Evaluating the Safety

- of Emerging Orthopaedic Technologies

Orthopaedic devices often obtain FDA approval through studies conducted in a controlled research setting, among highly skilled surgeons, using carefully selected patients, and in high volume hospitals. Once approved, these new technologies are used in less controlled settings by surgeons with varying experience, for expanded indications, and perhaps on less rigorously selected patients. The safety profile for new devices under “real world” conditions may be worse than the safety data reported in the FDA’s Summary of Safety and Effectiveness. An ongoing, systematic, population-based method would be highly desirable to monitor the safety of emerging orthopaedic devices as they disseminate into clinical practice.

The Dartmouth MCRC Project 3 (Development Project) seeks to expedite early detection of serious complications associated with new orthopaedic devices. Innovative aspects of the project include validation of administratively-derived safety measures, use of FDA-approval data as a benchmark for monitoring safety, and use of readily-available, population-based databases to evaluate the safety of emerging surgical devices. The project uses statistical modeling techniques that leverage medical claims data to continually assess the risks of new devices as additional data accrue on repeat surgery, infection, other complications, and death. We demonstrate the approach by examining the experience with bone morphogenetic protein, a biological agent used as an adjunct to spinal fusion surgery.
Brook Martin, PhD - Project Leader
Sohail Mirza, MD, MPH - Project Leader

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