Lateral Wedge Insoles With Arch Support in Knee Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Medial Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Knee osteoarthritis patients - No insoles

Without orthoses

Group Type NO_INTERVENTION

No interventions assigned to this group

Knee osteoarthritis patients - Customised

Medial arch support without lateral wedge

Group Type ACTIVE_COMPARATOR

Neutral customized foot orthoses

Intervention Type DEVICE

Foot orthoses with arch support and without lateral inclination

Knee osteoarthritis patients - Customised + 6°

6° lateral wedge insoles + Medial arch support

Group Type ACTIVE_COMPARATOR

6° lateral customized foot orthoses

Intervention Type DEVICE

Foot orthoses with arch support above insoles with lateral inclination set at 6°

Knee osteoarthritis patients - Customised + 10°

10° lateral wedge insoles + Medial arch support

Group Type ACTIVE_COMPARATOR

10° lateral customized foot orthoses

Intervention Type DEVICE

Foot orthoses with arch support above insoles with lateral inclination set at 10°

Interventions

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Neutral customized foot orthoses

Foot orthoses with arch support and without lateral inclination

Intervention Type DEVICE

6° lateral customized foot orthoses

Foot orthoses with arch support above insoles with lateral inclination set at 6°

Intervention Type DEVICE

10° lateral customized foot orthoses

Foot orthoses with arch support above insoles with lateral inclination set at 10°

Intervention Type DEVICE

Other Intervention Names

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Orthoconcept Inc, Laval, Qc, Canada Orthoconcept Inc, Laval, Qc, Canada Orthoconcept Inc, Laval, Qc, Canada

Eligibility Criteria

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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)

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No