Trial document





This trial has been registered retrospectively.
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  DRKS00006252

Trial Description

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Title

CT-based fusion assessment after monosegmental, ventral spondylodesis in cranial vertebral burst fractures of the thoraco-lumbar spine

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Assesment of bony fusion of tricortical iliac crest in monosegmental anterior spondylodesis of cranial burst fractures of the thoraco-lumbar juncton using a ct-based score

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Organizational Data

  •   DRKS00006252
  •   2014/06/18
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  •   yes
  •   No approval required according to EC
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Secondary IDs

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Health Condition or Problem studied

  •   S32.0 -  Fracture of lumbar vertebra
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Interventions/Observational Groups

  •   CT scans with three iliac crest fusion possibilities: bony fusion, partial fusion and failed fusion
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Fusion of the intervertebral space unsing a CT based score of Badke et al. with a minimal distance of twelve months to surgical intervention

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/01/06
  •   22
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

Inclusion criteria for this study were incomplete cranial burst fractures between 2009 and 2011, treatment with bisegmental posterior internal fixation and monosegmental ventral spondylodesis as described above and postoperative CT scans with coronal reconstructions with a minimum postoperative follow-up period of 12 months.

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Exclusion Criteria

nothing but default of inclusion criterias

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Addresses

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    • Klinik für Unfall-, Hand- und Wiederherstellungschirurgie. Chirurgische Klinik und Poliklinik. Universitätsmedizin Rostock
    • Mr.  Univ.-Prof. Dr. med.  Thomas  Mittlmeier 
    • Schillingallee 35
    • 18057  Rostock
    • Germany
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    • Klinik für Unfall-, Hand- und Wiederherstellungschirurgie. Chirurgische Klinik und Poliklinik, Universitätsmedizin Rostock
    • Mr.  PD Dr. med. habil.  Benjamin  Ulmar 
    • Schillingalle 35
    • 18057  Rostock
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Klinik für Unfall-, Hand- und Wiederherstellungschirurgie. Chirurgische Klinik und Poliklinik, Universitätsmedizin Rostock
    • Mr.  PD Dr. med. habil.  Benjamin  Ulmar 
    • Schillingallee 35
    • 18057  Rostock
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Unfall-, Hand- und Wiederherstellungschirurgie. Chirurgische Klinik und Poliklinik, Universitätsmedizin Rostock
    • Mr.  Univ.-Prof. Dr. med.   Thomas  Mittlmeier 
    • Schillingallee 35
    • 18057  Rostock
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/02/28
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.