Validating the Clinical Effect of a Knee Orthosis

NCT06655558 | Terminated Results

• 1 other identifier: 241_O3D_Quest
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The aging population is steadily increasing, partly due to increasing life expectancy. At the same time, chronic diseases, including those affecting the musculoskeletal system (e.g., osteoarthritis), whose prevalence increases with age, limit the daily activities of those affected and thus affect more and more people. Arthrosis is the most common form of these diseases worldwide. According to the l'Institut de la statistique du Québec, nearly one in two Quebecers aged 15 and over is affected by a chronic health problem. Knee orthosis is one form of treatment that helps patients suffering from knee gonarthrosis. This treatment aims to compensate for certain biomechanical deficits in patients. A variety of joint configurations exists to target specific biomechanical deficits. A constant challenge for companies manufacturing orthoses is transmitting the orthosis's biomechanical effect to the patient. The desired effect requires a change in the forces applied inside the knee, but the orthosis cannot directly transmit forces to the patient's bones due to its external nature to the body. Customization of orthoses is crucial to improve the transmission of the biomechanical effect as well as tolerance to it. O3D Inc. aims to validate the effectiveness of its new custom orthosis for treating knee gonarthrosis symptoms. Participants answered a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire before receiving their custom knee brace(Baseline) and after 8 weeks (56 days) of treatment.

Conditions

Medial Gonarthrosis

Keywords

knee orthosis; knee brace; validation; WOMAC; knee pain; knee stiffness; daily activities; knee function

Outcome Measures

Primary Outcomes (4)

• Change in WOMAC Total Score

  Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 24 item questionnaire about knee pain, stiffness and function. Each item uses a 5 point scale ranging from 0 (no pain, stiffness or difficulty) to 4 (extreme pain, stiffness or difficulty). Total score is the sum of all items and ranges from 0 to 96. Therefore low scores represent better knee health whereas high scores represent worse knee health. Change is calculated as : Change= Score after 8 weeks of treatment - Baseline Score

  At baseline and after 8 weeks of intervention(Day 56)

• Change in WOMAC Pain Score

  Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subcore of 5 items about knee pain. Each item uses a 5 point scale ranging from 0 (no pain) to 4 (extreme pain). Pain score is the sum of all 5 items, ranges from 0 to 20. Therefore low scores represent better knee pain whereas high scores represent worse knee pain. Change is calculated as : Change= Score after 8 weeks of treatment - Baseline Score

  At baseline and after 8 weeks of intervention(Day 56)

• Change in WOMAC Stiffness Score

  Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscore of 2 items about knee stiffness. Each item uses a 5 point scale ranging from 0 (no stiffness) to 4 (extreme stiffness). Stiffness score is the sum of 2 items, ranges from 0 to 8. Therefore low scores represent better knee stiffness whereas high scores represent worse knee stiffness. Change is calculated as : Change= Score after 8 weeks of treatment - Baseline Score

  At baseline and after 8 weeks of intervention(Day 56)

• Change in WOMAC Physical Function Score

  Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscore of 17 items about knee function. Each item uses a 5 point scale ranging from 0 (no dificulty) to 4 (extreme dificulty). Functionnal limitation score is the sum of all 17 items, ranges from 0 to 68. Therefore low scores represent better knee function whereas high scores represent worse knee function. Change is calculated as : Change= Score after 8 weeks of treatment - Baseline Score

  At baseline and after 8 weeks of intervention(Day 56)

Study Arms (1)

medial gonarthrosis

EXPERIMENTAL

Patients with medial gonarthrosis

Device: custom knee orthosis

Interventions

custom knee orthosis DEVICE

The custom knee orthosis will be worn for 8 weeks (56 days).

medial gonarthrosis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suffering from medial gonarthrosis
• Receiving a regular model of the O3D orthosis

You may not qualify if:

• Suffering from tricompartmental gonarthosis
• Having completed the delivery appointment for a O3D orthosis

Sponsors & Collaborators

• TOPMED: lead
• Natural Sciences and Engineering Research Council, Canada: collaborator
• O3D inc.: collaborator

Study Sites (1)

Topmed

Québec, G1S1C1, Canada

Location

Limitations and Caveats

Targeted enrollement of 30 participants was not reached. Interpretations should be taken with caution because of the small number of participants.

Results Point of Contact

• Title: Edith Martin
• Organization: Topmed

emartin@topmed.ca

418 683-2104

Study Officials

• Edith Martin, Phd.

  TOPMED

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Model Details: Longitudal treatment validation

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: July 31, 2024
• Primary Completion: December 22, 2024
• Study Completion: June 6, 2025
• Last Updated: September 4, 2025
• Results First Posted: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)