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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00015693 |
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Date of registration:
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07/11/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison of minimally invasive percutaneous vs. open dorsal fixation and additional thoracoscopic ventral spondylodesis in AO/OTA type A3 thoracolumbar fractures
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Scientific title:
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Comparison of minimally invasive percutaneous vs. open dorsal fixation and additional thoracoscopic ventral spondylodesis in AO/OTA type A3 thoracolumbar fractures - A3 |
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Date of first enrolment:
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01/12/2016 |
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Target sample size:
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87 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00015693 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: basic science
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Christoph
Erichsen |
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Address:
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Prof. Küntscher Str. 8
82418
Murnau
Germany |
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Telephone:
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08841 48480 |
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Email:
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christoph.erichsen@bgu-murnau.de |
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Affiliation:
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BG Unfallklinik Murnau |
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Name:
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Christoph
Erichsen |
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Address:
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Prof. Küntscher Str. 8
82418
Murnau
Germany |
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Telephone:
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08841 48480 |
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Email:
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christoph.erichsen@bgu-murnau.de |
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Affiliation:
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BG Unfallklinik Murnau |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria:
Detailed information and education
Signature of informed consent after sufficient time for reflection
Operative care according to the above techniques in the period 01.07.2012 to 31.05.2014.
Age 18-65 years
Exclusion criteria: Exclusion criteria:
Vertebral body fractures of other AO classifications
Patients with neurological deficits
fractures of other genesis (e.g. tumor / metastasis)
incapacity to consent
Osteoporotic fractures
Polytrauma with ISS>16
Kypho or vertebroplasty additives
Long-distance dorsal stabilizations (over more than 2 motion segments)
pregnancy
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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S32.02
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S32.01
S32.02
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S32.01
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Intervention(s)
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Group 1: Minimally invasive surgical technique,
early additive ventral stabilization
The examination takes place at least 2 years after the operation.
Evaluation of X-ray images
VAS Spine Score
Oswestry Disability Score
SF-36 Quality of life
Group 2: Open operative technique, late additiv ventral Stabilisation
The examination takes place at least 2 years after the operation.
Evaluation of X-ray images
VAS Spine Score
Oswestry Disability Score
SF-36 Quality of life
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Primary Outcome(s)
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Bisegmental kyphotic angle, radiological measurement
Functional outcome is ODI-Score by questionnaire
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Secondary Outcome(s)
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Sagital Alignment radiological
SF-36, VAS-Score by questionnaire
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Source(s) of Monetary Support
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Klinik und Poliklinik für Orthopädie, Unfallchirurgie und Plastische Chirurgie der Universitätsklinik Leipzig
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Ethics review
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Status: Approved
Approval date: 29/11/2016
Contact:
ethik@medizin.uni-leipzig.de
Geschäftsstelle der Ethik-Kommission an der Medizinischen Fakultät der Universität Leipzig c/o Zentrale Poststelle
+49-341-9715490
ethik@medizin.uni-leipzig.de
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