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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR2903 |
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Date of registration:
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17/05/2011 |
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Primary sponsor: |
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Public title:
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Using instrumented shoes in THA patients.
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Scientific title:
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Clinical study on total hip arthroplasty patients with instrumented shoes. - IFS THA |
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Date of first enrolment:
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1/6/2011 |
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Target sample size:
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25 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2903 |
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Study type:
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observational |
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Study design:
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Randomised: No; Masking: None; Control: Not applicable; Group: Crossover; Type: Single arm
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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A.
Martinez |
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Address:
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Universiteit Twente. Biomedische Signalen en Systemen. Postbus 217.
[default]
The Netherlands |
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Telephone:
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+ 31(0)53 4892765(2760) |
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Email:
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A.Martinez@ewi.utwente.nl |
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Affiliation:
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Name:
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A.
Martinez |
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Address:
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Universiteit Twente. Biomedische Signalen en Systemen. Postbus 217.
[default]
The Netherlands |
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Telephone:
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+ 31(0)53 4892765(2760) |
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Email:
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A.Martinez@ewi.utwente.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Age between 50 and 80 years;
2. Primary, unilateral, osteoarthritis of the hip;
3. Patients should be selected for a primary THA and undergo the operation within the next 4 months.
Exclusion criteria: 1. Have bilateral THA;
2. Have any kind of leg arthroplasties;
3. Have rheumatoid arthritis;
4. Have any neurological disorder;
5. Not able to perform the tasks because of pain or impairment;
6. Suffering also from other degenerative diseases;
7. Develop a bilateral disease;
8. Revision/re-operations of primary hip prosthesis;
9. Unable to understand instructions or the questionnaire.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Total Hip Arthroplasty, Rehabilitation, Instrumented force shoes, Ambulatory measurements
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Intervention(s)
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Patients undergoing THA will be measured before and 6-8 months after the operation. Both measurements include 3 functional mobility tasks while the subject is wearing instrumented force shoes (IFS). In the first task, the subject is instructed to walk several times through the corridor from the beginning to the predefined endpoint. Subsequently, the subject is asked to stand and sit in a chair with arms folded across the chest 5 consecutive times. The third task is to ascend and descend a total of 5 steps of a stair. Before and after each measurement a Visual Analogue Scale (VAS) will be used to score pain in the hip. Besides the VAS, after each measurement the Harris Hip Score (HHS) and the Functional capacity part of the Traditional Western Ontario and McMaster Universities osteoarthritis index (WOMAC-FC) will be administered.
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Primary Outcome(s)
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The first aim of this study is to investigate whether the IFS is a sufficiently sensitive instrument to show differences in mobility performance between before and after THA.
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Secondary Outcome(s)
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The second objective is to compare the IFS parameters to the gait velocity (assessed independently from the IFS) and questionnaire outcomes.
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Source(s) of Monetary Support
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University of Twente
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