Identification of Microcirculation and Inflammation After Posterior Stabilization of the Spine

Not Applicable

Completed

• Conditions: Vertebral Fracture
• Interventions: Procedure: Mantis; Procedure: XIA

• Registration Number: NCT01266200
• Lead Sponsor: RWTH Aachen University

Brief 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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-17
• Study First Submitted QC: 2010-12-22
• Study First Posted: 2010-12-24
• Status Verified: 2012-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Last Update Submitted: 2012-11-26
• Last Update Posted: 2012-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

older than 18 years, fracture in thoracal-lumbal region, deceleration of agreement signed

Exclusion Criteria

under age, pregnant, pathologic fractures, history of surgery in the examined area, history of metabolic bone disease, soft tissue damage, immunodeficient, polytrauma, history of significant heart or pulmonal diseases or diabetes mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Minimal-invasive treatment (Mantis)	Mantis	Patients, who received a minimal-invasive surgery and the fracture was fixed by a system called Mantis
Minimal-invasive treatment (Mantis)	XIA	Patients, who received a minimal-invasive surgery and the fracture was fixed by a system called Mantis
Conventional technique (XIA)	XIA	Patients who received a surgical treatment including one long cut (conventional operation technique) and the fracture was fixed by a conventional system called XIA

Primary Outcome Measures

Name	Time	Method
Infection rate	2 years	Rate of postoperative wound edge necrosis and superficial or deep infection determined by wound redness, secretion of pus, detection of a microbial agens, CRP elevation and detection of fluid by sonography.

Secondary Outcome Measures

Name	Time	Method
Microcirculation, inflammation and functional clinical outcome	2 years	clinical (computer-assisted movement analysis, functional scores) and radiographic (Böhler angle, arthritis signs)control measure of cytokine level, microcirculatory parameters

Trial Locations

Locations (1)

RWTH Aachen University Hospital; 🇩🇪 Aachen, NRW, Germany