Identification of Microcirculation and Inflammation After Posterior Stabilization of the Spine

NCT01266200 | Completed

• 1 other identifier: CTC-A10-027
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Vertebral Fracture

Keywords

microcirculation; vertebral fracture; inflammation; minimal-invasive surgery

Outcome Measures

Primary Outcomes (1)

• Infection rate

  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.

  2 years

Secondary Outcomes (1)

• Microcirculation, inflammation and functional clinical outcome

  2 years

Study Arms (2)

Minimal-invasive treatment (Mantis)

ACTIVE COMPARATOR

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

Procedure: Mantis; Procedure: XIA

Conventional technique (XIA)

ACTIVE COMPARATOR

Patients who received a surgical treatment including one long cut (conventional operation technique) and the fracture was fixed by a conventional system called XIA

Procedure: XIA

Interventions

Mantis PROCEDURE

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

Also known as: minimalinvasive surgery of spine

Minimal-invasive treatment (Mantis)

XIA PROCEDURE

Treatment of the fracture with Xia and conventional operation technique

Also known as: open surgery of spine

Conventional technique (XIA); Minimal-invasive treatment (Mantis)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• older than 18 years, fracture in thoracal-lumbal region, deceleration of agreement signed

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

RWTH Aachen University Hospital

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Spinal Fractures; Inflammation

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthias Knobe, MD

  Dpt. of Orthopedic Trauma, RWTH Aachen University

  PRINCIPAL INVESTIGATOR

• Hans-Christoph Pape, MD

  Dpt. of Orthopedic Trauma, RWTH Aachen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2010
• First Posted: December 24, 2010
• Study Start: December 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 27, 2012

Record last verified: 2012-11

Locations

DE (1)