A Slim-Fit Knee Brace for Young Adults With a Symptomatic Knee Following Anterior Cruciate Ligament Reconstruction: A Feasibility Randomized Controlled Trial
Abstract
CONTEXT
Early-onset osteoarthritis and associated symptoms are common after anterior cruciate ligament reconstruction (ACLR), but evidence for effective treatments is limited. We aimed to assess the feasibility of a slim-fit knee brace in young adults with a symptomatic knee post-ACLR.
DESIGN
6-week feasibility randomized controlled trial.
METHODS
Participants (aged 18-45, 1-8 y post-ACLR) with a symptomatic knee were randomized (2:1) to (1) a slim-fit knee brace group, to wear ≥1 hour daily and during aggravating activities; or (2) a no brace control group. Feasibility was assessed via eligibility, enrollment, recruitment, dropouts, adverse events, and adherence (temperature sensor). Acceptability was assessed via treatment satisfaction (100-point scale) and explored in semistructured interviews and analyzed thematically. Secondary outcomes included 6-week change in Knee injury and Osteoarthritis Outcome Score, Tampa Scale of Kinesiophobia, and hop performance.
RESULTS
Of 48 participants screened, 24 (50%) were eligible and 21 (88%) enrolled over 6 months (52% male, mean age 31 [6] y, n = 14 brace, n = 7 control). One control participant was lost to follow-up (5% dropout). In the brace group, there were 2 serious and 3 minor unrelated adverse events, and 6 minor skin-related events; the control group had 2 minor events. Brace adherence averaged ≥1 hour per day on 43% of days (participant range 0%-78%). For acceptability, satisfaction was rated 70/100 (19). Fourteen…
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. Reported size: 48 participants or records.
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