The feasibility of randomized controlled trials for early arthritis therapies (EARTH) involving acute anterior cruciate ligament tear cohorts

Constance R. Chu, Bruce D. Beynnon, Jason L. Dragoo, Glenn S. Fleisig, Joseph M. Hart, Michael S Khazzam, Kevin M. Marberry, Bradley J. Nelson

Research output: Contribution to journalArticle

7 Scopus citations

Abstract

Osteoarthritis (OA) is a leading cause of disability for which disease-modifying treatments are lacking. Anterior cruciate ligament (ACL) tear provides opportunities to study potential interventions from the initiation of heightened OA risk at the time of injury. This institutional review board (IRB)-approved prospective cross-sectional study (level of evidence: 2) was performed to test the hypothesis that adequate sample sizes of ACL-injured subjects to support randomized controlled trials (RCT) of early intervention strategies can be achieved. A total of 307 ACL-injured patients were entered into the database from 3-month collection periods at 7 clinical sites, with 65 subjects aged 18 to 30 years passing the inclusion/exclusion criteria. From sites that were IRB approved to ask, 89 of 96 (93%) subjects were willing to participate in an RCT. Extrapolating the 3-month data to a 1-year recruitment period would potentially yield 242 subjects aged 18 to 30 years willing to undergo randomization. This study shows that adequate sample sizes to perform RCT of early intervention strategies in ACL-injured cohorts comprising healthy young adults ages 18 to and 30 without prior joint injuries can be achieved within 1 to 2 years through recruitment at 5 to 7 orthopaedic sports medicine practices. Continued development of ACL-tear cohorts will provide the clinical base to critically evaluate new diagnostic and therapeutic strategies that can help transform clinical care of OA from palliation to prevention.

Original languageEnglish (US)
Pages (from-to)2648-2652
Number of pages5
JournalAmerican Journal of Sports Medicine
Volume40
Issue number11
DOIs
StatePublished - Nov 1 2012

Keywords

  • anterior cruciate ligament tear (ACL, ACLT)
  • clinical trials
  • disease modifying OA drugs (DMOAD)
  • osteoarthritis (OA)
  • randomized controlled trial (RCT)

ASJC Scopus subject areas

  • Orthopedics and Sports Medicine
  • Physical Therapy, Sports Therapy and Rehabilitation

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