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

NCT05350319 | Completed

• 1 other identifier: Pro00108187
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Arthroplasty

Outcome Measures

Primary Outcomes (5)

• Low Dose CT Images of Sufficient Pre-operative Planning Quality

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

  Day 1

• Glenoid Version

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

  Day 1

• Glenoid Inclination

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

  Day 1

• Humeral Head Subluxation

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

  Day 1

• Implant Selection

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

  Day 1

Study Arms (2)

Patients planning for total or reverse shoulder arthroplasty

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

Radiation: A low-dose CT scan of the shoulder

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.

Interventions

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).

Patients planning for total or reverse shoulder arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All individuals who are scheduled for a shoulder CT for the purpose of preoperative planning for a total shoulder arthroplasty are eligible to be included in this study assuming they meet the eligibility requirements as listed above.

You may qualify if:

• 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

You may not qualify if:

• Subjects who are pregnant
• Subjects under the age of 18
• Subjects who do not have the capacity to give informed consent.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27701, United States

Location

Related Publications (6)

• 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.

  PMID: 19651945 BACKGROUND

• 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.

  PMID: 25878309 BACKGROUND

• 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.

  PMID: 22805680 BACKGROUND

• 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.

  PMID: 29298261 BACKGROUND

• 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.

  PMID: 25905942 BACKGROUND

• 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.

  PMID: 22036540 BACKGROUND

Study Officials

• Christopher Klifto, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 28, 2022
• Study Start: November 21, 2022
• Primary Completion: July 19, 2023
• Study Completion: September 19, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)