Total Shoulder ArthroplastyNCT04416932
Ultrasound After Total Shoulder Arthroplasty
An observational study of Total Shoulder Arthroplasty and Rotator Cuff Tears, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study would be to evaluate a group of patients status post post-total shoulder arthroplasty to assess the integrity of the rotator cuff using ultrasound. We believe ultrasonography imaging to be a comparable and efficacious modality to evalute tenotomy healing rates and diagnose rotator cuff… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Shoulder Arthroplasty, Rotator Cuff Tears, Rotator Cuff Injuries
- What is being tested?
- Ultasound
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2021to 22 Mar 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
- No healthy volunteers
- Adult, Older adult
Study population: Duke patients who have had prior total shoulder arthroplasy surgery within the past 5 years who are 18 years of age or older.
Who may be able to join
- Primary or revision total shoulder arthroplasty with or without subscapularis tenotomy
- Primary or revision reverse shoulder arthroplasty with or without subscapularis tenotomy
- English speaking patients only
- Shoulder arthroplasty within the last 5 years
Who cannot join
- Revision shoulder arthroplasty for infection
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Advanced Imaging for Shoulder and Elbow Arthroplasty
The purpose of this study would be to evaluate a group of patients status post post-total shoulder arthroplasty to assess the integrity of the rotator cuff using ultrasound. We believe ultrasonography imaging to be a comparable and efficacious modality to evalute tenotomy healing rates and diagnose rotator cuff failure after total shoulder arthroplasty. In addition, we believe ultrasonography to be a cost-effective modality to asses the rotator cuff after total shoulder arthroplasty. Our population would consist of patients that received total shoulder arthroplasty within the last 5 years.
- Being tested
- Ultasound
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltasoundProcedure or surgery
Evaluation of post-operative patients who have had total shoulder arthroplasty and will assess the integrity of the rotator cuff using ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Post-operative patients who had total shoulder arthroplasty | Patients who have had a total shoulder replacement will be scheduled for an ultrasound at Duke Radiology. An ultrasound will be completed on the shoulder that has been replaced, which takes no more than an hour. This ends all study involvement. Receives: Procedure: Ultasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of confirmed healed rotator cuff tear as measured by ultrasound
Measured: time of procedure, up to 1 hour
Number of confirmed non-healed tenotomy
Measured: time of procedure, up to 1 hour
Number of confirmed rotator cuff tears
Measured: time of procedure, up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start20 May 2021
- Primary completion22 Mar 2023
- Study completion22 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Total 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Piedmont Orthopedic Society
- Responsible party
- Sponsor
- Investigators
- Christopher Klifto, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416932
- Sponsor's protocol ID
- Pro00103782
- Status last verified
- Jul 2024
- First submitted
- 2 Jun 2020
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Armstrong A, Lashgari C, Teefey S, Menendez J, Yamaguchi K, Galatz LM. Ultrasound evaluation and clinical correlation of subscapularis repair after total shoulder arthroplasty. J Shoulder Elbow Surg. 2006 Sep-Oct;15(5):541-8. doi: 10.1016/j.jse.2005.09.013. Epub 2006 Jul 27.
PubMed 16979047Dines JS. Editorial Commentary: Rotator Cuff Surgery Planning: Yet Another Reason for Orthopedic Surgeons to Learn to Use Ultrasound.... Arthroscopy. 2018 Aug;34(8):2285-2286. doi: 10.1016/j.arthro.2018.06.019.
PubMed 30077254Gilat R, Atoun E, Cohen O, Tsvieli O, Rath E, Lakstein D, Levy O. Recurrent rotator cuff tear: is ultrasound imaging reliable? J Shoulder Elbow Surg. 2018 Jul;27(7):1263-1267. doi: 10.1016/j.jse.2017.12.017. Epub 2018 Feb 3.
PubMed 29398398Horner NS, de Sa D, Heaven S, Simunovic N, Bedi A, Athwal GS, Ayeni OR. Indications and outcomes of shoulder arthroscopy after shoulder arthroplasty. J Shoulder Elbow Surg. 2016 Mar;25(3):510-8. doi: 10.1016/j.jse.2015.09.013. Epub 2015 Dec 2.
PubMed 26652703Iannotti JP, Ciccone J, Buss DD, Visotsky JL, Mascha E, Cotman K, Rawool NM. Accuracy of office-based ultrasonography of the shoulder for the diagnosis of rotator cuff tears. J Bone Joint Surg Am. 2005 Jun;87(6):1305-11. doi: 10.2106/JBJS.D.02100.
PubMed 15930541Karthikeyan S, Rai SB, Parsons H, Drew S, Smith CD, Griffin DR. Ultrasound dimensions of the rotator cuff in young healthy adults. J Shoulder Elbow Surg. 2014 Aug;23(8):1107-12. doi: 10.1016/j.jse.2013.11.012. Epub 2014 Jan 16.
PubMed 24439247Levy DM, Abrams GD, Harris JD, Bach BR Jr, Nicholson GP, Romeo AA. Rotator cuff tears after total shoulder arthroplasty in primary osteoarthritis: A systematic review. Int J Shoulder Surg. 2016 Apr-Jun;10(2):78-84. doi: 10.4103/0973-6042.180720.
PubMed 27186060Narasimhan R, Shamse K, Nash C, Dhingra D, Kennedy S. Prevalence of subscapularis tears and accuracy of shoulder ultrasound in pre-operative diagnosis. Int Orthop. 2016 May;40(5):975-9. doi: 10.1007/s00264-015-3043-9. Epub 2015 Nov 19.
PubMed 26585865Okoroha KR, Fidai MS, Tramer JS, Davis KD, Kolowich PA. Diagnostic accuracy of ultrasound for rotator cuff tears. Ultrasonography. 2019 Jul;38(3):215-220. doi: 10.14366/usg.18058. Epub 2018 Nov 17.
PubMed 30744304Okoroha KR, Mehran N, Duncan J, Washington T, Spiering T, Bey MJ, Van Holsbeeck M, Moutzouros V. Characterization of Rotator Cuff Tears: Ultrasound Versus Magnetic Resonance Imaging. Orthopedics. 2017 Jan 1;40(1):e124-e130. doi: 10.3928/01477447-20161013-04. Epub 2016 Oct 18.
PubMed 27755645Ostrander RV, Klauser JM, Menon S, Hackel JG. Ultrasound and Functional Assessment of Transtendinous Repairs of Partial-Thickness Articular-Sided Rotator Cuff Tears. Orthop J Sports Med. 2017 Mar 27;5(3):2325967117697375. doi: 10.1177/2325967117697375. eCollection 2017 Mar.
PubMed 28451606
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Imaging for Shoulder and Elbow Arthroplasty
- ClinicalTrials.gov ID
- NCT04416932
- Acronym / sponsor ID
- Pro00103782
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Piedmont Orthopedic Society
- Study start
- 20 May 2021 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 4 Jun 2020 (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.
The purpose of this study would be to evaluate a group of patients status post post-total shoulder arthroplasty to assess the integrity of the rotator cuff using ultrasound. We believe ultrasonography imaging to be a comparable and efficacious modality to evalute tenotomy healing rates and diagnose rotator cuff failure after total shoulder arthroplasty. In addition, we believe ultrasonography to be a cost-effective modality to asses the rotator cuff after total shoulder arthroplasty. Our population would consist of patients that received total shoulder arthroplasty within the last 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-operative patients who had total shoulder arthroplasty | – | Procedure: UltasoundPatients who have had a total shoulder replacement will be scheduled for an ultrasound at Duke Radiology. An ultrasound will be completed on the shoulder that has been replaced, which takes no more than an hour. This ends all study involvement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Duke patients who have had prior total shoulder arthroplasy surgery within the past 5 years who are 18 years of age or older.
Key inclusion criteria (4 listed)
- Primary or revision total shoulder arthroplasty with or without subscapularis tenotomy
- Primary or revision reverse shoulder arthroplasty with or without subscapularis tenotomy
- English speaking patients only
- Shoulder arthroplasty within the last 5 years
Key exclusion criteria (2 listed)
- Revision shoulder arthroplasty for infection
- Pregnancy
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 |
|---|---|---|
| UltasoundEvaluation of post-operative patients who have had total shoulder arthroplasty and will assess the integrity of the rotator cuff using ultrasound. | Procedure or surgery | Post-operative patients who had total shoulder arthroplasty |
Primary outcome
Number of confirmed healed rotator cuff tear as measured by ultrasound
Time frame: time of procedure, up to 1 hour
Number of confirmed non-healed tenotomy
Time frame: time of procedure, up to 1 hour
Number of confirmed rotator cuff tears
Time frame: time of procedure, up to 1 hour
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 22 Jul 2024.
- Background: PubMed 16979047Armstrong A, Lashgari C, Teefey S, Menendez J, Yamaguchi K, Galatz LM. Ultrasound evaluation and clinical correlation of subscapularis repair after total shoulder arthroplasty. J Shoulder Elbow Surg. 2006 Sep-Oct;15(5):541-8. doi: 10.1016/j.jse.2005.09.013. Epub 2006 Jul 27.
- Background: PubMed 30077254Dines JS. Editorial Commentary: Rotator Cuff Surgery Planning: Yet Another Reason for Orthopedic Surgeons to Learn to Use Ultrasound.... Arthroscopy. 2018 Aug;34(8):2285-2286. doi: 10.1016/j.arthro.2018.06.019.
- Background: PubMed 29398398Gilat R, Atoun E, Cohen O, Tsvieli O, Rath E, Lakstein D, Levy O. Recurrent rotator cuff tear: is ultrasound imaging reliable? J Shoulder Elbow Surg. 2018 Jul;27(7):1263-1267. doi: 10.1016/j.jse.2017.12.017. Epub 2018 Feb 3.
- Background: PubMed 26652703Horner NS, de Sa D, Heaven S, Simunovic N, Bedi A, Athwal GS, Ayeni OR. Indications and outcomes of shoulder arthroscopy after shoulder arthroplasty. J Shoulder Elbow Surg. 2016 Mar;25(3):510-8. doi: 10.1016/j.jse.2015.09.013. Epub 2015 Dec 2.
- Background: PubMed 15930541Iannotti JP, Ciccone J, Buss DD, Visotsky JL, Mascha E, Cotman K, Rawool NM. Accuracy of office-based ultrasonography of the shoulder for the diagnosis of rotator cuff tears. J Bone Joint Surg Am. 2005 Jun;87(6):1305-11. doi: 10.2106/JBJS.D.02100.
- Background: PubMed 24439247Karthikeyan S, Rai SB, Parsons H, Drew S, Smith CD, Griffin DR. Ultrasound dimensions of the rotator cuff in young healthy adults. J Shoulder Elbow Surg. 2014 Aug;23(8):1107-12. doi: 10.1016/j.jse.2013.11.012. Epub 2014 Jan 16.
- Background: PubMed 27186060Levy DM, Abrams GD, Harris JD, Bach BR Jr, Nicholson GP, Romeo AA. Rotator cuff tears after total shoulder arthroplasty in primary osteoarthritis: A systematic review. Int J Shoulder Surg. 2016 Apr-Jun;10(2):78-84. doi: 10.4103/0973-6042.180720.
- Background: PubMed 26585865Narasimhan R, Shamse K, Nash C, Dhingra D, Kennedy S. Prevalence of subscapularis tears and accuracy of shoulder ultrasound in pre-operative diagnosis. Int Orthop. 2016 May;40(5):975-9. doi: 10.1007/s00264-015-3043-9. Epub 2015 Nov 19.
- Background: PubMed 30744304Okoroha KR, Fidai MS, Tramer JS, Davis KD, Kolowich PA. Diagnostic accuracy of ultrasound for rotator cuff tears. Ultrasonography. 2019 Jul;38(3):215-220. doi: 10.14366/usg.18058. Epub 2018 Nov 17.
- Background: PubMed 27755645Okoroha KR, Mehran N, Duncan J, Washington T, Spiering T, Bey MJ, Van Holsbeeck M, Moutzouros V. Characterization of Rotator Cuff Tears: Ultrasound Versus Magnetic Resonance Imaging. Orthopedics. 2017 Jan 1;40(1):e124-e130. doi: 10.3928/01477447-20161013-04. Epub 2016 Oct 18.
- Background: PubMed 28451606Ostrander RV, Klauser JM, Menon S, Hackel JG. Ultrasound and Functional Assessment of Transtendinous Repairs of Partial-Thickness Articular-Sided Rotator Cuff Tears. Orthop J Sports Med. 2017 Mar 27;5(3):2325967117697375. doi: 10.1177/2325967117697375. eCollection 2017 Mar.
- Individual participant dataSharing planned: No
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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 Total Shoulder Arthroplasty and Rotator Cuff Tears, 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 4 inclusion and 2 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 22 Jul 2024. 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?
Number of confirmed healed rotator cuff tear as measured by ultrasound (time frame: time of procedure, up to 1 hour). The study lists 3 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 NCT04416932, which also lists 11 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 22 Jul 2024.