NCT05814471

Validation of a Knee Brace for Gonarthrosis

Protocol for the Clinical Validation of a Valgus Knee Brace for Gonarthrosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: TOPMED · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Gonarthrosis

Interventions

Type	Name	Description
DEVICE	Cable fastening system and 3d printed straps(14 days)	The participants will wear a Odra knee brace held in place with by a cable fastening system and 3d printed straps for 2 weeks.
DEVICE	Velcro straps system(14 days)	The participants will wear a Odra knee brace held in place with by a velcro straps system for 2 weeks.
DEVICE	Adjustment period(Velcro-14 days)	The participants will wear a new Odra knee brace held in place with by a velcro straps system for 2 weeks.

Timeline

• Start date: 2023-03-30
• Primary completion: 2023-09-27
• Completion: 2025-01-30
• First posted: 2023-04-14
• Last updated: 2025-07-29
• Results posted: 2025-07-29

Locations

1 site across 1 country: Canada