VuisT: Volume CT of the Wrist and Carpus After Trauma
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients with prospectively documented treatment changes after CT [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.
Secondary Outcome Measures
- Diagnostic performance of CT and conventional radiography (CR) for fracture pattern [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.
Other Outcome Measures
- Radiological feasibility [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 [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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients (18 years and older) who are referred to our hospital for conventional radiography of the wrist and carpus
-
Recent trauma mechanism (within 3 days before presentation)
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Clinical suspicion of fractures of the wrist and carpus. The carpus includes all carpal bones, but does not include the metacarpal bones.
Exclusion Criteria:
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Patients who were not evaluated by a clinician before imaging was performed.
-
Open fractures
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No informed consent or no prospective data collection could be obtained. Informed consent cannot be obtained in case patients do not speak or understand Dutch.
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Patients who cannot be positioned in upright position, immobilized on a spine board or transferred to the intensive care unit and cannot undergo upright CT
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Radboud University Nijmegen Medical Centre | Nijmegen | Netherlands | 6500 HB |
Sponsors and Collaborators
- Radboud University Medical Center
Investigators
- Principal Investigator: Mathias Prokop, MD, PhD, Radboud University Medical Center
- Study Chair: Monique Brink, MD, PhD, Radboud University Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL43482.091.13