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.
There is a need for standardization of radiostereometric (RSA) investigations to facilitate comparison of outcome reported from different research groups. In this document, 6 research centers have agreed upon standards for terminology, description and use of RSA arrangement including radiographic set-up and techniques. Consensus regarding minimum requirements for marker stability and scatter, choice of coordinate systems, and preferred way of describing prosthetic micromotion is of special interest. Some notes on data interpretation are also presented. Validation of RSA should be standardized by preparation of protocols for assessment of accuracy and precision. Practical issues related to loading of the joint by weight bearing or other conditions, follow-up intervals, length of follow-up, radiation dose, and the exclusion of patients due to technical errors are considered. Finally, we present a checklist of standardized output that should be included in any clinical RSA paper. This document will form the basis of a detailed standardization protocol under supervision of ISO and the European Standards Working Group on Joint Replacement Implants (CEN/TC 285/WG4). This protocol will facilitate inclusion of RSA in a standard protocol for implant testing before it is released for general use. Such a protocol—also including other recognized clinical outcome parameters—will reduce the risk of implanting potentially inferior prostheses on a large scale.
1 October 2008 in The Journal of Bone and Joint Surgery. British volume
We examined the relationships between the serum levels of chromium and cobalt ions and the inclination angle of the acetabular component and the level of activity in 214 patients implanted with a metal-on-metal resurfacing hip replacement. Each patient had a single resurfacing and no other metal in their body. All serum measurements were performed at a minimum of one year after operation. The inclination of the acetabular component was considered to be steep if the abduction angle was greater than 55°. There were significantly higher levels of metal ions in patients with steeply-inclined components (p = 0.002 for chromium, p = 0.003 for cobalt), but no correlation was found between the level of activity and the concentration of metal ions. A highly significant (p < 0.001) correlation with the arc of cover was found. Arcs of cover of less than 10 mm were correlated with a greater risk of high concentrations of serum metal ions. The arc of coverage was also related to the design of the component and to size as well as to the abduction angle of the acetabular component. Steeply-inclined acetabular components, with abduction angles greater than 55°, combined with a small size of component are likely to give rise to higher serum levels of cobalt and chromium ions. This is probably due to a greater risk of edge-loading.
1 August 2009 in The Journal of Bone and Joint Surgery. British volume
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.
This prospective study describes the outcome of the first 1000 phase 3 Oxford medial unicompartmental knee replacements (UKRs) implanted using a minimally invasive surgical approach for the recommended indications by two surgeons and followed up independently. The mean follow-up was 5.6 years (1 to 11) with 547 knees having a minimum follow-up of five years. At five years their mean Oxford knee score was 41.3 (sd 7.2), the mean American Knee Society Objective Score 86.4 (sd 13.4), mean American Knee Society Functional Score 86.1 (sd 16.6), mean Tegner activity score 2.8 (sd 1.1). For the entire cohort, the mean maximum flexion was 130° at the time of final review. The incidence of implant-related re-operations was 2.9%; of these 29 re-operations two were revisions requiring revision knee replacement components with stems and wedges, 17 were conversions to a primary total knee replacement, six were open reductions for dislocation of the bearing, three were secondary lateral UKRs and one was revision of a tibial component. The most common reason for further surgical intervention was progression of arthritis in the lateral compartment (0.9%), followed by dislocation of the bearing (0.6%) and revision for unexplained pain (0.6%). If all implant-related re-operations are considered failures, the ten-year survival rate was 96% (95% confidence interval, 92.5 to 99.5). If only revisions requiring revision components are considered failures the ten-year survival rate is 99.8% (confidence interval 99 to 100). This is the largest published series of UKRs implanted through a minimally invasive surgical approach and with ten-year survival data. The survival rates are similar to those obtained with a standard open approach whereas the function is better. This demonstrates the effectiveness and safety of a minimally invasive surgical approach for implanting the Oxford UKR.