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NCT04416932 Clinical Trial

Ultrasound After Total Shoulder Arthroplasty

Rotator Cuff Tears Clinical Trial

Official title:
Advanced Imaging for Shoulder and Elbow Arthroplasty

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT04416932
Other study ID # Pro00103782
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date May 20, 2021
Est. completion date May 2024

Study information
Verified date January 2024
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.

Recruitment information / eligibility
Status Suspended
Enrollment 60
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Revision shoulder arthroplasty for infection - Pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Ultasound
Evaluation of post-operative patients who have had total shoulder arthroplasty and will assess the integrity of the rotator cuff using ultrasound.

Locations
Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Duke University Piedmont Orthopedic Society

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

Dines 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. — View Citation

Gilat 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. — View Citation

Horner 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. — View Citation

Iannotti 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. — View Citation

Karthikeyan 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. — View Citation

Levy 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. — View Citation

Narasimhan 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. — View Citation

Okoroha 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. — View Citation

Okoroha 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. — View Citation

Ostrander 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary Number of confirmed healed rotator cuff tear as measured by ultrasound time of procedure, up to 1 hour
Primary Number of confirmed non-healed tenotomy time of procedure, up to 1 hour
Primary Number of confirmed rotator cuff tears time of procedure, up to 1 hour
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