Identification of Microcirculation and Inflammation After Posterior Stabilization of the Spine (MicroSpine)

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.

Study Overview

• Status: Completed
• Conditions: Vertebral Fracture
• Intervention / Treatment: Procedure: Mantis; Procedure: XIA

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Aachen, NRW, Germany, 52074
      • RWTH Aachen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: RWTH Aachen University

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: December 17, 2010
• First Submitted That Met QC Criteria: December 22, 2010
• First Posted (Estimate): December 24, 2010

Study Record Updates

• Last Update Posted (Estimate): November 27, 2012
• Last Update Submitted That Met QC Criteria: November 26, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: microcirculation; inflammation; vertebral fracture; minimal-invasive surgery
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Spinal Injuries; Back Injuries; Spinal Fractures
• Other Study ID Numbers: CTC-A10-027