- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01909596
Lateral Wedge Insoles With Arch Support in Knee Osteoarthritis
July 23, 2013 updated by: Laval University
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?
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Other: Without orthoses
- Device: 6° lateral wedge insoles
- Device: 10° lateral wedge insoles
- Device: Neutral customized foot orthoses
- Device: 6° lateral customized foot orthoses
- Device: 7° lateral customized foot orthoses
- Device: 8° lateral customized foot orthoses
- Device: 9° lateral customized foot orthoses
- Device: 10° lateral customized foot orthoses
- Device: Orthotist integrated lateral customized foot orthoses
- Device: Orthotist lateral customized foot orthoses
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Québec, Quebec, Canada, G1V 0A6
- Pavillon de l'Éducation Physique et des Sports - Université Laval
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Knee osteoarthritis patients
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
|
Condition control
Insoles with a lateral inclination set at 6°
Other Names:
Insoles with a lateral inclination set at 10°
Other Names:
Foot orthoses with arch support and without lateral inclination
Other Names:
Foot orthoses with arch support above insoles with lateral inclination set at 6°
Other Names:
Foot orthoses with arch support above insoles with lateral inclination set at 7°
Other Names:
Foot orthoses with arch support above insoles with lateral inclination set at 8°
Other Names:
Foot orthoses with arch support above insoles with lateral inclination set at 9°
Other Names:
Foot orthoses with arch support above insoles with lateral inclination set at 10°
Other Names:
Foot orthoses with arch support and integrated lateral inclination set according to orthotist experience
Other Names:
Foot orthoses with arch support above insoles with lateral inclination set according to orthotist experience
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knee pain
Time Frame: At time of device receipt
|
A 20-cm visual analog scale (0-100) is used to assess pain.
|
At time of device receipt
|
Knee adduction moment
Time Frame: At time of device receipt
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Foot orthoses comfort
Time Frame: At time of device receipt
|
A 20-cm visual analog scale (0-100) is used to assess comfort.
|
At time of device receipt
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
July 17, 2013
First Submitted That Met QC Criteria
July 23, 2013
First Posted (Estimate)
July 26, 2013
Study Record Updates
Last Update Posted (Estimate)
July 26, 2013
Last Update Submitted That Met QC Criteria
July 23, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OP-2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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