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

Duke University

Status: Completed

Conditions: Shoulder Arthroplasty

Treatments: Radiation: A low-dose CT scan of the shoulder

Study type: Observational

Funder types: Other

Identifiers

NCT05350319

Pro00108187

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

20 participants in 2 patient groups

Patients planning for total or reverse shoulder arthroplasty

Description:

Adult patients who are planning to undergo a total or reverse shoulder arthroplasty

Treatment:

Radiation: A low-dose CT scan of the shoulder

Retrospective group of patients who have already undergone preoperative planning

Description:

Retrospective cohort of patients who have undergone preoperative planning with a conventional shoulder CT for total or reverse shoulder arthroplasty.