Kryptonite - a Novel Osteosynthesis Method for Median Sternotomy

April 11, 2016 updated by: Rikke Vestergaard, Aarhus University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital, Skejby, Dept. of Cardiothoracic surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • undergoing elective Heart surgery

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
Control Group receiving standard treatment
Active Comparator: intervention group
Intervention Group receiving the standard treatment and the kryptonite-bone cement
Device: Kryptonite-bone cement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks, 3 and 6 months
Evaluation of sternal healing using PET-scan
Time Frame: 3 and 6 months
Change in bone healing using PET-scan
3 and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 3 weeks, 3 and 6 months
evaluation of the patients pain-levels using VAS
3 weeks, 3 and 6 months
General well-being
Time Frame: 3 weeks, 3 and 6 months
evaluation of the patients general well-being using SF-36
3 weeks, 3 and 6 months
sternal discomfort
Time Frame: 3 weeks, 3 and 6 months
evaluation of the specific discomfort related to median sternotomy using a specific questionnaire
3 weeks, 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 11, 2016

First Posted (Estimate)

April 14, 2016

Study Record Updates

Last Update Posted (Estimate)

April 14, 2016

Last Update Submitted That Met QC Criteria

April 11, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Kryptonite

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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