Dependency issues in survival analyses of 55 782 primary hip replacements from 47 355 patients

Artificial hip joints are used in only one hip for about 85 per cent of the patients and in both hips (bilateral) for about 15 per cent of the patients. The occurrence of bilateral prostheses and the influence they have in survival analyses of joint arthroplasties are seldom considered. In this study we therefore focus on issues related to bilateral primary hip prostheses, time to revision surgery, and some commonly used statistical methods. We used information from 47355 patients with 55782 primary hip prostheses reported to the Norwegian Arthroplasty Register between 1987 and 2000. Due to the large number of diagnoses, fixation techniques for the prostheses, and combination of prostheses brands, we furthermore considered a 'homogeneous' subset of 8703 prostheses from 7930 patients with primary osteoarthritis, and Charnley prosthesis fixed with antibiotic-containing Palacos cement. Kaplan-Meier curves for all prostheses, ignoring that some patients have bilateral prostheses, were compared with Kaplan-Meier curves using only the first inserted prostheses, and with survival curves modified for patients with bilateral prostheses. Cox regression analyses were used to assess explanatory variables and to adjust for confounding factors. The results from the ordinary Cox regression analyses were compared with results from a marginal model, a shared gamma frailty model, and a model using a time dependent covariate to condition on failures in the opposite hip. We found no practical difference between the three calculated survival curves for the hip replacement data. The ordinary Cox-model and the marginal model gave equivalent results. In the shared gamma frailty model estimates for the risk factors were comparable with the former two approaches. The estimated frailty variance was higher when all data were used, even after adjustment for confounding factors. For the 'homogeneous' data the estimated frailty variance was negligible. Using a time dependent covariate to condition on previous revisions in the opposite hip, we found a higher risk of revision for the remaining primary hip prosthesis if the opposite hip had been revised (RR=3.49, p<0.0001). There was no difference in risk for revision between right and left hip prostheses. If the time interval between the two primary operations was more than two years, for the full data, the first hip prosthesis had an increased risk of revision compared to prostheses in patients with only one prosthesis (RR=1.25, p=0.01). For the 'homogeneous' data no statistically significant difference was found between unilateral and bilateral prostheses. A revision in one hip, for patients with bilateral prostheses, is a risk factor for revision of the other hip. Thus, in analyses of prostheses survival, dependencies between two hip prostheses from one patient should be considered. However, ignoring possible dependencies does not necessarily have an impact on the results on standard risk factors. Copyright (C) 2004 John Wiley & Sons, Ltd.