NCT01266200

Identification of Microcirculation and Inflammation After Posterior Stabilization of the Spine

Identification of Cutaneous and Muscular Microcirculation and Inflammatory Response After Posterior Stabilization of the Spine

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: RWTH Aachen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Vertebral Fracture

Interventions

Type	Name	Description
PROCEDURE	Mantis	percutaneous minimal-invasive technique at the thoracal-lumbal junction with for cuts of about 3 cms
PROCEDURE	XIA	Treatment of the fracture with Xia and conventional operation technique

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2010-12-24
• Last updated: 2012-11-27

Locations

1 site across 1 country: Germany