Lateral Wedge Insoles With Arch Support in Knee Osteoarthritis

Medial Knee Osteoarthritis Clinical Trial

Official title:

Does it Exist a Relationship Between Inclination Angle of Foot Orthoses and Varus Angle of the Knee in the Relief of the Knee Osteoarthritis Symptoms?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909596
• Other study ID #: OP-2012
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2024
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this is to test lateral foot orthoses with different amount of wedging to find a model that predicts the optimal lateral inclination of foot orthosis based on biomechanical or feelings measures. This study was a cross-sectional study with patients serving as their own control. The investigators recruited 24 knee osteoarthritis. Knee radiography and clinical angles measures was carried out before making orthoses, then motion analysis with an optoelectronic system was performed with each pair of foot orthoses. During motion analysis, five gait trials were carried out in each condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Symptomatic medial knee osteoarthritis (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)

Related Conditions & MeSH terms

• Medial Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Neutral customized foot orthoses
Foot orthoses with arch support and without lateral inclination
• 6° lateral customized foot orthoses
Foot orthoses with arch support above insoles with lateral inclination set at 6°
• 10° lateral customized foot orthoses
Foot orthoses with arch support above insoles with lateral inclination set at 10°

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	Knee pain	A 20-cm visual analog scale (0-100) is used to assess pain.	At time of device receipt
Primary	Knee adduction moment	Measure of the knee adduction moment is a non invasive technic to identify change in medial knee loading, major problem in medial knee osteoarthritis.	At time of device receipt
Secondary	Foot orthoses comfort	A 20-cm visual analog scale (0-100) is used to assess comfort.	At time of device receipt