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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by University of Cologne.
Recruitment status was:  Recruiting
Ethicon Endo-Surgery (Europe) GmbH
Information provided by:
University of Cologne Identifier:
First received: June 15, 2009
Last updated: June 24, 2010
Last verified: June 2010
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 Intervention Phase
Fractures of Vertebral Bodies
Device: ultrasound scissors - Harmonic ACE
Device: electroscalpel (Erbe Vio 300; Aesculap AG)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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.

Resource links provided by NLM:

Further study details as provided by University of Cologne:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: December 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


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

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
  • pregnancy
  • malfunction of liver Child C
  Contacts and Locations
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Please refer to this study by its identifier: NCT00941213

Contact: Christina Otto, MD +49 221 478 86973

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
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
  More Information

Responsible Party: Dr. med. Peer Eysel, Head of the Department, University of Cologne, Department for Orthopaedics/Trauma Surgery Identifier: NCT00941213     History of Changes
Other Study ID Numbers: Uni-Koeln-1235
Study First Received: June 15, 2009
Last Updated: June 24, 2010

Keywords provided by University of Cologne:
fractures of vertebral bodies Th10-L2
(AO A1 with kyphosis, A2.3, B or C-type) processed this record on May 25, 2017