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Effects of a New Knee Brace for Treatment of the Knee Osteoarthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01866176
First Posted: May 31, 2013
Last Update Posted: March 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose
The purpose of this study is to evaluate the immediate effects of a knee brace with a new mechanism on the pain and medial knee loading during gait among medial knee osteoarthritis patients. The effects of this new brace is compared to a stabilizing brace and a typical valgus knee brace. The investigators recruited 24 knee osteoarthritis and they have to wear each of the three braces 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 (KOOS, WOMAC and Medical Outcome Score 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 brace and ten with the brace.

Condition Intervention
Knee Osteoarthritis Device: Stabilizing Knee Brace Device: Valgus Knee Brace Device: New Knee Brace

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of a New Knee Brace for Treatment of the Knee Osteoarthritis on the Medial Knee Loading During Gait

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 ]
  • 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 Outcome Measures:
  • Change in Spatiotemporal gait parameters [ Time Frame: Change from Baseline at 3 months ]
    Test of the gait symmetry with the gait phase duration and step length.

  • Change in Gait velocity [ Time Frame: Change from Baseline at 3 months ]
  • Change in Knee adduction angle [ Time Frame: Change from Baseline at 3 months ]
  • Change in Knee brace comfort [ Time Frame: Change from Baseline at 3 months ]
    A 20-cm visual analog scale (0-100) is used to assess comfort.


Enrollment: 24
Study Start Date: October 2011
Study Completion Date: August 2013
Primary Completion Date: May 2013 (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 Stabilizing Knee Brace Valgus Knee Brace New Knee Brace
Device: Stabilizing Knee Brace
Brace with no valgus action
Device: Valgus Knee Brace
Valgus brace with traditional three point bending system
Device: New Knee Brace
Brace with new mechanism to decrease the knee loading.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866176


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

Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT01866176     History of Changes
Other Study ID Numbers: OG2007-097-A4
First Submitted: May 9, 2013
First Posted: May 31, 2013
Last Update Posted: March 6, 2014
Last Verified: March 2014

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