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Monopolar Electrosurgery Versus Ultrasound Scissors in Thoracoscopic Ventral Spondylodesis (Harmonic)

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ClinicalTrials.gov Identifier: NCT00941213
Recruitment Status : Unknown
Verified June 2010 by University of Cologne.
Recruitment status was:  Recruiting
First Posted : July 17, 2009
Last Update Posted : June 25, 2010
Sponsor:
Collaborator:
Ethicon Endo-Surgery (Europe) GmbH
Information provided by:
University of Cologne

Brief 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.

Condition or disease Intervention/treatment Phase
Fractures of Vertebral Bodies Device: ultrasound scissors - Harmonic ACE Device: electroscalpel (Erbe Vio 300; Aesculap AG) Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
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.
Study Start Date : December 2009
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: Monopolar Electrosurgery
Preparation during the operation with Monopolar Electrosurgery
Device: electroscalpel (Erbe Vio 300; Aesculap AG)
preparation with electroscalpel during operation
Other Name: Generator Erbe Vio 300, hook from Aesculap AG

Experimental: Ultrasound scissors
Preparation during the operation with ultrasound scissors
Device: ultrasound scissors - Harmonic ACE
preparation with ultrasound scissors during operation
Other Name: Harmonic ACE; Firma Ethicon Endo-Surgery




Primary Outcome Measures :
  1. duration of the operation [ Time Frame: end of the scin suture at the end of operation ]

Secondary Outcome Measures :
  1. loss of blood during operation and at first day after the operation [ Time Frame: 24 hours after end of operation ]
  2. length of stay at the hospital [ Time Frame: day of discharge from hospitalization ]
  3. trauma of internal organs during operation [ Time Frame: end of the scin suure at the end of operation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • informed consent
  • fracture of vertebral bodies Th10-L2 with indication for operative treatment

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00941213


Contacts
Contact: Christina Otto, MD +49 221 478 86973 christina.otto@uk-koeln.de

Locations
Germany
University of Cologne, Department of Orthopaedics/Trauma surgery Recruiting
Cologne, NRW, Germany, 50924
Principal Investigator: Peer Eysel, Professor         
Sub-Investigator: Gereon Schiffer         
Sub-Investigator: Ulrich Thelen, MD         
Sub-Investigator: Timmo Koy, MD         
Sub-Investigator: Koroush Zarghooni, MD         
Sub-Investigator: Thomas Kaulhausen, MD         
Sub-Investigator: Jan Siewe, MD         
Sub-Investigator: Henning Kunter, MD         
Sub-Investigator: Christina Otto, MD         
Sub-Investigator: Bergita Ganse, MD         
Kliniken der Stadt Köln gGmbH Merheim Not yet recruiting
Cologne, NRW, Germany, 58448
Principal Investigator: Dieter Rixen, Professor         
Sub-Investigator: Thomas Paffrath, MD         
Sub-Investigator: Thorsten Tjardes, MD         
Sub-Investigator: Eva Steinhausen, MD         
Sponsors and Collaborators
University of Cologne
Ethicon Endo-Surgery (Europe) GmbH
Investigators
Study Director: Peer Eysel, Professor University of Cologne, Department of Orthopaedics/Trauma surgery
Principal Investigator: Gereon Schiffer, MD University of Cologne, Department of Orthopaedics/Trauma surgery

Responsible Party: Dr. med. Peer Eysel, Head of the Department, University of Cologne, Department for Orthopaedics/Trauma Surgery
ClinicalTrials.gov Identifier: NCT00941213     History of Changes
Other Study ID Numbers: Uni-Koeln-1235
Uni-Koeln-1235
First Posted: July 17, 2009    Key Record Dates
Last Update Posted: June 25, 2010
Last Verified: June 2010

Keywords provided by University of Cologne:
fractures of vertebral bodies Th10-L2
(AO A1 with kyphosis, A2.3, B or C-type)