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

Overview

MeSH Major

  • Cartilage, Articular
  • Orthopedic Procedures
  • Osteoarthritis

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.

publication date

  • January 2016

Research

keywords

  • Review

Identity

Language

  • eng

Digital Object Identifier (DOI)

  • 10.2106/JBJS.15.00573

PubMed ID

  • 27489325

Additional Document Info

start page

  • e63

volume

  • 98

number

  • 15