The MeTeOR Trial (Meniscal Tear in Osteoarthritis Research): Rationale and design features

Abstract This paper presents the rationale and design features of the MeTeOR Trial (Meniscal Tear in Osteoarthritis Research; Clinical Trials.gov NCT00597012). MeTeOR is an NIH-funded seven-center prospective randomized controlled trial (RCT) designed to establish the efficacy of arthroscopic partia...

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Veröffentlicht in:Contemporary clinical trials 2012-11, Vol.33 (6), p.1189-1196
Hauptverfasser: Katz, Jeffrey N, Chaisson, Christine E, Cole, Brian, Guermazi, Ali, Hunter, David J, Jones, Morgan, Levy, Bruce A, Mandl, Lisa A, Martin, Scott, Marx, Robert G, Safran-Norton, Clare, Roemer, Frank W, Skoniecki, Debra, Solomon, Daniel H, Spindler, Kurt P, Wright, John, Wright, Rick W, Losina, Elena
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Sprache:eng
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Zusammenfassung:Abstract This paper presents the rationale and design features of the MeTeOR Trial (Meniscal Tear in Osteoarthritis Research; Clinical Trials.gov NCT00597012). MeTeOR is an NIH-funded seven-center prospective randomized controlled trial (RCT) designed to establish the efficacy of arthroscopic partial meniscectomy combined with a standardized physical therapy program as compared with a standardized physical therapy program alone in patients with a symptomatic meniscal tear in the setting of mild to moderate knee osteoarthritic change (OA). The design and execution of a trial that compares surgery with a nonoperative treatment strategy presents distinctive challenges. The goal of this paper is to provide the clinical rationale for MeTeOR and to highlight salient design features, with particular attention to those that present clinical and methodologic challenges.
ISSN:1551-7144
1559-2030
DOI:10.1016/j.cct.2012.08.010