Randomised controlled trials in orthopaedic surgery and traumatology: overview of parameters and pitfalls.

There is a growing consensus that randomised controlled clinical trial (RCT) provide a secure basis for determining treatment effects. Prospective randomised clinical trials can be a powerful tool in medical science and evidence-based medicine. A well-defined study hypothesis, with a prospectively applied study design, blinded and randomised treatment allocation and assessment, with appropriate control groups can provide strong evidence in support of treatment decisions. However, the recent reviews of the medical literature indicate that the study design itself does not ensure the quality of science or useful and valid scientific data. Thus, regardless of the study design or level of evidence, it remains imperative for the physician and surgeon to critically evaluate a scientific report. Moreover, as randomisation, concealment of treatment allocation and blinding are difficult issues to resolve in orthopaedic surgery, future trials should focus on detailed and correct reporting of outcome measures.