Kryptonite - a Novel Osteosynthesis Method for Median Sternotomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Kryptonite - a Novel Osteosynthesis Method for Median Sternotomy

Conditions
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Pain

Intervention / Treatment
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* Device: Kryptonite-bone cement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: undergoing elective Heart surgery Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>Control Group receiving standard treatment | |
| Active Comparator: intervention group<br>Intervention Group receiving the standard treatment and the kryptonite-bone cement | Device: Kryptonite-bone cement<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Evaluation of sternal healing using PET-scan | Change in bone healing using PET-scan | 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | evaluation of the patients pain-levels using VAS | 3 weeks, 3 and 6 months | 
| General well-being | evaluation of the patients general well-being using SF-36 | 3 weeks, 3 and 6 months | 
| sternal discomfort | evaluation of the specific discomfort related to median sternotomy using a specific questionnaire | 3 weeks, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteogenesis, Positron-Emission Tomography, Radiostereometric analysis