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

NCT01866176 | Completed DMC

• 1 other identifier: OG2007-097-A4
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Change in Knee adduction moment

  Change from Baseline at 3 months

• Change in Knee pain

  A 20-cm visual analog scale (0-100) is used to assess pain.

  Change from Baseline at 3 months

Secondary Outcomes (4)

• Change in Spatiotemporal gait parameters

  Change from Baseline at 3 months

• 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

Study Arms (1)

Knee osteoarthritis patients

EXPERIMENTAL

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

Device: Stabilizing Knee Brace; Device: Valgus Knee Brace; Device: New Knee Brace

Interventions

Stabilizing Knee Brace DEVICE

Brace with no valgus action

Knee osteoarthritis patients

Valgus Knee Brace DEVICE

Valgus brace with traditional three point bending system

Knee osteoarthritis patients

New Knee Brace DEVICE

Brace with new mechanism to decrease the knee loading.

Knee osteoarthritis patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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°

You may not qualify if:

• 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)

Sponsors & Collaborators

• Laval University: lead
• Natural Sciences and Engineering Research Council, Canada: collaborator
• Fonds de la Recherche en Santé du Québec: collaborator
• Ergorecherche Inc.: collaborator

Study Sites (1)

Pavillon de l'Éducation Physique et des Sports - Université Laval

Québec, Quebec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Philippe Corbeil, PhD

  Laval University

  STUDY DIRECTOR

• Yoann Dessery, MSc

  Laval University

  PRINCIPAL INVESTIGATOR

• Étienne L Belzile, MD

  Laval University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: May 31, 2013
• Study Start: October 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 6, 2014

Record last verified: 2014-03

Locations

CA (1)