Designing clinical studies in orthopedic traumatology

The design of clinical studies in orthopedic traumatology is challenging in several respects. In this era of evidence-based medicine, the pressure is high to choose our treatments solely based on randomized controlled studies. This type of study, when well-constructed, makes it possible to discern the best treatment for a specific fracture in a given group of patients and in connection with a specific outcome. Randomized controlled trials require a lot of resources and are not designed to answer all research questions. Observational studies, such as case-control studies, prospective cohort studies, and cross-sectional studies, also have a role to play in improving scientific knowledge in orthopedic trauma. Regardless of the type of study chosen, the researcher must follow a strict methodology that conforms to practice guidelines in order to ensure the study's conclusions are valid. The guidelines for randomized studies can be found at http://www.consort-statement.org and at http://www.strobe-statement.org for cohort studies. It is also very important to register randomized studies before they begin on a website such as http://www.clinicaltrials.gov, since registration is an increasingly common requirement when submitting an article for publication. Although this preparation is relatively cumbersome, it is essential for producing articles that meet modern scientific criteria.