ROAM OA: Functional and Patient Reported Outcomes Wearing a Knee Brace for Unicompartmental OA

NCT07224958 | Recruiting FDA Device

• 1 other identifier: 23110204-IRB01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

knee brace; gait analysis

Outcome Measures

Primary Outcomes (2)

• Change in knee adduction moment during gait

  Change in peak knee adduction moment measured during gait analysis using instrumented motion capture and force platforms. Comparisons are made between baseline, 4 weeks, and 8 weeks.

  Baseline, 4 weeks, and 8 weeks

• Change in Visual Analog Scale (VAS) walking pain

  Change in walking pain measured by the Visual Analog Scale (VAS), in which participants rate their pain during walking along a 10-centimeter line ranging from 0 = no pain to 10 = worst imaginable pain. Lower scores indicate less pain and therefore a better outcome. Comparisons will be made between baseline, 4 weeks, and 8 weeks.

  Baseline, 4 weeks, and 8 weeks

Secondary Outcomes (2)

• Change in KOOS (Knee injury and Osteoarthritis Outcome Score) subscale scores

  Baseline, 4 weeks, and 8 weeks

• Change in knee range of motion (ROM)

  Baseline, 4 weeks, and 8 weeks

Study Arms (2)

ROAM OA brace

EXPERIMENTAL

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.

Device: ROAM OA Single Upright Knee Brace

Active Comparator: Unloader brace or standard of care

ACTIVE COMPARATOR

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.

Device: Ossur Unloader One Knee Brace or Standard of Care

Interventions

ROAM OA Single Upright Knee Brace DEVICE

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.

ROAM OA brace

Ossur Unloader One Knee Brace or Standard of Care DEVICE

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.

Active Comparator: Unloader brace or standard of care

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rush University Medical Center: lead
• Enovis: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Related Publications (2)

• Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, Towheed T, Welch V, Wells G, Tugwell P; American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012 Apr;64(4):465-74. doi: 10.1002/acr.21596.

  PMID: 22563589 BACKGROUND

• Chang J, Yuan Y, Fu M, Wang D. Health-related quality of life among patients with knee osteoarthritis in Guangzhou, China: a multicenter cross-sectional study. Health Qual Life Outcomes. 2023 May 27;21(1):50. doi: 10.1186/s12955-023-02133-x.

  PMID: 37244981 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Markus Wimmer, PhD

CONTACT

3129422789; markus_a_wimmer@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No blinding; all participants and study team are aware of the assigned brace.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Grainger Director of the RUSH Arthritis and Orthopedics Institute

Model Details: Randomized crossover assignment followed by a parallel continuation period. Participants will cross over between the ROAM OA brace and the comparator, then continue in a chosen brace for the remainder of the study.

Study Record Dates

• First Submitted: October 28, 2025
• First Posted: November 5, 2025
• Study Start: April 27, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-04

Locations

US (1)