Randomized-controlled trials for surgical implants: are registries an alternative?

摘要

Due to its success in pharmaceutical drug evaluation, randomized-controlled trials have been accepted as the method providing the highest level of evidence for the comparison of treatments.1'2 To date, it is regarded as the most reliable method of conducting clinical research.3 Randomization is considered almost indispensable for establishing the superiority or noninferiority of new therapeutic approaches over standard ones. The fundamental feature of randomization is to provide comparability of the treatment groups with respect to all known and unknown factors, thus permitting an unbiased comparison between groups. From a theoretical point of view, the advantages of randomized-controlled trials are undisputed, and their value has been proven in thousands of clinical trials. No alternative excludes all confounders when measuring ex-clusivelv treatment effects.