TY - JOUR
T1 - Cartilage-repair innovation at a standstill
T2 - Methodologic and regulatory pathways to breaking free
AU - Lyman, Stephen
AU - Nakamura, Norimasa
AU - Cole, Brian J.
AU - Erggelet, Christoph
AU - Gomoll, Andreas H.
AU - Farr, Jack
PY - 2016
Y1 - 2016
N2 - 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.
AB - 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.
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U2 - 10.2106/JBJS.15.00573
DO - 10.2106/JBJS.15.00573
M3 - Review article
C2 - 27489325
AN - SCOPUS:84992065266
VL - 98
SP - e63
JO - Journal of Bone and Joint Surgery - Series A
JF - Journal of Bone and Joint Surgery - Series A
SN - 0021-9355
IS - 15
ER -