title: OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for primary prevention of osteoarthritis by joint injury prevention in sport and recreation.
abstract: The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform the design, conduct and analytical approaches to RCTs evaluating the preventative effect of joint injury prevention strategies. Recommendations regarding the design, conduct, and reporting of RCTs evaluating injury prevention interventions were established based on the consensus of nine researchers internationally with expertise in epidemiology, injury prevention and/or osteoarthritis (OA). Input and resultant consensus was established through teleconference, face to face and email correspondence over a 1 year period. Recommendations for injury prevention RCTs include context specific considerations regarding the research question, research design, study participants, randomization, baseline characteristics, intervention, outcome measurement, analysis, implementation, cost evaluation, reporting and future considerations including the impact on development of PTOA. Methodological recommendations for injury prevention RCTs are critical to informing evidence-based practice and policy decisions in health care, public health and the community. Recommendations regarding the interpretation and conduct of injury prevention RCTs will inform the highest level of evidence in the field. These recommendations will facilitate between study comparisons to inform best practice in injury prevention that will have the greatest public health impact.
authors.affiliation: Sport Injury Prevention Research Centre, Faculty of Kinesiology and Alberta Children's Hospital Research Institute for Child and Maternal Health, Faculty of Medicine, University of Calgary, Calgary, Canada. Electronic address: caemery@ucalgary.ca.
authors.forename: C A
authors.initials: CA
authors.lastname: Emery
authors.affiliation: Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Denmark. Electronic address: eroos@health.sdu.dk.
authors.forename: E M
authors.initials: EM
authors.lastname: Roos
authors.affiliation: Department of Public and Occupational Health of the VU University Medical Center and EMGO Institute, Amsterdam, The Netherlands. Electronic address: e.verhagen@vumc.nl.
authors.forename: E
authors.initials: E
authors.lastname: Verhagen
authors.affiliation: Centre for Healthy and Safe Sport, Federation University Australia, Ballarat, Australia. Electronic address: c.finch@federation.edu.au.
authors.forename: C F
authors.initials: CF
authors.lastname: Finch
authors.affiliation: Centre for Health, Exercise and Sports Medicine, Melbourne School of Health Sciences, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Australia. Electronic address: k.bennell@unimelb.edu.au.
authors.forename: K L
authors.initials: KL
authors.lastname: Bennell
authors.affiliation: DePuy Synthes, Mitek Sports Medicine, Raynham, MA, USA. Electronic address: bstory1@ts.jnj.com.
authors.forename: B
authors.initials: B
authors.lastname: Story
authors.affiliation: Research in the Orthopaedic & Rheumatologic Institute, Cleveland Clinic, Cleveland, OH, USA. Electronic address: kurt.spindler@vanderbilt.edu.
authors.forename: K
authors.initials: K
authors.lastname: Spindler
authors.affiliation: Australian Centre for Research into Injury in Sport and its Prevention (ACRISP), Federation University, Australia. Electronic address: j.kemp@federation.edu.au.
authors.forename: J
authors.initials: J
authors.lastname: Kemp
authors.affiliation: Department of Clinical Science, Lund University, Lund, Sweden. Electronic address: Stefan.lohmander@med.lu.se.
authors.forename: L S
authors.initials: LS
authors.lastname: Lohmander
mesh_terms: D001265:Athletic Injuries / Q000150:complications* / Q000517:prevention & control; D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D007596:Joints / Q000293:injuries*; D010003:Osteoarthritis / Q000209:etiology / Q000517:prevention & control*; D017410:Practice Guidelines as Topic; D011322:Primary Prevention / Q000592:standards*
keywords: Injury prevention; Osteoarthritis; Randomized controlled trial; Recommendations