Clinical trial NCT05814471: Validation orthèse Pour Gonarthrose
Official title: Protocole de Validation d'Une orthèse de Genou Valgisante Pour Gonarthrose
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gonarthrosis
Keywords: knee brace
orthosis
treatment efficacy
arthrosis
comfort
ease of use
Lead sponsor: TOPMED
Sponsor class: OTHER
Collaborators: name: Conseil de recherches en sciences naturelles et en génie du Canada
name: Laboratoires Victhom
First posted: 2023-04-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized trial with condition crossover
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: ease of use
timeFrame: before the 2 weeks of use for each arm
measure: ease of use
timeFrame: after the 2 weeks of use for each arm
measure: Comfort
timeFrame: before 2 weeks of use for each arm
measure: Comfort
timeFrame: after 2 weeks of use for each arm
measure: Physical symptoms
timeFrame: Change between baseline and after 2 weeks adjustment period
measure: Physical symptoms
timeFrame: Change between baseline and after 2 weeks of use for each arm
measure: Physical symptoms
timeFrame: Change between after 2 weeks adjustment period and after 2 weeks of use for each arm
measure: Psychological symptoms
timeFrame: Change between baseline and after 2 weeks adjustment period
measure: Psychological symptoms
timeFrame: Change between baseline and after 2 weeks of use for each arm
measure: Psychological symptoms
timeFrame: Change between after 2 weeks adjustment period and after 2 weeks of use for each arm
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: TOPMED
state: Quebec
Study officials:
References: