Shoulder ArthroplastyNCT05350319
Prospective Low Dose CT for Total Shoulder Arthroplasty/Reverse Shoulder Arthroplasty
An observational study of Shoulder Arthroplasty, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shoulder Arthroplasty
- What is being tested?
- A low-dose CT scan of the shoulder
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2022to 19 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Subjects who are pregnant
- Subjects under the age of 18
- Subjects who do not have the capacity to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27701
About this study
Official title: Prospective Comparison of Simulated Low Dose Computed Tomography to Conventional Dose Computed Tomography for the Evaluation of Glenoid Anatomy in 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.
Read the 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
- Being tested
- A low-dose CT scan of the shoulder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A low-dose CT scan of the shoulderRadiation
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).
| Study group | Role | What they receive |
|---|---|---|
| Patients planning for total or reverse shoulder arthroplasty | Adult patients who are planning to undergo a total or reverse shoulder arthroplasty Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Glenoid Version
Representative CT images will be used to measure the version of each shoulder for preoperative purposes.
Measured: Day 1
Glenoid Inclination
Representative CT images will be used to measure the inclination of each shoulder for preoperative purposes.
Measured: Day 1
Humeral Head Subluxation
Representative CT images will be used to measure the humeral head subluxation of each shoulder for preoperative purposes.
Measured: Day 1
Implant Selection
Representative CT images will be used to determine the implant selection for preoperative purposes.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start21 Nov 2022
- Primary completion19 Jul 2023
- Study completion19 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Shoulder ArthroplastyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Klifto, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350319
- Sponsor's protocol ID
- Pro00108187
- Status last verified
- Dec 2023
- First submitted
- 22 Apr 2022
- Last updated
- 14 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is not planned to be shared outside of the collaborators of this project within the Duke University Medical Center. The data will only be reviewed by the study personnel listed on the Institutional Review Board (IRB), and not intended to be shared with an external institution or industry. However, when submitting data for manuscripts and publication purposes, all data will be deidentified of any public health information. All Protected Health Information (PHI) will be kept in a locked cabinet in the PI's office at Duke University and/or in a protected/encrypted folder in a file separate from the study information. Data will be analyzed by study team members using a computer that is password protected, and stored securely in encrypted Duke servers. Study files will be backed up onto Dr. Klifto's folder in a secure server provided to faculty in the Department of Orthopaedic Surgery. The subjects will not be identified in any reports or publications from this study.
Publications
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.
PubMed 19651945Iannotti 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.
PubMed 25878309Yu 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.
PubMed 22805680Boileau 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.
PubMed 29298261Tipnis 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.
PubMed 25905942Maurer 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.
PubMed 22036540
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Simulated Low Dose Computed Tomography to Conventional Dose Computed Tomography for the Evaluation of Glenoid Anatomy in Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT05350319
- Acronym / sponsor ID
- Pro00108187
- Conditions
- Shoulder Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 19 Sep 2023 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients planning for total or reverse shoulder arthroplasty | – | Radiation: A low-dose CT scan of the shoulderAdult patients who are planning to undergo a total or reverse shoulder arthroplasty |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Subjects who are pregnant
- Subjects under the age of 18
- Subjects who do not have the capacity to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A low-dose CT scan of the shoulderBriefly, 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). | Radiation | Patients planning for total or reverse shoulder arthroplasty |
Primary outcome
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.
Glenoid Version
Time frame: Day 1
Representative CT images will be used to measure the version of each shoulder for preoperative purposes.
Glenoid Inclination
Time frame: Day 1
Representative CT images will be used to measure the inclination of each shoulder for preoperative purposes.
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.
Implant Selection
Time frame: Day 1
Representative CT images will be used to determine the implant selection for preoperative purposes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Background: PubMed 19651945Biswas 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.
- Background: PubMed 25878309Iannotti 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.
- Background: PubMed 22805680Yu 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.
- Background: PubMed 29298261Boileau 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.
- Background: PubMed 25905942Tipnis 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.
- Background: PubMed 22036540Maurer 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.
- Individual participant dataSharing planned: No. Data is not planned to be shared outside of the collaborators of this project within the Duke University Medical Center. The data will only be reviewed by the study personnel listed on the Institutional Review Board (IRB), and not intended to be shared with an external institution or industry. However, when submitting data for manuscripts and publication purposes, all data will be deidentified of any public health information. All Protected Health Information (PHI) will be kept in a locked cabinet in the PI's office at Duke University and/or in a protected/encrypted folder in a file separate from the study information. Data will be analyzed by study team members using a computer that is password protected, and stored securely in encrypted Duke servers. Study files will be backed up onto Dr. Klifto's folder in a secure server provided to faculty in the Department of Orthopaedic Surgery. The subjects will not be identified in any reports or publications from this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Klifto, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Arthroplasty, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low Dose CT Images of Sufficient Pre-operative Planning Quality (time frame: Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05350319, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.