Kryptonite - a Novel Osteosynthesis Method for Median Sternotomy

Aarhus University Hospital

Status: Completed

Conditions: Pain

Treatments: Device: Kryptonite-bone cement

Study type: Interventional

Funder types: Other

Identifiers

NCT02738437

Kryptonite

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: Male

Ages: 60 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• undergoing elective Heart surgery

Exclusion criteria

• none

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

8 participants in 2 patient groups

control

No Intervention group

Description:

Control Group receiving standard treatment

intervention group

Active Comparator group

Description:

Intervention Group receiving the standard treatment and the kryptonite-bone cement

Treatment:

Device: Kryptonite-bone cement