AN RCT COMPARING THE EFFECTIVENESS OF FUNCTIONAL KNEE BRACE TO NEOPRENE SLEEVE USE FOLLOWING ACL RECONSTRUCTION

Abstract

Summary Results of this two-group parallel design randomised controlled trial indicated one and two year outcomes following ACL reconstruction were not different in one hundred and fifty patients using either an ACL functional knee brace or neoprene knee sleeve. Introduction: The primary objective of this study was to compare postoperative outcomes in patients using an ACL functional knee brace and patients using a neoprene knee sleeve

One hundred and fifty patients were randomised to receive an ACL functional knee brace (n=76) or a neoprene sleeve (n=74) at their six week postoperative visit following primary ACL reconstruction. Patients were instructed to wear the knee orthosis during participation in all physical activities. Patients were assessed preoperatively, six weeks, six, twelve, eighteen and twenty-four months postoperatively. Outcome measures included disease-specific quality of life (ACL QOL), KT 1000 and single limb forward hop test administered by a blinded research assistant. One and two-year outcomes were compared after adjusting for baseline scores. A priori directional subgroup hypotheses based on time from injury to surgery, pre-operative KT 1000 scores, and one and two-year compliance scores were evaluated using tests for interactions. Analysis was completed on an intention-to-treat basis.

There were no significant between-group differences for any of the outcomes at one and two-year follow-ups. Mean between-group differences at two years were: 2.87% (95% CI: −3.85 – 9.60) for the ACL QOL, 0.07mm (95% CI: −0.80 – 0.93) for KT 1000 side-to-side difference, and 2.64% (95% CI: −4.57 – 9.85) for hop limb symmetry index. There were no significant subgroup findings and adverse events were similar between groups.

Confidence intervals for between-group differences are narrow and exclude clinically important differences. These findings suggest a functional knee brace does not result in superior outcomes over a neoprene sleeve following ACL reconstruction.