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

RWTH Aachen University

Status: Completed

Conditions: Vertebral Fracture

Treatments: Procedure: XIA; Procedure: Mantis

Study type: Interventional

Funder types: Other

Identifiers

NCT01266200

CTC-A10-027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Minimal-invasive treatment (Mantis)

Active Comparator group

Description:

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

Treatment:

Procedure: Mantis

Procedure: XIA

Conventional technique (XIA)

Active Comparator group

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

Treatment:

Procedure: XIA