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Main
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Note: This record shows only 22 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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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02743208 |
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Date of registration:
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31/03/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluation of a Short Femoral Stem in Total Hip Arthroplasty
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Scientific title:
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Evaluation of a Short Femoral Stem in Total Hip Arthroplasty. A Comparative Study on Stability, Bone Remodelling and Patient Outcome. |
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Date of first enrolment:
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September 2019 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02743208 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Norway
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Contacts
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Name:
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Olav Foss, md phd |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Olavs Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- receiving primary total hip arthroplasty due to osteoarthritis, posttraumatic
arthritis, avascular necrosis, or developmental hip dysplasia (Crowe grade 1)
Exclusion Criteria:
- osteoporosis
- pregnancy
- musculoskeletal problems compromising rehabilitation
- corticosteroid treatment
- dementia
- developmental dysplasia (Crowe grade II-IV)
- osteosynthesis in place
- revision surgery
- joint infection
- malignancy of the femur/pelvis
Age minimum:
30 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Osteoarthritis, Hip
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Intervention(s)
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Device: Short stem hip arthroplasty (SHA)
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Device: Total hip arthroplasty (THA)
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Primary Outcome(s)
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Change in periprosthetic bone mineral density (BMD)
[Time Frame: 2 years]
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Secondary Outcome(s)
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Biomechanical reconstruction of hip anatomy
[Time Frame: 2 years]
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Migration of femoral stem
[Time Frame: 2 years]
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Harris hip score
[Time Frame: 2 years]
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Health-related quality of life (EQ-5D).
[Time Frame: 2 years]
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Hip disability osteoarthritis outcome score (HOOS)
[Time Frame: 2 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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