No bias of ignored bilaterality when analysing the revision risk of knee prostheses: analysis of a population based sample of 44,590 patients with 55,298 knee prostheses from the national Swedish Knee Arthroplasty Register.
Background: The current practice of the Swedish Knee Register is not to take into consideration if one or both knees in a patient are subject to surgery when evaluating risk of revision after arthroplasty. Risk calculations are typically done by statistical methods, such as Kaplan-Meier analyses and Cox's proportional hazards models, that are based on the assumption that observed events are independent, and this is rarely appreciated. The purpose of this study was to investigate if ignoring bilateral operations when using these methods biases the results. Methods: The bias of not taking bilateral operations into account was investigated by statistically analysing 55 298 prostheses in 44 590 patients, undergoing knee arthroplasty surgery in Sweden during 1985-1999, using traditional proportional hazards analysis, which assumes that all observations are independent, and a shared gamma frailty model, which allows patients to contribute repeated observations. Results: The effect of neglecting bilateral prostheses is minute, possibly because bilateral prosthesis failure is a rare event. Conclusion: We conclude that the revision risk of knee prostheses in general can be analysed without consideration for subject dependency, at least in study populations with a relatively low proportion of subjects having experienced bilateral revisions