Prospective Low Dose CT for Total Shoulder Arthroplasty/Reverse Shoulder Arthroplasty

Study Overview
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Brief Summary
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This study is a prospective, departmental funded study examining the outcomes of simulated Low Dose CT scans compared to Conventional Dose CT scans in patients who present to Duke University for total shoulder arthroplasty or reverse shoulder arthroplasty.

Detailed Description
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The purpose of this study is to compare the use of a conventional dose computed tomography scan (C-CT) to a simulated low dose computed tomography scan (L-CT) for preoperative planning in patients who are anticipated to undergo a total shoulder arthroplasty (TSA) or reverse shoulder arthroplasty (RSA) with the goal to reduce the radiation exposure to future patients undergoing preoperative planning. L-CT scans for analysis will be obtained prospectively as derived data from a C-CT scan performed on a dual source CT scanner. Briefly, a C-CT scan will be conducted, with scan images representing a reconstruction of simultaneous scans at two sensors. L-CT images will be derived from single source data (ie the scan data gathered by one of the emitters rather than a reconstruction from both). For additional validation, prospectively collected scans will be compared to retrospectively gathered scans of patients of similar demographics (age, sex, BMI) and degenerative changes who underwent a C-CT scan for an anticipated shoulder arthroplasty in the past. The reviewers will investigate the following outcome measures including 1) Are L-CT images of sufficient quality to be used for preoperative planning 2) Can accurate measurements including glenoid inclination, version, implant selection and humeral head subluxation be made on L-CT images 3) Do proposed treatment plans change with the use of L-CT relative to the chosen plans base on C-CT images. The investigators hypothesize L-CT images will be of sufficient image quality for diagnostic purposes, with similar measurements, and treatment outcomes.

Official Title
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Prospective Comparison of Simulated Low Dose Computed Tomography to Conventional Dose Computed Tomography for the Evaluation of Glenoid Anatomy in Shoulder Arthroplasty

Conditions
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Shoulder Arthroplasty

Intervention / Treatment
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* Radiation: A low-dose CT scan of the shoulder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects are planned to undergo total or reverse shoulder arthroplasty Subject must be 18 years or older Subjects who have capacity to give informed consent Exclusion Criteria: Subjects who are pregnant Subjects under the age of 18 Subjects who do not have the capacity to give informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients planning for total or reverse shoulder arthroplasty<br>Adult patients who are planning to undergo a total or reverse shoulder arthroplasty | Radiation: A low-dose CT scan of the shoulder<br>* Briefly, a conventional CT scan will be conducted, with scan images representing a reconstruction of simultaneous scans at two sensors. L-CT images will be derived from single source data (ie the scan data gathered by one of the emitters rather than a reconstruction from both).<br>|
| Retrospective group of patients who have already undergone preoperative planning<br>Retrospective cohort of patients who have undergone preoperative planning with a conventional shoulder CT for total or reverse shoulder arthroplasty. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low Dose CT Images of Sufficient Pre-operative Planning Quality | Low Dose CT Images will be compared to a standard dose to assess image quality. | Day 1 | 
| Glenoid Version | Representative CT images will be used to measure the version of each shoulder for preoperative purposes. | Day 1 | 
| Glenoid Inclination | Representative CT images will be used to measure the inclination of each shoulder for preoperative purposes. | Day 1 | 
| Humeral Head Subluxation | Representative CT images will be used to measure the humeral head subluxation of each shoulder for preoperative purposes. | Day 1 | 
| Implant Selection | Representative CT images will be used to determine the implant selection for preoperative purposes. | Day 1 |