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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870336
• Other study ID #: OC-2013
• Status: Completed
• Phase: N/A
• First received: May 23, 2013
• Last updated: March 3, 2016
• Start date: September 2012
• Est. completion date: May 2014

Study information

• Verified date: March 2016
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• 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

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Combined treatment of medial knee osteoarthritis

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		Change from Baseline at 3 months	No
Secondary	Change in Knee adduction angle		Change from Baseline at 3 months	No
Secondary	Change in Comfort	A 20-cm visual analog scale (0-100) is used to assess comfort.	Change from Baseline at 3 months	No