Clinical trial NCT03423043: Low Dose CT Distal Radius Fractures
Official title: Comparison of Low Dose Computed Tomography to Conventional Dose Computed Tomography in the Evaluation of Distal Radius Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radius Fractures
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Low Dose CT Images of Sufficient Diagnostic Quality
timeFrame: 12 months.
Secondary outcomes:
measure: Step Displacement
timeFrame: 12 months
measure: Gap Displacement
timeFrame: 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
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