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Lateral Wedge Insoles With Arch Support in Knee Osteoarthritis

Primary Purpose

Medial Knee Osteoarthritis

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Without orthoses

6° lateral wedge insoles

10° lateral wedge insoles

Neutral customized foot orthoses

6° lateral customized foot orthoses

7° lateral customized foot orthoses

8° lateral customized foot orthoses

9° lateral customized foot orthoses

10° lateral customized foot orthoses

Orthotist integrated lateral customized foot orthoses

Orthotist lateral customized foot orthoses

About this trial

This is an interventional treatment trial for Medial Knee Osteoarthritis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Pavillon de l'Éducation Physique et des Sports - Université Laval

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Knee osteoarthritis patients

Arm Description

Without orthoses 6° lateral wedge insoles 10° lateral wedge insoles Neutral customized foot orthoses 6° lateral customized foot orthoses 7° lateral customized foot orthoses 8° lateral customized foot orthoses 9° lateral customized foot orthoses 10° lateral customized foot orthoses Orthotist integrated lateral customized foot orthoses Orthotist lateral customized foot orthoses

Outcomes

Primary Outcome Measures

Knee pain

A 20-cm visual analog scale (0-100) is used to assess pain.

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.

Secondary Outcome Measures

Foot orthoses comfort

A 20-cm visual analog scale (0-100) is used to assess comfort.

Full Information

NCT ID

NCT01909596

First Posted

July 17, 2013

Last Updated

July 23, 2013

Sponsor

Laval University

Collaborators

Natural Sciences and Engineering Research Council, Canada, Fonds de la Recherche en Santé du Québec, Ergorecherche Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01909596

Brief Title

Lateral Wedge Insoles With Arch Support in Knee Osteoarthritis

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?

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laval University

Collaborators

Natural Sciences and Engineering Research Council, Canada, Fonds de la Recherche en Santé du Québec, Ergorecherche Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Medial Knee Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Knee osteoarthritis patients

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Without orthoses

Intervention Description

Condition control

Intervention Type

Device

Intervention Name(s)

6° lateral wedge insoles

Other Intervention Name(s)

Orthoconcept Inc, Laval, Qc, Canada

Intervention Description

Insoles with a lateral inclination set at 6°

Intervention Type

Device

Intervention Name(s)

10° lateral wedge insoles

Other Intervention Name(s)

Orthoconcept Inc, Laval, Qc, Canada

Intervention Description

Insoles with a lateral inclination set at 10°

Intervention Type

Device

Intervention Name(s)

Neutral customized foot orthoses

Other Intervention Name(s)

Orthoconcept Inc, Laval, Qc, Canada

Intervention Description

Foot orthoses with arch support and without lateral inclination

Intervention Type

Device

Intervention Name(s)

6° lateral customized foot orthoses

Other Intervention Name(s)

Orthoconcept Inc, Laval, Qc, Canada

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

7° lateral customized foot orthoses

Other Intervention Name(s)

Orthoconcept Inc, Laval, Qc, Canada

Intervention Description

Foot orthoses with arch support above insoles with lateral inclination set at 7°

Intervention Type

Device

Intervention Name(s)

8° lateral customized foot orthoses

Other Intervention Name(s)

Orthoconcept Inc, Laval, Qc, Canada

Intervention Description

Foot orthoses with arch support above insoles with lateral inclination set at 8°

Intervention Type

Device

Intervention Name(s)

9° lateral customized foot orthoses

Other Intervention Name(s)

Orthoconcept Inc, Laval, Qc, Canada

Intervention Description

Foot orthoses with arch support above insoles with lateral inclination set at 9°

Intervention Type

Device

Intervention Name(s)

10° lateral customized foot orthoses

Other Intervention Name(s)

Orthoconcept Inc, Laval, Qc, Canada

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Orthotist integrated lateral customized foot orthoses

Other Intervention Name(s)

Orthoconcept Inc, Laval, Qc, Canada

Intervention Description

Foot orthoses with arch support and integrated lateral inclination set according to orthotist experience

Intervention Type

Device

Intervention Name(s)

Orthotist lateral customized foot orthoses

Other Intervention Name(s)

Orthoconcept Inc, Laval, Qc, Canada

Intervention Description

Foot orthoses with arch support above insoles with lateral inclination set according to orthotist experience

Primary Outcome Measure Information:

Title

Knee pain

Description

A 20-cm visual analog scale (0-100) is used to assess pain.

Time Frame

At time of device receipt

Title

Knee adduction moment

Description

Measure of the knee adduction moment is a non invasive technic to identify change in medial knee loading, major problem in medial knee osteoarthritis.

Time Frame

At time of device receipt

Secondary Outcome Measure Information:

Title

Foot orthoses comfort

Description

A 20-cm visual analog scale (0-100) is used to assess comfort.

Time Frame

At time of device receipt

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philippe Corbeil, PhD

Organizational Affiliation

Laval University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Yoann Dessery, MSc

Organizational Affiliation

Laval University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Étienne L Belzile, MD

Organizational Affiliation

Laval University

Official's Role

Study Director

Facility Information:

Facility Name

Pavillon de l'Éducation Physique et des Sports - Université Laval

City

Québec

State/Province

Quebec

ZIP/Postal Code

G1V 0A6

Country

Canada

12. IPD Sharing Statement

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Lateral Wedge Insoles With Arch Support in Knee Osteoarthritis

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