Low Dose CT Distal Radius Fractures

Completed

• Conditions: Radius Fractures
• Interventions: Radiation: Low Dose CT Scan of the Wrist

• Registration Number: NCT03423043
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2018-01-31
• Study First Submitted QC: 2018-01-31
• Study First Posted: 2018-02-06
• Study Start: 2018-07-15
• Primary Completion: 2020-02-25
• Status Verified: 2020-06
• Study Completion: 2020-08-25
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Distal Radius Fracture Patients	Low Dose CT Scan of the Wrist	Adult patients who have sustained a Distal Radius Fracture.

Primary Outcome Measures

Name	Time	Method
Low Dose CT Images of Sufficient Diagnostic Quality	12 months.	Low Dose CT Images will be compared to a standard dose to assess image quality.

Secondary Outcome Measures

Name	Time	Method
Gap Displacement	12 months	Representative CT images will be used to measure the gap displacement of each fracture.
Step Displacement	12 months	Representative CT images will be used to measure the step displacement of each fracture.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States