ROAM OA Outcomes Study (Enovis Brace Study)

Study Overview

A prospective, single-center trial comparing the ROAM OA Single Upright brace to the Össur Unloader One brace for patients with medial compartment knee osteoarthritis, conducted through the Rush Motion Analysis Lab.

Sponsor

Enovis

Research Type

Prospective, single-center comparative trial (N=30)

Candidate Criteria

Adults ages 40 to 85 with a BMI under 35 and medial compartment knee osteoarthritis, with walking pain of at least 4 out of 10 at screening. Candidates must be able to walk unaided and independently for at least 20 minutes and be willing to wear a brace daily for the study duration. Full inclusion and exclusion criteria apply, including limits on recent injections, pain medication use, and other lower extremity conditions.

Purpose

To compare knee adduction moment during gait using the ROAM OA brace versus the Össur Unloader One brace, and to evaluate the long-term efficacy of the ROAM OA brace on pain and function over eight weeks.

Study Design

Patients complete a baseline gait analysis without a brace and with both braces. They are then split into two groups for eight weeks: Group A wears the ROAM OA brace daily at home, while Group B continues standard osteoarthritis care without a brace.

Study Procedures

1. Visit 1 (Baseline): Gait analysis without a brace, then with each brace
2. Weeks 1 through 8: Group A wears the ROAM OA brace daily; Group B receives standard care
3. Visit 2 (Week 4): Gait analysis and questionnaires, with Group A tested wearing the brace and Group B tested without
4. Visit 3 (Week 8, final): Gait analysis and questionnaires, with Group A tested both with and without the brace, and Group B tested without