While there is a consensus against bracing after anterior cruciate ligament (ACL) reconstruction, the question of its potential benefits, especially in cases involving meniscus repair, as well as its routine use by the majority of clinicians, remains a topic of debate. This study aims to assess the effectiveness of bracing in relation to clinical scores after ACL reconstruction, regardless of meniscus surgery. This randomised controlled study involved patients aged 15-55 years who underwent arthroscopic ACL reconstruction surgery. All eligible patients were assigned into two groups: one group received an adjustable frame with a four-point fixation knee brace for a four-week period, while the other did not.A single experienced surgeon performed standard anatomical single-bundle ACL reconstruction. All patients, irrespective of whether they underwent meniscus repair, followed the same rehabilitation protocol. Knee functional questionnaires, including the International Knee Documentation Committee (IKDC) score, Lysholm score, Tegner Activity Scale, Visual Analogue Scale (VAS), and examinations, were collected preoperatively, at six months, one year, and two years postoperatively. The study employed an intention-to-treat analysis and multilevel mixed-effects generalised linear models to compare continuous outcomes between the groups, adjusting for the times of follow-up. A total of 84 patients (42 patients per group) comprised of 75 males (89 %) and average age of 30±9.4 years old. Patient-reported function, physical examination findings, and surgical characteristics were comparable between the two groups. (P-value >0.05) Both groups demonstrated significant improvement in IKDC and Lysholm scores at the end of the two-year follow-up period. (P-value <0.0001) In multivariate analysis, bracing was significantly associated with lower Tegner activity scale than the non-brace group after adjustment for VAS and time (coefficient -0.49, 95 % confidence interval -0.87, -0.10, P-value=0.013). None of the graft ruptures were reported, and there was no significant difference of return to sports between the groups at the end of the follow-up. The study suggests that knee bracing after ACL reconstruction, regardless of any additional meniscus procedures, fails to enhance subjective or objective outcomes and could potentially have a negative impact on the Tegner activity scale, although the difference is not clinically significant. The routine use of a postoperative brace should be discontinued. Level I, Randomised controlled trial with no negative criteria.
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