Combination of Lateral Foot Orthoses and Knee Brace for Treatment of the Knee Osteoarthritis

NCT01870336 | Completed DMC

• 1 other identifier: OC-2013
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

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 (3)

• Change in Spatiotemporal gait parameters

  Change from Baseline at 3 months

• Change in Knee adduction angle

  Change from Baseline at 3 months

• Change in Comfort

  Change from Baseline at 3 months

Study Arms (3)

Lateral customized foot orthoses

EXPERIMENTAL

Foot orthoses with arch support and lateral inclination set at 7° (alone)

Device: Combined treatment of medial knee osteoarthritis

Knee brace

EXPERIMENTAL

OdrA Knee brace (alone)

Device: Combined treatment of medial knee osteoarthritis

Combination of the two treatments

EXPERIMENTAL

Combination of Lateral customized foot orthoses and knee brace

Device: Combined treatment of medial knee osteoarthritis

Interventions

Combined treatment of medial knee osteoarthritis DEVICE

Combination of the two treatments; Knee brace; Lateral customized foot orthoses

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• 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 23, 2013
• First Posted: June 6, 2013
• Study Start: September 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: March 4, 2016

Record last verified: 2016-03

Locations

CA (1)