Monopolar Electrosurgery Versus Ultrasound Scissors in Thoracoscopic Ventral Spondylodesis

Phase 4

• Conditions: Fractures of Vertebral Bodies
• Interventions: Device: electroscalpel (Erbe Vio 300; Aesculap AG); Device: ultrasound scissors - Harmonic ACE

• 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.

Study Timeline

• Study First Submitted: 2009-06-15
• Study First Submitted QC: 2009-07-16
• Study First Posted: 2009-07-17
• Study Start: 2009-12
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-24
• Last Update Posted: 2010-06-25
• Primary Completion: 2011-08
• Study Completion: 2011-08

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

Arm && Interventions

Group	Intervention	Description
Monopolar Electrosurgery	electroscalpel (Erbe Vio 300; Aesculap AG)	Preparation during the operation with Monopolar Electrosurgery
Ultrasound scissors	ultrasound scissors - Harmonic ACE	Preparation during the operation with ultrasound scissors

Primary Outcome Measures

Name	Time	Method
duration of the operation	end of the scin suture at the end of operation

Secondary Outcome Measures

Name	Time	Method
loss of blood during operation and at first day after the operation	24 hours after end of operation
length of stay at the hospital	day of discharge from hospitalization
trauma of internal organs during operation	end of the scin suure at the end of operation

Trial Locations

Locations (2)

Kliniken der Stadt Köln gGmbH Merheim; 🇩🇪 Cologne, NRW, Germany

University of Cologne, Department of Orthopaedics/Trauma surgery; 🇩🇪 Cologne, NRW, Germany