P. McLardy-Smith

Pseudotumours associated with metal-on-metal hip resurfacings

We report 17 patients (20 hips) in whom metal-on-metal resurfacing had been performed and who presented with various symptoms and a soft-tissue mass which we termed a pseudotumour. Each patient underwent plain radiography and in some, CT, MRI and ultrasonography were also performed. In addition, histological examination of available samples was undertaken. All the patients were women and their presentation was variable. The most common symptom was discomfort in the region of the hip. Other symptoms included spontaneous dislocation, nerve palsy, a noticeable mass or a rash. The common histological features were extensive necrosis and lymphocytic infiltration. To date, 13 of the 20 hips have required revision to a conventional hip replacement. Two are awaiting revision. We estimate that approximately 1% of patients who have a metal-on-metal resurfacing develop a pseudotumour within five years. The cause is unknown and is probably multifactorial. There may be a toxic reaction to an excess of particulate metal wear debris or a hypersensitivity reaction to a normal amount of metal debris. We are concerned that with time the incidence of these pseudotumours may increase. Further investigation is required to define their cause.

Hip resurfacings revised for inflammatory pseudotumour have a poor outcome

Inflammatory pseudotumours occasionally occur after metal-on-metal hip resurfacing and often lead to revision. Our aim was to determine the severity of this complication by assessing the outcome of revision in these circumstances and by comparing this with the outcome of other metal-on-metal hip resurfacing revisions as well as that of matched primary total hip replacements. We identified 53 hips which had undergone metal-on-metal hip resurfacing and required revision at a mean of 1.59 years (0.01 to 6.69) after operation. Of these, 16 were revised for pseudotumours, 21 for fracture and 16 for other reasons. These were matched by age, gender and diagnosis with 103 patients undergoing primary total hip replacement with the Exeter implant. At a mean follow-up of three years (0.8 to 7.2) the outcome of metal-on-metal hip resurfacing revision for pseudotumour was poor with a mean Oxford hip score of 20.9 (sd 9.3) and was significantly worse (p < 0.001) than the outcome for fracture with a mean Oxford hip score of 40.2 (sd 9.2) or that for other causes with a mean Oxford hip score of 37.8 (sd 9.4). The clinical outcome of revision for pseudotumour was also significantly worse (p < 0.001) than the outcome of matched primary total hip replacements. By contrast, the outcome for fracture and other causes was not significantly different from that of matched primary total hip replacements (p = 0.065). After revision for pseudotumour there were three cases of recurrent dislocation, three of palsy of the femoral nerve, one of stenosis of the femoral artery and two of loosening of the component. Five hips required further revision. In three of these there was evidence of recurrent pseudotumour, and one is currently awaiting further revision. The incidence of major complications after revision for pseudotumour (50%) was significantly higher (p = 0.018) than that after revision for other causes (14%). The outcome of revision for pseudotumour is poor and consideration should be given to early revision to limit the extent of the soft-tissue destruction. The outcome of resurfacing revision for other causes is good.

Analysis of wear of retrieved metal-on-metal hip resurfacing implants revised due to pseudotumours

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 microm/year (2.75 to 25.4) than the 1.79 microm/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 microm/year (1.61 to 24.9) was observed in the pseudotumour group compared with 1.28 microm/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.

Osteonecrosis in retrieved femoral heads after failed resurfacing arthroplasty of the hip

We present the histological findings of bone retrieved from beneath the femoral components of failed metal-on-metal hip resurfacing arthroplasties. Of a total of 377 patients who underwent resurfacing arthroplasty, 13 required revision; for fracture of the femoral neck in eight, loosening of a component in three and for other reasons in two. None of these cases had shown histological evidence of osteonecrosis in the femoral bone at the time of the initial implantation. Bone from the remnant of the femoral head showed changes of osteonecrosis in all but one case at revision. In two cases of fracture which occurred within a week of implantation, the changes were compatible with early necrosis of the edge of the fracture. In the remaining six fractures, there were changes of established osteonecrosis. In all but one of the non-fracture cases, patchy osteonecrosis was seen. We conclude that histological evidence of osteonecrosis is a common finding in failed resurfaced hips. Given that osteonecrosis is extensive in resurfaced femoral heads which fail by fracture, it is likely to play a role in the causation of these fractures.

The seven-year wear of highly cross-linked polyethylene in total hip arthroplasty: a double-blind, randomized controlled trial using radiostereometric analysis.

BACKGROUND The use of highly cross-linked polyethylene is now commonplace in total hip arthroplasty. Hip simulator studies and short-term in vivo measurements have suggested that the wear rate of highly cross-linked polyethylene is significantly less than that of conventional ultra-high molecular weight polyethylene. However, long-term data to support its use are limited. The aim of this study was to compare the intermediate-term steady-state wear of highly cross-linked polyethylene compared with that of conventional ultra-high molecular weight polyethylene acetabular liners in a prospective, double-blind, randomized controlled trial with use of radiostereometric analysis. METHODS Fifty-four patients were randomized to receive hip replacements with either conventional ultra-high molecular weight polyethylene acetabular liners (Zimmer) or highly cross-linked polyethylene liners (Longevity; Zimmer). All patients received a cemented, collarless, polished, tapered femoral component (CPT; Zimmer) and an uncemented acetabular component (Trilogy; Zimmer). Clinical outcomes were assessed and the three-dimensional penetration of the head into the socket was determined for a minimum of seven years. Linear regression was used to calculate the steady-state wear rate following the creep-dominated penetration seen during the first year. RESULTS At a minimum of seven years postoperatively, the mean total femoral head penetration was significantly lower in the highly cross-linked polyethylene group (0.33 mm; 95% confidence interval [CI], ±0.10 mm) than it was in the ultra-high molecular weight polyethylene group (0.55 mm; 95% CI, ±0.10 mm) (p = 0.005). The mean steady-state wear rate of highly cross-linked polyethylene was 0.005 mm/yr (95% CI, ±0.015 mm/yr), compared with 0.037 mm/yr (95% CI, ±0.019 mm/yr) for conventional ultra-high molecular weight polyethylene (p = 0.007). No patient in the highly cross-linked polyethylene group had a wear rate above the osteolysis threshold of 0.1 mm/yr, compared with 9% of patients in the ultra-high molecular weight polyethylene group. CONCLUSIONS This study demonstrates that highly cross-linked polyethylene has a significantly lower steady-state wear rate compared with that of conventional ultra-high molecular weight polyethylene. Longer-term follow-up is required to determine if this will translate into improved clinical performance and longevity of these implants.

A mobile-bearing total knee prosthesis compared with a fixed-bearing prosthesis: A MULTICENTRE SINGLE-BLIND RANDOMISED CONTROLLED TRIAL

Before proceeding to longer-term studies, we have studied the early clinical results of a new mobile-bearing total knee prosthesis in comparison with an established fixed-bearing device. Patients requiring bilateral knee replacement consented to have their operations under one anaesthetic using one of each prosthesis. They also agreed to accept the random choice of knee (right or left) and to remain ignorant as to which side had which implant. Outcomes were measured using the American Knee Society Score (AKSS), the Oxford Knee Score (OKS), and determination of the range of movement and pain scores before and at one year after operation. Preoperatively, there was no systematic difference between the right and left knees. One patient died in the perioperative period and one mobile-bearing prosthesis required early revision for dislocation of the meniscal component. At one year the mean AKSS, OKS and pain scores for the new device were slightly better (p < 0.025) than those for the fixed-bearing device. There was no difference in the range of movement. We believe that this is the first controlled, blinded trial to compare early function of a new knee prosthesis with that of a standard implant. It demonstrates a small but significant clinical advantage for the mobile-bearing design.

Optimal acetabular orientation for hip resurfacing

Pseudotumours are a rare complication of hip resurfacing. They are thought to be a response to metal debris which may be caused by edge loading due to poor orientation of the acetabular component. Our aim was to determine the optimal acetabular orientation to minimise the risk of pseudotumour formation. We matched 31 hip resurfacings revised for pseudotumour formation with 58 controls who had a satisfactory outcome from this procedure. The radiographic inclination and anteversion angles of the acetabular component were measured on anteroposterior radiographs of the pelvis using Einzel-Bild-Roentgen-Analyse software. The mean inclination angle (47 degrees, 10 degrees to 81 degrees) and anteversion angle (14 degrees, 4 degrees to 34 degrees) of the pseudotumour cases were the same (p = 0.8, p = 0.2) as the controls, 46 degrees (29 degrees to 60 degrees) and 16 degrees (4 degrees to 30 degrees) respectively, but the variation was greater. Assuming an accuracy of implantation of +/- 10 degrees about a target position, the optimal radiographic position was found to be approximately 45 degrees of inclination and 20 degrees of anteversion. The incidence of pseudotumours inside the zone was four times lower (p = 0.007) than outside the zone. In order to minimise the risk of pseudotumour formation we recommend that surgeons implant the acetabular component at an inclination of 45 degrees (+/- 10) and anteversion of 20 degrees (+/- 10) on post-operative radiographs. Because of differences between the radiographic and the operative angles, this may be best achieved by aiming for an inclination of 40 degrees and an anteversion of 25 degrees.

The effect of hip resurfacing on oxygen concentration in the femoral head.

We inserted an electrode up the femoral neck into the femoral head of ten patients undergoing a metal-on-metal hip resurfacing arthroplasty through a posterior surgical approach and measured the oxygen concentration during the operation. In every patient the blood flow was compromised during surgery, but the extent varied. In three patients, the oxygen concentration was zero at the end of the procedure. The surgical approach caused a mean 60% drop (p < 0.005) in oxygen concentration while component insertion led to a further 20% drop (p < 0.04). The oxygen concentration did not improve significantly on wound closure. This study demonstrates that during hip resurfacing arthroplasty, patients experience some compromise to their femoral head blood supply and some have complete disruption.

The creep and wear of highly cross-linked polyethylene: A THREE-YEAR RANDOMISED, CONTROLLED TRIAL USING RADIOSTEREOMETRIC ANALYSIS

The creep and wear behaviour of highly cross-linked polyethylene and standard polyethylene liners were examined in a prospective, double-blind randomised, controlled trial using radiostereometric analysis. We randomised 54 patients to receive hip replacements with either highly cross-linked polyethylene or standard liners and determined the three-dimensional penetration of the liners over three years. After three years the mean total penetration was 0.35 mm (SD 0.14) for the highly cross-linked polyethylene group and 0.45 mm (SD 0.19) for the standard group. The difference was statistically significant (p = 0.0184). From the pattern of penetration it was possible to discriminate creep from wear. Most (95%) of the creep occurred within six months of implantation and nearly all within the first year. There was no difference in the mean degree of creep between the two types of polyethylene (highly cross-linked polyethylene 0.26 mm, SD 0.17; standard 0.27 mm, SD 0.2; p = 0.83). There was, however, a significant difference (p = 0.012) in the mean wear rate (highly cross-linked polyethylene 0.03 mm/yr, SD 0.06; standard 0.07 mm/yr, SD 0.05). Creep and wear occurred in significantly different directions (p = 0.01); creep was predominantly proximal whereas wear was anterior, proximal and medial. We conclude that penetration in the first six months is creep-dominated, but after one year virtually all penetration is due to wear. Highly cross-linked polyethylene has a 60% lower rate of wear than standard polyethylene and therefore will probably perform better in the long term.

Evidence for the validity of a patient-based instrument for assessment of outcome after revision hip replacement

The Oxford hip score (OHS) is a patient-based instrument for assessment of outcome which is often used after total hip replacement, and the EuroQol 5D (EQ5D) is a patient-based generic questionnaire for health assessment. In an analysis of the outcome at one year of 609 revision hip replacements (RHRs), we compared the OHS and EQ5D scores, postoperative patient satisfaction and change in pain. About 25% of the operations were repeat RHRs. At one year, 57% of patients were very pleased with their operation. The correlation between preoperative and postoperative scores and change scores for the OHS and EQ5D was high. For both instruments the effect sizes were large, but the greater effect size of the OHS suggests that it is particularly sensitive to improvements after RHR. The effect scores of the OHS declined with the number of previous RHRs, while those for the EQ5D seemed less sensitive. Our results confirm the value of the OHS in assessing outcome after RHR.