NCT00941213

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 17, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

June 25, 2010

Status Verified

June 1, 2010

Enrollment Period

1.7 years

First QC Date

June 15, 2009

Last Update Submit

June 24, 2010

Conditions

Fractures of Vertebral Bodies

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • duration of the operation

    end of the scin suture at the end of operation

Secondary Outcomes (3)

  • 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

Study Arms (2)

Monopolar Electrosurgery

ACTIVE COMPARATOR

Preparation during the operation with Monopolar Electrosurgery

Device: electroscalpel (Erbe Vio 300; Aesculap AG)

Ultrasound scissors

EXPERIMENTAL

Preparation during the operation with ultrasound scissors

Device: ultrasound scissors - Harmonic ACE

Interventions

ultrasound scissors - Harmonic ACEDEVICE

preparation with ultrasound scissors during operation

Also known as: Harmonic ACE; Firma Ethicon Endo-Surgery
Ultrasound scissors
electroscalpel (Erbe Vio 300; Aesculap AG)DEVICE

preparation with electroscalpel during operation

Also known as: Generator Erbe Vio 300, hook from Aesculap AG
Monopolar Electrosurgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • informed consent
  • fracture of vertebral bodies Th10-L2 with indication for operative treatment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Cologne, Department of Orthopaedics/Trauma surgery

Cologne, North Rhine-Westphalia, 50924, Germany

RECRUITING

Kliniken der Stadt Köln gGmbH Merheim

Cologne, North Rhine-Westphalia, 58448, Germany

NOT YET RECRUITING

Study Officials

  • Peer Eysel, Professor

    University of Cologne, Department of Orthopaedics/Trauma surgery

    STUDY DIRECTOR

  • Gereon Schiffer, MD

    University of Cologne, Department of Orthopaedics/Trauma surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Otto, MD

CONTACT

+49 221 478 86973christina.otto@uk-koeln.de

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2009

First Posted

July 17, 2009

Study Start

December 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

June 25, 2010

Record last verified: 2010-06

Locations

DE(2)