Cartilage-Repair Innovation at a Standstill: Methodologic and Regulatory Pathways to Breaking Free. (3rd August 2016)

• Record Type: Journal Article
• Authors: Lyman, Stephen; Nakamura, Norimasa; Cole, Brian J.; Erggelet, Christoph; Gomoll, Andreas H.; Farr, Jack
• Is Part Of: Journal of bone and joint surgery. Volume 98:Number 15(2016)
• Publication Date: 2016-08-03
• Subjects: Bones -- Surgery -- Periodicals; Joints -- Surgery -- Periodicals; Orthopedics -- Periodicals; Orthopedics; General Surgery; Bone Diseases; Joint Diseases; Bones -- Surgery; Joints -- Surgery; Orthopedics; Bot (anatomie); Gewrichten; Chirurgie (geneeskunde); Periodicals; Electronic journals; Periodicals; 617.47005
• DOI: 10.2106/JBJS.15.00573
• Languages: English
• ISSNs: 0021-9355

Abstract

Abstract : Abstract: Articular cartilage defects strongly predispose patients to developing early joint degeneration and osteoarthritis, but for more than 15 years, no new cartilage-repair technologies that we know of have been approved by the U.S. Food and Drug Administration. Many studies examining novel approaches to cartilage repair, including cell, tissue, or matrix-based techniques, have shown great promise, but completing randomized controlled trials (RCTs) to establish safety and efficacy has been challenging, providing a major barrier to bringing these innovations into clinical use. In this article, we review reasons that surgical innovations are not well-suited for testing through RCTs. We also discuss how analytical methods for reducing bias, such as propensity scoring, make prospective observational studies a potentially viable alternative for testing the safety and efficacy of cartilage-repair and other novel therapies, offering the real possibility of therapeutic innovation.