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Clinical Trials/NCT03423043
NCT03423043
Completed
Not Applicable

Comparison of Low Dose Computed Tomography to Conventional Dose Computed Tomography in the Evaluation of Distal Radius Fractures

Duke University1 site in 1 country17 target enrollmentJuly 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Radius Fractures
Sponsor
Duke University
Enrollment
17
Locations
1
Primary Endpoint
Low Dose CT Images of Sufficient Diagnostic Quality
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This study is a prospective, departmental funded study examining the outcomes of Low Dose CT scans compared to Conventional Dose CT scans in patients who present to Duke University with a Distal Radius Fracture.

Detailed Description

The purpose of this study is to compare the use of a conventional dose computed tomography scan (C-CT) to a low dose computed tomography scan (L-CT) in the assessment of articular displacement, and development of a treatment plan for intraarticular distal radius fractures in an effort to reduce the radiation exposure to future patients with this injury pattern. Reviewers will be tasked with reporting data aimed at investigating 3 primary outcome measures: 1) Are L-CT images of sufficient quality to be used for diagnostic purposes, 2) Can accurate measurements of step and gap displacement be made on L-CT images, 3) Do proposed treatment plans change with the use of L-CT relative to those chosen based on C-CT images We hypothesize that reviewers will find L-CT images of sufficient image quality for diagnostic purposes, measurements of step and gap displacement will not be significantly different between L-CT and C-CT, and no significant differences in treatment options will be chosen based on the use of L-CT rather than C-CT for the same fracture. The secondary aim will be to evaluate the interobserver and intraobserver reliability of L-CT in evaluating intraarticular fractures of the distal radius.

Registry
clinicaltrials.gov
Start Date
July 15, 2018
End Date
August 25, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Subjects must be age 18 years or older.
  • Subject must have sustained an intraarticular distal radius fracture which undergo closed reduction and application of a below-elbow splint.
  • Subjects whos injury occurred less than 2 weeks prior to the time of enrollment.

Exclusion Criteria

  • Subject is under the age of 18 years.
  • Subject is unable to speak English for completion of consent process.
  • Subject sustained pathologic fracture.
  • Subject sustained open fracture.
  • Subject is a pregnant woman.

Outcomes

Primary Outcomes

Low Dose CT Images of Sufficient Diagnostic Quality

Time Frame: 12 months.

Low Dose CT Images will be compared to a standard dose to assess image quality.

Secondary Outcomes

  • Gap Displacement(12 months)
  • Step Displacement(12 months)

Study Sites (1)

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