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

IntroductionDespite 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.Methods and analysisIn 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.Ethics and disseminationThe 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.

Comparison of proprioception recovery following anterior cruciate ligament reconstruction using an artificial graft versus an autograft

“…Much more attention has been paid to proprioception related to rehabilitation and gait than to the surgery associated with the injury. To improve long-term function, physicians have established rehabilitation programs for patients that focus not only on range of motion and strengthening exercises but also on proprioceptive and neuromuscular control drills [ 20 , 32 – 34 ]. Müller et al showed that a functional neuromuscular training program was more effective than traditional muscle strength rehabilitation programs in improving function [ 34 ].…”

“…To improve long-term function, physicians have established rehabilitation programs for patients that focus not only on range of motion and strengthening exercises but also on proprioceptive and neuromuscular control drills [ 20 , 32 – 34 ]. Müller et al showed that a functional neuromuscular training program was more effective than traditional muscle strength rehabilitation programs in improving function [ 34 ]. The results from all these aforementioned studies indicated that appropriate proprioception exercises would be expected to achieve significant improvements in knee proprioception and function in patients following ACLR.…”

Ambulatory knee biomechanics and muscle activity 2 years after ACL surgery: InternalBraceTM-augmented ACL repair versus ACL reconstruction versus healthy controls

“…This study is a substudy of a larger non-randomised comparative umbrella study with retrospective data collection [ 22 ].…”

Favorable Patient-Reported, Clinical, and Functional Outcomes 2 Years After ACL Repair and InternalBrace Augmentation Compared With ACL Reconstruction and Healthy Controls

“…The detailed study protocol including all performed analyses has been previously published. 34 After careful evaluation of inclusion and exclusion criteria (Table 1), the following groups were included in our study: ACL-IB: consecutive patients 2 years after primary ACL repair and ligament augmentation operated at our institution and checked for inclusion and exclusion criteria (Table 1 and Figure 1) (n = 29). ACL-R: patients 2 years after ACL-R with autologous hamstring grafts were selected on the basis of sex and age from all patients treated in our clinic to obtain a sex-and age-matched comparison group (n = 27).…”