Volume CT of the Wrist and Carpus After Trauma (VuisT)
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|ClinicalTrials.gov Identifier: NCT01857570|
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : May 14, 2015
|Condition or disease||Intervention/treatment|
|Wounds and Injuries Wrist Injuries||Radiation: Volume Computed Tomography of the wrist and carpus|
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Volume CT of the Wrist and Carpus After Trauma: A Pilot Study|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||May 2015|
Adult, clinical suspicion fractures wrist or carpus
- Patients (18 years and older) who are referred to our hospital for conventional radiography of the wrist and carpus
|Radiation: Volume Computed Tomography of the wrist and carpus|
- Proportion of patients with prospectively documented treatment changes after CT [ Time Frame: within same visit (i.e. in one day) ]
This endpoint is defined as presence of difference in predefined treatment regimens before and after CT. These regimens include:
-Conservative treatment on the emergency ward (functional, immobilization with bandage, cast, or closed reduction and cast), closed operative treatment (reduction and cast on operation room, percutaneous pinning, or external fixation), open surgical treatment (dorsal, radial, or palmar exposure with reduction and internal fixation).
Additional regimens include: Second opinion from a colleague or consulting a different specialism.
- Diagnostic performance of CT and conventional radiography (CR) for fracture pattern [ Time Frame: within the same visit (one day) ]Fracture patterns are classified according to presence and type of fractured bones, presence of intra-articular components of distal radius fractures (including sigmoid notch involvement), presence of (fracture) dislocation or avulsion fractures of carpal bones. Standard of reference is presence of injuries at imaging, at surgery, and disability complains at 1-year follow up. In case of discrepancy, consensus will be reached at the end of the study by a panel of trauma surgeons and radiologists.
- Radiological feasibility [ Time Frame: Within an average of three days after CT ]Image quality (5-point scale), artifacts (5-point scale) noise (standard deviation Hounsfield Units), radiation dose, and presence of technical problems
- Patient outcome: Pain and disability [ Time Frame: one year ]Pain and disability according to the "Patient rated wrist and hand evaluation (PRWHE) score" 6 weeks, 6 months, and 12 months after trauma
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857570
|Radboud University Nijmegen Medical Centre|
|Nijmegen, Netherlands, 6500 HB|
|Principal Investigator:||Mathias Prokop, MD, PhD||Radboud University|
|Study Chair:||Monique Brink, MD, PhD||Radboud University|