of 49.5 years (SD 12.5)


Bone & Joint Research
Vol. 9, Issue 8 | Pages 515 - 523
1 Aug 2020
Bergiers S Hothi H Henckel J Eskelinen A Skinner J Hart A

Aims

The optimum clearance between the bearing surfaces of hip arthroplasties is unknown. Theoretically, to minimize wear, it is understood that clearances must be low enough to maintain optimal contact pressure and fluid film lubrication, while being large enough to allow lubricant recovery and reduce contact patch size. This study aimed to identify the relationship between diametrical clearance and volumetric wear, through the analysis of retrieved components.

Methods

A total of 81 metal-on-metal Pinnacle hips paired with 12/14 stems were included in this study. Geometrical analysis was performed on each component, using coordinate and roundness measuring machines. The relationship between their as-manufactured diametrical clearance and volumetric wear was investigated. The Mann-Whitney U test and unpaired t-test were used, in addition to calculating the non-parametric Spearman's correlation coefficient, to statistically evaluate the acquired data.


Bone & Joint Research
Vol. 8, Issue 10 | Pages 443 - 450
1 Oct 2019
Treacy RBC Holland JP Daniel J Ziaee H McMinn DJW

Objectives

Modern metal-on-metal (MoM) hip resurfacing arthroplasty (HRA), while achieving good results with well-orientated, well-designed components in ideal patients, is contraindicated in women, men with head size under 50 mm, or metal hypersensitivity. These patients currently have no access to the benefits of HRA. Highly crosslinked polyethylene (XLPE) has demonstrated clinical success in total hip arthroplasty (THA) and, when used in HRA, potentially reduces metal ion-related sequelae. We report the early performance of HRA using a direct-to-bone cementless mono-bloc XLPE component coupled with a cobalt-chrome femoral head, in the patient group for whom HRA is currently contraindicated.

Methods

This is a cross-sectional, observational assessment of 88 consecutive metal-on-XLPE HRAs performed in 84 patients between 2015 and 2018 in three centres (three surgeons, including the designer surgeon). Mean follow-up is 1.6 years (0.7 to 3.9). Mean age at operation was 56 years (sd 11; 21 to 82), and 73% of implantations were in female patients. All patients were individually counselled, and a detailed informed consent was obtained prior to operation. Primary resurfacing was carried out in 85 hips, and three cases involved revision of previous MoM HRA. Clinical, radiological, and Oxford Hip Score (OHS) assessments were studied, along with implant survival.


Bone & Joint Open
Vol. 1, Issue 9 | Pages 594 - 604
24 Sep 2020
James HK Pattison GTR Griffin J Fisher JD Griffin DR

Aims

To develop a core outcome set of measurements from postoperative radiographs that can be used to assess technical skill in performing dynamic hip screw (DHS) and hemiarthroplasty, and to validate these against Van der Vleuten’s criteria for effective assessment.

Methods

A Delphi exercise was undertaken at a regional major trauma centre to identify candidate measurement items. The feasibility of taking these measurements was tested by two of the authors (HKJ, GTRP). Validity and reliability were examined using the radiographs of operations performed by orthopaedic resident participants (n = 28) of a multicentre randomized controlled educational trial (ISRCTN20431944). Trainees were divided into novice and intermediate groups, defined as having performed < ten or ≥ ten cases each for DHS and hemiarthroplasty at baseline. The procedure-based assessment (PBA) global rating score was assumed as the gold standard assessment for the purposes of concurrent validity. Intra- and inter-rater reliability testing were performed on a random subset of 25 cases.


Bone & Joint Research
Vol. 8, Issue 3 | Pages 146 - 155
1 Mar 2019
Langton DJ Natu S Harrington CF Bowsher JG Nargol AVF

Objectives

We investigated the reliability of the cobalt-chromium (CoCr) synovial joint fluid ratio (JFR) in identifying the presence of a severe aseptic lymphocyte-dominated vasculitis-associated lesion (ALVAL) response and/or suboptimal taper performance (SOTP) following metal-on-metal (MoM) hip arthroplasty. We then examined the possibility that the CoCr JFR may influence the serum partitioning of Co and Cr.

Methods

For part A, we included all revision surgeries carried out at our unit with the relevant data, including volumetric wear analysis, joint fluid (JF) Co and Cr concentrations, and ALVAL grade (n = 315). Receiver operating characteristic curves were constructed to assess the reliability of the CoCr JFR in identifying severe ALVAL and/or SOTP. For part B, we included only patients with unilateral prostheses who had given matched serum and whole blood samples for Co and Cr analysis (n = 155). Multiple regression was used to examine the influence of JF concentrations on the serum partitioning of Co and Cr in the blood.


Bone & Joint Research
Vol. 7, Issue 6 | Pages 388 - 396
1 Jun 2018
Langton DJ Sidaginamale RP Joyce TJ Bowsher JG Holland JP Deehan D Nargol AVF Natu S

Objectives

We have encountered patients who developed large joint fluid collections with massive elevations in chromium (Cr) and cobalt (Co) concentrations following metal-on-metal (MoM) hip arthroplasties. In some cases, retrieval analysis determined that these ion concentrations could not be explained simply by the wear rates of the components. We hypothesized that these effects may be associated with aseptic lymphocyte-dominated vasculitis-associated lesion (ALVAL).

Patients and Methods

We examined the influence of the ALVAL grade on synovial fluid Co and Cr concentrations following adjustment for patient and device variables, including volumetric wear rates. Initially restricting the analysis to include only patients with one MoM hip resurfacing device, we performed multiple regression analyses of prospectively collected data. We then repeated the same statistical approach using results from a larger cohort with different MoM designs, including total hip arthroplasties.


Bone & Joint Research
Vol. 6, Issue 2 | Pages 113 - 122
1 Feb 2017
Scholes SC Hunt BJ Richardson VM Langton DJ Smith E Joyce TJ

Objectives

The high revision rates of the DePuy Articular Surface Replacement (ASR) and the DePuy ASR XL (the total hip arthroplasty (THA) version) have led to questions over the viability of metal-on-metal (MoM) hip joints. Some designs of MoM hip joint do, however, have reasonable mid-term performance when implanted in appropriate patients. Investigations into the reasons for implant failure are important to offer help with the choice of implants and direction for future implant designs. One way to assess the performance of explanted hip prostheses is to measure the wear (in terms of material loss) on the joint surfaces.

Methods

In this study, a coordinate measuring machine (CMM) was used to measure the wear on five failed cementless Biomet Magnum/ReCap/ Taperloc large head MoM THAs, along with one Biomet ReCap resurfacing joint. Surface roughness measurements were also taken. The reason for revision of these implants was pain and/or adverse reaction to metal debris (ARMD) and/or elevated blood metal ion levels.


Bone & Joint Research
Vol. 5, Issue 8 | Pages 338 - 346
1 Aug 2016
MacLeod AR Sullivan NPT Whitehouse MR Gill HS

Objectives

Modular junctions are ubiquitous in contemporary hip arthroplasty. The head-trunnion junction is implicated in the failure of large diameter metal-on-metal (MoM) hips which are the currently the topic of one the largest legal actions in the history of orthopaedics (estimated costs are stated to exceed $4 billion). Several factors are known to influence the strength of these press-fit modular connections. However, the influence of different head sizes has not previously been investigated. The aim of the study was to establish whether the choice of head size influences the initial strength of the trunnion-head connection.

Materials and Methods

Ti-6Al-4V trunnions (n = 60) and two different sizes of cobalt-chromium (Co-Cr) heads (28 mm and 36 mm; 30 of each size) were used in the study. Three different levels of assembly force were considered: 4 kN; 5 kN; and 6 kN (n = 10 each). The strength of the press-fit connection was subsequently evaluated by measuring the pull-off force required to break the connection. The statistical differences in pull-off force were examined using a Kruskal–Wallis test and two-sample Mann–Whitney U test. Finite element and analytical models were developed to understand the reasons for the experimentally observed differences.


Bone & Joint Research
Vol. 2, Issue 5 | Pages 84 - 95
1 May 2013
Sidaginamale RP Joyce TJ Lord JK Jefferson R Blain PG Nargol AVF Langton DJ

Objectives

The aims of this piece of work were to: 1) record the background concentrations of blood chromium (Cr) and cobalt (Co) concentrations in a large group of subjects; 2) to compare blood/serum Cr and Co concentrations with retrieved metal-on-metal (MoM) hip resurfacings; 3) to examine the distribution of Co and Cr in the serum and whole blood of patients with MoM hip arthroplasties; and 4) to further understand the partitioning of metal ions between the serum and whole blood fractions.

Methods

A total of 3042 blood samples donated to the local transfusion centre were analysed to record Co and Cr concentrations. Also, 91 hip resurfacing devices from patients who had given pre-revision blood/serum samples for metal ion analysis underwent volumetric wear assessment using a coordinate measuring machine. Linear regression analysis was carried out and receiver operating characteristic curves were constructed to assess the reliability of metal ions to identify abnormally wearing implants. The relationship between serum and whole blood concentrations of Cr and Co in 1048 patients was analysed using Bland-Altman charts. This relationship was further investigated in an in vitro study during which human blood was spiked with trivalent and hexavalent Cr, the serum then separated and the fractions analysed.


Bone & Joint Research
Vol. 1, Issue 4 | Pages 42 - 49
1 Apr 2012
Kwon Y Mellon SJ Monk P Murray DW Gill HS

Objectives

Pseudotumours (abnormal peri-prosthetic soft-tissue reactions) following metal-on-metal hip resurfacing arthroplasty (MoMHRA) have been associated with elevated metal ion levels, suggesting that excessive wear may occur due to edge-loading of these MoM implants. This study aimed to quantify in vivo edge-loading in MoMHRA patients with and without pseudotumours during functional activities.

Methods

The duration and magnitude of edge-loading in vivo was quantified during functional activities by combining the dynamic hip joint segment contact force calculated from the three-dimensional (3D) motion analysis system with the 3D reconstruction of orientation of the acetabular component and each patient’s specific hip joint centre, based on CT scans.


Bone & Joint Research
Vol. 1, Issue 4 | Pages 56 - 63
1 Apr 2012
Langton DJ Sidaginamale R Lord JK Nargol AVF Joyce TJ

Objectives

An ongoing prospective study to investigate failing metal-on-metal hip prostheses was commenced at our centre in 2008. We report on the results of the analysis of the first consecutive 126 failed mated total hip prostheses from a single manufacturer.

Methods

Analysis was carried out using highly accurate coordinate measuring to calculate volumetric and linear rates of the articular bearing surfaces and also the surfaces of the taper junctions. The relationship between taper wear rates and a number of variables, including bearing diameter and orientation of the acetabular component, was investigated.