Lateral Wedge Insoles With Arch Support in Knee Osteoarthritis

Overview

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.

Full Title of Study: “Does it Exist a Relationship Between Inclination Angle of Foot Orthoses and Varus Angle of the Knee in the Relief of the Knee Osteoarthritis Symptoms?”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: May 2012

Interventions

  • Other: Without orthoses
    • Condition control
  • Device: 6° lateral wedge insoles
    • Insoles with a lateral inclination set at 6°
  • Device: 10° lateral wedge insoles
    • Insoles with a lateral inclination set at 10°
  • Device: Neutral customized foot orthoses
    • Foot orthoses with arch support and without lateral inclination
  • Device: 6° lateral customized foot orthoses
    • Foot orthoses with arch support above insoles with lateral inclination set at 6°
  • Device: 7° lateral customized foot orthoses
    • Foot orthoses with arch support above insoles with lateral inclination set at 7°
  • Device: 8° lateral customized foot orthoses
    • Foot orthoses with arch support above insoles with lateral inclination set at 8°
  • Device: 9° lateral customized foot orthoses
    • Foot orthoses with arch support above insoles with lateral inclination set at 9°
  • Device: 10° lateral customized foot orthoses
    • Foot orthoses with arch support above insoles with lateral inclination set at 10°
  • Device: Orthotist integrated lateral customized foot orthoses
    • Foot orthoses with arch support and integrated lateral inclination set according to orthotist experience
  • Device: Orthotist lateral customized foot orthoses
    • Foot orthoses with arch support above insoles with lateral inclination set according to orthotist experience

Arms, Groups and Cohorts

  • Experimental: Knee osteoarthritis patients
    • Without orthoses 6° lateral wedge insoles 10° lateral wedge insoles Neutral customized foot orthoses 6° lateral customized foot orthoses 7° lateral customized foot orthoses 8° lateral customized foot orthoses 9° lateral customized foot orthoses 10° lateral customized foot orthoses Orthotist integrated lateral customized foot orthoses Orthotist lateral customized foot orthoses

Clinical Trial Outcome Measures

Primary Measures

  • Knee pain
    • Time Frame: At time of device receipt
    • A 20-cm visual analog scale (0-100) is used to assess pain.
  • Knee adduction moment
    • Time Frame: 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.

Secondary Measures

  • Foot orthoses comfort
    • Time Frame: At time of device receipt
    • A 20-cm visual analog scale (0-100) is used to assess comfort.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Laval University
  • Collaborator
    • Natural Sciences and Engineering Research Council, Canada
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Philippe Corbeil, PhD, Study Director, Laval University
    • Yoann Dessery, MSc, Principal Investigator, Laval University
    • Étienne L Belzile, MD, Study Director, Laval University

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