Rehabilitation versus surgical reconstruction for non-acute anterior cruciate ligament injury (ACL SNNAP): a pragmatic randomised controlled trial
David Beard, Loretta Davies, Jonathan Cook, Jamie Stokes, José Leal, Heidi Fletcher, Simon Abram, Katie Chegwin, Akiko Greshon, William F. Jackson, Nicholas Bottomley, Matt Dodd, Henry Bourke, Beverly A. Shirkey, Arsenio Páez, Sarah E Lamb, Karen Barker, Michael Phillips, Mark T. Brown, Vanessa Lythe, Burhan Mirza, Andrew Carr, Paul Monk, Carlos Areia, Sean O’Leary, Fares S. Haddad, Chris Wilson, Andrew Price, Richard Emsley, George Peat, Martyn Snow, Marion Campbell, Tessa Howell, Hilary Johnson, Stephen McDonnell, Thomas Pinkney, Mark R. Williams, Helen Campbell, Jackie Davies, Jiyang Li, C. Bagg, Laura Haywood, Anne Nicholson, Joanne Riches, Sean Symons, Mark Vertue, Louay Al Mouazzen, Rachel Bray, Damian Clark, James Coulthard, T. J. B. Holland, Nick Howells, Andrew K. Jones, Richard Kapur, Alastair Kiszely, Harry Krishnan, Karen MacDonald-Taylor, Jon Manara, James L. Murray, Corina Negrut, Vishai Pai, Andrew Porteous, Sven Putnis, James L. Robinson, Shav Rupasinghe, Veenesh Selvaratnam, James Q. Smith, Nick Smith, Jarrad Stevens, Clare Taylor, Anthony Theodorides, Niraj Vetharajan, Helen Vint, Lucy H. Young, S Bullock, Rebecca Cook, Alexander L. Dodds, Amanda Freeman-Hicks, Paula Hillout, Thomas Cornell, Abbie Coutts, Suzy Dean, Nicki Devooght-Johnson, Emma Ferrell, Eve Fletcher, Chrissie Hall, Benjamin Kent, Sandra Kessly, Robin Kincaid, Mohamed Lazizi, Ahmed Mostafa, Toby Nisbett, Timothy J. Powell, P Riddlestone, Andrew Roberton, Jessica J. Summers, Lucy Whitbread, Belinda Wroath, Emma Fenlon, Andrew Hall
Abstract
BACKGROUND: Anterior cruciate ligament (ACL) rupture is a common debilitating injury that can cause instability of the knee. We aimed to investigate the best management strategy between reconstructive surgery and non-surgical treatment for patients with a non-acute ACL injury and persistent symptoms of instability. METHODS: We did a pragmatic, multicentre, superiority, randomised controlled trial in 29 secondary care National Health Service orthopaedic units in the UK. Patients with symptomatic knee problems (instability) consistent with an ACL injury were eligible. We excluded patients with meniscal pathology with characteristics that indicate immediate surgery. Patients were randomly assigned (1:1) by computer to either surgery (reconstruction) or rehabilitation (physiotherapy but with subsequent reconstruction permitted if instability persisted after treatment), stratified by site and baseline Knee Injury and Osteoarthritis Outcome Score-4 domain version (KOOS4). This management design represented normal practice. The primary outcome was KOOS4 at 18 months after randomisation. The principal analyses were intention-to-treat based, with KOOS4 results analysed using linear regression. This trial is registered with ISRCTN, ISRCTN10110685, and ClinicalTrials.gov, NCT02980367. FINDINGS: Between Feb 1, 2017, and April 12, 2020, we recruited 316 patients. 156 (49%) participants were randomly assigned to the surgical reconstruction group and 160 (51%) to the rehabilitation group. Mean KOOS4 at 18 months was 73·0 (SD 18·3) in the surgical group and 64·6 (21·6) in the rehabilitation group. The adjusted mean difference was 7·9 (95% CI 2·5-13·2; p=0·0053) in favour of surgical management. 65 (41%) of 160 patients allocated to rehabilitation underwent subsequent surgery according to protocol within 18 months. 43 (28%) of 156 patients allocated to surgery did not receive their allocated treatment. We found no differences between groups in the proportion of intervention-related complications. INTERPRETATION: Surgical reconstruction as a management strategy for patients with non-acute ACL injury with persistent symptoms of instability was clinically superior and more cost-effective in comparison with rehabilitation management. FUNDING: The UK National Institute for Health Research Health Technology Assessment Programme.