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Kryptonite - a Novel Osteosynthesis Method for Median Sternotomy

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ClinicalTrials.gov Identifier: NCT02738437
Recruitment Status : Completed
First Posted : April 14, 2016
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Rikke Vestergaard, Aarhus University Hospital

Study Description
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Brief Summary:

The aim of this study was to investigate the beneficial effect of bone cement in combination with wire cerclage on the stability of the sternum following median sternotomy.

One half of the patients received only wire cerclage the other both bone cement and wire cerclage.


Condition or disease Intervention/treatment Phase
Pain Device: Kryptonite-bone cement Not Applicable

Detailed Description:

The aim of this study was to investigate the beneficial effect of bone cement in combination with wire cerclage on the stability of the sternum following median sternotomy.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Kryptonite - a Novel Osteosynthesis Method for Median Sternotomy
Study Start Date : August 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015
Arms and Interventions
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Arm Intervention/treatment
No Intervention: control
Control Group receiving standard treatment
Active Comparator: intervention group
Intervention Group receiving the standard treatment and the kryptonite-bone cement
 Device: Kryptonite-bone cement


Outcome Measures
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Primary Outcome Measures :
  1. Radiostereometric analysis [ Time Frame: 6 weeks, 3 and 6 months ]
    Evaluation of change of Stability/mobility of the osteotomy evaluated using radiostereometric analysis. The distance in cm between sternal halves is measured.

  2. Evaluation of sternal healing using PET-scan [ Time Frame: 3 and 6 months ]
    Change in bone healing using PET-scan


Secondary Outcome Measures :
  1. Pain [ Time Frame: 3 weeks, 3 and 6 months ]
    evaluation of the patients pain-levels using VAS

  2. General well-being [ Time Frame: 3 weeks, 3 and 6 months ]
    evaluation of the patients general well-being using SF-36

  3. sternal discomfort [ Time Frame: 3 weeks, 3 and 6 months ]
    evaluation of the specific discomfort related to median sternotomy using a specific questionnaire


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • undergoing elective Heart surgery

Exclusion Criteria:

  • none
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738437


Locations
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Denmark
Aarhus University Hospital, Skejby, Dept. of Cardiothoracic surgery
Aarhus, Denmark, 8200
Sponsors and Collaborators
Aarhus University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rikke Vestergaard, MD, PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT02738437    
Other Study ID Numbers: Kryptonite
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Rikke Vestergaard, Aarhus University Hospital:
osteogenesis
Positron-Emission Tomography
Radiostereometric analysis