NCT02738437

Kryptonite - a Novel Osteosynthesis Method for Median Sternotomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: Male
• Age: 60 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
DEVICE	Kryptonite-bone cement

Timeline

• Start date: 2011-08-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2016-04-14
• Last updated: 2016-04-14

Locations

1 site across 1 country: Denmark