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

Knee Osteoarthritis Clinical Trial

Official title:

Effects of a New Knee Brace for Treatment of the Knee Osteoarthritis on the Medial Knee Loading During Gait

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01866176
• Other study ID #: OG2007-097-A4
• Status: Completed
• Phase: N/A
• First received: May 9, 2013
• Last updated: March 5, 2014
• Start date: October 2011
• Est. completion date: August 2013

Study information

• Verified date: March 2014
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Stabilizing Knee Brace
Brace with no valgus action
• Valgus Knee Brace
Valgus brace with traditional three point bending system
• New Knee Brace
Brace with new mechanism to decrease the knee loading.

Locations

Country	Name	City	State
Canada	Pavillon de l'Éducation Physique et des Sports - Université Laval	Québec	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
Laval University	Ergorecherche Inc., Fonds de la Recherche en Santé du Québec, Natural Sciences and Engineering Research Council, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Knee adduction moment		Change from Baseline at 3 months	No
Primary	Change in Knee pain	A 20-cm visual analog scale (0-100) is used to assess pain.	Change from Baseline at 3 months	No
Secondary	Change in Spatiotemporal gait parameters	Test of the gait symmetry with the gait phase duration and step length.	Change from Baseline at 3 months	No
Secondary	Change in Gait velocity		Change from Baseline at 3 months	No
Secondary	Change in Knee adduction angle		Change from Baseline at 3 months	No
Secondary	Change in Knee brace comfort	A 20-cm visual analog scale (0-100) is used to assess comfort.	Change from Baseline at 3 months	No