Identification of Microcirculation and Inflammation After Posterior Stabilization of the Spine

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vertebral Fracture

Intervention / Treatment
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* Procedure: Mantis
* Procedure: XIA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Minimal-invasive treatment (Mantis)<br>Patients, who received a minimal-invasive surgery and the fracture was fixed by a system called Mantis | Procedure: Mantis<br>* percutaneous minimal-invasive technique at the thoracal-lumbal junction with for cuts of about 3 cms<br>* Other names: minimalinvasive surgery of spine;Procedure: XIA<br>* Treatment of the fracture with Xia and conventional operation technique<br>* Other names: open surgery of spine;|
| Active Comparator: Conventional technique (XIA)<br>Patients who received a surgical treatment including one long cut (conventional operation technique) and the fracture was fixed by a conventional system called XIA | Procedure: XIA<br>* Treatment of the fracture with Xia and conventional operation technique<br>* Other names: open surgery of spine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection rate | 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. | 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microcirculation, vertebral fracture, inflammation, minimal-invasive surgery