Monopolar Electrosurgery Versus Ultrasound Scissors in Thoracoscopic Ventral Spondylodesis

Comparison of the Quantity of Bleeding and the Duration of Operation in Thoracoscopic Ventral Spondylodesis During Preparation With Monopolar Electrosurgery Compared to Ultrasound Scissors.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00941213

Acronym

Harmonic

Enrollment

Registered

2009-07-17

Start date

2009-12-31

Completion date

2011-08-31

Last updated

2010-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fractures of Vertebral Bodies

Keywords

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

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.

Interventions

DEVICEultrasound scissors - Harmonic ACE

preparation with ultrasound scissors during operation

DEVICEelectroscalpel (Erbe Vio 300; Aesculap AG)

preparation with electroscalpel during operation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
duration of the operation	end of the scin suture at the end of operation

Secondary

Measure	Time frame
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

Countries

Germany

Contacts

Primary ContactChristina Otto, MD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026