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

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

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.

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries; Wrist Injuries
• Intervention / Treatment: Radiation: Volume Computed Tomography of the wrist and carpus

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6500 HB
    • Radboud University Nijmegen Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with prospectively documented treatment changes after CT	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.	within same visit (i.e. in one day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance of CT and conventional radiography (CR) for fracture pattern	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.	within the same visit (one day)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological feasibility	Image quality (5-point scale), artifacts (5-point scale) noise (standard deviation Hounsfield Units), radiation dose, and presence of technical problems	Within an average of three days after CT
Patient outcome: Pain and disability	Pain and disability according to the "Patient rated wrist and hand evaluation (PRWHE) score" 6 weeks, 6 months, and 12 months after trauma	one year

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: May 10, 2013
• First Submitted That Met QC Criteria: May 15, 2013
• First Posted (Estimate): May 20, 2013

Study Record Updates

• Last Update Posted (Estimate): May 14, 2015
• Last Update Submitted That Met QC Criteria: May 13, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Radius fracture; Scaphoid fracture; Tomography, x-ray computed
• Additional Relevant MeSH Terms: Arm Injuries; Wounds and Injuries; Wrist Injuries
• Other Study ID Numbers: NL43482.091.13