Rotator Cuff Tears Clinical Trial
Official title:
Advanced Imaging for Shoulder and Elbow Arthroplasty
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 |
Verified date | January 2024 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | Piedmont Orthopedic Society |
United States,
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
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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