The Crisis in Orthopaedic Technology Puts Evidence-based Medicine at Risk

S. Raymond Golish, MD, PhD, MBA; William M. Mihalko, MD, PhD; J. Tracy Watson, MD

Improvements in orthopaedic patient care are typically connected to improvements in orthopaedic technology. However, the supply of new implants and procedures is not guaranteed. The successful commercialization of truly novel orthopaedic technology currently faces stiff headwinds, including regulatory risk, payer risk, and market risk. This may reduce interest in financing novel technologies within the venture community and among major device manufacturers.

Clinical Trials for Cervical Disk Replacement

S. Raymond Golish, MD, PhD, MBA; Steven M. Kurtz, PhD; Richard D. Guyer, MD

Each of the seven cervical total disk replacements (cTDR) currently available in the United States has undergone a clinical trial providing evidence of safety and efficacy that supports U.S. Food and Drug Administration (FDA) premarket approval.