title: The feasibility of randomized controlled trials for early arthritis therapies (Earth) involving acute anterior cruciate ligament tear cohorts.
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.
authors.affiliation: University of Pittsburgh, PA 15213, USA. ConstanceRChu@gmail.com
authors.forename: Constance R
authors.initials: CR
authors.lastname: Chu
authors.forename: Bruce D
authors.initials: BD
authors.lastname: Beynnon
authors.forename: Jason L
authors.initials: JL
authors.lastname: Dragoo
authors.forename: Glenn S
authors.initials: GS
authors.lastname: Fleisig
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Hart
authors.forename: Michael
authors.initials: M
authors.lastname: Khazzam
authors.forename: Kevin M
authors.initials: KM
authors.lastname: Marberry
authors.forename: Bradley J
authors.initials: BJ
authors.lastname: Nelson
mesh_terms: D000293:Adolescent; D000328:Adult; D000070598:Anterior Cruciate Ligament Injuries; D015331:Cohort Studies; D005260:Female; D006801:Humans; D007718:Knee Injuries / Q000150:complications* / Q000628:therapy; D008297:Male; D020370:Osteoarthritis, Knee / Q000209:etiology / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic; D018401:Sample Size; D055815:Young Adult