NCT05350319

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Shoulder Arthroplasty

Interventions

Type	Name	Description
RADIATION	A 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).

Timeline

• Start date: 2022-11-21
• Primary completion: 2023-07-19
• Completion: 2023-09-19
• First posted: 2022-04-28
• Last updated: 2023-12-14

Locations

1 site across 1 country: United States