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

Laval University

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Device: Combined treatment of medial knee osteoarthritis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01870336

OC-2013

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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22 participants in 3 patient groups

Lateral customized foot orthoses

Experimental group

Description:

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

Treatment:

Device: Combined treatment of medial knee osteoarthritis

Knee brace

Experimental group

Description:

OdrA Knee brace (alone)

Treatment:

Device: Combined treatment of medial knee osteoarthritis

Combination of the two treatments

Experimental group

Description:

Combination of Lateral customized foot orthoses and knee brace

Treatment:

Device: Combined treatment of medial knee osteoarthritis