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J Bone Joint Surg Am. 2016 Aug 3;98(15):e63. doi: 10.2106/JBJS.15.00573.

Cartilage-Repair Innovation at a Standstill: Methodologic and Regulatory Pathways to Breaking Free.

Author information

1
Hospital for Special Surgery Healthcare Research Institute, New York, NY lymans@hss.edu.
2
Department of Orthopedics, Osaka Health Science University, Osaka, Japan.
3
Department of Orthopedics, Rush University Medical Center, Chicago, Illinois.
4
Center for Biologic Joint Surgery, Department of Orthopaedic Surgery and Traumatology, University of Freiburg Medical Center, Freiburg, Germany.
5
Department of Orthopaedic Surgery, Brigham & Women's Hospital, Harvard Medical School, Boston, Massachusetts.
6
Indiana University School of Medicine and OrthoIndy Hospital, Indianapolis, Indiana.

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.

PMID:
27489325
DOI:
10.2106/JBJS.15.00573
[Indexed for MEDLINE]

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