Monopolar electrosurgery is the gold standard for surgical preparation in thoracoscopic spine procedures. However, use of ultrasound scissors could decrease blood loss, accelerate the preparation time and improve patient safety, while minimizing operative costs. This trial compares both preparation techniques for ventral thoracoscopic spondylodesis.
The study design is an open, prospective, randomized, and double-blinded two-armed clinical trial performed in two centres. Forty-one patients with vertebral body fractures from T10 to L2 were included. Primary endpoint: preparation time. Secondary endpoints: blood loss, organ injuries, duration of hospitalization.
Primary and secondary endpoints did not differ significantly between groups (p level 0.05). Increased blood loss (150 ml or more) was eliminated with ultrasound scissors (p = 0.0014).
Primary and secondary endpoints did not differ significantly between the two preparation techniques. The use of either ultrasound scissors or electric scalpel offers safe and effective preparation for thoracoscopic spine surgery.
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This trial was conducted in compliance with the Declaration of Helsinki (2008) and under approval of the responsible ethics committee. The DIN EN ISO 14155 guidelines, as well as the corresponding laws, were observed. The study complied with the German “Medical Devices Act”: the devices are certified and verified (Medical Device Directive 93/42/EEC). All participants received insurance according to § 20 MPG (German Medical Devices Act). Informed consent was obtained from all patients prior to inclusion in the study.
Conflict of interest
The authors, except Gereon Schiffer and Thomas Paffrath, declare that they have no conflicting or competing interests in carrying out this study. Gereon Schiffer and Thomas Paffrath received contributor fees from Ethicon Endo-Surgery (Europe) GmbH. Ethicon Endo-Surgery (Europe) GmbH offered financial support for implementation of the study. Ethicon Endo-Surgery (Europe) GmbH was not involved in the design of the study and was not involved in analysis of the data and/or publication. None of the authors has received or will receive any funding from Ethicon Endo-Surgery (Europe) GmbH.
C. Otto and G. Schiffer shared first authorship.
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Otto, C., Schiffer, G., Tjardes, T. et al. Blood loss and operative duration using monopolar electrosurgery versus ultrasound scissors for surgical preparation during thoracoscopic ventral spondylodesis: results of a randomized, blinded, controlled trial. Eur Spine J 23, 1783–1790 (2014). https://doi.org/10.1007/s00586-014-3303-1