Recruitment and baseline characteristics of young adults at risk of early-onset knee osteoarthritis after ACL reconstruction in the SUPER-Knee trial

Objectives The study aims to (1) report the process of recruiting young adults into a secondary knee osteoarthritis prevention randomised controlled trial (RCT) after anterior cruciate ligament reconstruction (ACLR); (2) determine the number of individuals needed to be screened to include one partic...

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Main Authors: Ewa M Roos, Christian J Barton, Kay M Crossley, Edwin H G Oei, Matthew Alexander, Brooke E Patterson, Adam G Culvenor, Matthew Evans, Peter Choong, Richard Page, Steven M McPhail, Mark J Scholes, Andrea M Bruder, Susan Liew, Peter Schoch, Emily Cross, Ashley Carr, Richard B Souza, Libby Spiers, Phong Tran, Raphael Hau, Nathan White, Michael A Girdwood, Justin Wong, Melissa Haberfield, Thomas J West, Jusuk Lee, Jamon L Couch, Andrew Hardidge, Laura To, Lara Kimmel, Chris Cimoli, Leanne Roddy, Katelyn Bailey, Leonie Lewis, Hayden Morris, Dirk van Bavel, Simon Talbot, Richard Kjar, Luke Spencer, Sebastian Evans
Format: Article
Language:English
Published: BMJ Publishing Group 2024-04-01
Series:BMJ Open Sport & Exercise Medicine
Online Access:https://bmjopensem.bmj.com/content/10/2/e001909.full
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Summary:Objectives The study aims to (1) report the process of recruiting young adults into a secondary knee osteoarthritis prevention randomised controlled trial (RCT) after anterior cruciate ligament reconstruction (ACLR); (2) determine the number of individuals needed to be screened to include one participant (NNS) and (3) report baseline characteristics of randomised participants.Methods The SUpervised exercise-therapy and Patient Education Rehabilitation (SUPER)-Knee RCT compares SUPER and minimal intervention for young adults (aged 18–40 years) with ongoing symptoms (ie, mean score of <80/100 from four Knee injury and Osteoarthritis Outcome Score subscales (KOOS4)) 9–36 months post-ACLR. The NNS was calculated as the number of prospective participants screened to enrol one person. At baseline, participants provided medical history, completed questionnaires (demographic, injury/surgery, rehabilitation characteristics) and underwent physical examination.Results 1044 individuals were screened to identify 567 eligible people, from which 184 participants (63% male) enrolled. The sample of enrolled participants was multicultural (29% born outside Australia; 2% Indigenous Australians). The NNS was 5.7. For randomised participants, mean±SD age was 30±6 years. The mean body mass index was 27.3±5.2 kg/m2, with overweight (43%) and obesity (21%) common. Participants were, on average, 2.3 years post-ACLR. Over half completed <8 months of postoperative rehabilitation, with 56% having concurrent injury/surgery to meniscus and/or cartilage. The most affected KOOS (0=worst, 100=best) subscale was quality of life (mean 43.7±19.1).Conclusion Young adults post-ACLR were willing to participate in a secondary osteoarthritis prevention trial. Sample size calculations should be multiplied by at least 5.7 to provide an estimate of the NNS. The SUPER-Knee cohort is ideally positioned to monitor and intervene in the early development and trajectory of osteoarthritis.Trial registration number ACTRN12620001164987.
ISSN:2055-7647