Randomized Clinical Feasibility Trial: Comparing a Restrictive and Protective Range-of-Motion Brace for the Nonsurgical Management of the Medial Collateral Ligament of the Knee
Abstract
OBJECTIVES
(1) Assess medial collateral ligament (MCL) laxity differences in nonoperatively treated acute MCL and anterior cruciate ligament (ACL)-MCL injuries with 2 range of motion (ROM) knee brace settings. (2) Describe knee ROM, brace satisfaction, overall knee score, adherence, pain, quality of life, and knee function. (3) Assess feasibility of larger trial.
DESIGN
Prospective, randomized, single-blinded feasibility clinical trial.
PARTICIPANTS
Sixty-four adults with acute moderate-to-severe isolated MCL or combined ACL-MCL injuries at the University of Calgary Sport Medicine Centre.
INTERVENTION
Random assignment to the protected (0-90 degrees) or restricted (30-90 degrees) brace group. Four weeks of constant brace wearing, followed by daytime wear until 6 weeks. Rehabilitation exercises prescribed from 2 weeks onward. Follow-up for 12 weeks.
MAIN OUTCOME MEASURES
Clinical outcomes included side-to-side difference (SSD) MCL laxity (mm) at 30 degrees knee flexion and 0 degree, ROM, patient-reported pain, overall knee ratings, brace satisfaction, daily adherence, international knee documentation committee subjective, and ACL-quality of life (QOL) collected throughout 12 weeks (baseline, 2, 4, 6, 8, and 12 weeks). The outcome assessor was masked to treatment group allocation.
RESULTS
At 12 weeks, 73% had <1 mm SSD valgus laxity at 30 degrees knee flexion, with 82% in the restricted group and 67% in the protected group. All patients reported improved pain; none suffered a…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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