Validating the Clinical Effect of a Knee Orthosis

NCT ID: NCT06655558

Last Updated: 2025-09-04

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2025-06-06

Brief Summary

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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.

Detailed Description

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Conditions

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Medial Gonarthrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Longitudal treatment validation
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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medial gonarthrosis

Patients with medial gonarthrosis

Group Type EXPERIMENTAL

custom knee orthosis

Intervention Type DEVICE

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

Interventions

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custom knee orthosis

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Natural Sciences and Engineering Research Council, Canada

OTHER

Sponsor Role collaborator

O3D inc.

UNKNOWN

Sponsor Role collaborator

TOPMED

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edith Martin, Phd.

Role: PRINCIPAL_INVESTIGATOR

TOPMED

Locations

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Topmed

Québec, , Canada

Site Status

Countries

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Canada

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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241_O3D_Quest

Identifier Type: -

Identifier Source: org_study_id

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