BACKGROUND: Despite a lack of evidence for their effectiveness, functional knee braces are commonly prescribed to patients after anterior cruciate ligament (ACL) reconstruction. PURPOSE: This trial was conducted to compare postoperative outcomes in patients using an ACL functional knee brace and patients using a neoprene knee sleeve. HYPOTHESIS: Patients using a brace will have superior outcomes than those using a sleeve. STUDY DESIGN: Randomized controlled clinical trial; level of evidence, 1. METHODS: One hundred fifty patients were randomized to receive a brace (n = 76) or neoprene sleeve (n = 74) at their 6-week postoperative visit after primary ACL reconstruction with hamstring autograft. Patients were assessed preoperatively, then 6 weeks and 6, 12, and 24 months postoperatively. Outcome measures included disease-specific quality of life (Anterior Cruciate Ligament-Quality of Life (ACL-QOL) Questionnaire), anterior tibial translation (KT-1000 arthrometer side-to-side difference), the single-limb forward hop test (limb symmetry index), and Tegner Activity Scale. Outcomes at 1 and 2 years were compared after adjusting for baseline scores. Subjective ratings of how patients felt while using the brace/sleeve were also collected for descriptive purposes using a questionnaire. Four a priori directional subgroup hypotheses were evaluated using tests for interactions. RESULTS: There were no significant differences between brace (n = 62) and sleeve (n = 65) groups for any of the outcomes at 1- and 2-year follow-ups. Adjusted mean differences at 2 years were as follows: -0.94 (95% confidence interval (CI) -7.52 to 5.64) for the ACL-QOL Questionnaire -0.10 mm (95% CI -0.99 to 0.81) for KT-1000 arthrometer side-to-side difference -0.87% (95% CI -8.89 to 7.12) for hop limb symmetry index, and -0.05 (95% CI -0.72 to 0.62) for the Tegner Activity Scale. Subjective ratings of confidence in the knee provided by the brace/sleeve were higher for the brace group than the sleeve group. Subgroup findings were minimal. Adverse events were few and similar between groups. CONCLUSIONS: A functional knee brace does not result in superior outcomes compared with a neoprene sleeve after ACL reconstruction. Current evidence does not support the recommendation of using an ACL functional knee brace after ACL reconstruction.

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