Clinical trial NCT01866176: 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
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Natural Sciences and Engineering Research Council, Canada
name: Fonds de la Recherche en Santé du Québec
name: Ergorecherche Inc.
First posted: 2013-05-31
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change in Knee adduction moment
timeFrame: Change from Baseline at 3 months
measure: Change in Knee pain
timeFrame: Change from Baseline at 3 months
Secondary outcomes:
measure: Change in Spatiotemporal gait parameters
timeFrame: Change from Baseline at 3 months
measure: Change in Gait velocity
timeFrame: Change from Baseline at 3 months
measure: Change in Knee adduction angle
timeFrame: Change from Baseline at 3 months
measure: Change in Knee brace comfort
timeFrame: Change from Baseline at 3 months
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Pavillon de l'Éducation Physique et des Sports - Université Laval
state: Quebec
Study officials:
affiliation: Laval University
name: Philippe Corbeil, PhD
role: STUDY_DIRECTOR
affiliation: Laval University
name: Yoann Dessery, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Laval University
name: Étienne L Belzile, MD
role: STUDY_DIRECTOR
References: