Combination of Lateral Foot Orthoses and Knee Brace for Treatment of the Knee Osteoarthritis

NCT ID: NCT01870336

Last Updated: 2016-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-05-31

Brief Summary

The purpose of this study is to evaluate the immediate and short-term effects of the combination of lateral customized foot orthoses on the pain and medial knee loading during gait among medial knee osteoarthritis patients. The effects of the combination is compared to the single use of these devices. The investigators recruited 22 knee osteoarthritis. They have to wear each of treatments (foot orthoses, knee brace and combination) 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 (Knee Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC) and Medical Outcome Study 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 treatment and ten with the treatment.

Conditions

Osteoarthritis, Knee

Study Design

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

Study Groups

Lateral customized foot orthoses

Foot orthoses with arch support and lateral inclination set at 7° (alone)

Group Type: EXPERIMENTAL

Combined treatment of medial knee osteoarthritis

Intervention Type: DEVICE

Knee brace

OdrA Knee brace (alone)

Group Type: EXPERIMENTAL

Combined treatment of medial knee osteoarthritis

Intervention Type: DEVICE

Combination of the two treatments

Combination of Lateral customized foot orthoses and knee brace

Group Type: EXPERIMENTAL

Combined treatment of medial knee osteoarthritis

Intervention Type: DEVICE

Interventions

Combined treatment of medial knee osteoarthritis

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: No

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

OC-2013

Identifier Type: -

Identifier Source: org_study_id