A feasibility randomised trial evaluating the levitation tri-compartment offloader knee brace for multicompartment knee osteoarthritis

Area of Science:

• Orthopedics
• Biomedical Engineering
• Clinical Trials

Background:

• Knee osteoarthritis (OA) is a prevalent condition causing significant pain and disability.
• The Levitation™ Tri-Compartment Offloader (TCO) knee brace is a novel device designed to alleviate OA knee pain.
• No controlled clinical trials have yet compared the TCO brace to standard OA treatments.

Purpose of the Study:

• To assess the feasibility of conducting a full-scale randomized controlled trial (RCT) for the TCO knee brace.
• To determine the sample size needed for a future RCT by analyzing Visual Analog Scale (VAS) pain scores.
• To refine the study protocol for optimal efficiency and appropriateness in a larger trial.

Main Methods:

• A prospective, single-centre, 3-group feasibility RCT was conducted with individuals experiencing moderate to severe knee OA.
• Participants were randomized to standard care, standard care plus a knee sleeve, or standard care plus the TCO brace.
• Feasibility was evaluated through recruitment rates, adherence, response rates, data quality, dropout rates, and adverse events over a 3-month period.

Main Results:

• Twenty-nine participants were recruited, with an estimated sample size of 93 for a full RCT.
• High intervention adherence (86% at 3 months) and data quality were observed.
• Protocol modifications were identified to enhance the efficiency and suitability of a full-scale RCT.

Conclusions:

• The feasibility of a full-scale RCT for the TCO knee brace is supported by this study.
• The TCO brace shows potential for managing knee OA pain compared to standard conservative treatments.
• An adequately powered RCT is warranted to definitively evaluate the clinical effectiveness of the TCO knee brace.