Volume CT of the Wrist and Carpus After Trauma

Wounds and Injuries Clinical Trial

— VuisT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857570
• Other study ID #: NL43482.091.13
• Status: Completed
• Phase: N/A
• First received: May 10, 2013
• Last updated: May 13, 2015
• Start date: June 2013
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Wounds and Injuries
• Wrist Injuries

Intervention

Radiation:
• Volume Computed Tomography of the wrist and carpus

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Primary	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)	No
Secondary	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)	No