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

Primary Purpose

Fractures of Vertebral Bodies

Status

Unknown status

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

ultrasound scissors - Harmonic ACE

electroscalpel (Erbe Vio 300; Aesculap AG)

About this trial

This is an interventional supportive care trial for Fractures of Vertebral Bodies focused on measuring fractures of vertebral bodies Th10-L2, (AO A1 with kyphosis, A2.3, B or C-type)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Cologne, Department of Orthopaedics/Trauma surgeryRecruiting
Kliniken der Stadt Köln gGmbH Merheim

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Monopolar Electrosurgery

Ultrasound scissors

Arm Description

Preparation during the operation with Monopolar Electrosurgery

Preparation during the operation with ultrasound scissors

Outcomes

Primary Outcome Measures

duration of the operation

Secondary Outcome Measures

loss of blood during operation and at first day after the operation

length of stay at the hospital

trauma of internal organs during operation

Full Information

NCT ID

NCT00941213

First Posted

June 15, 2009

Last Updated

June 24, 2010

Sponsor

University of Cologne

Collaborators

Ethicon Endo-Surgery (Europe) GmbH

1. Study Identification

Unique Protocol Identification Number

NCT00941213

Brief Title

Monopolar Electrosurgery Versus Ultrasound Scissors in Thoracoscopic Ventral Spondylodesis

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2010

Overall Recruitment Status

Unknown status

Study Start Date

December 2009 (undefined)

Primary Completion Date

August 2011 (Anticipated)

Study Completion Date

August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University of Cologne

Collaborators

Ethicon Endo-Surgery (Europe) GmbH

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fractures of Vertebral Bodies

Keywords

fractures of vertebral bodies Th10-L2, (AO A1 with kyphosis, A2.3, B or C-type)

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Monopolar Electrosurgery

Arm Type

Active Comparator

Arm Description

Preparation during the operation with Monopolar Electrosurgery

Arm Title

Ultrasound scissors

Arm Type

Experimental

Arm Description

Preparation during the operation with ultrasound scissors

Intervention Type

Device

Intervention Name(s)

ultrasound scissors - Harmonic ACE

Other Intervention Name(s)

Harmonic ACE; Firma Ethicon Endo-Surgery

Intervention Description

preparation with ultrasound scissors during operation

Intervention Type

Device

Intervention Name(s)

electroscalpel (Erbe Vio 300; Aesculap AG)

Other Intervention Name(s)

Generator Erbe Vio 300, hook from Aesculap AG

Intervention Description

preparation with electroscalpel during operation

Primary Outcome Measure Information:

Title

duration of the operation

Time Frame

end of the scin suture at the end of operation

Secondary Outcome Measure Information:

Title

loss of blood during operation and at first day after the operation

Time Frame

24 hours after end of operation

Title

length of stay at the hospital

Time Frame

day of discharge from hospitalization

Title

trauma of internal organs during operation

Time Frame

end of the scin suure at the end of operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christina Otto, MD

Phone

+49 221 478 86973

christina.otto@uk-koeln.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peer Eysel, Professor

Organizational Affiliation

University of Cologne, Department of Orthopaedics/Trauma surgery

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Gereon Schiffer, MD

Organizational Affiliation

University of Cologne, Department of Orthopaedics/Trauma surgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Cologne, Department of Orthopaedics/Trauma surgery

City

Cologne

State/Province

NRW

ZIP/Postal Code

50924

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peer Eysel, Professor

First Name & Middle Initial & Last Name & Degree

Gereon Schiffer

First Name & Middle Initial & Last Name & Degree

Ulrich Thelen, MD

First Name & Middle Initial & Last Name & Degree

Timmo Koy, MD

First Name & Middle Initial & Last Name & Degree

Koroush Zarghooni, MD

First Name & Middle Initial & Last Name & Degree

Thomas Kaulhausen, MD

First Name & Middle Initial & Last Name & Degree

Jan Siewe, MD

First Name & Middle Initial & Last Name & Degree

Henning Kunter, MD

First Name & Middle Initial & Last Name & Degree

Christina Otto, MD

First Name & Middle Initial & Last Name & Degree

Bergita Ganse, MD

Facility Name

Kliniken der Stadt Köln gGmbH Merheim

City

Cologne

State/Province

NRW

ZIP/Postal Code

58448

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dieter Rixen, Professor

First Name & Middle Initial & Last Name & Degree

Thomas Paffrath, MD

First Name & Middle Initial & Last Name & Degree

Thorsten Tjardes, MD

First Name & Middle Initial & Last Name & Degree

Eva Steinhausen, MD

12. IPD Sharing Statement

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Monopolar Electrosurgery Versus Ultrasound Scissors in Thoracoscopic Ventral Spondylodesis

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