Validation orthèse Pour Gonarthrose
Primary Purpose
Gonarthrosis
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cable fastening system and 3d printed straps
Velcro straps system
Sponsored by
About this trial
This is an interventional treatment trial for Gonarthrosis focused on measuring knee brace, orthosis, treatment efficacy, arthrosis, comfort, ease of use
Eligibility Criteria
Inclusion Criteria: Has worn an ODRA knee brace multiple hours a day during the last 6 months Exclusion Criteria: Wounds on the lower body
Sites / Locations
- TOPMEDRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cable fastening system
Velcro straps
Arm Description
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.
The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a velcro straps system.
Outcomes
Primary Outcome Measures
ease of use
5 items with 5 point scale rating system(1 lowest - 5 highest)
ease of use
5 items with 5 point scale rating system(1 lowest - 5 highest)
Comfort
2 items with 5 point scale rating system(1 lowest - 5 highest)
Comfort
2 items with 5 point scale rating system(1 lowest - 5 highest)
Physical symptoms
Knee injury and Osteoarthritis Outcome Score (KOOS), translated to French(Quebec)
Physical symptoms
Knee injury and Osteoarthritis Outcome Score (KOOS), translated to French(Quebec)
Physical symptoms
Knee injury and Osteoarthritis Outcome Score (KOOS), translated to French(Quebec)
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.)
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.)
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.)
Secondary Outcome Measures
Full Information
NCT ID
NCT05814471
First Posted
March 16, 2023
Last Updated
April 12, 2023
Sponsor
TOPMED
Collaborators
Conseil de recherches en sciences naturelles et en génie du Canada, Laboratoires Victhom
1. Study Identification
Unique Protocol Identification Number
NCT05814471
Brief Title
Validation orthèse Pour Gonarthrose
Official Title
Protocole de Validation d'Une orthèse de Genou Valgisante Pour Gonarthrose
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TOPMED
Collaborators
Conseil de recherches en sciences naturelles et en génie du Canada, Laboratoires Victhom
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gonarthrosis
Keywords
knee brace, orthosis, treatment efficacy, arthrosis, comfort, ease of use
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized trial with condition crossover
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cable fastening system
Arm Type
Experimental
Arm Description
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.
Arm Title
Velcro straps
Arm Type
Active Comparator
Arm Description
The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a velcro straps system.
Intervention Type
Device
Intervention Name(s)
Cable fastening system and 3d printed straps
Intervention Description
The participants will wear a Odra knee brace held in place with by a cable fastening system and 3d printed straps for 2 weeks.
Intervention Type
Device
Intervention Name(s)
Velcro straps system
Intervention Description
The participants will wear a Odra knee brace held in place with by a velcro straps system for 2 weeks.
Primary Outcome Measure Information:
Title
ease of use
Description
5 items with 5 point scale rating system(1 lowest - 5 highest)
Time Frame
before the 2 weeks of use for each arm
Title
ease of use
Description
5 items with 5 point scale rating system(1 lowest - 5 highest)
Time Frame
after the 2 weeks of use for each arm
Title
Comfort
Description
2 items with 5 point scale rating system(1 lowest - 5 highest)
Time Frame
before 2 weeks of use for each arm
Title
Comfort
Description
2 items with 5 point scale rating system(1 lowest - 5 highest)
Time Frame
after 2 weeks of use for each arm
Title
Physical symptoms
Description
Knee injury and Osteoarthritis Outcome Score (KOOS), translated to French(Quebec)
Time Frame
Change between baseline and after 2 weeks adjustment period
Title
Physical symptoms
Description
Knee injury and Osteoarthritis Outcome Score (KOOS), translated to French(Quebec)
Time Frame
Change between baseline and after 2 weeks of use for each arm
Title
Physical symptoms
Description
Knee injury and Osteoarthritis Outcome Score (KOOS), translated to French(Quebec)
Time Frame
Change between after 2 weeks adjustment period and after 2 weeks of use for each arm
Title
Psychological symptoms
Description
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.)
Time Frame
Change between baseline and after 2 weeks adjustment period
Title
Psychological symptoms
Description
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.)
Time Frame
Change between baseline and after 2 weeks of use for each arm
Title
Psychological symptoms
Description
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.)
Time Frame
Change between after 2 weeks adjustment period and after 2 weeks of use for each arm
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has worn an ODRA knee brace multiple hours a day during the last 6 months
Exclusion Criteria:
Wounds on the lower body
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edith Martin, Ph.D
Phone
4187801301
Email
emartin@topmed.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Claude Morin
Facility Information:
Facility Name
TOPMED
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1S1C1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edith Martin, PhD
Phone
4187801301
Email
emartin@topmed.ca
First Name & Middle Initial & Last Name & Degree
Marianne Lancelot
Phone
4187801301
Email
mlancelot@topmed.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Validation orthèse Pour Gonarthrose
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