Combination of Lateral Foot Orthoses and 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 and short-term effects of the combination of lateral customized foot orthoses on the pain and medial knee loading during gait among medial knee osteoarthritis patients. The effects of the combination is compared to the single use of these devices. The investigators recruited 22 knee osteoarthritis. They have to wear each of treatments (foot orthoses, knee brace and combination) 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 (Knee Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC) and Medical Outcome Study 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 treatment and ten with the treatment.

Official Title
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Combination of Lateral Foot Orthoses and Knee Brace for Treatment of the Medial Knee Osteoarthritis

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Combined treatment of medial knee osteoarthritis


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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No

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: Lateral customized foot orthoses<br>Foot orthoses with arch support and lateral inclination set at 7° (alone) | Device: Combined treatment of medial knee osteoarthritis<br> <br> |
| Experimental: Knee brace<br>OdrA Knee brace (alone) | Device: Combined treatment of medial knee osteoarthritis<br> <br> |
| Experimental: Combination of the two treatments<br>Combination of Lateral customized foot orthoses and knee brace | Device: Combined treatment of medial knee osteoarthritis<br> <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 |  | Change from Baseline at 3 months | 
| Change in Knee adduction angle |  | Change from Baseline at 3 months | 
| Change in Comfort | A 20-cm visual analog scale (0-100) is used to assess comfort. | Change from Baseline at 3 months |