Validation orthèse Pour Gonarthrose

Gonarthrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05814471
• Other study ID #: RD-241-VicD_1
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: May 2024
• Source: TOPMED
• Contact: Edith Martin, Ph.D
• Phone: 4187801301
• Email: emartin[@]topmed.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has worn an ODRA knee brace multiple hours a day during the last 6 months

Exclusion Criteria:

• Wounds on the lower body

Related Conditions & MeSH terms

• Gonarthrosis
• Osteoarthritis, Knee

Intervention

Device:
• Cable fastening system and 3d printed straps
The participants will wear a Odra knee brace held in place with by a cable fastening system and 3d printed straps for 2 weeks.
• Velcro straps system
The participants will wear a Odra knee brace held in place with by a velcro straps system for 2 weeks.

Locations

Country	Name	City	State
Canada	TOPMED	Québec	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
TOPMED	Conseil de recherches en sciences naturelles et en génie du Canada, Laboratoires Victhom

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ease of use	5 items with 5 point scale rating system(1 lowest - 5 highest)	before the 2 weeks of use for each arm
Primary	ease of use	5 items with 5 point scale rating system(1 lowest - 5 highest)	after the 2 weeks of use for each arm
Primary	Comfort	2 items with 5 point scale rating system(1 lowest - 5 highest)	before 2 weeks of use for each arm
Primary	Comfort	2 items with 5 point scale rating system(1 lowest - 5 highest)	after 2 weeks of use for each arm
Primary	Physical symptoms	Knee injury and Osteoarthritis Outcome Score (KOOS), translated to French(Quebec)	Change between baseline and after 2 weeks adjustment period
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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