Trial document





This trial has been registered retrospectively.
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  DRKS00004960

Trial Description

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Title

percutanous, transpedicular vertebral body stenting trough titanium implant in case of vertebral body fracture and the clinical outcome over a time period of 2 years

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

measurement of the funtional benefit and the rate of complication in a group of patients undergoing an operation. The surgical procedure include the percuanous, wire- guided approach to the vertebral body trough a bony channel. This after, a titanium stent is placed within the fractured vertebral body and is dilatated. The resulting less- spongious space can be filled with cement.

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Brief Summary in Scientific Language

prospective study towards the functional outcome of the intervertebral body stenting for vertebral body fracture over a time period of 2 years

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Organizational Data

  •   DRKS00004960
  •   2013/05/28
  •   [---]*
  •   yes
  •   Approved
  •   12-181A, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   S32 -  Fracture of lumbar spine and pelvis
  •   C79.5 -  Secondary malignant neoplasm of bone and bone marrow
  •   M80 -  Osteoporosis with pathological fracture
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Interventions/Observational Groups

  •   A percutanour, transpedicular approach is used to gain access to the fracured vertebral body. Using guidance- wires, a titanium stent is placed within the ertebral body and is dilatated. The cavity can be filled with cement. the surgery is performed in general anesthesia.

    The patients receive pre-/ postoperative a questionnaire including questions towards the functional status (oswestry disability index), pain in different body- regions and patients descriptives (e.g. working status, pain medication intake etc.).
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Characteristics

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

functional outcome, measures through a patient- based questionnaire, providing the oswestry disability index of the patient, filled out preoperativ and postoperativ after 2 days/ 14 days/ 2 month/ 6 month/ 1 year and 2 years.

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Secondary Outcome

complication rate perioperative, assessed through the data provided by the surgeon and the doctor until the dismissal of the patient from the hospital

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/01/01
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

vertebral body fracture without progredient neurologic deficits

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Exclusion Criteria

local infect at the operation site

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Addresses

  • start of 1:1-Block address primary-sponsor
    • UKSH, Sektion für Orthopädie
    • Mr.  Bastian  Himpe 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • UKSH, Sektion für Orthopädie
    • Mr.  Bastian  Himpe 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • UKSH, Sektion für Orthopädie
    • Mr.  Bastian  Himpe 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • UKSH, Sektion für Orthopädie
    • Mr.  Bastian  Himpe 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.