Efficacy Study of an Unloading Brace for Knee Osteoarthritis

Study Overview
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Brief Summary
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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.

Detailed Description
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This investigation will recruit 72 subjects from the clinical population of the investigators with symptomatic unicompartmental osteoarthritis of the medial compartment of the knee who meet the inclusion criteria of the investigation. Subjects who meet the recruitment conditions will be prospectively randomized into one of two treatment groups for 6 month evaluation: Fusion Osteoarthritis Knee Brace No brace group 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

Official Title
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Efficacy of Medial Compartment Unloading Brace Use for Osteoarthritis of the the Knee: A Prospective Randomized Study

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Device: Breg Fusion Unloading Brace


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects who meet the recruitment conditions will be prospectively randomized into one of two treatment groups for 6 month evaluation: Breg Fusion Osteoarthritis Knee Brace No brace group Both groups will be allowed to continue standard conservative treatment of osteoarthritis including anti-inflammatory medications, home exercises and joint supplements.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>This group receives no experimental bracing intervention in the study. | |
| Active Comparator: Experimental Group<br>This group will receive the Breg Fusion Osteoarthritis Knee Unloading Brace to wear for a determined amount of time per study protocol for the treatment of osteoarthritis pain. | Device: Breg Fusion Unloading Brace<br>* This group is assigned to wear an unloading brace and report pain and quality of life by completion of a pain diary and related questionnaires.<br>* Other names: Breg Fusion Osteoarthritis Knee Unloading Brace;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score | The Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire will be administered to collect patient reported outcomes as they relate to pain, function, and quality of life. The pain scale range is 0-10 with lower scores indicating less pain. | Baseline, 6 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee osteoarthritis unicompartmental unloading brace