Department of Orthopaedics, Antwerp University Hospital, Wilrijkstraat 10, 2650, Edegem, Belgium.
Clinical Trial Center (CTC), CRC Antwerp, Antwerp University Hospital, University of Antwerp, Wilrijkstraat 10, 2650, Edegem, Belgium.
BMC Musculoskelet Disord. 2019 Nov 18;20(1):547. doi: 10.1186/s12891-019-2926-0.
The current gold standard for the treatment of an anterior cruciate ligament (ACL) rupture is reconstruction with tendon graft. Recently, two surgical ACL repair techniques have been developed for treating an acute ACL rupture: Dynamic Intraligamentary Stabilization (DIS, Ligamys®) and Internal Brace Ligament Augmentation (IBLA, InternalBrace™). We will conduct a single-blind, multi-center, randomized controlled trial which compares DIS, IBLA and reconstruction for relative clinical efficacy and economic benefit.
Subjects, aged 18-50 years, with a proximal, primary and repairable ACL rupture will be included. DIS is preferably performed within 4 weeks post-rupture, IBLA within 12 weeks and reconstruction after 4 weeks post-rupture. Patients are included in study 1 if they present within 0-4 weeks post-rupture and surgery is feasible within 4 weeks post-rupture. Patients of study 1 will be randomized to either DIS or IBLA. Patients are included in study 2 if they present after 4 weeks post-rupture and surgery is feasible between 5 and 12 weeks post-rupture. Patients of study 2 will be randomized to either IBLA or reconstruction. A total of 96 patients will be included, with 48 patients per study and 24 patients per study arm. Patients will be followed-up for 2 years. The primary outcome is change from baseline (pre-rupture) in International Knee Documentation Committee score to 6 months post-operatively. The main secondary outcomes are the EQ-5D-5 L, Tegner score, Lysholm score, Lachman test, isokinetic and proprioceptive measurements, magnetic resonance imaging outcome, return to work and sports, and re-rupture/failure rates. The statistical analysis will be based on the intention-to-treat principle. The economic impact of the surgery techniques will be evaluated by the cost-utility analysis. The LIBRƎ study is to be conducted between 2018 and 2022.
This LIBRƎ study protocol is the first study to compare DIS, IBLA and ACL reconstruction for relative clinical efficacy and economic benefit. The outcomes of this study will provide data which could aid orthopaedic surgeons to choose between the different treatment options for the surgical treatment of an acute ACL rupture.
This study is registered at ClinicalTrials.gov; NCT03441295. Date registered 13.02.2018.
目前治疗前交叉韧带（ACL）断裂的金标准是用肌腱移植物进行重建。最近，为治疗急性 ACL 断裂，已经开发了两种外科 ACL 修复技术：动态内韧带稳定术（DIS，Ligamys®）和内部支具韧带增强术（IBLA，InternalBrace™）。我们将进行一项单盲、多中心、随机对照试验，比较 DIS、IBLA 和重建术的相对临床疗效和经济效益。
纳入年龄在 18-50 岁之间、有近端、原发性和可修复性 ACL 断裂的受试者。DIS 最好在破裂后 4 周内进行，IBLA 在 12 周内进行，重建在破裂后 4 周内进行。如果患者在破裂后 0-4 周内就诊且在破裂后 4 周内可行手术，则患者将纳入研究 1。如果患者在破裂后 4 周以上就诊且在破裂后 5-12 周内可行手术，则患者将纳入研究 2。研究 1 的患者将随机分为 DIS 或 IBLA 组。研究 2 的患者将随机分为 IBLA 或重建组。共纳入 96 例患者，每组 48 例，每组 24 例。患者将随访 2 年。主要结局是国际膝关节文献委员会评分从基线（破裂前）到术后 6 个月的变化。主要次要结局是 EQ-5D-5L、Tegner 评分、Lysholm 评分、Lachman 试验、等速和本体感觉测量、磁共振成像结果、重返工作和运动以及再断裂/失败率。统计分析将基于意向治疗原则。通过成本效用分析评估手术技术的经济影响。LIBRƎ 研究计划于 2018 年至 2022 年进行。
本 LIBRƎ 研究方案是第一项比较 DIS、IBLA 和 ACL 重建术相对临床疗效和经济效益的研究。该研究的结果将为骨科医生提供数据，帮助他们在治疗急性 ACL 断裂的不同治疗方案之间做出选择。
本研究在 ClinicalTrials.gov 注册；NCT03441295。注册日期 2018 年 2 月 13 日。
