Vertebral Fracture Clinical Trial
Official title:
Identification of Cutaneous and Muscular Microcirculation and Inflammatory Response After Posterior Stabilization of the Spine
In this project, with unstable vertebral fractures, the microcirculation of the skin and muscle (O2C,Laser-Doppler/White-light -Spectroscopy and contrast-enhanced sonography) will be evaluated in both conventional and in percutaneous minimally invasive technique (XIA versus Mantis) at the thoracolumbar junction.
In this project, with unstable vertebral fractures, the microcirculation of the skin and
muscle (O2C,Laser-Doppler/Whitelight-Spectroscopy and contrast-enhanced sonography) will be
evaluated in both conventional and in percutaneous minimal-invasive technique (XIA versus
Mantis) at the thoracolumbar junction. And after placing a fixator, the inflammatory potency
(laboratory chemicals, cytokines, immune status) and the muscular injury (EMG) of acess are
examined.
The study is planned as a randomized prospective study. In the study a total of at least 100
patients should be included, 50 with minimally invasive fixation-implantation and 50
patients with conventional procedure.
The radiological imaging (post-surgical control, possibly after mobilization, CT) ist
routinely.
The patient outcome is determined using established scores (clinical score, visual analogue
scale, SF-12).
The study also indicates by comparing the damage of the microcirculation of the two surgical
techniques to make statements on wound healing and muscle blood flow heavily in order to
filter out the less complications and tissue-method.
In this research project, the limits in the microcirculation measurement with the O2C and
contrast enhanced sonography be established at an early stage to help in future wound
healing disorders can be treated so well.
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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