Clinical trial NCT01870336: Combination of Lateral Foot Orthoses and Knee Brace for Treatment of the Knee Osteoarthritis
Official title: Combination of Lateral Foot Orthoses and Knee Brace for Treatment of the Medial Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
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: 2013-06-06
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


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 Knee adduction angle
timeFrame: Change from Baseline at 3 months
measure: Change in 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: