Validation orthèse Pour Gonarthrose

Study Overview
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Brief Summary
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A study about the effects of different fastening systems for knee braces on comfort, ease of installation and treatment efficacy both physical and psychological. Two different systems will be tested, velcro straps and a cable-fastening system.

Detailed Description
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There are 2 main types of knee braces for gonarthrosis: soft knee braces and rigid knee braces. Soft knee braces use malleable materials such as cloth or rubber to apply forces on the leg whereas rigid braces use plastic or metal shells. Three main types of fastening systems are used on these types of orthoses: velcro systems, hybrid systems and cable fastening systems. Therefore, different configurations exist to reduce biomechanical deficits caused by the pathology. Each fastening system has its advantages and disadvantages. Velcro straps are fast and intuitive to use, altough multiple difficulties are mentionned: adjusment, cleaning, the number of straps needed to maintain the knee brace in position as well as the noise while detaching the straps. Hybrid systems regularly use velcro straps to which are added quick-release fasteners to simplify the installation and uninstallation process. Cable fastening systems also use quick-release fasteners. The adjusment process is simple and precise with minimal noise with these systems. Comfort, efficacy and ease of use are essential qualities of a knee brace. Confort is primordial as it is directly linked to treatment adherence by the patients. Efficacy of a knee brace treatment may be measured by symptom or medication use evolution but also with daily practice of problematic movement by the patient. Ease of use must be optimized as it presents an opportunity to increase treatment adherence. The goal of the fastening system developped in partnership with Laboratoires Victhom is the increase the ease of use of the knee brace while maintaining comfort and treatment efficacy.

Official Title
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Protocole de Validation d'Une orthèse de Genou Valgisante Pour Gonarthrose

Conditions
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Gonarthrosis

Intervention / Treatment
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* Device: Cable fastening system and 3d printed straps
* Device: Velcro straps system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has worn an ODRA knee brace multiple hours a day during the last 6 months Exclusion Criteria: Wounds on the lower body

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized trial with condition crossover
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cable fastening system<br>The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a cable fastening system and 3d printed straps. | Device: Cable fastening system and 3d printed straps<br>* The participants will wear a Odra knee brace held in place with by a cable fastening system and 3d printed straps for 2 weeks.<br>|
| Active Comparator: Velcro straps<br>The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a velcro straps system. | Device: Velcro straps system<br>* The participants will wear a Odra knee brace held in place with by a velcro straps system for 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ease of use | 5 items with 5 point scale rating system(1 lowest - 5 highest) | before the 2 weeks of use for each arm | 
| ease of use | 5 items with 5 point scale rating system(1 lowest - 5 highest) | after the 2 weeks of use for each arm | 
| Comfort | 2 items with 5 point scale rating system(1 lowest - 5 highest) | before 2 weeks of use for each arm | 
| Comfort | 2 items with 5 point scale rating system(1 lowest - 5 highest) | after 2 weeks of use for each arm | 
| Physical symptoms | Knee injury and Osteoarthritis Outcome Score (KOOS), translated to French(Quebec) | Change between baseline and after 2 weeks adjustment period | 
| Physical symptoms | Knee injury and Osteoarthritis Outcome Score (KOOS), translated to French(Quebec) | Change between baseline and after 2 weeks of use for each arm | 
| Physical symptoms | Knee injury and Osteoarthritis Outcome Score (KOOS), translated to French(Quebec) | Change between after 2 weeks adjustment period and after 2 weeks of use for each arm | 
| Psychological symptoms | Psychological Symptoms Inventory(Ilfeld, F. W. (1976). Further validation of a psychiatric symptom index in a normal population. Psychological Reports, 39(3, Pt 2), 1215-1228.) | Change between baseline and after 2 weeks adjustment period | 
| Psychological symptoms | Psychological Symptoms Inventory(Ilfeld, F. W. (1976). Further validation of a psychiatric symptom index in a normal population. Psychological Reports, 39(3, Pt 2), 1215-1228.) | Change between baseline and after 2 weeks of use for each arm | 
| Psychological symptoms | Psychological Symptoms Inventory(Ilfeld, F. W. (1976). Further validation of a psychiatric symptom index in a normal population. Psychological Reports, 39(3, Pt 2), 1215-1228.) | Change between after 2 weeks adjustment period and after 2 weeks of use for each arm | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee brace, orthosis, treatment efficacy, arthrosis, comfort, ease of use