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.

We review the history and literature of hip resurfacing arthroplasty. Resurfacing and the science behind it continues to evolve. Recent results, particularly from the national arthroplasty registers, have spread disquiet among both surgeons and patients. A hip resurfacing arthroplasty is not a total hip replacement, but should perhaps be seen as a means of delaying it. The time when hip resurfacing is offered to a patient may be different from that for a total hip replacement. The same logic can apply to the timing of revision surgery. Consequently, the comparison of resurfacing with total hip replacement may be a false one. Nevertheless, the need for innovative solutions for young arthroplasty patients is clear. Total hip replacement can be usefully delayed in many of these patients by the use of hip resurfacing arthroplasty.

We compared the medium-term clinical and radiological results of hybrid total hip replacement (THR) with metal-on-metal Birmingham hip resurfacing (BHR) in two groups of 54 young patients matched for age, gender, body mass index and pre-operative levels of activity.

The clinical outcome was assessed by the University of California, Los Angeles (UCLA) activity score, the Oxford Hip Score (OHS) and the EuroQol scores. Radiologically, all hips were assessed for migration and osteolysis, the hybrid THRs for polyethylene wear and the BHRs for a pedestal sign. The mean follow-up of the patients with a hybrid THR was ten years and for those with a BHR, nine years. Four patients with a hybrid THR and one with a BHR had died. In each group five were lost to follow-up. The revision rate of the hybrid THRs was 16.7% (9 of 54) and of the BHRs 9.3% (5 of 54) (p = 0.195). Radiographs of a further eight hybrid THRs demonstrated wear and osteolysis, and they await revision (p = 0.008). Of the unrevised BHRs 90% had radiological changes, of which approximately 50% had progressed over the previous four years. All hybrid THRs demonstrated linear polyethylene wear with a mean of 1.24 mm (0.06 to 3.03). The BHRs recorded superior OHS (p = 0.013), UCLA (p = 0.008), and EuroQol visual analogue scores (p = 0.009).

After nine years, patients with BHRs remained more active and had a lower rate of revision than those with hybrid THRs. Both groups demonstrated progressive radiological changes at medium-term follow-up.

This study reports the mid-term results of a large-bearing hybrid metal-on-metal total hip replacement in 199 hips (185 patients) with a mean follow-up of 62 months (32 to 83).

Two patients died of unrelated causes and 13 were lost to follow-up. In all, 17 hips (8.5%) have undergone revision, and a further 14 are awaiting surgery. All revisions were symptomatic. Of the revision cases, 14 hips showed evidence of adverse reactions to metal debris. The patients revised or awaiting revision had significantly higher whole blood cobalt ion levels (p = 0.001), but no significant difference in acetabular component size or position compared with the unrevised patients. Wear analysis (n = 5) showed increased wear at the trunnion-head interface, normal levels of wear at the articulating surfaces and evidence of corrosion on the surface of the stem.

The cumulative survival rate, with revision for any reason, was 92.4% (95% confidence interval 87.4 to 95.4) at five years. Including those awaiting surgery, the revision rate would be 15.1% with a cumulative survival at five years of 89.6% (95% confidence interval 83.9 to 93.4).

This hybrid metal-on-metal total hip replacement series has shown an unacceptably high rate of failure, with evidence of high wear at the trunnion-head interface and passive corrosion of the stem surface. This raises concerns about the use of large heads on conventional 12/14 tapers.

Resurfacing arthroplasties of the hip are being undertaken with increasing frequency and the complications associated with this procedure are well documented. We have encountered a further problem with a fracture of the centralising peg of the femoral component in a prosthesis which had been in situ for three years.

The cause of fracture of the femoral neck after hip resurfacing is poorly understood. In order to evaluate the role of avascular necrosis we compared 19 femoral heads retrieved at revision for fracture of the femoral neck and 13 retrieved for other reasons.

We developed a new technique of assessing avascular necrosis in the femoral head by determining the percentage of empty osteocyte lacunae present. Femoral heads retrieved as controls at total hip replacement for osteoarthritis and avascular necrosis had 9% (sd 4; n = 13) and 85% (sd 5; n = 10, p < 0.001) empty lacunae, respectively.

In the fracture group the percentage of empty lacunae was 71% (sd 22); in the other group it was 21% (sd 13). The differences between the groups were highly significant (p < 0.001).

We conclude that fracture after resurfacing of the hip is associated with a significantly greater percentage of empty osteocyte lacunae within the trabecular bone. This indicates established avascular necrosis and suggests that damage to the blood supply at the time of surgery is a potent risk factor for fracture of the femoral neck after hip resurfacing.

Pseudotumour is a rare but important complication of metal-on-metal hip resurfacing that occurs much more commonly in women than in men. We examined the relationship between head-neck ratio (HNR) and pseudotumour formation in 18 resurfaced hips (18 patients) revised for pseudotumour and 42 asymptomatic control resurfaced hips (42 patients).

Patients in whom pseudotumour formation had occurred had higher pre-operative HNR than the control patients (mean 1.37 (sd 0.10) vs mean 1.30 (sd 0.08) p = 0.001). At operation the patients with pseudotumours had a greater reduction in the size of their femoral heads (p = 0.035) and subsequently had greater neck narrowing (mean 10.1% (sd 7.2) vs mean 3.8% (sd 3.2) p < 0.001). No female patient with a pre-operative HNR ≤ 1.3 developed a pseudotumour.

We suggest that reducing the size of the femoral head, made possible by a high pre-operative HNR, increases the risk of impingement and edge loading, and may contribute to high wear and pseudotumour formation. As the incidence of pseudotumour is low in men, it appears safe to perform resurfacing in men. However, this study suggests that it is also reasonable to resurface in women with a pre-operative HNR ≤ 1.3.

Endoprosthetic replacement of the proximal femur may be required to treat primary bone tumours or destructive metastases either with impending or established pathological fracture. Modular prostheses are available off the shelf and can be adapted to most reconstructive situations for this purpose. We have assessed the clinical and functional outcome of using the METS (Stanmore Implants Worldwide) modular tumour prosthesis to reconstruct the proximal femur in 100 consecutive patients between 2001 and 2006. We compared the results with the published series for patients managed with modular and custom-made endoprosthetic replacements for the same conditions.

There were 52 males and 48 females with a mean age of 56.3 years (16 to 84) and a mean follow-up of 24.6 months (0 to 60). In 65 patients the procedure was undertaken for metastases, in 25 for a primary bone tumour, and in ten for other malignant conditions. A total of 46 patients presented with a pathological fracture, and 19 presented with failed fixation of a previous pathological fracture. The overall patient survival was 63.6% at one year and 23.1% at five years, and was significantly better for patients with a primary bone tumour than for those with metastatic tumour (82.3% vs 53.3%, respectively at one year (p = 0.003)). There were six early dislocations of which five could be treated by closed reduction. No patient needed revision surgery for dislocation. Revision surgery was required by six (6%) patients, five for pain caused by acetabular wear and one for tumour progression. Amputation was needed in four patients for local recurrence or infection.

The estimated five-year implant survival with revision as the endpoint was 90.7%. The mean Toronto Extremity Salvage score was 61% (51% to 95%). The implant survival and complications resulting from the use of the modular system were comparable to the published series of both custom-made and other modular proximal femoral implants.

We conclude that at intermediate follow-up the modular tumour prosthesis for proximal femur replacement provides versatility, a low incidence of implant-related complications and acceptable function for patients with metastatic tumours, pathological fractures and failed fixation of the proximal femur. It also functions as well as a custom-made endoprosthetic replacement.

We have investigated the accuracy of placement of the femoral component using imageless navigation in 100 consecutive Birmingham Hip Resurfacings. Pre-operative templating determined the native neck-shaft angle and planned stem-shaft angle of the implant. The latter were verified post-operatively using digital anteroposterior unilateral radiographs of the hip.

The mean neck-shaft angle determined before operation was 132.7° (118° to 160°). The mean planned stem-shaft angle was a relative valgus alignment of 9.7° (sd 2.6). The stem-shaft angle after operation differed from that planned by a mean of 2.8° (sd 2.0) and in 86% of cases the final angle measured within ± 5° of that planned. We had no instances of notching of the neck or varus alignment of the implant in our series. A learning curve was observed in the time taken for navigation, but not for accurate placement of the implant.

Navigation in hip resurfacing may afford the surgeon a reliable and accurate method of placement of the femoral component.

A prospective study of serum and urinary ion levels was undertaken in a triathlete who had undergone a metal-on-metal resurfacing arthroplasty of the hip four years previously. The one month study period included the final two weeks of training, the day of the triathlon, and the two weeks immediately post-race. Serum cobalt and chromium levels did not vary significantly throughout this period, including levels recorded on the day after the 11-hour triathlon. Urinary excretion of chromium increased immediately after the race and had returned to pre-race levels six days later. The clinical implications are discussed.

A 34-year-old woman with a benign form of osteopetrosis developed osteoarthritis of the hip. In order to avoid the difficulties associated with inserting the femoral component of a conventional total hip arthroplasty, a hybrid metal-on-metal resurfacing was performed. There were several technical challenges associated with the procedure, including the sizing of the component, press-fit fixation of the acetabular component and femoral head preparation, as well as trying to avoid a fracture. No surgical complication occurred. After more than a year following surgery, the patient showed excellent clinical function and remained satisfied with the outcome. We conclude that the hybrid metal-on-metal resurfacing arthroplasty represents a valuable option for the treatment of patients with osteopetrosis and secondary hip osteoarthritis.

A total of 20 pairs of fresh-frozen cadaver femurs were assigned to four alignment groups consisting of relative varus (10° and 20°) and relative valgus (10° and 20°), 75 composite femurs of two neck geometries were also used. In both the cadaver and the composite femurs, placing the component in 20° of valgus resulted in a significant increase in load to failure. Placing the component in 10° of valgus had no appreciable effect on increasing the load to failure except in the composite femurs with varus native femoral necks. Specimens in 10° of varus were significantly weaker than the neutrally-aligned specimens.

The results suggest that retention of the intact proximal femoral strength occurs at an implant angulation of ≥ 142°. However, the benefit of extreme valgus alignment may be outweighed in clinical practice by the risk of superior femoral neck notching, which was avoided in this study.

Patients considered suitable for total hip resurfacing arthroplasty often have bilateral disease. The peri-operative complications, transfusion requirements, hospital stay, outcome and costs in patients undergoing one-stage bilateral total hip resurfacing were compared with a group of patients undergoing a two-stage procedure. A total of 92 patients were included in the study, of which 37 (40%) had a one-stage and 55 (60%) had a two-stage resurfacing. There were no significant differences in age, gender, or American Society of Anaesthesiologists grade between the groups (p = 0.31, p = 0.23, p = 0.13, respectively). There were three systemic complications in the one-stage group (8.1%) and one in the two-stage group (1.8% of patients; 0.9% of procedures). There was no significant difference in the complication rate (p = 0.72) or the transfusion requirements (p = 0.32) between the two groups. The one-stage group had a reduced total hospital stay of five days (95% confidence interval 4.0 to 6.9; p < 0.001), reduced length of time to completion of all surgery of five months (95% confidence interval 2.6 to 8.3; p < 0.001), and the reduced cost was 35% less than that of a two-stage procedure. However, the total anaesthetic time was significantly longer for the one-stage group (p < 0.001; 95% confidence interval 31 to 52).

This study demonstrates that consideration should be given to one-stage surgery for patients with bilateral symptomatic disease suitable for metal-on-metal hip resurfacing. A one-stage procedure appears to have benefits for both the patient and the hospital without additional complications.

This is a longitudinal study of the daily urinary output and the concentrations in whole blood of cobalt and chromium in patients with metal-on-metal resurfacings over a period of four years.

Twelve-hour urine collections and whole blood specimens were collected before and periodically after a Birmingham hip resurfacing in 26 patients. All ion analyses were carried out using a high-resolution inductively-coupled plasma mass spectrometer. Clinical and radiological assessment, hip function scoring and activity level assessment revealed excellent hip function.

There was a significant early increase in urinary metal output, reaching a peak at six months for cobalt and one year for chromium post-operatively. There was thereafter a steady decrease in the median urinary output of cobalt over the following three years, although the differences are not statistically significant. The mean whole blood levels of cobalt and chromium also showed a significant increase between the pre-operative and one-year post-operative periods. The blood levels then decreased to a lower level at four years, compared with the one-year levels. This late reduction was statistically significant for chromium but not for cobalt.

The effects of systemic metal ion exposure in patients with metal-on-metal resurfacing arthroplasties continue to be a matter of concern. The levels in this study provide a baseline against which the in vivo wear performance of newer bearings can be compared.

We present the early clinical and radiological results of Articular Surface Replacement (ASR) resurfacings in 214 hips (192 patients) with a mean follow-up of 43 months (30 to 57). The mean age of the patients was 56 years (28 to 74) and 85 hips (40%) were in 78 women.

The mean Harris hip score improved from 52 (11 to 81) to 95 (27 to 100) at two years and the mean University of California, Los Angeles activity score from 3.9 (1 to 10) to 7.4 (2 to 10) in the same period. Narrowing of the neck (to a maximum of 9%) was noted in 124 of 209 hips (60%). There were 12 revisions (5.6%) involving four (1.9%) early fractures of the femoral neck and two (0.9%) episodes of collapse of the femoral head secondary to avascular necrosis. Six patients (2.8%) had failure related to metal wear debris. The overall survival for our series was 93% (95% confidence interval 80 to 98) and 89% (95% confidence interval 82 to 96) for hips with acetabular components smaller than 56 mm in diameter.

The ASR implant has a lower diametrical clearance and a subhemispherical acetabular component when compared with other more frequently implanted metal-on-metal hip resurfacings. These changes may contribute to the higher failure rate than in other series, compared with other designs. Given our poor results with the small components we are no longer implanting the smaller size.

We carried out a cross-sectional study with analysis of the demographic, clinical and laboratory characteristics of patients with metal-on-metal hip resurfacing, ceramic-on-ceramic and metal-on-polyethylene hip replacements. Our aim was to evaluate the relationship between metal-on-metal replacements, the levels of cobalt and chromium ions in whole blood and the absolute numbers of circulating lymphocytes. We recruited 164 patients (101 men and 63 women) with hip replacements, 106 with metal-on-metal hips and 58 with non-metal-on-metal hips, aged < 65 years, with a pre-operative diagnosis of osteoarthritis and no pre-existing immunological disorders.

Laboratory-defined T-cell lymphopenia was present in13 patients (15%) (CD8⁺ lymphopenia) and 11 patients (13%) (CD3⁺ lymphopenia) with unilateral metal-on-metal hips. There were significant differences in the absolute CD8⁺ lymphocyte subset counts for the metal-on-metal groups compared with each control group (p-values ranging between 0.024 and 0.046). Statistical modelling with analysis of covariance using age, gender, type of hip replacement, smoking and circulating metal ion levels, showed that circulating levels of metal ions, especially cobalt, explained the variation in absolute lymphocyte counts for almost all lymphocyte subsets.

We report a retrospective review of the incidence of venous thromboembolism in 463 consecutive patients who underwent primary total hip arthroplasty (487 procedures). Treatment included both total hip replacement and hip resurfacing, and the patients were managed without anticoagulants. The thromboprophylaxis regimen included an antiplatelet agent, generally aspirin, hypotensive epidural anaesthesia, elastic compression stockings and early mobilisation. In 258 of these procedures (244 patients) performed in 2005 (cohort A) mechanical compression devices were not used, whereas in 229 (219 patients) performed during 2006 (cohort B) bilateral intermittent pneumatic calf compression was used.

All operations were performed through a posterior mini-incision approach. Patients who required anticoagulation for pre-existing medical problems and those undergoing revision arthroplasty were excluded. Doppler ultrasonographic screening for deep-vein thrombosis was performed in all patients between the fourth and sixth post-operative days. All patients were reviewed at a follow-up clinic six to ten weeks after the operation. In addition, reponse to a questionnaire was obtained at the end of 12 weeks post-operatively.

No symptomatic calf or above-knee deep-vein thrombosis or pulmonary embolism occurred. In 25 patients in cohort A (10.2%) and in ten patients in cohort B (4.6%) asymptomatic calf deep-vein thromboses were detected ultrasonographically. This difference was statistically significant (p = 0.03). The regimen followed by cohort B offers the prospect of a low incidence of venous thromboembolism without subjecting patients to the higher risk of bleeding associated with anticoagulant use.

Increased concentrations of metal ions after metal-on-metal resurfacing arthroplasty of the hip remain a concern. Although there has been no proven link to long-term health problems or early prosthetic failure, variables associated with high metal ion concentrations should be identified and, if possible, corrected. Our study provides data on metal ion levels from a series of 76 consecutive patients (76 hips) after resurfacing arthroplasty with the Articular Surface Replacement. Chromium and cobalt ion concentrations in the whole blood of patients with smaller (≤ 51 mm) femoral components were significantly higher than in those with the larger (≥ 53 mm) components (p < 0.01). Ion concentrations in the former group were significantly related to the inclination (p = 0.01) and anteversion (p = 0.01) of the acetabular component. The same relationships were not significant in the patients with larger femoral components (p = 0.61 and p = 0.49, respectively). Accurate positioning of the acetabular component intra-operatively is essential in order to reduce the concentration of metal ions in the blood after hip resurfacing arthroplasty with the Articular Surface Replacement implant.

Previous research has shown an increase in chromosomal aberrations in patients with worn implants. The type of aberration depended on the type of metal alloy in the prosthesis. We have investigated the metal-specific difference in the level of DNA damage (DNA stand breaks and alkali labile sites) induced by culturing human fibroblasts in synovial fluid retrieved at revision arthroplasty.

All six samples from revision cobalt-chromium metal-on-metal and four of six samples from cobalt-chromium metal-on-polyethylene prostheses caused DNA damage. By contrast, none of six samples from revision stainless-steel metal-on-polyethylene prostheses caused significant damage. Samples of cobalt-chromium alloy left to corrode in phosphate-buffered saline also caused DNA damage and this depended on a synergistic effect between the cobalt and chromium ions.

Our results further emphasise that epidemiological studies of orthopaedic implants should take account of the type of metal alloy used.