Sham-Controlled Surgical Trials in Orthopedics: A Long-Existing Challenge .

A recent BMJ umbrella review reignited debate in orthopedics by concluding that many common elective procedures lack strong, readily available RCT evidence—largely because sham-controlled surgical trials are rare. This gap doesn’t imply these operations are ineffective, but rather highlights how difficult it is to disentangle placebo effects, natural history, and true treatment benefit without rigorous trials. Ethical, methodological, and practical barriers make sham surgery challenging across medicine, not just orthopedics. In areas where sham-controlled RCTs are not feasible, high-quality observational studies often serve as the best available evidence. The field still needs more rigorous trials—but never at the expense of ethical or methodological standards.