Volume CT of the Wrist and Carpus After Trauma

NCT01857570 | Completed

• 1 other identifier: NL43482.091.13
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds and Injuries; Wrist Injuries

Keywords

Radius fracture; Scaphoid fracture; Tomography, x-ray computed

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Diagnostic performance of CT and conventional radiography (CR) for fracture pattern

  within the same visit (one day)

Other Outcomes (2)

• Radiological feasibility

  Within an average of three days after CT

• Patient outcome: Pain and disability

  one year

Study Arms (1)

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

Interventions

Volume Computed Tomography of the wrist and carpus RADIATION

Adult, clinical suspicion fractures wrist or carpus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Wounds and Injuries; Wrist Injuries; Radius Fractures

Condition Hierarchy (Ancestors)

Arm Injuries; Forearm Injuries; Fractures, Bone

Study Officials

• Mathias Prokop, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Monique Brink, MD, PhD

  Radboud University Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: May 20, 2013
• Study Start: June 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2015
• Last Updated: May 14, 2015

Record last verified: 2015-05

Locations

NL (1)