Monopolar Electrosurgery Versus Ultrasound Scissors in Thoracoscopic Ventral Spondylodesis

Fractures of Vertebral Bodies Clinical Trial

— Harmonic  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00941213
• Other study ID #: Uni-Koeln-1235
• Secondary ID: Uni-Koeln-1235
• Status: Recruiting
• Phase: Phase 4
• First received: June 15, 2009
• Last updated: June 24, 2010
• Start date: December 2009
• Est. completion date: August 2011

Study information

• Verified date: June 2010
• Source: University of Cologne
• Contact: Christina Otto, MD
• Phone: +49 221 478 86973
• Email: christina.otto[@]uk-koeln.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fractures of Vertebral Bodies

Intervention

Device:
• ultrasound scissors - Harmonic ACE
preparation with ultrasound scissors during operation
• electroscalpel (Erbe Vio 300; Aesculap AG)
preparation with electroscalpel during operation

Locations

Country	Name	City	State
Germany	Kliniken der Stadt Köln gGmbH Merheim	Cologne	NRW
Germany	University of Cologne, Department of Orthopaedics/Trauma surgery	Cologne	NRW

Sponsors (2)

Lead Sponsor	Collaborator
University of Cologne	Ethicon Endo-Surgery (Europe) GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of the operation		end of the scin suture at the end of operation	No
Secondary	loss of blood during operation and at first day after the operation		24 hours after end of operation	Yes
Secondary	length of stay at the hospital		day of discharge from hospitalization	Yes
Secondary	trauma of internal organs during operation		end of the scin suure at the end of operation	Yes