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Completed

NCT Number: NCT03423043

Low Dose CT Distal Radius Fractures

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Dose CT Scan of the Wrist

Radiation

A low dose CT scan will be obtained in patients with a distal radius fracture of the wrist.

Primary outcomes

  1. 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

  1. Step Displacement

    Time frame: 12 months

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

  2. Gap Displacement

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 6, 2018
Registry last updated
Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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