Volume CT of the Wrist and Carpus After Trauma (VuisT)
The purpose of this study is to evaluate whether standard volume computed tomography (CT) has impact on treatment in patients with suspicion of fractures of the wrist and carpus.
Wounds and Injuries
Radiation: Volume Computed Tomography of the wrist and carpus
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Volume CT of the Wrist and Carpus After Trauma: A Pilot Study|
- Proportion of patients with prospectively documented treatment changes after CT [ Time Frame: within same visit (i.e. in one day) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Pain and disability according to the "Patient rated wrist and hand evaluation (PRWHE) score" 6 weeks, 6 months, and 12 months after trauma
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||May 2015|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: 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|