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Low Dose CT Distal Radius Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03423043
Recruitment Status : Completed
First Posted : February 6, 2018
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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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
Radius Fractures 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
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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 : July 15, 2018
Actual Primary Completion Date : February 25, 2020
Actual Study Completion Date : August 25, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who meet above eligibility criteria who present to the Duke University Medical Center for distal radius fracture evaluation.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423043


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
More Information
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Publications:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03423043    
Other Study ID Numbers: Pro00089089
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Data is not planned to be shared outside of the collaborators of this project within the Duke University Medical Center. The data will only be reviewed by the study personnel listed on the Institutional Review Board (IRB), and not intended to be shared with an external institution or industry.

However, when submitting data for manuscripts and publication purposes, all data will be deidentified of any public health information. All Protected Health Information (PHI) will be kept in a locked cabinet in the PI's office at Duke University and/or in a protected/encrypted folder in a file separate from the study information. Data will be analyzed by study team members using a computer that is password protected, and stored securely in encrypted Duke servers. Study files will be backed up onto Dr. Klifto's folder in a secure server provided to faculty in the Department of Orthopaedic Surgery. The subjects will not be identified in any reports or publications from this study.

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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:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries