Rehabilitation versus surgical reconstruction for non-acute anterior cruciate ligament injury (ACL SNNAP): a pragmatic randomised controlled trial

被引：68

作者：

Beard, David J. ^{[1
]}

Davies, Loretta ^{[1
]}

Cook, Jonathan A. ^{[1
]}

Stokes, Jamie ^{[1
]}

Leal, Jose ^{[2
]}

Fletcher, Heidi ^{[1
]}

Abram, Simon ^{[1
]}

Chegwin, Katie ^{[1
]}

Greshon, Akiko ^{[1
]}

Jackson, William ^{[3
]}

Bottomley, Nicholas ^{[3
]}

Dodd, Matt ^{[5
]}

Bourke, Henry ^{[6
]}

Shirkey, Beverly A. ^{[1
]}

Paez, Arsenio ^{[1
]}

Lamb, Sarah E. ^{[4
]}

Barker, Karen ^{[3
]}

Phillips, Michael ^{[7
]}

Brown, Mark ^{[7
]}

Lythe, Vanessa ^{[2
]}

Mirza, Burhan ^{[2
]}

Carr, Andrew ^{[1
]}

Monk, Paul ^{[1
]}

Areia, Carlos Morgado ^{[1
]}

O'Leary, Sean ^{[8
]}

Haddad, Fares ^{[9
]}

Wilson, Chris ^{[10
,11
]}

Price, Andrew ^{[1
]}

机构：

[1] Univ Oxford, Nuffield Dept Orthopaed Rheumatobgy & Musculoskel, Botnar Res Ctr, Oxford OX3 7LD, England

[2] Univ Oxford, Nuffield Dept Populat Hlth, Oxford, England

[3] Oxford Univ Hosp NHS Fdn Trust, Nuffield Orthopaed Ctr, Oxford, England

[4] Univ Exeter, Coll Med & Hlth, Swansea, W Glam, Wales

[5] Swansea Bay Univ Hlth Board, Swansea, W Glam, Wales

[6] Frimley Hlth NHS Fdn Trust, Heatherwood & Wexham Pk Hosp, Slough, Berks, England

[7] Fr3dont UK, Brighton, E Sussex, England

[8] Royal Berkshire NHS Fdn Trust, Royal Berkshire Hosp, Reading, Berks, England

[9] Univ Coll London Hosp NHS Fdn Trust, Univ Coll Hosp, London, England

[10] Univ Hosp Wales, Cardiff, Wales

[11] Vale Univ Hlth Board, Cardiff, Wales

来源：

LANCET | 2022年 / 400卷 / 10352期

基金：

英国医学研究理事会;

关键词：

SURGERY; RUPTURE;

D O I：

10.1016/S0140-6736(22)01424-6

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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

引用

页码：605 / 615

页数：11

共 28 条

[1] Anterior cruciate ligament (ACL) reconstruction and meniscal repair rates have both increased in the past 20 years in England: hospital statistics from 1997 to 2017 [J].