Polyethylene wear debris can cause osteolysis and the failure of total hip arthroplasty. We present the five-year wear rates of a highly cross-linked polyethylene (X3) bearing surface when used in conjunction with a 36 mm ceramic femoral head.

This was a prospective study of a cohort of 100 THAs in 93 patients. Pain and activity scores were measured pre- and post-operatively. Femoral head penetration was measured at two months, one year, two years and at five years using validated edge-detecting software (PolyWare Auto).

At a mean of 5.08 years (3.93 to 6.01), 85 hips in 78 patients were available for study. The mean age of these patients was 59.08 years (42 to 73, the mean age of males (n = 34) was 59.15 years, and females (n = 44) was 59.02 years). All patients had significant improvement in their functional scores (p < 0.001). The steady state two-dimensional linear wear rate was 0.109 mm/year. The steady state volumetric wear rate was 29.61 mm³/year. No significant correlation was found between rate of wear and age (p = 0.34), acetabular component size (p = 0.12) or clinical score (p = 0.74).

Our study shows low steady state wear rates at five years in X3 highly cross-linked polyethylene in conjunction with a 36 mm ceramic femoral head. The linear wear rate was almost identical to the osteolysis threshold of 0.1 mm/year recommended in the literature.

Cite this article: Bone Joint J 2015;97-B:1470–4.

Aims

The objective of this five-year prospective, blinded, randomised controlled trial (RCT) was to compare femoral head penetration into a vitamin E diffused highly cross-linked polyethylene (HXLPE) liner with penetration into a medium cross-linked polyethylene control liner using radiostereometric analysis.

Objectives

High failure rates of metal-on-metal hip arthroplasty implants have highlighted the need for more careful introduction and monitoring of new implants and for the evaluation of the safety of medical devices. The National Joint Registry and other regulatory services are unable to detect failing implants at an early enough stage. We aimed to identify validated surrogate markers of long-term outcome in patients undergoing primary total hip arthroplasty (THA).

Aims

We sought to establish whether an oxidised zirconium (OxZr) femoral component causes less loss of polyethylene volume than a cobalt alloy (CoCr) femoral component in total knee arthroplasty.

Objectives

Wear debris released from bearing surfaces has been shown to provoke negative immune responses in the recipient. Excessive wear has been linked to early failure of prostheses. Analysis using coordinate measuring machines (CMMs) can provide estimates of total volumetric material loss of explanted prostheses and can help to understand device failure. The accuracy of volumetric testing has been debated, with some investigators stating that only protocols involving hundreds of thousands of measurement points are sufficient. We looked to examine this assumption and to apply the findings to the clinical arena.

Aims

The purpose of this study was to compare the long-term results of primary total hip arthroplasty (THA) in young patients using either a conventional (CPE) or a highly cross-linked (HXLPE) polyethylene liner in terms of functional outcome, incidence of osteolysis, radiological wear and rate of revision.

We report the five-year outcome of a randomised controlled trial which used radiostereometric analysis (RSA) to assess the influence of surface oxidised zirconium (OxZr, Oxinium) on polyethylene wear in vivo.

A total of 120 patients, 85 women and 35 men with a mean age of 70 years (59 to 80) who were scheduled for primary cemented total hip arthroplasty were randomly allocated to four study groups. Patients were blinded to their group assignment and received either a conventional polyethylene (CPE) or a highly cross-linked (HXL) acetabular component of identical design. On the femoral side patients received a 28 mm head made of either cobalt-chromium (CoCr) or OxZr.

The proximal head penetration (wear) was measured with repeated RSA examinations over five years. Clinical outcome was measured using the Harris hip score.

There was no difference in polyethylene wear between the two head materials when used with either of the two types of acetabular component (p = 0.3 to 0.6). When comparing the two types of polyethylene there was a significant difference in favour of HXLPE, regardless of the head material used (p < 0.001).

In conclusion, we found no advantage of OxZr over CoCr in terms of polyethylene wear after five years of follow-up. Our findings do not support laboratory results which have shown a reduced rate of wear with OxZr. They do however add to the evidence on the better resistance to wear of HXLPE over CPE.

Cite this article: Bone Joint J 2015;97-B:1463–9.

The Articular Surface Replacement (ASR) hip resurfacing arthroplasty has a failure rate of 12.0% at five years, compared with 4.3% for the Birmingham Hip Resurfacing (BHR). We analysed 66 ASR and 64 BHR explanted metal-on-metal hip replacements with the aim of understanding their mechanisms of failure. We measured the linear wear rates of the acetabular and femoral components and analysed the clinical cause of failure, pre-revision blood metal ion levels and orientation of the acetabular component.

There was no significant difference in metal ion levels (chromium, p = 0.82; cobalt, p = 0.40) or head wear rate (p = 0.14) between the two groups. The ASR had a significantly increased rate of wear of the acetabular component (p = 0.03) and a significantly increased occurrence of edge loading (p < 0.005), which can be attributed to differences in design between the ASR and BHR. The effects of differences in design on the in vivo wear rates are discussed: these may provide an explanation as to why the ASR is more sensitive to suboptimal positioning than the BHR.

We conducted a systematic review and meta-analysis of randomised controlled trials comparing cross-linked with conventional polyethylene liners for total hip replacement in order to determine whether these liners reduce rates of wear, radiological evidence of osteolysis and the need for revision. The MEDLINE, EMBASE and COCHRANE databases were searched from their inception to May 2010 for all trials involving the use of cross-linked polyethylene in total hip replacement. Eligibility for inclusion in the review included the random allocation of treatments, the use of cross-linked and conventional polyethylene, and radiological wear as an outcome measure. The pooled mean differences were calculated for bedding-in, linear wear rate, three-dimensional linear wear rate, volumetric wear rate and total linear wear. Pooled risk ratios were calculated for radiological osteolysis and revision hip replacement. A search of the literature identified 194 potential studies, of which 12 met the inclusion criteria. All reported a significant reduction in radiological wear for cross-linked polyethylene.

The pooled mean differences for linear rate of wear, three-dimensional linear rate of wear, volumetric wear rate and total linear wear were all significantly reduced for cross-linked polyethylene. The risk ratio for radiological osteolysis was 0.40 (95% confidence interval 0.27 to 0.58; I² = 0%), favouring cross-linked polyethylene. The follow-up was not long enough to show a difference in the need for revision surgery.

There are many methods for analysing wear volume in failed polyethylene acetabular components. We compared a radiological technique with three recognised ex vivo methods of measurement. We tested 18 ultra-high-molecular-weight polyethylene acetabular components revised for wear and aseptic loosening, of which 13 had pre-revision radiographs, from which the wear volume was calculated based upon the linear wear. We used a shadowgraph technique on silicone casts of all of the retrievals and a coordinate measuring method on the components directly. For these techniques, the wear vector was calculated for each component and the wear volume extrapolated using mathematical equations. The volumetric wear was also measured directly using a fluid-displacement method. The results of each technique were compared. The series had high wear volumes (mean 1385 mm. 3. ; 730 to 1850) and high wear rates (mean 205 mm. 3. /year; 92 to 363). There were wide variations in the measurements of wear volume between the radiological and the other techniques. Radiograph-derived wear volume correlated poorly with that of the fluid-displacement method, co-ordinate measuring method and shadowgraph methods, becoming less accurate as the wear increased. The mean overestimation in radiological wear volume was 47.7% of the fluid-displacement method wear volume. Fluid-displacement method, coordinate measuring method and shadowgraph determinations of wear volume were all better than that of the radiograph-derived linear measurements since they took into account the direction of wear. However, only radiological techniques can be used in vivo and remain useful for monitoring linear wear in the clinical setting. Interpretation of radiological measurements of acetabular wear must be done judiciously in the clinical setting. In vitro laboratory techniques, in particular the fluid-displacement method, remain the most accurate and reliable methods of assessing the wear of acetabular polyethylene

We have compared four computer-assisted methods to measure penetration of the femoral head into the acetabular component in total hip replacement. These were the Martell Hip Analysis suite 7.14, Rogan HyperOrtho, Rogan View Pro-X and Roman v1.70. The images used for the investigation comprised 24 anteroposterior digital radiographs and 24 conventional acetate radiographs which were scanned to provide digital images. These radiographs were acquired from 24 patients with an uncemented total hip replacement with a follow-up of approximately eight years (mean 8.1; 6.3 to 9.1). Each image was measured twice by two blinded observers. The mean annual rates of penetration of the femoral head measured in the eight-year single image analysis were: Martell, 0.24 (SD 0.19); HyperOrtho, 0.12 (SD 0.08); View Pro-X, 0.12 (SD 0.06); Roman, 0.12 (SD 0.07). In paired analysis of the six-month and eight-year radiographs: Martell, 0.35 (SD 0.22); HyperOrtho, 0.15 (SD 0.13); View Pro-X, 0.11 (SD 0.06); Roman, 0.11 (SD 0.07). The intra- and inter-observer variability for the paired analysis was best for View Pro-X and Roman software, with intraclass correlations of 0.97, 0.87 and 0.96, 0.87, respectively, and worst for HyperOrtho and Martell, with intraclass correlations of 0.46, 0.13 and 0.33, 0.39, respectively.

The Roman method proved the most precise and the most easy to use in clinical practice and the software is available free of charge. The Martell method showed the lowest precision, indicating a problem with its edge detection algorithm on digital images.

We measured the orientation of the acetabular and femoral components in 45 patients (33 men, 12 women) with a mean age of 53.4 years (30 to 74) who had undergone revision of metal-on-metal hip resurfacings. Three-dimensional CT was used to measure the inclination and version of the acetabular component, femoral version and the horizontal femoral offset, and the linear wear of the removed acetabular components was measured using a roundness machine.

We found that acetabular version and combined version of the acetabular and femoral components were weakly positively correlated with the rate of wear. The acetabular inclination angle was strongly positively correlated with the rate of wear. Femoral version was weakly negatively correlated with the rate of wear. Application of a threshold of > 5 μm/year for the rate of wear in order to separate the revisions into low or high wearing groups showed that more high wearing components were implanted outside Lewinnek’s safe zone, but that this was mainly due to the inclination of the acetabular component, which was the only parameter that significantly differed between the groups.

We were unable to show that excess version of the acetabular component alone or combined with femoral version was associated with an increase in the rate of wear based on our assessment of version using CT.

We reviewed the results at nine to 13 years of 125 total hip replacements in 113 patients using the monoblock uncemented Morscher press-fit acetabular component. The mean age at the time of operation was 56.9 years (36 to 74). The mean clinical follow-up was 11 years (9.7 to 13.5) and the mean radiological follow-up was 9.4 years (7.7 to 13.1). Three hips were revised, one immediately for instability, one for excessive wear and one for deep infection.

No revisions were required for aseptic loosening. A total of eight hips (7.0%) had osteolytic lesions greater than 1 cm, in four around the acetabular component (3.5%). One required bone grafting behind a well-fixed implant. The mean wear rate was 0.11 mm/year (0.06 to 0.78) and was significantly higher in components with a steeper abduction angle.

Kaplan-Meier survival curves at 13 years showed survival of 96.8% (95% confidence interval 90.2 to 99.0) for revision for any cause and of 95.7% (95% confidence interval 88.6 to 98.4) for any acetabular re-operation.

In this prospective study we studied the effect of the inclination angle of the acetabular component on polyethylene wear and component migration in cemented acetabular sockets using radiostereometric analysis.

A total of 120 patients received either a cemented Reflection All-Poly ultra-high-molecular-weight polyethylene or a cemented Reflection All-Poly highly cross-linked polyethylene acetabular component, combined with either cobalt–chrome or Oxinium femoral heads. Femoral head penetration and migration of the acetabular component were assessed with repeated radiostereometric analysis for two years. The inclination angle was measured on a standard post-operative anteroposterior pelvic radiograph. Linear regression analysis was used to determine the relationship between the inclination angle and femoral head penetration and migration of the acetabular component.

We found no relationship between the inclination angle and penetration of the femoral head at two years’ follow-up (p = 0.9). Similarly, our data failed to reveal any statistically significant correlation between inclination angle and migration of these cemented acetabular components (p = 0.07 to p = 0.9).

This multicentre study analysed 12 alumina ceramic-on-ceramic components retrieved from squeaking total hip replacements after a mean of 23 months in situ (11 to 61). The rates and patterns of wear seen in these squeaking hips were compared with those seen in matched controls using retrieval data from 33 ‘silent’ hip replacements with similar ceramic bearings. All 12 bearings showed evidence characteristic of edge-loading wear. The median rate of volumetric wear was 3.4 mm³/year for the acetabular component, 2.9 mm³/year on the femoral heads and 6.3 mm³/year for head and insert combined. This was up to 45 times greater than that of previously reported silent ceramic-on-ceramic retrievals. The rate of wear seen in ceramic components revised for squeaking hips appears to be much greater than in that seen in retrievals from ‘silent’ hips.

We studied 33 third generation, alumina ceramic-on-ceramic bearings retrieved from cementless total hip replacements after more than six months in situ. Wear volume was measured with a Roundtest machine, and acetabular orientation from the anteroposterior pelvic radiograph. The overall median early wear rate was 0.1 mm³/yr for the femoral heads, and 0.04 mm³/yr for the acetabular liners. We then excluded hips where the components had migrated. In this stable subgroup of 22 bearings, those with an acetabular anteversion of < 15° (seven femoral heads) had a median femoral head wear rate of 1.2 mm³/yr, compared with 0 mm³/yr for those with an anteversion of ≥15° (15 femoral heads, p < 0.001). Even under edge loading, wear volumes with ceramic-on-ceramic bearings are small in comparison to other bearing materials. Low acetabular anteversion is associated with greater wear.

The Oxford unicompartmental knee replacement (UKR) was designed to minimise wear utilising a fully-congruent, mobile, polyethylene bearing. Wear of polyethylene is a significant cause of revision surgery in UKR in the first decade, and the incidence increases in the second decade. Our study used model-based radiostereometric analysis to measure the combined wear of the upper and lower bearing surfaces in 13 medial-compartment Oxford UKRs at a mean of 20.9 years (17.2 to 25.9) post-operatively.

The mean linear penetration of the polyethylene bearing was 1.04 mm (0.307 to 2.15), with a mean annual wear rate of 0.045 mm/year (0.016 to 0.099). The annual wear rate of the phase-2 bearings (mean 0.022 mm/year) was significantly less (p = 0.01) than that of phase-1 bearings (mean 0.07 mm/year).

The linear wear rate of the Oxford UKR remains very low into the third decade. We believe that phase-2 bearings had lower wear rates than phase-1 implants because of the improved bearing design and surgical technique which decreased the incidence of impingement. We conclude that the design of the Oxford UKR gives low rates of wear in the long term.

Increasing follow-up identifies the outcome in younger patients who have undergone total hip replacement (THR) and reveals the true potential for survival of the prosthesis. We identified 28 patients (39 THRs) who had undergone cemented Charnley low friction arthroplasty between 1969 and 2001. Their mean age at operation was 17.9 years (12 to 19) and the maximum follow-up was 34 years. Two patients (4 THRs) were lost to follow-up, 13 (16 THRs) were revised at a mean period of 19.1 years (8 to 34) and 13 (19 THRs) continue to attend regular follow-up at a mean of 12.6 years (2.3 to 29). In this surviving group one acetabular component was radiologically loose and all femoral components were secure. In all the patients the diameter of the femoral head was 22.225 mm with Charnley femoral components used in 29 hips and C-stem femoral components in ten. In young patients who require THR the acetabular bone stock is generally a limiting factor for the size of the component. Excellent long-term results can be obtained with a cemented polyethylene acetabular component and a femoral head of small diameter.

The presence of pseudotumours, which are soft-tissue masses relating to the hip, after metal-on-metal hip resurfacing arthroplasty has been associated with elevated levels of metal ions in serum, suggesting that pseudotumours occur when there is increased wear. We aimed to quantify the wear in vivo of implants revised for pseudotumours (eight) and of a control group of implants (22) revised for other reasons of failure.

We found that the implant group with pseudotumours had a significantly higher rate of median linear wear of the femoral component at 8.1 μm/year (2.75 to 25.4) than the 1.79 μm/year (0.82 to 4.15; p = 0.002) of the non-pseudotumour group. For the acetabular component a significantly higher rate of median linear wear of 7.36 μm/year (1.61 to 24.9) was observed in the pseudotumour group compared with 1.28 μm/year (0.81 to 3.33, p = 0.001) in the other group. Wear of the acetabular component in the pseudotumour group always involved the edge of the implant, indicating that edge-loading had occurred.

Our findings are the first direct evidence that pseudotumour is associated with increased wear at the metal-on-metal articulation. Furthermore, edge-loading with the loss of fluid-film lubrication may be an important mechanism of generation of wear in patients with a pseudotumour.

Hip simulators have been used for ten years to determine the tribological performance of large-head metal-on-metal devices using traditional test conditions. However, the hip simulator protocols were originally developed to test metal-on-polyethylene devices. We have used patient activity data to develop a more physiologically relevant test protocol for metal-on-metal devices. This includes stop/start motion, a more appropriate walking frequency, and alternating kinetic and kinematic profiles.

There has been considerable discussion about the effect of heat treatments on the wear of metal-on-metal cobalt chromium molybdenum (CoCrMo) devices. Clinical studies have shown a higher rate of wear, levels of metal ions and rates of failure for the heat-treated metal compared to the as-cast metal CoCrMo devices. However, hip simulator studies in vitro under traditional testing conditions have thus far not been able to demonstrate a difference between the wear performance of these implants.

Using a physiologically relevant test protocol, we have shown that heat treatment of metal-on-metal CoCrMo devices adversely affects their wear performance and generates significantly higher wear rates and levels of metal ions than in as-cast metal implants.