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Using instrumented shoes in THA patients.


- candidate number9442
- NTR NumberNTR2903
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-mei-2011
- Secondary IDsP11-17 METC TWENTE
- Public TitleUsing instrumented shoes in THA patients.
- Scientific TitleClinical study on total hip arthroplasty patients with instrumented shoes.
- ACRONYMIFS THA
- hypothesisThe aim of this first study is to evaluate the use of the IFS for quantitative assessment of mobility performance in comparison with gait velocity and questionnaires already validated and studied in patients before and after THA in an outpatient clinical setting. If the IFS parameters appear to be sensitive, future patients shall benefit from the results because functional mobility performance before/after THA can be assessed quantitatively in a clinical setting, which can help the orthopedic surgeon in the future to evaluate the effect of THA.
- Healt Condition(s) or Problem(s) studiedTotal Hip Arthroplasty, Rehabilitation, Instrumented force shoes, Ambulatory measurements
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jun-2011
- planned closingdate1-mei-2012
- Target number of participants25
- InterventionsPatients 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.
- Primary outcomeThe 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.
- Secondary outcomeThe second objective is to compare the IFS parameters to the gait velocity (assessed independently from the IFS) and questionnaire outcomes.
- TimepointsPatients undergoing THA will be measured before and 6-8 months after the operation.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES A. Martinez
- CONTACT for SCIENTIFIC QUERIES A. Martinez
- Sponsor/Initiator University of Twente
- Funding
(Source(s) of Monetary or Material Support)
University of Twente
- PublicationsN/A
- Brief summaryTotal hip arthroplasty (THA) is a successful surgical procedure to treat orthopedic osteoarthritis. Studying the differences in movement during various activities of daily living before and after total hip replacement is important for the follow up of the patients. Instrumented force shoes (IFS) can be used to quantify the movement patterns in an outpatient setting. 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. Prospective cohort study with two measurement sessions: pre-operative and 6-8 months post-operative. In total 25 patients with primary osteoarthritis of the hip selected for a primary THA will perform 3 functional mobility tasks, walking, sit-to-stand, stad-to-sit, stairs ascend and stairs descend in both measurements.
- Main changes (audit trail)
- RECORD17-mei-2011 - 24-mei-2011


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