Lateral Wedge Insoles With Arch Support in Knee Osteoarthritis

Laval University

Status: Completed

Conditions: Medial Knee Osteoarthritis

Treatments: Device: Neutral customized foot orthoses; Device: 6° lateral customized foot orthoses; Device: 10° lateral customized foot orthoses

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01909596

OP-2012

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

24 participants in 4 patient groups

Knee osteoarthritis patients - No insoles

No Intervention group

Description:

Without orthoses

Knee osteoarthritis patients - Customised

Active Comparator group

Description:

Medial arch support without lateral wedge

Treatment:

Device: Neutral customized foot orthoses

Knee osteoarthritis patients - Customised + 6°

Active Comparator group

Description:

6° lateral wedge insoles + Medial arch support

Treatment:

Device: 6° lateral customized foot orthoses

Knee osteoarthritis patients - Customised + 10°

Active Comparator group

Description:

10° lateral wedge insoles + Medial arch support

Treatment:

Device: 10° lateral customized foot orthoses