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Completed

NCT Number: NCT01909596

Lateral Wedge Insoles With Arch Support in Knee Osteoarthritis

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.

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Key information

Conditions

Medial Knee Osteoarthritis

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Québec, Quebec, G1V 0A6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Neutral customized foot orthoses

Device

Foot orthoses with arch support and without lateral inclination

Other names: Orthoconcept Inc, Laval, Qc, Canada

6° lateral customized foot orthoses

Device

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

Other names: Orthoconcept Inc, Laval, Qc, Canada

10° lateral customized foot orthoses

Device

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

Other names: Orthoconcept Inc, Laval, Qc, Canada

Primary outcomes

  1. Knee pain

    Time frame: At time of device receipt

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

  2. 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 outcomes

  1. Foot orthoses comfort

    Time frame: At time of device receipt

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

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

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

Registry information

Official study title

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?

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 26, 2013
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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