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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.

Original languageEnglish
Pages (from-to)605-615
Number of pages11
JournalThe Lancet
Volume400
Issue number10352
DOIs
Publication statusPublished - 20 Aug 2022

Bibliographical note

Funding Information:
The ACL SNNAP study was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (HTA 14/140/63). The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NHS, the NIHR, Medical Research Council, Central Commissioning Facility, NIHR Evaluation, Trials, and Studies Coordinating Centre, the NIHR HTA Programme or the Department of Health. The study sponsor is the University of Oxford (Oxford, UK). The study was managed by the Oxford Surgical Intervention Trials Unit (SITU) in collaboration with the Oxford Clinical Trials Research Unit. SITU is supported by the Royal College of Surgeons (RCS) Surgical Trials Initiative and the Oxford NIHR Biomedical Research Centre. DJB's RCS Trials Chair is supported by the Rosetrees Trust. The authors wish to thank the PIs and their teams at each of the ACL SNNAP sites.

Funding Information:
The ACL SNNAP study was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (HTA 14/140/63). The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NHS, the NIHR, Medical Research Council, Central Commissioning Facility, NIHR Evaluation, Trials, and Studies Coordinating Centre, the NIHR HTA Programme or the Department of Health. The study sponsor is the University of Oxford (Oxford, UK). The study was managed by the Oxford Surgical Intervention Trials Unit (SITU) in collaboration with the Oxford Clinical Trials Research Unit. SITU is supported by the Royal College of Surgeons (RCS) Surgical Trials Initiative and the Oxford NIHR Biomedical Research Centre. DJB's RCS Trials Chair is supported by the Rosetrees Trust. The authors wish to thank the PIs and their teams at each of the ACL SNNAP sites.

Publisher Copyright:
© 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license

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