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NCT Number: NCT05350319

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

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.

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Key information

Conditions

Shoulder Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

A low-dose CT scan of the shoulder

Radiation

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).

Primary outcomes

  1. Low Dose CT Images of Sufficient Pre-operative Planning Quality

    Time frame: Day 1

    Low Dose CT Images will be compared to a standard dose to assess image quality.

  2. Glenoid Version

    Time frame: Day 1

    Representative CT images will be used to measure the version of each shoulder for preoperative purposes.

  3. Glenoid Inclination

    Time frame: Day 1

    Representative CT images will be used to measure the inclination of each shoulder for preoperative purposes.

  4. Humeral Head Subluxation

    Time frame: Day 1

    Representative CT images will be used to measure the humeral head subluxation of each shoulder for preoperative purposes.

  5. Implant Selection

    Time frame: Day 1

    Representative CT images will be used to determine the implant selection for preoperative purposes.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 28, 2022
Registry last updated
Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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