NCT02738437

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 14, 2016

Completed
Last Updated

April 14, 2016

Status Verified

April 1, 2016

Enrollment Period

4.3 years

First QC Date

April 5, 2016

Last Update Submit

April 11, 2016

Conditions

Pain

Keywords

osteogenesisPositron-Emission TomographyRadiostereometric analysis

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (3)

  • Pain

    3 weeks, 3 and 6 months

  • General well-being

    3 weeks, 3 and 6 months

  • sternal discomfort

    3 weeks, 3 and 6 months

Study Arms (2)

control

NO INTERVENTION

Control Group receiving standard treatment

intervention group

ACTIVE COMPARATOR

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

Device: Kryptonite-bone cement

Interventions

Kryptonite-bone cementDEVICE
intervention group

Eligibility Criteria

Age60 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • undergoing elective Heart surgery

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, Skejby, Dept. of Cardiothoracic surgery

Aarhus, 8200, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 29776382DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 14, 2016

Study Start

August 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 14, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will share

Locations

DK(1)