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Completed

NCT Number: NCT01857570

Volume CT of the Wrist and Carpus After Trauma

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.

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Key information

Conditions

Wounds and Injuries Arm Injuries Forearm Injuries Fractures, Bone Radius Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Volume Computed Tomography of the wrist and carpus

Radiation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Acronym: VuisT

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
May 20, 2013
Registry last updated
May 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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