Effects of a New Knee Brace for Treatment of the Knee Osteoarthritis

NCT ID: NCT01866176

Last Updated: 2014-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-08-31

Brief Summary

The purpose of this study is to evaluate the immediate effects of a knee brace with a new mechanism on the pain and medial knee loading during gait among medial knee osteoarthritis patients. The effects of this new brace is compared to a stabilizing brace and a typical valgus knee brace. The investigators recruited 24 knee osteoarthritis and they have to wear each of the three braces during three months. A fifteen days wash-out period is given after each three months. Biomechanical evaluation is carried out before and after each three months. This evaluation consisted of three questionnaires (KOOS, WOMAC and Medical Outcome Score Short Form-36 (MOS-SF36)), a motion analysis with an optoelectronic system, then a 6-min walk test. During motion analysis, ten gait trials are executed without brace and ten with the brace.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Knee osteoarthritis patients

Knee osteoarthritis patients with Kellgren \& Lawrence grade I, II or III Stabilizing Knee Brace Valgus Knee Brace New Knee Brace

Group Type: EXPERIMENTAL

Stabilizing Knee Brace

Intervention Type: DEVICE

Brace with no valgus action

Valgus Knee Brace

Intervention Type: DEVICE

Valgus brace with traditional three point bending system

New Knee Brace

Intervention Type: DEVICE

Brace with new mechanism to decrease the knee loading.

Interventions

Stabilizing Knee Brace

Brace with no valgus action

Intervention Type: DEVICE

Valgus Knee Brace

Valgus brace with traditional three point bending system

Intervention Type: DEVICE

New Knee Brace

Brace with new mechanism to decrease the knee loading.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Symptomatic medial knee OA (Kellgren-Lawrence grade I, II or III) according to clinical and radiological criteria of the American College of Rheumatology
• Knee pain > 31/100 (Western Ontario and McMaster Universities Arthritis Index - WOMAC)
• Moderately active
• Varus knee alignment equal or superior to 2°

Exclusion Criteria

• Severe knee OA (K-L grade IV)
• Rheumatoid arthritis or other inflammatory arthritis
• Avascular necrosis
• History of periarticular fracture or septic arthritis
• Bone metabolic disease
• Pigmented villonodular synovitis
• Cartilaginous disease
• Neuropathic arthropathy
• Synovial osteochondromatosis
• Total or partial knee arthroplasty
• Flexion contracture of ipsi- or contra-lateral knee greater than 15°
• Hip or ankle joint damage with mobility limitation
• Obesity (BMI ≥ 40)
• Intra-articular corticosteroids injection in the affected knee during the two previous months
• Reduced mobility (Charnley class C)

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Natural Sciences and Engineering Research Council, Canada

OTHER

Sponsor Role: collaborator

Fonds de la Recherche en Santé du Québec

OTHER_GOV

Sponsor Role: collaborator

Ergorecherche Inc.

INDUSTRY

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Corbeil, PhD

Role: STUDY_DIRECTOR

Laval University

Yoann Dessery, MSc

Role: PRINCIPAL_INVESTIGATOR

Laval University

Étienne L Belzile, MD

Role: STUDY_DIRECTOR

Laval University

Locations

Pavillon de l'Éducation Physique et des Sports - Université Laval

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

OG2007-097-A4

Identifier Type: -

Identifier Source: org_study_id