手术重建治疗非急性前交叉韧带损伤患者优于康复治疗

　　本期文章： 《柳叶刀》：Volume 400 Number 10352

　　英国牛津大学David J Beard团队比较了非急性前交叉韧带损伤的康复与手术重建的疗效与安全性。相关论文于2022年8月20日发表在《柳叶刀》杂志上。

　　前交叉韧带（ACL）断裂是一种常见的致残性损伤，可导致膝关节不稳定。课题组旨在研究非急性ACL损伤和持续不稳定症状患者的重建手术和非手术治疗之间的最佳管理策略。

　　研究组在英国29个二级保健国家卫生服务骨科单位进行了一项务实、多中心、优越性、随机对照试验。符合ACL损伤的症状性膝关节问题（不稳定）患者符合条件。研究组排除了需要立即手术的半月板病变患者。

　　通过计算机将患者随机分配（1:1）到手术（重建）组或康复组（物理治疗，但如果治疗后不稳定持续存在，则允许随后的手术重建），根据部位和基线膝关节损伤和骨关节炎结果评分-4域版本（KOOS4）进行分层。这种管理设计代表了正常实践。主要结局是随机分组后18个月的KOOS4。主要分析基于意向治疗，使用线性回归分析KOOS4结果。

　　2017年2月1日至2020年4月12日，研究组招募了316名患者。156名（49%）被随机分配到外科重建组，160名（51%）被分配到康复组。18个月时，手术组的平均KOOS4为73.0，康复组为64.6。组间差异显著，校正后的平均差异为7.9，有利于手术治疗。

　　160名康复患者中有6植物壮根素含激素吗5名（41%）在18个月内按照方案进行了后续手术。156名手术患者中有43名（28%）未接受分配的治疗。研究组发现两组之间干预相关并发症的发生率没有差异。

　　研究结果表明，与康复治疗相比，手术重建作为非急性前交叉韧带损伤伴持续不稳定症状患者的治疗策略在临床上更优越，更具成本效益。

　　附：英文原文

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

　　Author: David J Beard, Loretta Davies, Jonathan A Cook, Jamie Stokes, Jose Leal, Heidi Fletcher, Simon Abram, Katie Chegwin, Akiko Greshon, William Jackson, Nicholas Bottomley, Matt Dodd, Henry Bourke, Beverly A Shirkey, Arsenio Paez, Sarah E Lamb, Karen Barker, Michael Phillips, Mark Brown, Vanessa Lythe, Burhan Mirza, Andrew Carr, Paul Monk, Carlos Morgado Areia, Sean OLeary, Fares Haddad, Chris Wilson, Andrew Price, Richard Emsley, George Peat, Martyn Snow, Marion Campbell, Tessa Howell, 植物壮根素商家批发Hilary Johnson, Stephen McDonnell, Thomas Pinkney, Mark Williams, Helen Campbell, Jackie Davies, Jiyang Li, Christina Bagg, Laura Haywood, Anne Nicholson, Joanne Riches, Sean Symons, Mark Vertue, Louay Al Mouazzen, Rachel Bray, Damian Clark, James Coulthard, Tim Holland, Nick Howells, Andrew Jones, Richard Kapur, Alastair Kiszely, Harry Krishnan, Karen MacDonald-Taylor, Jon Manara, James Murray, Corina Negrut, Vishai Pai, Andrew Porteous, Sven Putnis, James Robinson, Shav Rupasinghe, Veenesh Selvaratnam, James Smith, Nick Smith, Jarrad Stevens, Clare Taylor, Anthony Theodorides, Niraj Vetharajan, Helen Vint, Lucy Young, Susan Bullock, Rebecca Cook, Alexander 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, Tim Powell, Peter Riddlestone, Andrew Roberton, Jessica Summers, Lucy Whitbread, Belinda Wroath, Emma Fenlon, Andrew Hall, Helen Jeffrey, Raghuram Thonse, Debra Dunne, Andy Metcalfe, Kerri McGowan, Simon Middleton, Feisal Shah, Tim Spalding, Charlie Marie Suddens, Tamar Sweed, Joanna Teuke, Peter Thompson, David Wright, Justine Amero, Emma Brown, Hugh Chissell, Andrea Croucher, Gareth Dickinson, Catherine Hawkes-Blackburn, Alice Peacocke, Graham Smith

　　Issue&Volume: 2022/08/20

　　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植物壮根素药店有买不%) 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.

　　DOI: 10.1016/S0140-673植物壮根素功效及副作用 6(22)01424-6

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