We have evaluated the difference in the migration patterns over two years of two cementless stems in a randomised, controlled trial using radiostereophotogrammetric analysis (RSA). The implants studied were the Furlong HAC stem, which has good long-term results and the Furlong Active stem, which is a modified version of the former designed to minimise stress concentrations between the implant and bone, and thus to improve fixation. A total of 23 Furlong HAC and 20 Furlong Active stems were implanted in 43 patients. RSA examinations were carried out immediately post-operatively and at six, 12 and 24 months post-operatively. The subsidence during the first year in the Furlong HAC stem, was approximately one-third that of the Furlong Active stem, the measured mean subsidence of the femoral head at six months being 0.27 mm (95% confidence interval (CI) 0.03 to 0.51) and 0.99 mm (95% CI 0.38 to 1.60), respectively (p = 0.03). One Active stem continued to subside during the second year. All hips, regardless of the type of stem were clinically successful as judged by the Oxford hip score and a derived pain score without any distinction between the two types of stem. The initial stability of the Furlong Active stem was not as good as the established stem which might compromise osseo-integration to the detriment of long-term success. The changes in the geometry of the stem, to minimise stress have affected the attainment of initial stability.
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°, 10° to 81°) and anteversion angle (14°, 4° to 34°) of the pseudotumour cases were the same (p = 0.8, p = 0.2) as the controls, 46° (29° to 60°) and 16° (4° to 30°) respectively, but the variation was greater. Assuming an accuracy of implantation of ± 10° about a target position, the optimal radiographic position was found to be approximately 45° of inclination and 20° 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° (± 10) and anteversion of 20° (± 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° and an anteversion of 25°.
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.
Metal-on-metal hip resurfacing is commonly performed for osteoarthritis in young active patients. We have observed cystic or solid masses, which we have called inflammatory pseudotumours, arising around these devices. They may cause soft-tissue destruction with severe symptoms and a poor outcome after revision surgery. The aim of this study was to determine the incidence of and risk factors for pseudotumours that are serious enough to require revision surgery. Since 1999, 1419 metal-on-metal hip resurfacings have been implanted by our group in 1224 patients; 1.8% of the patients had a revision for pseudotumour. In this series the Kaplan-Meier cumulative revision rate for pseudotumour increased progressively with time. At eight years, in all patients, it was 4% (95% confidence interval (CI) 2.2 to 5.8). Factors significantly associated with an increase in revision rate were female gender (p <
0.001), age under 40 (p = 0.003), small components (p = 0.003), and dysplasia (p = 0.019), whereas implant type was not (p = 0.156). These factors were inter-related, however, and on fitting a Cox proportional hazard model only gender (p = 0.002) and age (p = 0.024) had a significant independent influence on revision rate; size nearly reached significance (p = 0.08). Subdividing the cohort according to significant factors, we found that the revision rate for pseudotumours in men was 0.5% (95% CI 0 to 1.1) at eight years wheras in women over 40 years old it was 6% (95% CI 2.3 to 10.1) at eight years and in women under 40 years it was 13.1% at six years (95% CI 0 to 27) (p <
0.001). We recommend that resurfacings are undertaken with caution in women, particularly those under 40 years of age but they remain a good option in young men. Further work is required to understand the aetiology of pseudotumours so that this complication can be avoided.
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.
We report the clinical, radiographic and histologic features of these cases.
There were no infections in this series. Three subjects required revision surgery.
This study suggests that resurfacing arthoplasty can also induce a local hypersensitivity reaction in response to metal wear debris. It therefore raises new concerns regarding the long-term safety of this procedure.
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.
The Charnley Elite femoral component was first introduced in 1992 as a new design variant of the original Charnley femoral component (De Puy, Leeds, UK) with modified neck and stem geometry. The original component had undergone few changes in nearly forty years and has excellent long-term results. Early migration of the new stem design was determined by Roentgen Stereophotogrammetric Analysis (RSA)1. Rapid early migration of a component relative to the bone, measured by RSA, is predictive of subsequent aseptic loosening for a number of femoral stems. As there was rapid early migration and rotation of the Charnley Elite stem, we predicted that the long-term results would be poor. An outcome assessment is indicated as stems of this type are still being implanted. One hundred Charnley Elite stems, implanted in our centre between 1994 and 1997 were included in a prospective, cross-sectional follow-up study. Outcome measures include validated clinical scores (Charnley hip score, Harris hip score and Oxford hip score) and radiological scores (Gruen classification) as well as revision rates over the past 10 years. The clinical follow-up supports the RSA predictions of early failure of the Charnley Elite femoral stem.
Early migration of the new stem design was determined by Roentgen Stereophotogrammetric Analysis (RSA). Rapid early migration of a component relative to the bone, measured by RSA, is predictive of subsequent aseptic loosening for a number of femoral stems. As there was rapid early migration and rotation of the Charnley Elite stem, we predicted that the long-term results would be poor. An outcome assessment is required as stems of this type are still being implanted.
Preliminary clinical scores in the patients who had not undergone any subsequent surgery were adequate (Oxford Hip Score mean average of 23.9). Thirteen percent of radiographs analysed had evidence of loosening, giving an overall loosening rate of 14% at 8 years.
We performed a clinical and radiological study to determine the rate of failure of the Charnley Elite-Plus femoral component. Our aim was to confirm or refute the predictions of a previous roentgen stereophotogrammetric analysis study in which 20% of the Charnley Elite-Plus stems had shown rapid posterior head migration. It was predicted that this device would have a high early rate of failure. We examined 118 patients at a mean of nine years after hip replacement, including the 19 patients from the original roentgen stereophotogrammetric study. The number of revision procedures was recorded and clinical and radiological examinations were performed. The rate of survival of the femoral stems at ten years was 83% when revision alone was considered to be a failure. It decreased to 59% when a radiologically loose stem was also considered to be a failure. All the patients previously shown in the roentgen stereophotogrammetric study to have high posterior head migration went on to failure. There was a highly significant difference (p = 0.002) in posterior head migration measured at two years after operation between failed and non-failed femoral stems, but there was no significant difference in subsidence between these two groups. Our study has shown that the Charnley Elite-Plus femoral component has an unacceptably high rate of failure. It confirms that early evaluation of new components is important and that roentgen stereophotogrammetric is a good tool for this. Our findings have also shown that rapid posterior head migration is predictive of premature loosening and a better predictor than subsidence.
This study presents the 2 year migration results of the BHR femoral component using Roentgen Stereophoto-grammteric Analysis (RSA).
Polished, tapered stems are now widely used for cemented total hip replacement and many such designs have been introduced. However, a change in stem geometry may have a profound influence on stability. Stems with a wide, rectangular proximal section may be more stable than those which are narrower proximally. We examined the influence of proximal geometry on stability by comparing the two-year migration of the Exeter stem with a more recent design, the CPS-Plus, which has a wider shoulder and a more rectangular cross-section. The hypothesis was that these design features would increase rotational stability. Both stems subsided approximately 1 mm relative to the femur during the first two years after implantation. The Exeter stem was found to rotate into valgus (mean 0.2°,
Increasing the width of the proximal section of a polished tapered stem enhances its rotational stability.
The Birmingham hip resurfacing (BHR) arthroplasty is a metal-on-metal prosthesis for which no medium- or long-term results have been published. Despite this, it is increasing in popularity as an alternative to stemmed prostheses for younger patients. Since the fixation of the socket is conventional, the major concern is long-term failure of the femoral component. This can be predicted by the use of roentgen stereophotogrammetric analysis (RSA). We have therefore undertaken such a study of the BHR femoral component over a period of two years. Twenty patients (22 hips) underwent a standard BHR procedure. Migration of the femoral component was measured by RSA at intervals of three, six, 12 and 24 months. At 24 months the total three-dimensional migration of the head was 0.2 mm. This was not statistically significant. Previous studies have shown that implants which loosen quickly have rapid early migration. Our results therefore suggest that the BHR femoral component is an inherently stable device which is likely to perform well in the long term.