MedPath

Monopolar Electrosurgery Versus Ultrasound Scissors in Thoracoscopic Ventral Spondylodesis

Phase 4
Conditions
Fractures of Vertebral Bodies
Registration Number
NCT00941213
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
40
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
duration of the operationend of the scin suture at the end of operation
Secondary Outcome Measures
NameTimeMethod
loss of blood during operation and at first day after the operation24 hours after end of operation
length of stay at the hospitalday of discharge from hospitalization
trauma of internal organs during operationend of the scin suure at the end of operation

Trial Locations

Locations (2)

University of Cologne, Department of Orthopaedics/Trauma surgery

🇩🇪

Cologne, NRW, Germany

Kliniken der Stadt Köln gGmbH Merheim

🇩🇪

Cologne, NRW, Germany

University of Cologne, Department of Orthopaedics/Trauma surgery
🇩🇪Cologne, NRW, Germany
Peer Eysel, Professor
Principal 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
Sub Investigator

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.