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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Cologne.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ethicon Endo-Surgery (Europe) GmbH
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00941213
First received: June 15, 2009
Last updated: June 24, 2010
Last verified: June 2010
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • loss of blood during operation and at first day after the operation [ Time Frame: 24 hours after end of operation ] [ Designated as safety issue: Yes ]
  • length of stay at the hospital [ Time Frame: day of discharge from hospitalization ] [ Designated as safety issue: Yes ]
  • trauma of internal organs during operation [ Time Frame: end of the scin suure at the end of operation ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: June 15, 2009
Last Updated: June 24, 2010
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013