Editorial Commentary: Published Sham Trials in Orthopaedic Surgery Are Flawed and Potentially Unethical-A Wolf in Sheep's Clothing.

Sham controlled randomized controlled trials attempt to isolate the beneficial health effects of orthopaedic surgery from benefits due to patients' belief in surgery. The physiological effects of sham surgery, genetic variations that influence responsiveness to placebo, cultural, and geographic influences confound results of these trials. There is a need for high methodological standard for sham-controlled trials as there is potential for direct patient harm and indirect harm from misinformation generated from poorly conducted studies. Confounding factors that affect the reliability of published sham trails expose patients to the potential harm from sham surgery without adequate methodological rigor which could be unethical.