Validating the Clinical Effect of a Knee Orthosis

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.

Study Overview

• Status: Terminated
• Conditions: Medial Gonarthrosis
• Intervention / Treatment: Device: custom knee orthosis

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Québec, Canada, G1S1C1
    • Topmed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: medial gonarthrosis; Patients with medial gonarthrosis	Device: custom knee orthosis; The custom knee orthosis will be worn for 8 weeks (56 days).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: TOPMED
• Collaborators: Natural Sciences and Engineering Research Council, Canada; O3D inc.
• Investigators: Principal Investigator: Edith Martin, Phd., Topmed

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2024
• Primary Completion (Actual): December 22, 2024
• Study Completion (Actual): June 6, 2025

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 31, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: WOMAC; knee pain; validation; daily activities; knee stiffness; knee function; knee brace; knee orthosis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 241_O3D_Quest

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No