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Validating the Clinical Effect of a Knee Orthosis

T

TOPMED

Status

Terminated

Conditions

Medial Gonarthrosis

Treatments

Device: custom knee orthosis

Study type

Interventional

Funder types

Other

Identifiers

NCT06655558
241_O3D_Quest

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

2 participants in 1 patient group

medial gonarthrosis
Experimental group
Description:
Patients with medial gonarthrosis
Treatment:
Device: custom knee orthosis

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Mathieu Germain Robitaille, M.Sc. in kinesiology; Edith Martin, Phd. metallurgical engineering

Data sourced from clinicaltrials.gov

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