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NCT Number: NCT01870336

Combination of Lateral Foot Orthoses and Knee Brace for Treatment of the Knee Osteoarthritis

The purpose of this study is to evaluate the immediate and short-term effects of the combination of lateral customized foot orthoses on the pain and medial knee loading during gait among medial knee osteoarthritis patients. The effects of the combination is compared to the single use of these devices. The investigators recruited 22 knee osteoarthritis. They have to wear each of treatments (foot orthoses, knee brace and combination) during three months. A fifteen days wash-out period is given after each three months. Biomechanical evaluation is carried out before and after each three months. This evaluation consisted of three questionnaires (Knee Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC) and Medical Outcome Study Short Form-36( MOS-SF36)), a motion analysis with an optoelectronic system, then a 6-min walk test. During motion analysis, ten gait trials are executed without treatment and ten with the treatment.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year and older

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 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

Combined treatment of medial knee osteoarthritis

Device

Primary outcomes

  1. Change in Knee adduction moment

    Time frame: Change from Baseline at 3 months

  2. Change in Knee pain

    Time frame: Change from Baseline at 3 months

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

Secondary outcomes

  1. Change in Spatiotemporal gait parameters

    Time frame: Change from Baseline at 3 months

  2. Change in Knee adduction angle

    Time frame: Change from Baseline at 3 months

  3. Change in Comfort

    Time frame: Change from Baseline at 3 months

    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

Combination of Lateral Foot Orthoses and Knee Brace for Treatment of the Medial Knee Osteoarthritis

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 6, 2013
Registry last updated
Mar 4, 2016

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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