CompletedNot Applicable

Efficacy Study of an Unloading Brace for Knee Osteoarthritis

United States51 participantsStarted 2010-02

Plain-language summary

Subjects with symptomatic unicompartmental osteoarthritis of the knee will be invited to participate in this randomized study. Subjects will be assigned to either a Fusion Osteoarthritis Knee Brace group, or a control group that does not wear a brace. It is hypothesized that use of the Fusion Osteoarthritis Knee Brace will have a better outcome on osteoarthritis knee pain and quality of life compared to those who do not receive bracing intervention.

Who can participate

Age range

30 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 30-80. * History of medial unicompartmental knee pain \> 3 months duration (medial compartment only). * Narrowing of medial joint space \< one half of lateral compartment * Varus deformity no greater than 80 * Mild to moderate limitation in Activities of Daily Living (ADL's) and/or recreational activities. * Must read and understand English language and demonstrate the ability and willingness to follow the protocol and complete the questionnaires and diaries. * Manual dexterity sufficient to perform all tasks required of study participants. * Willingness to wear the brace a minimum of 4 hours per day. Exclusion Criteria: * Arthritides other than osteoarthritis. * Previous high tibial osteotomy of the affected knee. * Previous surgery of affected knee other than diagnostic arthroscopy with joint debridement, soft tissue reconstruction, menisectomy. * Fixed flexion deformities / limitations \>10 degrees as compared to the contralateral limb. * Flexion limitation \> 20 degrees. * Significant soft tissue compromise preventing long-term brace use. * Peripheral vascular disease or other neurovascular complaints. * Leg-length discrepancy \> 2cm.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score

Timeframe: Baseline, 6 month follow-up

Trial details

NCT IDNCT02150057

SponsorAndrews Research & Education Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-06

Results submitted2019-01-08

View on ClinicalTrials.gov More Osteoarthritis of the Knee trials