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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | Control Group receiving standard treatment | |
| intervention group | Active Comparator | Intervention Group receiving the standard treatment and the kryptonite-bone cement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kryptonite-bone cement | Device |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital, Skejby, Dept. of Cardiothoracic surgery | Aarhus | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29776382 | Derived | Vestergaard RF, Soballe K, Hasenkam JM, Stilling M. Sternal instability measured with radiostereometric analysis. A study of method feasibility, accuracy and precision. J Cardiothorac Surg. 2018 May 18;13(1):41. doi: 10.1186/s13019-018-0735-4. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |