Pain Clinical Trial
Official title:
Kryptonite - a Novel Osteosynthesis Method for Median Sternotomy
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
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