Effects of a New Knee Brace for Treatment of the Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Stabilizing Knee Brace
Valgus Knee Brace
New Knee Brace
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility 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)
Sites / Locations
- Pavillon de l'Éducation Physique et des Sports - Université Laval
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Knee osteoarthritis patients
Arm Description
Knee osteoarthritis patients with Kellgren & Lawrence grade I, II or III Stabilizing Knee Brace Valgus Knee Brace New Knee Brace
Outcomes
Primary Outcome Measures
Change in Knee adduction moment
Change in Knee pain
A 20-cm visual analog scale (0-100) is used to assess pain.
Secondary Outcome Measures
Change in Spatiotemporal gait parameters
Test of the gait symmetry with the gait phase duration and step length.
Change in Gait velocity
Change in Knee adduction angle
Change in Knee brace comfort
A 20-cm visual analog scale (0-100) is used to assess comfort.
Full Information
NCT ID
NCT01866176
First Posted
May 9, 2013
Last Updated
March 5, 2014
Sponsor
Laval University
Collaborators
Natural Sciences and Engineering Research Council, Canada, Fonds de la Recherche en Santé du Québec, Ergorecherche Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01866176
Brief Title
Effects of a New Knee Brace for Treatment of the Knee Osteoarthritis
Official Title
Effects of a New Knee Brace for Treatment of the Knee Osteoarthritis on the Medial Knee Loading During Gait
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laval University
Collaborators
Natural Sciences and Engineering Research Council, Canada, Fonds de la Recherche en Santé du Québec, Ergorecherche Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Knee osteoarthritis patients
Arm Type
Experimental
Arm Description
Knee osteoarthritis patients with Kellgren & Lawrence grade I, II or III Stabilizing Knee Brace Valgus Knee Brace New Knee Brace
Intervention Type
Device
Intervention Name(s)
Stabilizing Knee Brace
Intervention Description
Brace with no valgus action
Intervention Type
Device
Intervention Name(s)
Valgus Knee Brace
Intervention Description
Valgus brace with traditional three point bending system
Intervention Type
Device
Intervention Name(s)
New Knee Brace
Intervention Description
Brace with new mechanism to decrease the knee loading.
Primary Outcome Measure Information:
Title
Change in Knee adduction moment
Time Frame
Change from Baseline at 3 months
Title
Change in Knee pain
Description
A 20-cm visual analog scale (0-100) is used to assess pain.
Time Frame
Change from Baseline at 3 months
Secondary Outcome Measure Information:
Title
Change in Spatiotemporal gait parameters
Description
Test of the gait symmetry with the gait phase duration and step length.
Time Frame
Change from Baseline at 3 months
Title
Change in Gait velocity
Time Frame
Change from Baseline at 3 months
Title
Change in Knee adduction angle
Time Frame
Change from Baseline at 3 months
Title
Change in Knee brace comfort
Description
A 20-cm visual analog scale (0-100) is used to assess comfort.
Time Frame
Change from Baseline at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Corbeil, PhD
Organizational Affiliation
Laval University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yoann Dessery, MSc
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Étienne L Belzile, MD
Organizational Affiliation
Laval University
Official's Role
Study Director
Facility Information:
Facility Name
Pavillon de l'Éducation Physique et des Sports - Université Laval
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada
12. IPD Sharing Statement
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Effects of a New Knee Brace for Treatment of the Knee Osteoarthritis
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