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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
8
Aarhus University Hospital, Skejby, Dept. of Cardiothoracic surgery
Aarhus, Denmark
Radiostereometric analysis
Evaluation of change of Stability/mobility of the osteotomy evaluated using radiostereometric analysis. The distance in cm between sternal halves is measured.
Time frame: 6 weeks, 3 and 6 months
Evaluation of sternal healing using PET-scan
Change in bone healing using PET-scan
Time frame: 3 and 6 months
Pain
evaluation of the patients pain-levels using VAS
Time frame: 3 weeks, 3 and 6 months
General well-being
evaluation of the patients general well-being using SF-36
Time frame: 3 weeks, 3 and 6 months
sternal discomfort
evaluation of the specific discomfort related to median sternotomy using a specific questionnaire
Time frame: 3 weeks, 3 and 6 months
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