NCT03423043

Low Dose CT Distal Radius Fractures

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 17 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radius Fractures

Interventions

Type	Name	Description
RADIATION	Low Dose CT Scan of the Wrist	A low dose CT scan will be obtained in patients with a distal radius fracture of the wrist.

Timeline

• Start date: 2018-07-15
• Primary completion: 2020-02-25
• Completion: 2020-08-25
• First posted: 2018-02-06
• Last updated: 2020-09-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study