Lateral Wedge Insoles With Arch Support in Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Medial Knee Osteoarthritis
• Interventions: Device: 10° lateral customized foot orthoses; Device: Neutral customized foot orthoses; Device: 6° lateral customized foot orthoses

• Registration Number: NCT01909596
• Lead Sponsor: Laval University

Brief Summary

The purpose of this is to test lateral foot orthoses with different amount of wedging to find a model that predicts the optimal lateral inclination of foot orthosis based on biomechanical or feelings measures. This study was a cross-sectional study with patients serving as their own control. The investigators recruited 24 knee osteoarthritis. Knee radiography and clinical angles measures was carried out before making orthoses, then motion analysis with an optoelectronic system was performed with each pair of foot orthoses. During motion analysis, five gait trials were carried out in each condition.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Study First Submitted: 2013-07-17
• Study First Submitted QC: 2013-07-23
• Study First Posted: 2013-07-26
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Symptomatic medial knee osteoarthritis (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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Knee osteoarthritis patients - Customised + 10°	10° lateral customized foot orthoses	10° lateral wedge insoles + Medial arch support
Knee osteoarthritis patients - Customised	Neutral customized foot orthoses	Medial arch support without lateral wedge
Knee osteoarthritis patients - Customised + 6°	6° lateral customized foot orthoses	6° lateral wedge insoles + Medial arch support

Primary Outcome Measures

Name	Time	Method
Knee adduction moment	At time of device receipt	Measure of the knee adduction moment is a non invasive technic to identify change in medial knee loading, major problem in medial knee osteoarthritis.
Knee pain	At time of device receipt	A 20-cm visual analog scale (0-100) is used to assess pain.

Secondary Outcome Measures

Name	Time	Method
Foot orthoses comfort	At time of device receipt	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