Identification of Cutaneous and Muscular Microcirculation and Inflammatory Response After Posterior Stabilization of the Spine
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- RWTH Aachen University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Infection rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Minimal-invasive treatment (Mantis)
Patients, who received a minimal-invasive surgery and the fracture was fixed by a system called Mantis
Intervention: Mantis (Procedure)
Minimal-invasive treatment (Mantis)
Patients, who received a minimal-invasive surgery and the fracture was fixed by a system called Mantis
Intervention: XIA (Procedure)
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
Intervention: XIA (Procedure)
Outcomes
Primary Outcomes
Infection rate
Time Frame: 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 Outcomes
- Microcirculation, inflammation and functional clinical outcome(2 years)