Brace-Free Rehabilitation after Isolated Anterior Cruciate Ligament Reconstruction with Hamstring Tendon Autograft Is Not Inferior to Brace-Based Rehabilitation—A Randomised Controlled Trial

Purpose: The postoperative use of a rehabilitative knee brace after isolated primary anterior cruciate ligament (ACL) reconstruction (ACLR) using a hamstring tendon (HT) autograft is controversial. A knee brace may provide subjective safety but can cause damage if applied incorrectly. The aim of this study is to evaluate the effect of a knee brace on clinical outcomes following isolated ACLR using HT autograft. Methods: In this prospective randomised trial, 114 adults (32.4 ± 11.5 years, 35.1% women) underwent isolated ACLR using HT autograft after primary ACL rupture. Patients were randomly assigned to wear either a knee brace (n = 58) or no brace (n = 56) for 6 weeks postoperatively. An initial examination was performed preoperatively, and at 6 weeks and 4, 6, and 12 months. The primary endpoint was the subjective International Knee Documentation Committee (IKDC) score to measure participants’ subjective perceptions. Secondary endpoints included objective knee function assessed by IKDC, instrumented knee laxity measurements, isokinetic strength tests of the knee extensors and flexors, Lysholm Knee Score, Tegner Activity Score, Anterior Cruciate Ligament—Return to Sport after Injury Score, and quality of life determined by Short Form-36 (SF36). Results: There were no statistically significant or clinically meaningful differences in IKDC scores between the two study groups (3.29, 95% confidence interval (CI) −1.39 to 7.97, p = 0.03 for evidence of non-inferiority of brace-free compared with brace-based rehabilitation). The difference in Lysholm score was 3.20 (95% CI −2.47 to 8.87); the difference in SF36 physical component score 0.09 (95% CI −1.93 to 3.03). In addition, isokinetic testing did not reveal any clinically relevant differences between the groups (n.s.). Conclusions: Brace-free rehabilitation is non-inferior to a brace-based protocol regarding physical recovery 1 year after isolated ACLR using HT autograft. Consequently, the use of a knee brace might be avoided after such a procedure. Level of Evidence: Level I, therapeutic study.