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

June 15, 2009
June 24, 2010
December 2009
August 2011   (final data collection date for primary outcome measure)
duration of the operation [ Time Frame: end of the scin suture at the end of operation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00941213 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Monopolar Electrosurgery Versus Ultrasound Scissors in Thoracoscopic Ventral Spondylodesis
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Fractures of Vertebral Bodies
  • Device: ultrasound scissors - Harmonic ACE
    preparation with ultrasound scissors during operation
    Other Name: Harmonic ACE; Firma Ethicon Endo-Surgery
  • Device: electroscalpel (Erbe Vio 300; Aesculap AG)
    preparation with electroscalpel during operation
    Other Name: Generator Erbe Vio 300, hook from Aesculap AG
  • Active Comparator: Monopolar Electrosurgery
    Preparation during the operation with Monopolar Electrosurgery
    Intervention: Device: electroscalpel (Erbe Vio 300; Aesculap AG)
  • Experimental: Ultrasound scissors
    Preparation during the operation with ultrasound scissors
    Intervention: Device: ultrasound scissors - Harmonic ACE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Christina Otto, MD +49 221 478 86973 christina.otto@uk-koeln.de
Germany
 
NCT00941213
Uni-Koeln-1235, Uni-Koeln-1235
No
Dr. med. Peer Eysel, Head of the Department, University of Cologne, Department for Orthopaedics/Trauma Surgery
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
University of Cologne
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP