NCT06655558

Validating the Clinical Effect of a Knee Orthosis

Terminated NA Results posted Last updated 4 September 2025

What this trial tests

NA trial testing custom knee orthosis in Medial Gonarthrosis in 2 participants. Terminated before completion.

Timeline

31 July 2024

Primary endpoint
22 December 2024

6 June 2025

Quick facts

Lead sponsor	TOPMED
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	31 July 2024
Primary completion	22 December 2024
Estimated completion	6 June 2025
Sites	1 location across Canada

Drugs / interventions tested

• custom knee orthosis

Conditions studied

• Medial Gonarthrosis — all drugs for Medial Gonarthrosis →

Sponsor

TOPMED

Who can join

Adults 18 to 75, any sex, with Medial Gonarthrosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in WOMAC Total Score Primary · At baseline and after 8 weeks of intervention(Day 56)

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

Group	Value	95% CI
Medial Gonarthrosis	6	± 0

Change in WOMAC Pain Score Primary · At baseline and after 8 weeks of intervention(Day 56)

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

Group	Value	95% CI
Medial Gonarthrosis	3	± 0

Change in WOMAC Stiffness Score Primary · At baseline and after 8 weeks of intervention(Day 56)

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

Group	Value	95% CI
Medial Gonarthrosis	1	± 0

Change in WOMAC Physical Function Score Primary · At baseline and after 8 weeks of intervention(Day 56)

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

Group	Value	95% CI
Medial Gonarthrosis	2	± 0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.