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Identification of Microcirculation and Inflammation After Posterior Stabilization of the Spine

NCT ID: NCT01266200

Last Updated: 2012-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-11-30

Brief Summary

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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

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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.

Conditions

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Vertebral Fracture

Keywords

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microcirculation vertebral fracture inflammation minimal-invasive surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Minimal-invasive treatment (Mantis)

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

Group Type ACTIVE_COMPARATOR

Mantis

Intervention Type PROCEDURE

percutaneous minimal-invasive technique at the thoracal-lumbal junction with for cuts of about 3 cms

XIA

Intervention Type PROCEDURE

Treatment of the fracture with Xia and conventional operation technique

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

Group Type ACTIVE_COMPARATOR

XIA

Intervention Type PROCEDURE

Treatment of the fracture with Xia and conventional operation technique

Interventions

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Mantis

percutaneous minimal-invasive technique at the thoracal-lumbal junction with for cuts of about 3 cms

Intervention Type PROCEDURE

XIA

Treatment of the fracture with Xia and conventional operation technique

Intervention Type PROCEDURE

Other Intervention Names

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minimalinvasive surgery of spine open surgery of spine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthias Knobe, MD

Role: PRINCIPAL_INVESTIGATOR

Dpt. of Orthopedic Trauma, RWTH Aachen University

Hans-Christoph Pape, MD

Role: STUDY_CHAIR

Dpt. of Orthopedic Trauma, RWTH Aachen University

Locations

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RWTH Aachen University Hospital

Aachen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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CTC-A10-027

Identifier Type: -

Identifier Source: org_study_id