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The Journal of Bone & Joint Surgery British Volume
Vol. 88-B, Issue 6 | Pages 716 - 720
1 Jun 2006
Hardoon SL Lewsey JD Gregg PJ Reeves BC van der Meulen JHP

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.


The Journal of Bone & Joint Surgery British Volume
Vol. 83-B, Issue 6 | Pages 838 - 842
1 Aug 2001
Chambers IR Fender D McCaskie AW Reeves BC Gregg PJ

The radiological features of the cement mantle around total hip replacements (THRs) have been used to assess aseptic loosening. In this case-control study we investigated the risk of failure of THR as predictable by a range of such features using data from patients recruited to the Trent Regional Arthroplasty Study (TRAS).

An independent radiological assessment was undertaken on Charnley THRs with aseptic loosening within five years of surgery and on a control group from the TRAS database. Chi-squared tests were used to test the probability of obtaining the observed data by chance, and odds ratios were calculated to estimate the strength of association for different features.

Several features were associated with a clinically important increase (> twofold) in the risk of loosening, which was statistically significant for four features (p < 0.01). Inadequate cementation (Barrack C and D grades) was the most significant feature, with an estimated odds ratio of 9.5 (95% confidence interval 3.2 to 28.4, p < 0.0001) for failure.