Combination of Lateral Foot Orthoses and Knee Brace for Treatment of the Knee Osteoarthritis
- Conditions
- Osteoarthritis, Knee
- Interventions
- Device: Combined treatment of medial knee osteoarthritis
- Registration Number
- NCT01870336
- Lead Sponsor
- Laval University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- 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°
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Combination of the two treatments Combined treatment of medial knee osteoarthritis Combination of Lateral customized foot orthoses and knee brace Lateral customized foot orthoses Combined treatment of medial knee osteoarthritis Foot orthoses with arch support and lateral inclination set at 7° (alone) Knee brace Combined treatment of medial knee osteoarthritis OdrA Knee brace (alone)
- Primary Outcome Measures
Name Time Method Change in Knee adduction moment Change from Baseline at 3 months Change in Knee pain Change from Baseline at 3 months A 20-cm visual analog scale (0-100) is used to assess pain.
- Secondary Outcome Measures
Name Time Method Change in Spatiotemporal gait parameters Change from Baseline at 3 months Change in Knee adduction angle Change from Baseline at 3 months Change in Comfort Change from Baseline at 3 months A 20-cm visual analog scale (0-100) is used to assess comfort.
Trial Locations
- Locations (1)
Pavillon de l'Éducation Physique et des Sports - Université Laval
🇨🇦Québec, Quebec, Canada