New brands of joint prosthesis are released for general implantation with limited evidence of their long-term performance in patients. The CUSUM continuous monitoring method is a statistical testing procedure which could be used to provide prospective evaluation of brands as soon as implantation in patients begins and give early warning of poor performance. We describe the CUSUM and illustrate the potential value of this monitoring tool by applying it retrospectively to the 3M Capital Hip experience. The results show that if the clinical data and methodology had been available, the CUSUM would have given an alert to the underperformance of this prosthesis almost four years before the issue of a Hazard Notice by the Medical Devices Agency. This indicates that the CUSUM can be a valuable tool in monitoring joint prostheses, subject to timely and complete collection of data. Regional or national joint registries provide an opportunity for future centralised, continuous monitoring of all hip and knee prostheses using these techniques.
Using a regional arthroplasty register, we assessed the outcome, at five years, of 1198 primary Charnley total hip replacements (THRs) undertaken across a single health region in England in 1990. An independent clinical and radiological assessment was completed for 497 operations, carried out in 18 different hospitals, under the care of 56 consultants and by differing grades of surgeon. The overall number of failures in this group was 44 (8.9%). We found that the risk of failure in patients operated on by a consultant whose firm carried out 60 or more THRs in 1990 was 25% of that of patients under the care of a consultant whose firm undertook less than 30, adjusting for a number of patient, surgeon and hospital characteristics (16% Our study shows that the early outcome of hip replacement surgery varies with the number of replacements undertaken by the consultant firm. A national arthroplasty register would be a convenient source for such data.
