Vertebral Fracture
Conditions
Keywords
microcirculation, vertebral fracture, inflammation, minimal-invasive surgery
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.
Interventions
PROCEDUREMantis
percutaneous minimal-invasive technique at the thoracal-lumbal junction with for cuts of about 3 cms
PROCEDUREXIA
Treatment of the fracture with Xia and conventional operation technique
Sponsors
RWTH Aachen University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infection rate | 2 years | 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
| Measure | Time frame | Description |
|---|---|---|
| Microcirculation, inflammation and functional clinical outcome | 2 years | clinical (computer-assisted movement analysis, functional scores) and radiographic (Böhler angle, arthritis signs)control measure of cytokine level, microcirculatory parameters |
Countries
Germany
Outcome results
None listed