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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Natural Sciences and Engineering Research Council, Canada
Fonds de la Recherche en Santé du Québec
Ergorecherche Inc.
Information provided by (Responsible Party):
Laval University
ClinicalTrials.gov Identifier:
NCT01870336
First received: May 23, 2013
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Medial Knee Osteoarthritis
Device: Lateral customized foot orthoses
Device: Knee brace
Device: Combination of the two treatments

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Combination of Lateral Foot Orthoses and Knee Brace for Treatment of the Medial Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • Change in Knee adduction moment [ Time Frame: Change from Baseline at 3 months ] [ Designated as safety issue: No ]
  • Change in Knee pain [ Time Frame: Change from Baseline at 3 months ] [ Designated as safety issue: No ]
    A 20-cm visual analog scale (0-100) is used to assess pain.


Secondary Outcome Measures:
  • Change in Spatiotemporal gait parameters [ Time Frame: Change from Baseline at 3 months ] [ Designated as safety issue: No ]
  • Change in Knee adduction angle [ Time Frame: Change from Baseline at 3 months ] [ Designated as safety issue: No ]
  • Change in Comfort [ Time Frame: Change from Baseline at 3 months ] [ Designated as safety issue: No ]
    A 20-cm visual analog scale (0-100) is used to assess comfort.


Enrollment: 22
Study Start Date: September 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Knee osteoarthritis patients
Knee osteoarthritis patients with Kellgren & Lawrence grade I, II or III Lateral customized foot orthoses Knee brace Combination of the two treatments
Device: Lateral customized foot orthoses
Foot orthoses with arch support and lateral inclination set at 7°
Device: Knee brace
Knee brace (OdrA)
Device: Combination of the two treatments
Combination of Lateral customized foot orthoses and knee brace

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01870336

Locations
Canada, Quebec
Pavillon de l'Éducation Physique et des Sports - Université Laval
Québec, Quebec, Canada, G1V 0A6
Sponsors and Collaborators
Laval University
Natural Sciences and Engineering Research Council, Canada
Fonds de la Recherche en Santé du Québec
Ergorecherche Inc.
Investigators
Study Director: Philippe Corbeil, PhD Laval University
Principal Investigator: Yoann Dessery, MSc Laval University
Study Director: Étienne L Belzile, MD Laval University
  More Information

No publications provided

Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT01870336     History of Changes
Other Study ID Numbers: OC-2013
Study First Received: May 23, 2013
Last Updated: March 5, 2014
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 31, 2014