ABSTRACT
Introduction: In clinical studies involving common orthopedic problems and traumatic injuries, randomization methods are difficult to orchestrate. The lack of high-level clinical evidence based on prospective, randomized, double-blind studies is often cited as a major reason for rejecting proposed therapeutic advances in orthopedic surgery. Materials and methods: This opinion document summarizes the limitations of clinical trials in surgical subspecialties. A consensus is presented about how the practicing orthopedic surgeon can produce high-quality clinical evidence and thus make changes to their clinical practice protocols. Results: This literature review revealed that level of evidence classifications vary among surgical subspecialties. Research in orthopedics and traumatology is primarily directed toward diagnosis, preferred treatment, and economic decision analysis, while other prognostic classifications are preferred in other areas, such as plastic surgery. In orthopedics, double-blind controlled studies are rare and often impractical or even unethical. Crossover between randomized surgical trials of study groups is more common. Other difficulties in surgical trials range from: lack of organizational and financial support, institutional approval or ethics committee and registration requirements for clinical trials, and to insufficient time outside of an already busy clinical program to dedicate to this laborious task. uncompensated task. Conclusion: Orthopedic surgery is a subspecialty based on experience and skill. Many innovations begin with enterprising surgeons reporting opinion reports or retrospective cohort studies, many of which are biased. Prospective observational cohort studies with consistent results may offer higher grade clinical evidence than poorly executed randomized trials.