RetroBRACE: clinical, socioeconomic and functional-biomechanical outcomes 2 years after ACL repair and InternalBrace augmentation in comparison to ACL reconstruction and healthy controls-experimental protocol of a non-randomised single-centre comparative study.

Abstract

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.