Kryptonite - a Novel Osteosynthesis Method for Median Sternotomy
NCT ID: NCT02738437
Last Updated: 2016-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2011-08-31
2015-12-31
Brief Summary
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One half of the patients received only wire cerclage the other both bone cement and wire cerclage.
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Detailed Description
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It has been shown previously that wire cerclage alone does not provide a stabile osteosynthesis following median sternotomy. The hypothesis is that if a stabile osteosynthesis can be achieved patient recovery can be hastened and patient discomfort and pain reduced.
One half of the patients received only wire cerclage the other both bone cement and wire cerclage.
The stability of the sternum was evaluated using radiostereometric analysis, PET-CT and patient reported outcomes in the form of SF-36 and VAS.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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control
Control Group receiving standard treatment
No interventions assigned to this group
intervention group
Intervention Group receiving the standard treatment and the kryptonite-bone cement
Kryptonite-bone cement
Interventions
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Kryptonite-bone cement
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
60 Years
70 Years
MALE
No
Sponsors
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Aarhus University Hospital
OTHER
Responsible Party
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Rikke Vestergaard
MD, PhD
Locations
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Aarhus University Hospital, Skejby, Dept. of Cardiothoracic surgery
Aarhus, , Denmark
Countries
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References
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Vestergaard RF, Soballe K, Hasenkam JM, Stilling M. Sternal instability measured with radiostereometric analysis. A study of method feasibility, accuracy and precision. J Cardiothorac Surg. 2018 May 18;13(1):41. doi: 10.1186/s13019-018-0735-4.
Other Identifiers
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Kryptonite
Identifier Type: -
Identifier Source: org_study_id
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