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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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25 April 2016 |
Main ID: |
NCT02738437 |
Date of registration:
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05/04/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Kryptonite - a Novel Osteosynthesis Method for Median Sternotomy
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Scientific title:
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Kryptonite - a Novel Osteosynthesis Method for Median Sternotomy |
Date of first enrolment:
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August 2011 |
Target sample size:
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8 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02738437 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- undergoing elective Heart surgery
Exclusion Criteria:
Age minimum:
60 Years
Age maximum:
70 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Pain
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Intervention(s)
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Device: Kryptonite-bone cement
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Primary Outcome(s)
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Radiostereometric analysis
[Time Frame: 6 weeks, 3 and 6 months]
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Evaluation of sternal healing using PET-scan
[Time Frame: 3 and 6 months]
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Secondary Outcome(s)
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sternal discomfort
[Time Frame: 3 weeks, 3 and 6 months]
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General well-being
[Time Frame: 3 weeks, 3 and 6 months]
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Pain
[Time Frame: 3 weeks, 3 and 6 months]
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Secondary ID(s)
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Kryptonite
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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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