Validation of a Knee Brace for Gonarthrosis

TOPMED

Status: Completed

Conditions: Gonarthrosis

Treatments: Device: Cable fastening system and 3d printed straps(14 days); Device: Adjustment period(Velcro-14 days); Device: Velcro straps system(14 days)

Study type: Interventional

Funder types: Other

Identifiers

NCT05814471

RD-241-VicD_1

Details and patient eligibility

About

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.

Full 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 to increase ease of use of the knee brace while maintaining comfort and treatment efficacy.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Wounds on the lower body

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Adjustement period(velcro)first, then Cable fastening system then Velcro Straps

Experimental group

Description:

A new knee brace is worn for a 14 days adjustement period with velcro straps. Then the brace is worn with a cable fastening system for a first 14 days intervention period, therefore the knee brace is held in place by a cable fastening system and 3d printed straps. The second 14 days intervention period is done with velcro straps keeping the brace in position.

Treatment:

Device: Velcro straps system(14 days)

Device: Adjustment period(Velcro-14 days)

Device: Cable fastening system and 3d printed straps(14 days)

Adjustement period(velcro)first, then Velcro Straps then Cable fastening system

Active Comparator group

Description:

A new knee brace is worn for a 14 days adjustement period with velcro straps. The first 14 days intervention period is done with velcro straps keeping the brace in position. Then the brace is worn with a cable fastening system for a second 14 days intervention period, therefore the knee brace is held in place by a cable fastening system and 3d printed straps.

Treatment:

Device: Velcro straps system(14 days)

Device: Adjustment period(Velcro-14 days)

Device: Cable fastening system and 3d printed straps(14 days)