Identification of Microcirculation and Inflammation After Posterior Stabilization of the Spine (MicroSpine)
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| First Received Date ICMJE | December 17, 2010 | ||||||||
| Last Updated Date | November 26, 2012 | ||||||||
| Start Date ICMJE | December 2010 | ||||||||
| Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Infection rate [ Time Frame: 2 years ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01266200 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Microcirculation, inflammation and functional clinical outcome [ Time Frame: 2 years ] [ Designated as safety issue: No ] clinical (computer-assisted movement analysis, functional scores) and radiographic (Böhler angle, arthritis signs)control measure of cytokine level, microcirculatory parameters |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Identification of Microcirculation and Inflammation After Posterior Stabilization of the Spine | ||||||||
| Official Title ICMJE | Identification of Cutaneous and Muscular Microcirculation and Inflammatory Response After Posterior Stabilization of the Spine | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Vertebral Fracture | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 40 | ||||||||
| Completion Date | November 2012 | ||||||||
| Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01266200 | ||||||||
| Other Study ID Numbers ICMJE | CTC-A10-027 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | RWTH Aachen University | ||||||||
| Study Sponsor ICMJE | RWTH Aachen University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | RWTH Aachen University | ||||||||
| Verification Date | November 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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