Clinical trial NCT01266200: Identification of Microcirculation and Inflammation After Posterior Stabilization of the Spine
Official title: Identification of Cutaneous and Muscular Microcirculation and Inflammatory Response After Posterior Stabilization of the Spine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vertebral Fracture
Keywords: microcirculation
vertebral fracture
inflammation
minimal-invasive surgery
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2010-12-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Infection rate
timeFrame: 2 years
Secondary outcomes:
measure: Microcirculation, inflammation and functional clinical outcome
timeFrame: 2 years
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: RWTH Aachen University Hospital
state: NRW
Study officials:
affiliation: Dpt. of Orthopedic Trauma, RWTH Aachen University
name: Matthias Knobe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dpt. of Orthopedic Trauma, RWTH Aachen University
name: Hans-Christoph Pape, MD
role: STUDY_CHAIR
References: