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Completed

NCT Number: NCT05814471

Validation of a Knee Brace for Gonarthrosis

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.

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Key information

Conditions

Gonarthrosis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TOPMED

Québec, Quebec, G1S1C1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Wounds on the lower body

Treatment and study plan

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

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)

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)

Device

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

Primary outcomes

  1. Ease of Use Measurement Scale

    Time frame: Before the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.

    The scale was developped for this study. The mesure is an average of 5 items with 5 point scale rating system(1 harder to use; 5 easier to use). Mean score ranges from (1 harder to use; 5 easier to use)

  2. Ease of Use Measurement Scale

    Time frame: Directly after the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.

    The scale was developped for this study. The mesure is an average of 5 items with 5 point scale rating system(1 harder to use; 5 easier to use). Mean score ranges from (1 harder to use; 5 easier to use)

  3. Comfort Measurement Scale

    Time frame: Before the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.

    The scale was developped for this study. The mesure is an average of 2 items with 5 point scale rating system(1 lowest comfort; 5 highest comfort). Total score is adjusted to 0 (lowest comfort) to 100 (highest comfort).

  4. Comfort Measurement Scale

    Time frame: Directly after the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.

    The scale was developped for this study. The mesure is an average of 2 items with 5 point scale rating system(1 lowest comfort; 5 highest comfort). Total score is adjusted to 0 (lowest comfort) to 100 (highest comfort).

  5. Physical Symptoms

    Time frame: Change between baseline(directly before adjustment period) and directly after 2 weeks adjustment period.

    Knee injury and Osteoarthritis Outcome Total Score (KOOS), translated to French(Quebec). Minimum=0(worst symptoms); Maximum=100(no symptoms);

  6. Physical Symptoms

    Time frame: Change between directly after 2 weeks adjustment period and directly after 2 weeks of use for each arm

    Knee injury and Osteoarthritis Outcome Total Score (KOOS), translated to French(Quebec). Minimum=0(worst symptoms); Maximum=100(no symptoms);

  7. Psychological Symptoms

    Time frame: Change between baseline(directly before adjustment period) and directly after 2 weeks adjustment period.

    Psychological Symptoms Inventory Total Score(Ilfeld, F. W. (1976). Further validation of a psychiatric symptom index in a normal population. Psychological Reports, 39(3, Pt 2), 1215-1228.). Minimum=0; (No symptoms); Maximum=100(Worst Symptoms);

  8. Psychological Symptoms

    Time frame: Change between directly after 2 weeks adjustment period and directly after 2 weeks of use for each arm

    Psychological Symptoms Inventory Total Score(Ilfeld, F. W. (1976). Further validation of a psychiatric symptom index in a normal population. Psychological Reports, 39(3, Pt 2), 1215-1228.). Minimum=0; (No symptoms); Maximum=100(Worst Symptoms);

Sponsors and collaborators

Lead sponsor

TOPMED

Other

Collaborators

  • Laboratoire Victhom
  • Natural Sciences and Engineering Research Council, Canada

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Apr 14, 2023
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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