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

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Device: Stabilizing Knee Brace; Device: Valgus Knee Brace; Device: New Knee Brace

• Registration Number: NCT01866176
• Lead Sponsor: Laval University

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 available

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2013-05
• Study First Submitted: 2013-05-09
• Study First Submitted QC: 2013-05-27
• Study First Posted: 2013-05-31
• Study Completion: 2013-08
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-05
• Last Update Posted: 2014-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Knee osteoarthritis patients	Stabilizing Knee Brace	Knee osteoarthritis patients with Kellgren \& Lawrence grade I, II or III Stabilizing Knee Brace Valgus Knee Brace New Knee Brace
Knee osteoarthritis patients	New Knee Brace	Knee osteoarthritis patients with Kellgren \& Lawrence grade I, II or III Stabilizing Knee Brace Valgus Knee Brace New Knee Brace
Knee osteoarthritis patients	Valgus Knee Brace	Knee osteoarthritis patients with Kellgren \& Lawrence grade I, II or III Stabilizing Knee Brace Valgus Knee Brace New Knee Brace

Primary Outcome Measures

Name	Time	Method
Change in Knee adduction moment	Change from Baseline at 3 months
Change in Knee pain	Change from Baseline at 3 months	A 20-cm visual analog scale (0-100) is used to assess pain.

Secondary Outcome Measures

Name	Time	Method
Change in Spatiotemporal gait parameters	Change from Baseline at 3 months	Test of the gait symmetry with the gait phase duration and step length.
Change in Gait velocity	Change from Baseline at 3 months
Change in Knee adduction angle	Change from Baseline at 3 months
Change in Knee brace comfort	Change from Baseline at 3 months	A 20-cm visual analog scale (0-100) is used to assess comfort.

Trial Locations

Locations (1)

Pavillon de l'Éducation Physique et des Sports - Université Laval; 🇨🇦 Québec, Quebec, Canada