Mechanics of Knee Bracing

Study Overview
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Brief Summary
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The overall objective of this project is to determine whether the provision of a pneumatic knee brace in patients with medial knee osteoarthritis (OA) improves knee mechanics. Secondary objectives will be to assess if the brace relieves knee pain and improves function. We will test the hypothesis that compared to the control treatment (see below for the definition) the use of a pneumatic knee brace is effective in medial knee OA.

Detailed Description
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This study is closed to enrollment and in the data analysis phase

Official Title
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Mechanics of Knee Bracing

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: pneumatic brace


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: knee pain, aching or stiffness on most of the past 30 days x-ray verified predominant medial tibiofemoral osteoarthritis (TFOA) overall pain that is due to the medial TFOA (versus being referred from the back, hips, or other pre-existing conditions) ambulatory persons Exclusion Criteria: use of a crutch, walker, or wheelchair or cane more than 50% of the time history of Deep Vein Thrombosis Pain emanating more from back or hip than from knee Low pain score on WOMAC predominant patellofemoral disease or knee pathology other than medial compartment OA likely to be causing their knee pain. Planning to move from area within 1 month of study screening. Unable to fit the brace properly BMI greater than 35 corticosteriod injections in the past month Bilateral total knee replacements or plan for TKR Other types of arthritis including Rheumatoid Arthritis, Systemic Lupus Erythematosus, gout, psoriatic arthritis, pseudogout. woman who are pregnant (due to x-rays taken to determine eligibility)

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: pneumatic brace|pneumatic knee brace with three trial conditions: air bladders inflated at 0psi, 7 psi, and 12 psi|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To undertake a clinical trial in patients with medial knee OA to determine whether provision of a pneumatic knee brace leads to a reduced adduction moment during the time of this treatment than during the use of a control treatment. |  | At study visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To undertake a clinical trial in patients with medial knee OA to determine whether provision of a pneumatic knee brace leads to a lower pain score and improved function during the time of this treatment than during the use of a control treatment. |  | During study visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee Osteoarthritis, pneumatic bracing