Trial document




This trial has been registered retrospectively.
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  DRKS00005052

Trial Description

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Title

Percutaneous Stabilization of thoracolumbal spine fractures

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

We investigate in our study if percutaneous stabilization of spine fractures improves spine function. Furthermore, we want to check if there is an influence on stability and loss of correction.
Patient satisfaction, sport activity and time until return to work are evaluated as well.

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Brief Summary in Scientific Language

Percutaneous Stabilization of thoracolumbal spine fractures

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Organizational Data

  •   DRKS00005052
  •   2013/09/23
  •   [---]*
  •   yes
  •   Approved
  •   91/2011, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

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

  •   spine fracture
  •   S32 -  Fracture of lumbar spine and pelvis
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Interventions/Observational Groups

  •   Minimal-invasive stabilized patients are followed up 9-12 months postoperatively. Clinical evaluation was performed by subjective evaluation of the final results by patients themselves
  •   Control Group (historical) from existing data
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Historical
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Spine function (VAS Spine Score) after implant removal (9-12 months postoperative)

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Secondary Outcome

radiographic evaluation of the segmental kyphosis and the wedging deformity of the involved vertebral body performed during clinical follow up

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2012/05/15
  •   125
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

a. Acute (< 3 weeks) traumatic injuries from T1 to L5 with percutaneous internal fixation

b.written consent

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Exclusion Criteria

a. concomitant injuries, which influence spine function
b. pediatric fractures c. kyphoplasty d.no written consent

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Addresses

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    • Universitätsklinikum Düsseldorf, Klinik für Unfall- und Handchirurgie
    • Mr.  Dr. med.  Tobias  Gensior 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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    • Universitätsklinikum Düsseldorf, Klinik für Unfall- und Handchirurgie
    • Mr.  Dr. med.  Tobias  Gensior 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
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    • Universitätsklinikum Düsseldorf, Klinik für Unfall- und Handchirurgie
    • Mr.  Dr. med.  Tobias  Gensior 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Düsseldorf, Klinik für Unfall- und Handchirurgie
    • Mr.  Dr. med.  Tobias  Gensior 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • 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.