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

Primary Purpose

Vertebral Fracture

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mantis
XIA
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vertebral Fracture focused on measuring microcirculation, vertebral fracture, inflammation, minimal-invasive surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • RWTH Aachen University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Minimal-invasive treatment (Mantis)

Conventional technique (XIA)

Arm Description

Patients, who received a minimal-invasive surgery and the fracture was fixed by a system called Mantis

Patients who received a surgical treatment including one long cut (conventional operation technique) and the fracture was fixed by a conventional system called XIA

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 17, 2010
Last Updated
November 26, 2012
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT01266200
Brief Title
Identification of Microcirculation and Inflammation After Posterior Stabilization of the Spine
Acronym
MicroSpine
Official Title
Identification of Cutaneous and Muscular Microcirculation and Inflammatory Response After Posterior Stabilization of the Spine
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertebral Fracture
Keywords
microcirculation, vertebral fracture, inflammation, minimal-invasive surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minimal-invasive treatment (Mantis)
Arm Type
Active Comparator
Arm Description
Patients, who received a minimal-invasive surgery and the fracture was fixed by a system called Mantis
Arm Title
Conventional technique (XIA)
Arm Type
Active Comparator
Arm Description
Patients who received a surgical treatment including one long cut (conventional operation technique) and the fracture was fixed by a conventional system called XIA
Intervention Type
Procedure
Intervention Name(s)
Mantis
Other Intervention Name(s)
minimalinvasive surgery of spine
Intervention Description
percutaneous minimal-invasive technique at the thoracal-lumbal junction with for cuts of about 3 cms
Intervention Type
Procedure
Intervention Name(s)
XIA
Other Intervention Name(s)
open surgery of spine
Intervention Description
Treatment of the fracture with Xia and conventional operation technique
Primary Outcome Measure Information:
Title
Infection rate
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Microcirculation, inflammation and functional clinical outcome
Description
clinical (computer-assisted movement analysis, functional scores) and radiographic (Böhler angle, arthritis signs)control measure of cytokine level, microcirculatory parameters
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Knobe, MD
Organizational Affiliation
Dpt. of Orthopedic Trauma, RWTH Aachen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hans-Christoph Pape, MD
Organizational Affiliation
Dpt. of Orthopedic Trauma, RWTH Aachen University
Official's Role
Study Chair
Facility Information:
Facility Name
RWTH Aachen University Hospital
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

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Identification of Microcirculation and Inflammation After Posterior Stabilization of the Spine

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