Validation of a Knee Brace for Gonarthrosis

NCT ID: NCT05814471

Last Updated: 2025-07-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-30

Study Completion Date

2025-01-30

Brief Summary

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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

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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

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Gonarthrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized trial with condition crossover
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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(14 days)

Intervention Type DEVICE

The participants will wear a Odra knee brace held in place with by a velcro straps system for 2 weeks.

Adjustment period(Velcro-14 days)

Intervention Type DEVICE

The participants will wear a new Odra knee brace held in place with by a velcro straps system for 2 weeks.

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

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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(14 days)

Intervention Type DEVICE

The participants will wear a Odra knee brace held in place with by a velcro straps system for 2 weeks.

Adjustment period(Velcro-14 days)

Intervention Type DEVICE

The participants will wear a new Odra knee brace held in place with by a velcro straps system for 2 weeks.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Wounds on the lower body
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Natural Sciences and Engineering Research Council, Canada

OTHER

Sponsor Role collaborator

Laboratoire Victhom

UNKNOWN

Sponsor Role collaborator

TOPMED

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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TOPMED

Québec, Quebec, Canada

Site Status

Countries

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Canada

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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RD-241-VicD_1

Identifier Type: -

Identifier Source: org_study_id

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