Lateral Wedge Insoles With Arch Support in Knee Osteoarthritis

NCT01909596 | Completed DMC

• 1 other identifier: OP-2012
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Medial Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Knee pain

  A 20-cm visual analog scale (0-100) is used to assess pain.

  At time of device receipt

• Knee adduction moment

  Measure of the knee adduction moment is a non invasive technic to identify change in medial knee loading, major problem in medial knee osteoarthritis.

  At time of device receipt

Secondary Outcomes (1)

• Foot orthoses comfort

  At time of device receipt

Study Arms (4)

Knee osteoarthritis patients - No insoles

NO INTERVENTION

Without orthoses

Knee osteoarthritis patients - Customised

ACTIVE COMPARATOR

Medial arch support without lateral wedge

Device: Neutral customized foot orthoses

Knee osteoarthritis patients - Customised + 6°

ACTIVE COMPARATOR

6° lateral wedge insoles + Medial arch support

Device: 6° lateral customized foot orthoses

Knee osteoarthritis patients - Customised + 10°

ACTIVE COMPARATOR

10° lateral wedge insoles + Medial arch support

Device: 10° lateral customized foot orthoses

Interventions

Neutral customized foot orthoses DEVICE

Foot orthoses with arch support and without lateral inclination

Also known as: Orthoconcept Inc, Laval, Qc, Canada

Knee osteoarthritis patients - Customised

6° lateral customized foot orthoses DEVICE

Foot orthoses with arch support above insoles with lateral inclination set at 6°

Also known as: Orthoconcept Inc, Laval, Qc, Canada

Knee osteoarthritis patients - Customised + 6°

10° lateral customized foot orthoses DEVICE

Foot orthoses with arch support above insoles with lateral inclination set at 10°

Also known as: Orthoconcept Inc, Laval, Qc, Canada

Knee osteoarthritis patients - Customised + 10°

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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°

You may not qualify if:

• 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)

Sponsors & Collaborators

• Laval University: lead
• Natural Sciences and Engineering Research Council, Canada: collaborator
• Fonds de la Recherche en Santé du Québec: collaborator
• Ergorecherche Inc.: collaborator

Study Sites (1)

Pavillon de l'Éducation Physique et des Sports - Université Laval

Québec, Quebec, G1V 0A6, Canada

Location

Study Officials

• Philippe Corbeil, PhD

  Laval University

  STUDY DIRECTOR

• Yoann Dessery, MSc

  Laval University

  PRINCIPAL INVESTIGATOR

• Étienne L Belzile, MD

  Laval University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 26, 2013
• Study Start: May 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

CA (1)