Department of Orthopaedic Surgery, Western Health, Footscray Hospital, Level 1 South, Gordon St, Footscray, Melbourne, VIC, 3011, Australia.
Trials. 2023 Mar 24;24(1):224. doi: 10.1186/s13063-023-07127-0.
Anterior cruciate ligament (ACL) reconstruction aims to restore anteroposterior and rotatory stability to the knee following ACL injury. This requires the graft to withstand the forces applied during the process of ligamentisation and the rehabilitative period. We hypothesise that the use of suture tape augmentation of single bundle ACL reconstruction (ACLR) will reduce residual knee laxity and improve patient-reported outcomes at 2-year follow-up. We will conduct a 1:1 parallel arm single-centre randomised controlled trial comparing suture tape augmented ACLR to standard ACLR technique.
The study design will be a parallel arm 1:1 allocation ratio randomised controlled trial. Sixty-six patients aged 18 and over waitlisted for primary ACLR will be randomised. Patients requiring osteotomy and extra-articular tenodesis and who have had previous contralateral ACL rupture or repair of meniscal or cartilage pathology that modifies the post-operative rehabilitation will be excluded. The primary outcome measure will be the side-to-side difference in anterior tibial translation (measured on the GNRB arthrometer) at 24 months post-surgery. GNRB arthrometer measures will also be taken preoperatively, at 3 months and 12 months post-surgery. Secondary outcomes will include patient-reported outcome measures (PROMs) collected online, including quality of life, activity and readiness to return to sport, complication rates (return to theatre, graft failure and rates of sterile effusion), examination findings and return to sport outcomes. Participants will be seen preoperatively, at 6 weeks, 3 months, 12 months and 24 months post-surgery. Participants and those taking arthrometer measures will be blinded to allocation.
This will be the first randomised trial to investigate the effect of suture-tape augmentation of ACLR on either objective or subjective outcome measures. The use of suture-tape augmentation in ACLR has been associated with promising biomechanical and animal-level studies, exhibiting equivalent complication profiles to the standard technique, with initial non-comparative clinical studies establishing possible areas of advantage for the technique. The successful completion of this trial will allow for an improved understanding of the in situ validity of tape augmentation whilst potentially providing a further platform for surgical stabilisation of the ACL graft.
Australia New Zealand Clinical Trial Registry ACTRN12621001162808. Universal Trial Number (UTN): U1111-1268-1487. Registered prospectively on 27 August 2021.
前交叉韧带（ACL）重建旨在在 ACL 损伤后恢复膝关节的前后和旋转稳定性。这需要移植物能够承受韧带形成过程中和康复期间施加的力。我们假设使用缝线带增强单束 ACL 重建（ACLR）将减少膝关节残余松弛度并改善患者在 2 年随访时的报告结果。我们将进行一项 1:1 平行臂单中心随机对照试验，比较缝线带增强 ACLR 与标准 ACLR 技术。
研究设计将是一项平行臂 1:1 分配比随机对照试验。66 名年龄在 18 岁及以上、等待接受初次 ACLR 的患者将被随机分组。需要截骨和关节外肌腱固定术的患者以及有对侧 ACL 断裂或半月板或软骨病理修复史的患者，这些病理改变了术后康复过程，将被排除在外。主要结局测量指标将是术后 24 个月时胫骨前移的侧间差异（使用 GNRB 关节计测量）。GNRB 关节计还将在术前、术后 3 个月和 12 个月进行测量。次要结局将包括在线收集的患者报告结局测量（PROM），包括生活质量、活动和重返运动的准备情况、并发症发生率（重返手术室、移植物失败和无菌性渗出液发生率）、检查结果和重返运动结果。参与者将在术前、术后 6 周、3 个月、12 个月和 24 个月进行随访。参与者和进行关节计测量的人员将对分组情况进行盲法。
这将是第一项旨在研究缝线带增强 ACLR 对客观或主观结局测量的效果的随机试验。缝线带在 ACLR 中的应用与有前途的生物力学和动物水平研究相关，其并发症谱与标准技术相当，最初的非对照临床研究为该技术可能的优势领域提供了证据。这项试验的成功完成将使我们更好地了解带增强的体内有效性，同时可能为 ACL 移植物的进一步手术稳定提供一个平台。
澳大利亚和新西兰临床试验注册 ACTRN12621001162808。通用试验编号（UTN）：U1111-1268-1487。于 2021 年 8 月 27 日前瞻性注册。
