Department of Orthopaedics and Traumatology, University Hospital Basel, Basel, Switzerland
Department of Biomedical Engineering, University of Basel, Allschwil, Switzerland.
BMJ Open. 2022 Feb 1;12(2):e054709. doi: 10.1136/bmjopen-2021-054709.
Despite good clinical outcomes reported in the literature, to date, scientific evidence for the functional and biomechanical benefit of primary anterior cruciate ligament (ACL) repair with augmentation is scarce. We present an experimental protocol for a detailed multimodal (clinical, socioeconomic, functional and biomechanical) comparative study in patients after primary ACL repair and InternalBrace augmentation, patients after ACL reconstruction and healthy controls.
In this non-randomised single-centre comparative study with prospective data collection with three arms (patients 2 years after ACL repair and InternalBrace augmentation; patients 2 years after ACL reconstruction using hamstring autografts; and healthy controls), 30 participants per study arm will be included. The study is designed as non-inferiority study with three arms. Required sample size was estimated based on data reported in the literature on muscle strength, proprioception and balance parameters, resulting in at least 28 participants per group. Outcome parameters include patient-reported outcome measures (EQ-5D-5L, Tegner Activity Scale, Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee and ACL-Return to Sports Injury Scale), socio-economic parameters, anterior tibial translation, range of motion and functional-biomechanical data of the lower extremities. Functional-biomechanical parameters include proprioception, isokinetic muscle strength, single-leg balance, walking, running and single-leg hops with additional lower extremity 3D joint kinematics and kinetics and muscle activity. These parameters will be compared between limbs in patients, between groups and to the current literature.
The results of this study will be disseminated through peer-reviewed publications and presentations at national and international conferences. Ethical approval was obtained by the regional ethics board (Ethics Committee Northwest Switzerland EKNZ 2020-00551), and the study is registered at clinicaltrials.gov.Trial registration numberNCT04429165.
尽管文献中报道了良好的临床结果，但迄今为止，关于原发性前交叉韧带（ACL）修复加增强的功能和生物力学益处的科学证据仍然很少。我们提出了一项详细的多模态（临床、社会经济学、功能和生物力学）比较研究的实验方案，该研究涉及原发性 ACL 修复和 InternalBrace 增强后的患者、ACL 重建后和健康对照组的患者。
这是一项非随机、单中心、前瞻性数据收集的比较研究，分为三组（ACL 修复和 InternalBrace 增强后 2 年的患者；使用自体腘绳肌腱重建 ACL 后 2 年的患者；和健康对照组），每组 30 名参与者。该研究设计为具有三个臂的非劣效性研究。根据文献中关于肌肉力量、本体感觉和平衡参数的报道，估计所需的样本量，每组至少需要 28 名参与者。主要结果包括患者报告的结果测量（EQ-5D-5L、Tegner 活动量表、膝关节损伤和骨关节炎结果评分（KOOS）、国际膝关节文献委员会和 ACL-重返运动损伤量表）、社会经济学参数、胫骨前平移、活动范围和下肢的功能-生物力学数据。功能-生物力学参数包括本体感觉、等速肌肉力量、单腿平衡、步行、跑步和单腿跳跃，以及下肢的 3D 关节运动学和动力学以及肌肉活动。这些参数将在患者的肢体之间、组之间以及与当前文献进行比较。
本研究的结果将通过同行评议的出版物和在国家和国际会议上的演讲进行传播。该研究已获得地区伦理委员会（瑞士西北伦理委员会 EKNZ 2020-00551）的批准，并在 clinicaltrials.gov 上注册。试验注册号 NCT04429165。
