Monopolar Electrosurgery Versus Ultrasound Scissors in Thoracoscopic Ventral Spondylodesis

NCT ID: NCT00941213

Last Updated: 2010-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-08-31

Brief Summary

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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

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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.

Conditions

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Fractures of Vertebral Bodies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Monopolar Electrosurgery

Preparation during the operation with Monopolar Electrosurgery

Group Type ACTIVE_COMPARATOR

electroscalpel (Erbe Vio 300; Aesculap AG)

Intervention Type DEVICE

preparation with electroscalpel during operation

Ultrasound scissors

Preparation during the operation with ultrasound scissors

Group Type EXPERIMENTAL

ultrasound scissors - Harmonic ACE

Intervention Type DEVICE

preparation with ultrasound scissors during operation

Interventions

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ultrasound scissors - Harmonic ACE

preparation with ultrasound scissors during operation

Intervention Type DEVICE

electroscalpel (Erbe Vio 300; Aesculap AG)

preparation with electroscalpel during operation

Intervention Type DEVICE

Other Intervention Names

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Harmonic ACE; Firma Ethicon Endo-Surgery Generator Erbe Vio 300, hook from Aesculap AG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ethicon Endo-Surgery (Europe) GmbH

INDUSTRY

Sponsor Role collaborator

University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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University of Cologne, Department for Orthopaedics/Trauma Surgery

Principal Investigators

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Peer Eysel, Professor

Role: STUDY_DIRECTOR

University of Cologne, Department of Orthopaedics/Trauma surgery

Gereon Schiffer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cologne, Department of Orthopaedics/Trauma surgery

Locations

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University of Cologne, Department of Orthopaedics/Trauma surgery

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Kliniken der Stadt Köln gGmbH Merheim

Cologne, North Rhine-Westphalia, Germany

Site Status NOT_YET_RECRUITING

Countries

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Germany

Central Contacts

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Christina Otto, MD

Role: CONTACT

+49 221 478 86973

Other Identifiers

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Uni-Koeln-1235

Identifier Type: -

Identifier Source: secondary_id

Uni-Koeln-1235

Identifier Type: -

Identifier Source: org_study_id

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