Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-01-02 @ 1:24 AM
Study NCT ID:
NCT04416932
Status:
COMPLETED
Last Update Posted:
2024-07-22
First Post:
2020-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound After Total Shoulder Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-19', 'studyFirstSubmitDate': '2020-06-02', 'studyFirstSubmitQcDate': '2020-06-02', 'lastUpdatePostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of confirmed healed rotator cuff tear as measured by ultrasound', 'timeFrame': 'time of procedure, up to 1 hour'}, {'measure': 'Number of confirmed non-healed tenotomy', 'timeFrame': 'time of procedure, up to 1 hour'}, {'measure': 'Number of confirmed rotator cuff tears', 'timeFrame': 'time of procedure, up to 1 hour'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Total Shoulder Arthroplasty', 'Rotator Cuff Tears', 'Rotator Cuff Injuries']}, 'referencesModule': {'references': [{'pmid': '16979047', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30077254', 'type': 'BACKGROUND', '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.'}, {'pmid': '29398398', 'type': 'BACKGROUND', '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.'}, {'pmid': '26652703', 'type': 'BACKGROUND', '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.'}, {'pmid': '15930541', 'type': 'BACKGROUND', '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.'}, {'pmid': '24439247', 'type': 'BACKGROUND', '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.'}, {'pmid': '27186060', 'type': 'BACKGROUND', '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.'}, {'pmid': '26585865', 'type': 'BACKGROUND', '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.'}, {'pmid': '30744304', 'type': 'BACKGROUND', '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.'}, {'pmid': '27755645', 'type': 'BACKGROUND', '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.'}, {'pmid': '28451606', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Duke patients who have had prior total shoulder arthroplasy surgery within the past 5 years who are 18 years of age or older.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary or revision total shoulder arthroplasty with or without subscapularis tenotomy\n* Primary or revision reverse shoulder arthroplasty with or without subscapularis tenotomy\n* English speaking patients only\n* Shoulder arthroplasty within the last 5 years\n\nExclusion Criteria:\n\n* Revision shoulder arthroplasty for infection\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04416932', 'briefTitle': 'Ultrasound After Total Shoulder Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Advanced Imaging for Shoulder and Elbow Arthroplasty', 'orgStudyIdInfo': {'id': 'Pro00103782'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Post-operative patients who had total shoulder arthroplasty', 'description': '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.', 'interventionNames': ['Procedure: Ultasound']}], 'interventions': [{'name': 'Ultasound', 'type': 'PROCEDURE', 'description': 'Evaluation of post-operative patients who have had total shoulder arthroplasty and will assess the integrity of the rotator cuff using ultrasound.', 'armGroupLabels': ['Post-operative patients who had total shoulder arthroplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Christopher Klifto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Piedmont Orthopedic Society', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}