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

NCT ID: NCT05350319

Last Updated: 2023-12-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-21
• Study Completion Date: 2023-09-19

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.

Conditions

Shoulder Arthroplasty

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients planning for total or reverse shoulder arthroplasty

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

A low-dose CT scan of the shoulder

Intervention Type: 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).

Retrospective group of patients who have already undergone preoperative planning

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

No interventions assigned to this group

Interventions

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).

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Klifto, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

Biswas D, Bible JE, Bohan M, Simpson AK, Whang PG, Grauer JN. Radiation exposure from musculoskeletal computerized tomographic scans. J Bone Joint Surg Am. 2009 Aug;91(8):1882-9. doi: 10.2106/JBJS.H.01199.

Reference Type: BACKGROUND

PMID: 19651945 (View on PubMed)

Iannotti JP, Weiner S, Rodriguez E, Subhas N, Patterson TE, Jun BJ, Ricchetti ET. Three-dimensional imaging and templating improve glenoid implant positioning. J Bone Joint Surg Am. 2015 Apr 15;97(8):651-8. doi: 10.2106/JBJS.N.00493.

Reference Type: BACKGROUND

PMID: 25878309 (View on PubMed)

Yu L, Shiung M, Jondal D, McCollough CH. Development and validation of a practical lower-dose-simulation tool for optimizing computed tomography scan protocols. J Comput Assist Tomogr. 2012 Jul-Aug;36(4):477-87. doi: 10.1097/RCT.0b013e318258e891.

Reference Type: BACKGROUND

PMID: 22805680 (View on PubMed)

Boileau P, Cheval D, Gauci MO, Holzer N, Chaoui J, Walch G. Automated Three-Dimensional Measurement of Glenoid Version and Inclination in Arthritic Shoulders. J Bone Joint Surg Am. 2018 Jan 3;100(1):57-65. doi: 10.2106/JBJS.16.01122.

Reference Type: BACKGROUND

PMID: 29298261 (View on PubMed)

Tipnis SV, Spampinato MV, Hungerford J, Huda W. Thyroid Doses and Risks to Adult Patients Undergoing Neck CT Examinations. AJR Am J Roentgenol. 2015 May;204(5):1064-8. doi: 10.2214/AJR.14.13102.

Reference Type: BACKGROUND

PMID: 25905942 (View on PubMed)

Maurer A, Fucentese SF, Pfirrmann CW, Wirth SH, Djahangiri A, Jost B, Gerber C. Assessment of glenoid inclination on routine clinical radiographs and computed tomography examinations of the shoulder. J Shoulder Elbow Surg. 2012 Aug;21(8):1096-103. doi: 10.1016/j.jse.2011.07.010. Epub 2011 Oct 29.

Reference Type: BACKGROUND

PMID: 22036540 (View on PubMed)

Other Identifiers

Pro00108187

Identifier Type: -

Identifier Source: org_study_id