Recruiting

ROAM OA & Unloader One

Sponsor:

Rush University Medical Center

Code:

NCT07224958

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

ROAM OA Single Upright Knee Brace

Ossur Unloader One Knee Brace or Standard of Care

Study Details

Brief summary:

The aim of this study is to conduct a comparative evaluation of the ROAM OA Single Upright Brace and the Ossur Unloader One Knee Brace in subjects with medial compartment osteoarthritis. The focus is on comparing the immediate and short-term biomechanical effects of these braces on knee adduction moments and spatiotemporal gait parameters, as well as assessing the long-term efficacy of the ROAM OA brace in improving pain and functional outcomes for individuals with osteoarthritis.

Conditions

Knee Osteoarthritis

Study ID

NCT07224958

Start date

Apr 27, 2026

Status verified date

Apr, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Inclusion Criteria:
  • Age 40-85 years.
  • BMI ≤ 35.
  • Physician-diagnosed medial compartment knee osteoarthritis.
  • Visual Analog Scale (VAS) walking pain ≥ 4.
  • Willing to wear assigned brace ≥ 4 hours/day.
  • Able to walk independently for 20 minutes unaided.
  • Stable pain medication regimen ≥ 4 weeks.
  • ≥3 months since last hyaluronic acid (HA), platelet-rich plasma (PRP), or steroid injection.

Exclusion Criteria:

  • Lateral or patellofemoral osteoarthritis.
  • Prior knee replacement.
  • Significant ligament injury or acute lower limb injury.
  • Neurological condition affecting gait.
  • Severe psychiatric or neurological disorder affecting pain perception.
  • Skin condition or allergy preventing brace use.
  • Current use of another brace or assistive device.
  • Recent opioid or corticosteroid use (<4 weeks).
  • Pregnant.

Exclusion Criteria:

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Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ROAM OA brace

Participants receive the ROAM OA Single Upright Knee Brace (Enovis) to wear daily for the study duration. The brace is designed to offload the medial compartment of the knee and improve pain and function.

active comparator: Active Comparator: Unloader brace or standard of care

Participants receive the Ossur Unloader One knee brace or no brace (standard of care) and will follow standard pain management and physical therapy guidelines. This group serves as an active comparator to the ROAM OA brace.

Interventions

ROAM OA Single Upright Knee Brace

A commercially available single-upright knee brace designed to offload the medial compartment of the knee in patients with unicompartmental osteoarthritis; manufactured by Enovis. Participants will wear the brace daily for the duration of the study.

Ossur Unloader One Knee Brace or Standard of Care

Participants will receive the Ossur Unloader One knee brace or no brace (standard of care) and will follow standard management and physical therapy guidelines. This group serves as the active comparator to the ROAM OA brace.

Primary outcome measure

  • Change in knee adduction moment during gait [ Time Frame: Baseline, 4 weeks, and 8 weeks ]
  • Change in Visual Analog Scale (VAS) walking pain [ Time Frame: Baseline, 4 weeks, and 8 weeks ]

Central Contacts and Locations

Central contacts

Markus Wimmer, PhD

3129422789markus_a_wimmer@rush.edu

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Christopher Knowlton, PhD

312-942-6938christopher_knowlton@rush.edu

More Information

Sponsor

Rush University Medical Center

Last update posted

May 12, 2026

Last verified

Apr, 2026

Keywords

  • knee brace
  • gait analysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-05-12.