An observational study in Radius Fractures, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-10.
Sponsored by Duke University · Observational
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.
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.
62 studies on the registry are indexed under Radius Fractures; 6 are open to participants now.
This study's enrollment of 17 is below the median of 50 across 13 observational studies indexed under Radius Fractures.
Browse Radius Fractures studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients who meet above eligibility criteria who present to the Duke University Medical Center for distal radius fracture evaluation.
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Exclusion Criteria:
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.
Low Dose CT Images of Sufficient Diagnostic Quality
Low Dose CT Images will be compared to a standard dose to assess image quality.
Time frame: 12 months.
Step Displacement
Representative CT images will be used to measure the step displacement of each fracture.
Time frame: 12 months
Gap Displacement
Representative CT images will be used to measure the gap displacement of each fracture.
Time frame: 12 months
Plan to share: No — 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.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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