PainNCT02738437
Kryptonite - a Novel Osteosynthesis Method for Median Sternotomy
A study testing Kryptonite-bone cement in people with Pain, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 70 years, men only
- Conditions the study is for
- Pain
- What is being tested?
- Kryptonite-bone cement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing elective Heart surgery
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Skejby, Dept. of Cardiothoracic surgery
Aarhus, 8200
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.
One half of the patients received only wire cerclage the other both bone cement and wire cerclage.
Read the 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
- Being tested
- Kryptonite-bone cement
- Keywords
- osteogenesis, Positron-Emission Tomography, Radiostereometric analysis
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kryptonite-bone cementDevice
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Control Group receiving standard treatment |
| intervention group | Active comparator | Intervention Group receiving the standard treatment and the kryptonite-bone cement Receives: Device: Kryptonite-bone cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiostereometric analysis
Evaluation of change of Stability/mobility of the osteotomy evaluated using radiostereometric analysis. The distance in cm between sternal halves is measured.
Measured: 6 weeks, 3 and 6 months
Evaluation of sternal healing using PET-scan
Change in bone healing using PET-scan
Measured: 3 and 6 months
Secondary outcomes (3)
Pain
evaluation of the patients pain-levels using VAS
Measured: 3 weeks, 3 and 6 months
General well-being
evaluation of the patients general well-being using SF-36
Measured: 3 weeks, 3 and 6 months
sternal discomfort
evaluation of the specific discomfort related to median sternotomy using a specific questionnaire
Measured: 3 weeks, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startAug 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rikke Vestergaard, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738437
- Sponsor's protocol ID
- Kryptonite
- Status last verified
- Apr 2016
- First submitted
- 5 Apr 2016
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 29776382
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kryptonite - a Novel Osteosynthesis Method for Median Sternotomy
- ClinicalTrials.gov ID
- NCT02738437
- Acronym / sponsor ID
- Kryptonite
- Conditions
- Pain
- Keywords
- osteogenesis, Positron-Emission Tomography, Radiostereometric analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Control Group receiving standard treatment |
| intervention group | Active comparator | Device: Kryptonite-bone cementIntervention Group receiving the standard treatment and the kryptonite-bone cement |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergoing elective Heart surgery
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kryptonite-bone cement | Device | intervention group |
Primary outcome
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.
Evaluation of sternal healing using PET-scan
Time frame: 3 and 6 months
Change in bone healing using PET-scan
3 secondary outcomes
Pain
Time frame: 3 weeks, 3 and 6 months
General well-being
Time frame: 3 weeks, 3 and 6 months
sternal discomfort
Time frame: 3 weeks, 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Derived from this study: PubMed 29776382Vestergaard 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kryptonite-bone cement in people with Pain, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiostereometric analysis (time frame: 6 weeks, 3 and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02738437, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016; AzTrials last refreshed its copy on 29 Oct 2026.