Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 9:56 AM
Study NCT ID:
NCT07060469
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-11
First Post:
2025-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Anatomic Shoulder Arthroplasty, Hemiarthroplasty, and Reverse Shoulder Arthroplasty.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2025-04-23', 'studyFirstSubmitQcDate': '2025-07-01', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rotator cuff failure', 'timeFrame': 'within the last 10 years', 'description': 'Information will be retrieved from the UK National Joint Registry in. Patients that had a shoulder replacement-anatomic, reverse, or hemi-arthroplasty. This will indicate the failure rate of these types of shoulder replacement.'}], 'secondaryOutcomes': [{'measure': 'Oxford Shoulder Score (OSS)', 'timeFrame': 'within the last 7 years', 'description': 'The study population includes patients with recorded Oxford Shoulder Scores at a minimum of one year and a maximum of seven years postoperatively. The lower the score indicates the greatest disability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shoulder Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '36911771', 'type': 'BACKGROUND', 'citation': "Hao KA, Boschert EN, O'Keefe DS, Saengchote SA, Schoch BS, Wright JO, Wright TW, Farmer KW, Struk AM, King JJ. Comparison of clinical outcomes of revision reverse total shoulder arthroplasty for failed primary anatomic vs. reverse shoulder arthroplasty. JSES Int. 2022 Dec 16;7(2):257-263. doi: 10.1016/j.jseint.2022.11.003. eCollection 2023 Mar."}, {'pmid': '34293419', 'type': 'BACKGROUND', 'citation': 'Heifner JJ, Kumar AD, Wagner ER. Glenohumeral osteoarthritis with intact rotator cuff treated with reverse shoulder arthroplasty: a systematic review. J Shoulder Elbow Surg. 2021 Dec;30(12):2895-2903. doi: 10.1016/j.jse.2021.06.010. Epub 2021 Jul 20.'}, {'pmid': '37075936', 'type': 'BACKGROUND', 'citation': 'Orvets ND, Chan PH, Taylor JM, Prentice HA, Navarro RA, Garcia IA. Similar rates of revision surgery following primary anatomic compared with reverse shoulder arthroplasty in patients aged 70 years or older with glenohumeral osteoarthritis: a cohort study of 3791 patients. J Shoulder Elbow Surg. 2023 Sep;32(9):1893-1900. doi: 10.1016/j.jse.2023.03.021. Epub 2023 Apr 17.'}, {'pmid': '37588441', 'type': 'BACKGROUND', 'citation': 'Su F, Nuthalapati P, Feeley BT, Lansdown DA. Outcomes of anatomic and reverse total shoulder arthroplasty in patients over the age of 70: a systematic review. JSES Rev Rep Tech. 2023 Mar 4;3(2):181-188. doi: 10.1016/j.xrrt.2023.02.003. eCollection 2023 May.'}, {'pmid': '33484829', 'type': 'BACKGROUND', 'citation': 'Jensen AR, Tangtiphaiboontana J, Marigi E, Mallett KE, Sperling JW, Sanchez-Sotelo J. Anatomic total shoulder arthroplasty for primary glenohumeral osteoarthritis is associated with excellent outcomes and low revision rates in the elderly. J Shoulder Elbow Surg. 2021 Jul;30(7S):S131-S139. doi: 10.1016/j.jse.2020.11.030. Epub 2021 Jan 20.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate outcomes in patients over 70 years of age who underwent anatomic shoulder arthroplasty, hemiarthroplasty, or reverse shoulder arthroplasty, focusing on revision rates, rotator cuff integrity as primary and Oxford Shoulder Scores as secondary outcome measures.', 'detailedDescription': "Despite numerous studies, the literature presents conflicting evidence regarding the comparative effectiveness of anatomic shoulder arthroplasty (aTSA) versus reverse shoulder arthroplasty in primary humeral osteoarthritis among patients aged over 70 years.\n\nThere is anecdotal evidence that doing a shoulder replacement in the above 70-year-old patient could potentially lead to early failure and revision due to rotator cuff tears. There is currently a UK run RCT looking into randomising patient above 60 in reverse or anatomic shoulder replacement. Current literature provides inconclusive evidence, and our local practice does not suggest early failure and revision of anatomic shoulder replacement in the over 70s. The aim of the study is to investigate this and provide solid evidence.\n\nThis retrospective analysis will utilize a decade of data from a single surgeon's practice, supplemented by information retrieved from the UK National Joint Registry in. Patients that had a shoulder replacement-anatomic, reverse, or hemi-arthroplasty-aged over 70 at the time of surgery will be included. Data will be cross-referenced with local databases for pre- and postoperative Oxford Shoulder Scores (OSS), primary diagnoses, and complications. The study population includes patients with recorded Oxford Shoulder Scores at a minimum of one year and a maximum of seven years postoperatively. IBM SPSS V.25 will be used for statistical analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who have had a shoulder replacement within the last 10 years anatomic, reverse, or hemi-arthroplasty and who are aged over 70 at the time of surgery will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll genders Over 70 All ethnic groups Anatomic / Reverse / Hemi shoulder replacement\n\nExclusion Criteria:\n\nUnder 70 years of age Shoulder replacement for trauma/tumour'}, 'identificationModule': {'nctId': 'NCT07060469', 'briefTitle': 'Comparison Between Anatomic Shoulder Arthroplasty, Hemiarthroplasty, and Reverse Shoulder Arthroplasty.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust'}, 'officialTitle': 'Comparative Analysis of Anatomic Shoulder Arthroplasty, Hemiarthroplasty, and Reverse Shoulder Arthroplasty in Patients Over 70: A Retrospective Single Unit Single Surgeon Study', 'orgStudyIdInfo': {'id': 'RL1 905'}, 'secondaryIdInfos': [{'id': 'RL1 905', 'type': 'OTHER', 'domain': 'The Robert Jones and Agnes Hunt Orthopaedic Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anatomic Shoulder Arthroplasty', 'description': 'Type of shoulder replacement'}, {'label': 'Hemiarthroplasty', 'description': 'Type of shoulder replacement'}, {'label': 'Reverse Shoulder Arthroplasty', 'description': 'Type of shoulder replacement'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Julie Steen', 'role': 'CONTACT', 'email': 'julie.steen@nhs.net', 'phone': '01691404418'}], 'overallOfficials': [{'name': 'Mr I Tsolis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Robert Jones and Agnes Hunt Orthopaedic Hospital Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}