Effects of a New Knee Brace for Treatment of the Knee Osteoarthritis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the immediate effects of a knee brace with a new mechanism on the pain and medial knee loading during gait among medial knee osteoarthritis patients. The effects of this new brace is compared to a stabilizing brace and a typical valgus knee brace. The investigators recruited 24 knee osteoarthritis and they have to wear each of the three braces during three months. A fifteen days wash-out period is given after each three months. Biomechanical evaluation is carried out before and after each three months. This evaluation consisted of three questionnaires (KOOS, WOMAC and Medical Outcome Score Short Form-36 (MOS-SF36)), a motion analysis with an optoelectronic system, then a 6-min walk test. During motion analysis, ten gait trials are executed without brace and ten with the brace.

Official Title
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Effects of a New Knee Brace for Treatment of the Knee Osteoarthritis on the Medial Knee Loading During Gait

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: Stabilizing Knee Brace
* Device: Valgus Knee Brace
* Device: New Knee Brace


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic medial knee OA (Kellgren-Lawrence grade I, II or III) according to clinical and radiological criteria of the American College of Rheumatology Knee pain > 31/100 (Western Ontario and McMaster Universities Arthritis Index - WOMAC) Moderately active Varus knee alignment equal or superior to 2° Exclusion Criteria: Severe knee OA (K-L grade IV) Rheumatoid arthritis or other inflammatory arthritis Avascular necrosis History of periarticular fracture or septic arthritis Bone metabolic disease Pigmented villonodular synovitis Cartilaginous disease Neuropathic arthropathy Synovial osteochondromatosis Total or partial knee arthroplasty Flexion contracture of ipsi- or contra-lateral knee greater than 15° Hip or ankle joint damage with mobility limitation Obesity (BMI ≥ 40) Intra-articular corticosteroids injection in the affected knee during the two previous months Reduced mobility (Charnley class C)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Knee osteoarthritis patients<br>Knee osteoarthritis patients with Kellgren & Lawrence grade I, II or III Stabilizing Knee Brace Valgus Knee Brace New Knee Brace | Device: Stabilizing Knee Brace<br>* Brace with no valgus action<br>Device: Valgus Knee Brace<br>* Valgus brace with traditional three point bending system<br>Device: New Knee Brace<br>* Brace with new mechanism to decrease the knee loading.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Knee adduction moment |  | Change from Baseline at 3 months | 
| Change in Knee pain | A 20-cm visual analog scale (0-100) is used to assess pain. | Change from Baseline at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Spatiotemporal gait parameters | Test of the gait symmetry with the gait phase duration and step length. | Change from Baseline at 3 months | 
| Change in Gait velocity |  | Change from Baseline at 3 months | 
| Change in Knee adduction angle |  | Change from Baseline at 3 months | 
| Change in Knee brace comfort | A 20-cm visual analog scale (0-100) is used to assess comfort. | Change from Baseline at 3 months |