Pain
Conditions
Keywords
osteogenesis, Positron-Emission Tomography, Radiostereometric analysis
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.
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.
Interventions
DEVICEKryptonite-bone cement
Sponsors
Aarhus University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
60 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* undergoing elective Heart surgery
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiostereometric analysis | 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. |
| Evaluation of sternal healing using PET-scan | 3 and 6 months | Change in bone healing using PET-scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain | 3 weeks, 3 and 6 months | evaluation of the patients pain-levels using VAS |
| General well-being | 3 weeks, 3 and 6 months | evaluation of the patients general well-being using SF-36 |
| sternal discomfort | 3 weeks, 3 and 6 months | evaluation of the specific discomfort related to median sternotomy using a specific questionnaire |
Countries
Denmark
Outcome results
None listed