Anterior cruciate ligament reconstruction combined with anterolateral ligament reconstruction using hamstring autograft versus anterior cruciate ligament reconstruction using bone–patellar tendon–bone autograft: a randomised controlled trial with 5-year follow-up

IF 15.7 Q1 HEALTH CARE SCIENCES & SERVICES

Lancet Regional Health-Europe Pub Date : 2026-03-01 Epub Date: 2025-12-20 DOI:10.1016/j.lanepe.2025.101561

Bertrand Sonnery-Cottet , Alessandro Carrozzo , Hervé Poilvache , Jean-Marie Fayard , Benjamin Freychet , Mathieu Thaunat , Thais Dutra Vieira , Adnan Saithna

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引用次数: 0

Abstract

Background

Anterior Cruciate Ligament (ACL) rupture is common knee injury. Although ACL reconstruction (ACLR) is standard, graft failure rates remain high in young active patients. This study investigated whether combining ACLR with anterolateral ligament (ALL) reconstruction (ALLR) reduces grafts failure compared with ACLR.

Methods

In this prospective, single-centre, randomised controlled trial conducted at the Santy Orthopedic Center in Lyon, France, patients aged 18–35 years with symptomatic ACL rupture were randomly allocated (1:1) to ACL + ALL reconstruction using hamstring tendon autograft (ACLR + ALLR) or ACLR with bone-patellar tendon-bone autograft (ACLR). Randomisation was performed with a block size of four using telematic software by an independent study coordinator, with concealed allocation. Surgeons were informed of the assigned procedure on the morning of surgery. Outcome assessors were not blinded. The primary outcome was graft failure at 5 years, assessed clinically and by magnetic resonance imaging (MRI) by an independent sports medicine physicians not involved in the index surgery. Efficacy analyses were performed on the Full Analysis Set in accordance with the intention-to-treat principle, while safety analyses were conducted on the Safety Set. Trial registration: ClinicalTrials.gov, ID NCT03740022. The trial has been completed.

Findings

Between November 11, 2016, and January 20, 2020, 593 patients were randomized (297 assigned to ACLR + ALLR and 296 to ACLR). The mean age was 25.0 years (SD 4.5); 447 (75%) participants were male and 146 (25%) female. Of these 593 patients, 556 (94%) completed a mean 5-year follow-up. Graft failure occurred in 12/283 (4.2%) with ACLR + ALLR versus 28/273 (10.3%) with ACLR (p = 0.006; adjusted odds ratio 2.54 [95% CI 1.27; 5.36]—p = 0.008). The number needed to treat was 17 overall, and 9 in patients younger than 25 years.

Interpretation

In our study of young, active adults with ACL rupture, who are considered high-risk for graft failure, combining ACL reconstruction with anterolateral ligament reconstruction (ACLR + ALLR) significantly decreased graft failure compared with ACLR. These results suggest that ACLR + ALLR might be beneficial for young or highly active individuals and provide a basis for future research to refine patient selection, evaluate long-term outcomes beyond five years, and explore benefits in other subgroups of patients with ACL injuries.

Funding

GCS Ramsay Santé pour l'Enseignement et la Recherche funds the scientific activity at the Santy center.

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前交叉韧带重建联合前外侧韧带重建采用腘绳肌腱自体移植物与前交叉韧带重建采用骨-髌腱-骨自体移植物：一项5年随访的随机对照试验

前交叉韧带（ACL）断裂是常见的膝关节损伤。虽然前交叉韧带重建（ACLR）是标准的，但在年轻的活跃患者中移植物失败率仍然很高。本研究探讨与ACLR相比，ACLR联合前外侧韧带（ALL）重建（ALLR）是否能减少移植物衰竭。方法在法国里昂的Santy骨科中心进行的这项前瞻性、单中心、随机对照试验中，年龄在18-35岁的有症状的ACL断裂患者被随机分配（1:1）到ACL + ALL重建使用腘绳肌腱自体移植物（ACLR + ALLR）或ACLR结合骨-髌骨肌腱-骨自体移植物（ACLR）。随机分组由独立研究协调员使用远程信息处理软件进行，分组大小为4个，并进行隐蔽分配。外科医生在手术当天早上被告知指定的手术程序。结果评估者没有采用盲法。主要结果是5年时移植物失败，由独立的运动医学医生通过临床和磁共振成像（MRI）评估，该医生没有参与指数手术。根据意向治疗原则对全分析集进行疗效分析，对安全集进行安全性分析。试验注册：ClinicalTrials.gov，编号NCT03740022。审判已经结束。在2016年11月11日至2020年1月20日期间，593例患者被随机分配（297例分配到ACLR + ALLR， 296例分配到ACLR）。平均年龄25.0岁（SD 4.5）；447名（75%）参与者为男性，146名（25%）参与者为女性。在这593例患者中，556例（94%）完成了平均5年的随访。ACLR + ALLR组的移植失败发生率为12/283(4.2%)，而ACLR组的移植失败发生率为28/273 (10.3%)（p = 0.006；校正优势比2.54 [95% CI 1.27; 5.36] -p = 0.008）。需要治疗的总人数为17人，25岁以下的患者为9人。在我们的研究中，年轻、活跃的成年ACL破裂患者被认为是移植物失败的高危人群，与ACLR相比，ACL重建联合前外侧韧带重建（ACLR + ALLR）可显著减少移植物失败。这些结果表明，ACLR + ALLR可能对年轻或高度活跃的个体有益，并为未来的研究提供基础，以完善患者选择，评估5年以上的长期结果，并探索其他亚组ACL损伤患者的益处。gcs Ramsay sant pour l’enseignement et la Recherche为圣中心的科学活动提供资金。

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来源期刊

Lancet Regional Health-Europe Multiple-

CiteScore

19.90

自引率

1.40%

发文量

260

审稿时长

9 weeks

期刊介绍： The Lancet Regional Health – Europe, a gold open access journal, is part of The Lancet's global effort to promote healthcare quality and accessibility worldwide. It focuses on advancing clinical practice and health policy in the European region to enhance health outcomes. The journal publishes high-quality original research advocating changes in clinical practice and health policy. It also includes reviews, commentaries, and opinion pieces on regional health topics, such as infection and disease prevention, healthy aging, and reducing health disparities.