Shoulder Arthroplasty
Conditions
Brief summary
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
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.
Interventions
RADIATIONA low-dose CT scan of the shoulder
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).
Sponsors
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Low Dose CT Images of Sufficient Pre-operative Planning Quality | Day 1 | Low Dose CT Images will be compared to a standard dose to assess image quality. |
| Glenoid Version | Day 1 | Representative CT images will be used to measure the version of each shoulder for preoperative purposes. |
| Glenoid Inclination | Day 1 | Representative CT images will be used to measure the inclination of each shoulder for preoperative purposes. |
| Humeral Head Subluxation | Day 1 | Representative CT images will be used to measure the humeral head subluxation of each shoulder for preoperative purposes. |
| Implant Selection | Day 1 | Representative CT images will be used to determine the implant selection for preoperative purposes. |
Countries
United States
Outcome results
None listed