Trial document




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  DRKS00023589

Trial Description

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Title

Incidence and Estimated Number of Unreported Cases of Wrist and Carpal Injuries on Whole-Body Computed Tomographies

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

During a historical data analysis this study aims to determine the frequency of bony injuries of the wrist and hand on wholebody computertomographies (WBCT). During 01/2020-08/2020 all patients will be screened for a trauma which resulted in a WBCT. Minors will be excluded from this study as well as cases in which the hands are not fully depicted on the scans. A total of 500 patients will be included in this study and each hand will be reexamined by radiologists. Incidence and an estimated number of unreported cases will be analyzed and the accuracy of WBCT in detecting injuries of the wrist and hand will be calculated.

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Brief Summary in Scientific Language

This retrospective study aims to determine the incidence of bony injuries of the wrist and hand on wholebody computertomographies (WBCT). During 01/2020-08/2020 all patients will be screened for traumas which resulted in a WBCT. Minors will be excluded from this study as well as cases in which the hands are not fully depicted on the scans. A total of 500 patients will be included in this study and each hand will be reexamined by radiologists. Incidence and an estimated number of unreported cases will be analyzed and the diagnostic accuracy of WBCT in detecting injuries of the wrist and hand will be calculated.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

study plan, anonymized data collection, statistical analysis

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Organizational Data

  •   DRKS00023589
  •   2020/11/17
  •   [---]*
  •   yes
  •   Approved
  •   Eth-45/20, Ethik-Kommission der Ärztekammer Berlin
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Secondary IDs

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

  •   S62 -  Fracture at wrist and hand level
  •   S63 -  Dislocation, sprain and strain of joints and ligaments at wrist and hand level
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Interventions/Observational Groups

  •   Single-arm, uncenter, retrospective study. 500 consecutive patients who received a whole body CT due to an accident during the study period.
    Both hands of each patient will be reconstructed and Images will be revised by radiologists to discover any bony injuries. Cases with bony injuries will be examined further using the patient records to search for the mechanism of injury, the clinical presentation of the patient on the day of admission, and further therapies.
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Characteristics

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

Evaluation whether a bony wrist or hand injury was present, the incidence of these injuries in the collective and the amount of unreported cases.

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Secondary Outcome

Diagnostic accuracy of WBCTs for detecting bony injuries of hand wrist.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2020/12/01
  •   500
  •   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

whole body CT due to an accident

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Exclusion Criteria

<18 years, hands not fully depicted

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Addresses

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    • BG Unfallkrankenhaus BerlinRadiologie/Neuroradiologie
    • Mr.  Prof. Dr.  Sven  Mutze 
    • Warener Straße 7
    • 10119  Berlin
    • Germany
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    • BG Unfallkrankenhaus Berlin, Institut für Radiologie und Neuroradiologie
    • Ms.  Dr.  Leonie  Gölz 
    • Warener Str. 7
    • 12683  Berlin
    • Germany
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    • BG Unfallkrankenhaus Berlin, Institut für Radiologie und Neuroradiologie
    • Ms.  Dr.  Leonie  Gölz 
    • Warener Str. 7
    • 12683  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • BG Unfallkrankenhaus BerlinRadiologie/Neuroradiologie
    • Mr.  Prof. Dr.  Sven  Mutze 
    • Warener Straße 7
    • 10119  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   [---]*
  •   [---]*
  •   2021/05/02
  •   506
  •   506
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Trial Publications, Results and other Documents

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