Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention
Vertebral Fracture
Procedure: Mantis
Procedure: XIA

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Identification of Cutaneous and Muscular Microcirculation and Inflammatory Response After Posterior Stabilization of the Spine

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 40
Study Start Date: December 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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: 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 Name: open surgery of spine

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266200

Locations
Germany
RWTH Aachen University Hospital
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
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
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01266200     History of Changes
Other Study ID Numbers: CTC-A10-027
Study First Received: December 17, 2010
Last Updated: November 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
microcirculation
vertebral fracture
inflammation
minimal-invasive surgery

Additional relevant MeSH terms:
Spinal Fractures
Back Injuries
Fractures, Bone
Spinal Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014