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

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ClinicalTrials.gov Identifier: NCT01866176
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : March 6, 2014
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

Tracking Information
First Submitted Date  ICMJE May 9, 2013
First Posted Date  ICMJE May 31, 2013
Last Update Posted Date March 6, 2014
Study Start Date  ICMJE October 2011
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2013)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2013)
  • Change in Spatio-temporal 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of a New Knee Brace for Treatment of the Knee Osteoarthritis
Official Title  ICMJE Effects of a New Knee Brace for Treatment of the Knee Osteoarthritis on the Medial Knee Loading During Gait
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: Knee osteoarthritis patients
Knee osteoarthritis patients with Kellgren & Lawrence grade I, II or III Stabilizing Knee Brace Valgus Knee Brace New Knee Brace
Interventions:
  • Device: Stabilizing Knee Brace
  • Device: Valgus Knee Brace
  • Device: New Knee Brace
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2013)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01866176
Other Study ID Numbers  ICMJE OG2007-097-A4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Laval University
Study Sponsor  ICMJE Laval University
Collaborators  ICMJE
  • Natural Sciences and Engineering Research Council, Canada
  • Fonds de la Recherche en Santé du Québec
  • Ergorecherche Inc.
Investigators  ICMJE
Study Director: Philippe Corbeil, PhD Laval University
Principal Investigator: Yoann Dessery, MSc Laval University
Study Director: Étienne L Belzile, MD Laval University
PRS Account Laval University
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP