Auswirkungen der Qualität klinischer Studien in der Orthopädie und Unfallchirurgie auf den Erkenntnisstand.

Medical decisions have to be founded on the current scientific state of the art. To evaluate the efficacy of any therapeutical measure, controlled clinical trials are necessary. Firstly, we describe important principles for the design and conduct of controlled clinical trials. Secondly, we list examples from the topical literature and discuss these regarding adherence to the described principles. The accepted quality criteria for clinical trials have insufficiently been transferred to the area of clinical orthopedic and traumatologic research. As a consequence, the evidence for many therapeutical measures is low. We point out frequently occurring flaws in the design and conduct of controlled clinical trials. A brief introduction to the interpretation of clinical trials and meta analyses is given. In orthopedics and traumatology, well designed controlled clinical trials have to be enforced. This is a prerequisite for evaluating therapeutical measures on a scientific basis.