Identification of Microcirculation and Inflammation After Posterior Stabilization of the Spine

Vertebral Fracture Clinical Trial

— MicroSpine  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01266200
• Other study ID #: CTC-A10-027
• Status: Completed
• Phase: N/A
• First received: December 17, 2010
• Last updated: November 26, 2012
• Start date: December 2010
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Fractures
• Vertebral Fracture

Intervention

Procedure:
• Mantis
percutaneous minimal-invasive technique at the thoracal-lumbal junction with for cuts of about 3 cms
• XIA
Treatment of the fracture with Xia and conventional operation technique

Locations

Country	Name	City	State
Germany	RWTH Aachen University Hospital	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No