Cartilage-repair innovation at a standstill: Methodologic and regulatory pathways to breaking free

Stephen Lyman, Norimasa Nakamura, Brian J. Cole, Christoph Erggelet, Andreas H. Gomoll, Jack Farr

研究成果: Contribution to journalReview article査読

16 被引用数 (Scopus)

抄録

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.

本文言語英語
ページ(範囲)e63
ジャーナルJournal of Bone and Joint Surgery - American Volume
98
15
DOI
出版ステータス出版済み - 2016
外部発表はい

All Science Journal Classification (ASJC) codes

  • Surgery
  • Orthopedics and Sports Medicine

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