Low Dose CT Distal Radius Fractures

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT03423043
Collaborator
(none)
17
1
25.4
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Low Dose CT Scan of the Wrist

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 Design

Study Type:
Observational
Actual Enrollment :
17 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of Low Dose Computed Tomography to Conventional Dose Computed Tomography in the Evaluation of Distal Radius Fractures
Actual Study Start Date :
Jul 15, 2018
Actual Primary Completion Date :
Feb 25, 2020
Actual Study Completion Date :
Aug 25, 2020

Arms and Interventions

Arm Intervention/Treatment
Distal Radius Fracture Patients

Adult patients who have sustained a Distal Radius Fracture.

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Step Displacement [12 months]

    Representative CT images will be used to measure the step displacement of each fracture.

  2. Gap Displacement [12 months]

    Representative CT images will be used to measure the gap displacement of each fracture.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Medical Center Durham North Carolina United States 27705

Sponsors and Collaborators

  • Duke University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT03423043
Other Study ID Numbers:
  • Pro00089089
First Posted:
Feb 6, 2018
Last Update Posted:
Sep 10, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 10, 2020