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Volume CT of the Wrist and Carpus After Trauma

Volume CT of the Wrist and Carpus After Trauma: A Pilot Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01857570
Acronym
VuisT
Enrollment
100
Registered
2013-05-20
Start date
2013-06-30
Completion date
2015-05-31
Last updated
2015-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wounds and Injuries, Wrist Injuries

Keywords

Radius fracture, Scaphoid fracture, Tomography, x-ray computed

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.

Interventions

RADIATIONVolume Computed Tomography of the wrist and carpus

Sponsors

Radboud University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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) * Clinical suspicion of fractures of the wrist and carpus. The carpus includes all carpal bones, but does not include the metacarpal bones.

Exclusion criteria

* Patients who were not evaluated by a clinician before imaging was performed. * Open fractures * 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. * 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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients with prospectively documented treatment changes after CTwithin 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

MeasureTime frameDescription
Diagnostic performance of CT and conventional radiography (CR) for fracture patternwithin 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

MeasureTime frameDescription
Radiological feasibilityWithin an average of three days after CTImage quality (5-point scale), artifacts (5-point scale) noise (standard deviation Hounsfield Units), radiation dose, and presence of technical problems
Patient outcome: Pain and disabilityone yearPain and disability according to the Patient rated wrist and hand evaluation (PRWHE) score 6 weeks, 6 months, and 12 months after trauma

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026