Validation of a Knee Brace for Gonarthrosis

NCT05814471 | Completed Results

• 1 other identifier: RD-241-VicD_1
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Gonarthrosis

Keywords

knee brace; orthosis; treatment efficacy; arthrosis; comfort; ease of use

Outcome Measures

Primary Outcomes (8)

• Ease of Use Measurement Scale

  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)

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

• Ease of Use Measurement Scale

  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)

  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.

• Comfort Measurement Scale

  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).

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

• Comfort Measurement Scale

  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).

  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.

• Physical Symptoms

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

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

• Physical Symptoms

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

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

• Psychological Symptoms

  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);

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

• Psychological Symptoms

  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);

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

Study Arms (2)

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

EXPERIMENTAL

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.

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

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

ACTIVE COMPARATOR

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.

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

Interventions

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.

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

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.

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Wounds on the lower body

Sponsors & Collaborators

• TOPMED: lead
• Natural Sciences and Engineering Research Council, Canada: collaborator
• Laboratoire Victhom: collaborator

Study Sites (1)

TOPMED

Québec, Quebec, G1S1C1, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Edith Martin
• Organization: Topmed

emartin@topmed.ca

418 683-2104

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized trial with condition crossover

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 14, 2023
• Study Start: March 30, 2023
• Primary Completion: September 27, 2023
• Study Completion: January 30, 2025
• Last Updated: July 29, 2025
• Results First Posted: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)