Trial document




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  DRKS00014298

Trial Description

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Title

Use of dual-energy computed tomography in early detection of pelvic injury

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Trial Acronym

DETECT-PI

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In this study we evaluate the capability of dual-energy computed tomography to detect bone marrow edema as a signal of pelvic injury. Patients ≥ 18 years of age with clinical suspected pelvic injury are enrolled. Additionally, a focus is on patients without a pelvic fracture in regular CT, but with highly suspicious injury mechanism, medical precondition (e.g. osteoporosis) and clinical evaluation indicative of a pelvic injury. Furthermore we compare the edema in dual-energy CT with the established diagnostic tool of pelvic MRI.

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Brief Summary in Scientific Language

We enroll patients ≥ 18 years of age in this study when we clinically suspect a pelvic injury. With the use of dual-energy CT we will be able to detect bone marrow edema at the site of pelvic fractures and independent of them. The prevalence of undetected pelvic injury in regular CT scans will be relevant and bone marrow edema in dual-energy CT will correlate with the MRI.

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Organizational Data

  •   DRKS00014298
  •   2018/04/04
  •   [---]*
  •   yes
  •   Approved
  •   151/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   S32.1 -  Fracture of sacrum
  •   S32.2 -  Fracture of coccyx
  •   S32.3 -  Fracture of ilium
  •   S32.4 -  Fracture of acetabulum
  •   S32.5 -  Fracture of pubis
  •   S32.81 -  [generalization S32.8: Fracture of other and unspecified parts of lumbar spine and pelvis]
  •   S32.89 -  [generalization S32.8: Fracture of other and unspecified parts of lumbar spine and pelvis]
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Interventions/Observational Groups

  •   Patients with suspected pelvic injury receive a pelvic dual-energy-CT (computed tomography) and a pelvic MRI (Magnetic Resonance Imaging).
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Characteristics

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

Sensitivity and Specificity of dual-energy computed tomography (CT) in diagnostic of bone marrow edema in pelvic injury.

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Secondary Outcome

Prevalence of undetected pelvic injuries

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2018/04/09
  •   50
  •   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

Clinically highly suspected pelvic injury

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Exclusion Criteria

Pregnancy. Contraindication for MRI. Informed consent for study participation not given or revoked.

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Klinik für Orthopädie und Unfallchirurgie, Universitätsklinikum Freiburg
    • Mr.  Dr.  Jörg  Bayer 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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    • Klinik für Orthopädie und Unfallchirurgie, Universitätsklinikum Freiburg
    • Mr.  Dr.  Jörg  Bayer 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

  •   EK-Freiburg 151/16
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* This entry means the parameter is not applicable or has not been set.