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Completed

NCT Number: NCT02738437

Kryptonite - a Novel Osteosynthesis Method for Median Sternotomy

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Skejby, Dept. of Cardiothoracic surgery

Aarhus, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • undergoing elective Heart surgery

Exclusion criteria

  • none

Treatment and study plan

Kryptonite-bone cement

Device

Primary outcomes

  1. Radiostereometric analysis

    Time frame: 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.

  2. Evaluation of sternal healing using PET-scan

    Time frame: 3 and 6 months

    Change in bone healing using PET-scan

Secondary outcomes

  1. Pain

    Time frame: 3 weeks, 3 and 6 months

    evaluation of the patients pain-levels using VAS

  2. General well-being

    Time frame: 3 weeks, 3 and 6 months

    evaluation of the patients general well-being using SF-36

  3. sternal discomfort

    Time frame: 3 weeks, 3 and 6 months

    evaluation of the specific discomfort related to median sternotomy using a specific questionnaire

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 14, 2016
Registry last updated
Apr 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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