Fractures of Vertebral BodiesPhase 4HarmonicNCT00941213
Monopolar Electrosurgery Versus Ultrasound Scissors in Thoracoscopic Ventral Spondylodesis
A Phase 4 study testing ultrasound scissors - Harmonic ACE and electroscalpel (Erbe Vio 300; Aesculap AG) in people with Fractures of Vertebral Bodies, run by University of Cologne at 2 sites in Germany.
Trial summary
This study was undertaken to investigate the effect of using ultrasound scissors in the preparation for Thoracoscopic Ventral Spondylodesis. Quantity of bleeding and the duration of operation in Thoracoscopic Ventral Spondylodesis are compared to the preparation with monopolar electrosurgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractures of Vertebral Bodies
- What is being tested?
- ultrasound scissors - Harmonic ACE and electroscalpel (Erbe Vio 300; Aesculap AG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesGermany
- Study dates
- Dec 2009to Aug 2011
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent
- fracture of vertebral bodies Th10-L2 with indication for operative treatment
Who cannot join
- missing informed consent
- mission indication for operative treatment
- revision of the trailing edge
- clotting inhibition therapy
- ASA III/IV
- pregnancy
- malfunction of liver Child C
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
University of Cologne, Department of Orthopaedics/Trauma surgery
Cologne, North Rhine-Westphalia, 50924
Peer Eysel, Professor
Gereon Schiffer
- Not yet recruiting
Kliniken der Stadt Köln gGmbH Merheim
Cologne, North Rhine-Westphalia, 58448
Dieter Rixen, Professor
Thomas Paffrath, MD
About this study
Official title: Comparison of the Quantity of Bleeding and the Duration of Operation in Thoracoscopic Ventral Spondylodesis During Preparation With Monopolar Electrosurgery Compared to Ultrasound Scissors.
This study was undertaken to investigate the effect of using ultrasound scissors in the preparation for Thoracoscopic Ventral Spondylodesis. Quantity of bleeding and the duration of operation in Thoracoscopic Ventral Spondylodesis are compared to the preparation with monopolar electrosurgery.
Read the detailed description
One group of patients will be operated on using ultrasound scissors in the preparation during Thoracoscopic Ventral Spondylodesis. The other group will be operated on using Monopolar Electrosurgery.
The study is designed as a randomized trial. That means that all patients who have given their consent to participate in the study will be allocated to either ultrasound scissors or Monopolar Electrosurgery by chance.
A total of 40 patients will be included in this study. The study ends with finishing of the first day after the operation, there is no longer follow up.
- Conditions
- Fractures of Vertebral Bodies
- Being tested
- ultrasound scissors - Harmonic ACE, electroscalpel (Erbe Vio 300; Aesculap AG)
- Keywords
- fractures of vertebral bodies Th10-L2, (AO A1 with kyphosis, A2.3, B or C-type)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound scissors - Harmonic ACEDevice
Also called Harmonic ACE; Firma Ethicon Endo-Surgery
preparation with ultrasound scissors during operation
electroscalpel (Erbe Vio 300; Aesculap AG)Device
Also called Generator Erbe Vio 300, hook from Aesculap AG
preparation with electroscalpel during operation
| Study group | Role | What they receive |
|---|---|---|
| Monopolar Electrosurgery | Active comparator | Preparation during the operation with Monopolar Electrosurgery Receives: Device: electroscalpel (Erbe Vio 300; Aesculap AG) |
| Ultrasound scissors | Experimental | Preparation during the operation with ultrasound scissors Receives: Device: ultrasound scissors - Harmonic ACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of the operation
Measured: end of the scin suture at the end of operation
Secondary outcomes (3)
loss of blood during operation and at first day after the operation
Measured: 24 hours after end of operation
length of stay at the hospital
Measured: day of discharge from hospitalization
trauma of internal organs during operation
Measured: end of the scin suure at the end of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startDec 2009
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures of Vertebral BodiesStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon Endo-Surgery (Europe) GmbH
- Investigators
- Peer Eysel, Professor, Study director, University of Cologne, Department of Orthopaedics/Trauma surgeryGereon Schiffer, MD, Principal investigator, University of Cologne, Department of Orthopaedics/Trauma surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941213
- Sponsor's protocol ID
- Uni-Koeln-1235
- Other IDs
- Uni-Koeln-1235
- Acronym
- Harmonic
- Status last verified
- Jun 2010
- First submitted
- 15 Jun 2009
- Last updated
- 25 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Quantity of Bleeding and the Duration of Operation in Thoracoscopic Ventral Spondylodesis During Preparation With Monopolar Electrosurgery Compared to Ultrasound Scissors.
- ClinicalTrials.gov ID
- NCT00941213
- Acronym / sponsor ID
- Harmonic / Uni-Koeln-1235
- Conditions
- Fractures of Vertebral Bodies
- Keywords
- fractures of vertebral bodies Th10-L2, (AO A1 with kyphosis, A2.3, B or C-type)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- Ethicon Endo-Surgery (Europe) GmbH
- Study start
- Dec 2009
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 17 Jul 2009 (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.
This study was undertaken to investigate the effect of using ultrasound scissors in the preparation for Thoracoscopic Ventral Spondylodesis. Quantity of bleeding and the duration of operation in Thoracoscopic Ventral Spondylodesis are compared to the preparation with monopolar electrosurgery.
Detailed description
One group of patients will be operated on using ultrasound scissors in the preparation during Thoracoscopic Ventral Spondylodesis. The other group will be operated on using Monopolar Electrosurgery.
The study is designed as a randomized trial. That means that all patients who have given their consent to participate in the study will be allocated to either ultrasound scissors or Monopolar Electrosurgery by chance.
A total of 40 patients will be included in this study. The study ends with finishing of the first day after the operation, there is no longer follow up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monopolar Electrosurgery | Active comparator | Device: electroscalpel (Erbe Vio 300; Aesculap AG)Preparation during the operation with Monopolar Electrosurgery |
| Ultrasound scissors | Experimental | Device: ultrasound scissors - Harmonic ACEPreparation during the operation with ultrasound scissors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- informed consent
- fracture of vertebral bodies Th10-L2 with indication for operative treatment
Key exclusion criteria (7 listed)
- missing informed consent
- mission indication for operative treatment
- revision of the trailing edge
- clotting inhibition therapy
- ASA III/IV
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 |
|---|---|---|
| ultrasound scissors - Harmonic ACEAlso: Harmonic ACE; Firma Ethicon Endo-Surgerypreparation with ultrasound scissors during operation | Device | Ultrasound scissors |
| electroscalpel (Erbe Vio 300; Aesculap AG)Also: Generator Erbe Vio 300, hook from Aesculap AGpreparation with electroscalpel during operation | Device | Monopolar Electrosurgery |
Primary outcome
duration of the operation
Time frame: end of the scin suture at the end of operation
3 secondary outcomes
loss of blood during operation and at first day after the operation
Time frame: 24 hours after end of operation
length of stay at the hospital
Time frame: day of discharge from hospitalization
trauma of internal organs during operation
Time frame: end of the scin suure at the end of operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2010.
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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.
Peer Eysel, Professor study director
University of Cologne, Department of Orthopaedics/Trauma surgery
Gereon Schiffer, MD principal investigator
University of Cologne, Department of Orthopaedics/Trauma surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ultrasound scissors - Harmonic ACE and electroscalpel (Erbe Vio 300; Aesculap AG) in people with Fractures of Vertebral Bodies, run by University of Cologne at 2 sites in Germany.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina Otto, MD (+49 221 478 86973, christina.otto@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of the operation (time frame: end of the scin suture at the end of operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2010.