Vertebral FractureMicroSpineNCT01266200
Identification of Microcirculation and Inflammation After Posterior Stabilization of the Spine
A study testing Mantis and XIA in people with Vertebral Fracture, run by RWTH Aachen University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Fracture
- What is being tested?
- Mantis and XIA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2010to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than 18 years, fracture in thoracal-lumbal region, deceleration of agreement signed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
RWTH Aachen University Hospital
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: Identification of Cutaneous and Muscular Microcirculation and Inflammatory Response After Posterior Stabilization of the Spine
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.
Read the 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.
- Conditions
- Vertebral Fracture
- Being tested
- Mantis, XIA
- Keywords
- microcirculation, vertebral fracture, inflammation, minimal-invasive surgery
- Medical subject headings
- Spinal Fractures, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MantisProcedure or surgery
Also called minimalinvasive surgery of spine
percutaneous minimal-invasive technique at the thoracal-lumbal junction with for cuts of about 3 cms
XIAProcedure or surgery
Also called open surgery of spine
Treatment of the fracture with Xia and conventional operation technique
| Study group | Role | What they receive |
|---|---|---|
| Minimal-invasive treatment (Mantis) | Active comparator | Patients, who received a minimal-invasive surgery and the fracture was fixed by a system called Mantis Receives: 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 Receives: Procedure: XIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
Microcirculation, inflammation and functional clinical outcome
clinical (computer-assisted movement analysis, functional scores) and radiographic (Böhler angle, arthritis signs)control measure of cytokine level, microcirculatory parameters
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias Knobe, MD, Principal investigator, Dpt. of Orthopedic Trauma, RWTH Aachen UniversityHans-Christoph Pape, MD, Study chair, Dpt. of Orthopedic Trauma, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266200
- Sponsor's protocol ID
- CTC-A10-027
- Acronym
- MicroSpine
- Status last verified
- Nov 2012
- First submitted
- 17 Dec 2010
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Cutaneous and Muscular Microcirculation and Inflammatory Response After Posterior Stabilization of the Spine
- ClinicalTrials.gov ID
- NCT01266200
- Acronym / sponsor ID
- MicroSpine / CTC-A10-027
- Conditions
- Vertebral Fracture
- Keywords
- microcirculation, vertebral fracture, inflammation, minimal-invasive surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 24 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal-invasive treatment (Mantis) | Active comparator | Procedure: Mantis, Procedure: XIAPatients, who received a minimal-invasive surgery and the fracture was fixed by a system called Mantis |
| Conventional technique (XIA) | Active comparator | Procedure: XIAPatients who received a surgical treatment including one long cut (conventional operation technique) and the fracture was fixed by a conventional system called XIA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- older than 18 years, fracture in thoracal-lumbal region, deceleration of agreement signed
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MantisAlso: minimalinvasive surgery of spinepercutaneous minimal-invasive technique at the thoracal-lumbal junction with for cuts of about 3 cms | Procedure or surgery | Minimal-invasive treatment (Mantis) |
| XIAAlso: open surgery of spineTreatment of the fracture with Xia and conventional operation technique | Procedure or surgery | Conventional technique (XIA), Minimal-invasive treatment (Mantis) |
Primary outcome
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.
1 secondary outcome
Microcirculation, inflammation and functional clinical outcome
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Knobe, MD principal investigator
Dpt. of Orthopedic Trauma, RWTH Aachen University
Hans-Christoph Pape, MD study chair
Dpt. of Orthopedic Trauma, RWTH Aachen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mantis and XIA in people with Vertebral Fracture, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2012.