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NCT02738437 Clinical Trial

Kryptonite - a Novel Osteosynthesis Method for Median Sternotomy

Pain Clinical Trial

Official title:
Kryptonite - a Novel Osteosynthesis Method for Median Sternotomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02738437
Other study ID # Kryptonite
Secondary ID
Status Completed
Phase N/A
First received April 5, 2016
Last updated April 11, 2016
Start date August 2011
Est. completion date December 2015

Study information
Verified date April 2016
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Male
Age group 60 Years to 70 Years
Eligibility Inclusion Criteria:

- undergoing elective Heart surgery

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• Kryptonite-bone cement

Locations
Country Name City State
Denmark Aarhus University Hospital, Skejby, Dept. of Cardiothoracic surgery Aarhus

Sponsors (1)
Lead Sponsor Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Radiostereometric analysis Evaluation of change of Stability/mobility of the osteotomy evaluated using radiostereometric analysis. The distance in cm between sternal halves is measured. 6 weeks, 3 and 6 months No
Primary Evaluation of sternal healing using PET-scan Change in bone healing using PET-scan 3 and 6 months No
Secondary Pain evaluation of the patients pain-levels using VAS 3 weeks, 3 and 6 months No
Secondary General well-being evaluation of the patients general well-being using SF-36 3 weeks, 3 and 6 months No
Secondary sternal discomfort evaluation of the specific discomfort related to median sternotomy using a specific questionnaire 3 weeks, 3 and 6 months No
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