Validating the Clinical Effect of a Knee Orthosis

Not Applicable

Recruiting

• Conditions: Medial Gonarthrosis

• Registration Number: NCT06655558
• Lead Sponsor: TOPMED

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-31
• Status Verified: 2024-10
• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-21
• Study First Posted: 2024-10-23
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26
• Primary Completion: 2025-07-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
WOMAC total score	Before intervention begins and after 8 weeks of intervention	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). 5 item questionnaire about knee pain. Each item uses a 5 point scale ranging from 0 (no pain) to 4 (extreme pain). Therefore low scores represent better knee health whereas high scores represent worse knee health.
WOMAC pain score	Before intervention begins and after 8 weeks of intervention	5 item questionnaire about knee pain. Each item uses a 5 point scale ranging from 0 (no pain) to 4 (extreme pain). Therefore low scores represent better knee pain whereas high scores represent worse knee pain.
WOMAC stiffness score	Before intervention begins and after 8 weeks of intervention	2 item questionnaire about knee stiffness. Each item uses a 5 point scale ranging from 0 (no stiffness) to 4 (extreme stiffness). Therefore low scores represent better knee stiffness whereas high scores represent worse knee stiffness.
WOMAC functional limitation score	Before intervention begins and after 8 weeks of intervention	17 item questionnaire about knee function. Each item uses a 5 point scale ranging from 0 (no dificulty) to 4 (extreme dificulty). Therefore low scores represent better knee function whereas high scores represent worse knee function.

Trial Locations

Locations (1)

Topmed; 🇨🇦 Québec, Quebec, Canada