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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01266200
First received: December 17, 2010
Last updated: November 26, 2012
Last verified: November 2012

December 17, 2010
November 26, 2012
December 2010
November 2012   (final data collection date for primary outcome measure)
Infection rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01266200 on ClinicalTrials.gov Archive Site
Microcirculation, inflammation and functional clinical outcome [ Time Frame: 2 years ] [ Designated as safety issue: No ]
clinical (computer-assisted movement analysis, functional scores) and radiographic (Böhler angle, arthritis signs)control measure of cytokine level, microcirculatory parameters
Same as current
Not Provided
Not Provided
 
Identification of Microcirculation and Inflammation After Posterior Stabilization of the Spine
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Vertebral Fracture
  • Procedure: Mantis
    percutaneous minimal-invasive technique at the thoracal-lumbal junction with for cuts of about 3 cms
    Other Name: minimalinvasive surgery of spine
  • Procedure: XIA
    Treatment of the fracture with Xia and conventional operation technique
    Other Name: open surgery of spine
  • Active Comparator: Minimal-invasive treatment (Mantis)
    Patients, who received a minimal-invasive surgery and the fracture was fixed by a system called Mantis
    Interventions:
    • Procedure: Mantis
    • Procedure: XIA
  • 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
    Intervention: Procedure: XIA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
November 2012
November 2012   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01266200
CTC-A10-027
No
RWTH Aachen University
RWTH Aachen University
Not Provided
Principal Investigator: Matthias Knobe, MD Dpt. of Orthopedic Trauma, RWTH Aachen University
Study Chair: Hans-Christoph Pape, MD Dpt. of Orthopedic Trauma, RWTH Aachen University
RWTH Aachen University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP