Lateral Wedge Insoles With Arch Support in Knee Osteoarthritis

Study Overview
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Brief Summary
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The purpose of this is to test lateral foot orthoses with different amount of wedging to find a model that predicts the optimal lateral inclination of foot orthosis based on biomechanical or feelings measures. This study was a cross-sectional study with patients serving as their own control. The investigators recruited 24 knee osteoarthritis. Knee radiography and clinical angles measures was carried out before making orthoses, then motion analysis with an optoelectronic system was performed with each pair of foot orthoses. During motion analysis, five gait trials were carried out in each condition.

Official Title
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Does it Exist a Relationship Between Inclination Angle of Foot Orthoses and Varus Angle of the Knee in the Relief of the Knee Osteoarthritis Symptoms?

Conditions
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Medial Knee Osteoarthritis

Intervention / Treatment
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* Other: Without orthoses
* Device: 6° lateral wedge insoles
* Device: 10° lateral wedge insoles
* Device: Neutral customized foot orthoses
* Device: 6° lateral customized foot orthoses
* Device: 7° lateral customized foot orthoses
* Device: 8° lateral customized foot orthoses
* Device: 9° lateral customized foot orthoses
* Device: 10° lateral customized foot orthoses
* Device: Orthotist integrated lateral customized foot orthoses
* Device: Orthotist lateral customized foot orthoses


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
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Knee osteoarthritis patients<br>Without orthoses 6° lateral wedge insoles 10° lateral wedge insoles Neutral customized foot orthoses 6° lateral customized foot orthoses 7° lateral customized foot orthoses 8° lateral customized foot orthoses 9° lateral customized foot orthoses 10° lateral customized foot orthoses Orthotist integrated lateral customized foot orthoses Orthotist lateral customized foot orthoses | Other: Without orthoses<br>* Condition control<br>Device: 6° lateral wedge insoles<br>* Insoles with a lateral inclination set at 6°<br>* Other names: Orthoconcept Inc, Laval, Qc, Canada;Device: 10° lateral wedge insoles<br>* Insoles with a lateral inclination set at 10°<br>* Other names: Orthoconcept Inc, Laval, Qc, Canada;Device: Neutral customized foot orthoses<br>* Foot orthoses with arch support and without lateral inclination<br>* Other names: Orthoconcept Inc, Laval, Qc, Canada;Device: 6° lateral customized foot orthoses<br>* Foot orthoses with arch support above insoles with lateral inclination set at 6°<br>* Other names: Orthoconcept Inc, Laval, Qc, Canada;Device: 7° lateral customized foot orthoses<br>* Foot orthoses with arch support above insoles with lateral inclination set at 7°<br>* Other names: Orthoconcept Inc, Laval, Qc, Canada;Device: 8° lateral customized foot orthoses<br>* Foot orthoses with arch support above insoles with lateral inclination set at 8°<br>* Other names: Orthoconcept Inc, Laval, Qc, Canada;Device: 9° lateral customized foot orthoses<br>* Foot orthoses with arch support above insoles with lateral inclination set at 9°<br>* Other names: Orthoconcept Inc, Laval, Qc, Canada;Device: 10° lateral customized foot orthoses<br>* Foot orthoses with arch support above insoles with lateral inclination set at 10°<br>* Other names: Orthoconcept Inc, Laval, Qc, Canada;Device: Orthotist integrated lateral customized foot orthoses<br>* Foot orthoses with arch support and integrated lateral inclination set according to orthotist experience<br>* Other names: Orthoconcept Inc, Laval, Qc, Canada;Device: Orthotist lateral customized foot orthoses<br>* Foot orthoses with arch support above insoles with lateral inclination set according to orthotist experience<br>* Other names: Orthoconcept Inc, Laval, Qc, Canada;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee pain | A 20-cm visual analog scale (0-100) is used to assess pain. | At time of device receipt | 
| Knee adduction moment | Measure of the knee adduction moment is a non invasive technic to identify change in medial knee loading, major problem in medial knee osteoarthritis. | At time of device receipt | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot orthoses comfort | A 20-cm visual analog scale (0-100) is used to assess comfort. | At time of device receipt |