Evaluation of a Distraction-rotation Knee Unloader Brace in Patients With Medial Knee Osteoarthritis.

Study Overview
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Brief Summary
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The aim of this study is to confirm the biomechanical effects and evaluate functional benefits of a new knee brace combining valgus inducing effect on medial compartment and leg external rotation during the stance phase in patients with symptomatic medial knee osteoarthritis.

Official Title
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Evaluation of a Distraction-rotation Knee Unloader Brace in Patients With Medial Knee Osteoarthritis.

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: PROTEOR Internal unicompartmental knee brace


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient understanding simple order and able to give written consent. Man or woman with age between 40 et 75 years Unilateral medial symptomatic knee osteoarthritis, defined using the American College of Rheumatology classification Radiologic grade II, III ou IV (Kellgren et Lawrence (KL) classification) Medial knee compartment (Medial K&L g rade higher than lateral K&L grade Knee pain > 40/100 on visual analog scale and <30/100 for the other No change in medical treatment for at least 3 months. Latest radiographic image < 12 months before inclusion Exclusion Criteria: Patient without healthcare insurance. Inflammatory knee arthritis, Indication of knee surgery Pregnancy, breastfeeding Associate neurologic or orthopaedic affection that interferes with gait analysis Rapidly destructive arthritis. Alzheimer's disease, Parkinson's disease, motor neuronal disorders Patient under guardianship or tutelage

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Internal unicompartmental knee brace<br> | Device: PROTEOR Internal unicompartmental knee brace<br> <br> * Other names: trademark :  PROTEOR  : code name 2H-200;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score on visual analogic scale | Pain was self-evaluated by patient on visual analogic scale (VAS: 0-100, 0 = no pain at all; 100 = worst pain appendix 1). Such pain is widely used and validated in the literature for the evaluation of knee osteoarthritis treatment outcome. | Baseline | 
| Pain score on visual analogic scale | Pain was self-evaluated by patient on visual analogic scale (VAS: 0-100, 0 = no pain at all; 100 = worst pain appendix 1). Such pain is widely used and validated in the literature for the evaluation of knee osteoarthritis treatment outcome. | Baseline + 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the functional capacities: KOOS questionnaire. |  | baseline | 
| Evaluation of the functional capacities: KOOS questionnaire. |  | baseline + 5 weeks |