Volume CT of the Wrist and Carpus After Trauma (VuisT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01857570
First received: May 10, 2013
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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 Intervention
Wounds and Injuries
Wrist Injuries
Radiation: Volume Computed Tomography of the wrist and carpus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Volume CT of the Wrist and Carpus After Trauma: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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


Enrollment: 100
Study Start Date: June 2013
Estimated Study Completion Date: May 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All consecutive patients who enter the emergency or radiology department of the Radboud University Nijmegen Medical Centre for suspicion on fractures of the wrist and study are eligible for this study.

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)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01857570

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Mathias Prokop, MD, PhD Radboud University
Study Chair: Monique Brink, MD, PhD Radboud University
  More Information

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01857570     History of Changes
Other Study ID Numbers: NL43482.091.13
Study First Received: May 10, 2013
Last Updated: May 5, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Radboud University:
Radius fracture
Scaphoid fracture
Tomography, x-ray computed

Additional relevant MeSH terms:
Wounds and Injuries
Wrist Injuries
Arm Injuries

ClinicalTrials.gov processed this record on August 28, 2014