Volume CT of the Wrist and Carpus After Trauma

Completed

• Conditions: Wounds and Injuries; Wrist Injuries
• Interventions: Radiation: Volume Computed Tomography of the wrist and carpus

• Registration Number: NCT01857570
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-10
• Study First Submitted QC: 2013-05-15
• Study First Posted: 2013-05-20
• Study Start: 2013-06
• Primary Completion: 2014-04
• Status Verified: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-13
• Last Update Posted: 2015-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult, clinical suspicion fractures wrist or carpus	Volume Computed Tomography of the wrist and carpus	- Patients (18 years and older) who are referred to our hospital for conventional radiography of the wrist and carpus

Primary Outcome Measures

Name	Time	Method
Proportion of patients with prospectively documented treatment changes after CT	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 Outcome Measures

Name	Time	Method
Diagnostic performance of CT and conventional radiography (CR) for fracture pattern	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.

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands