Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
Study NCT ID:
NCT04093804
Status:
UNKNOWN
Last Update Posted:
2019-09-18
First Post:
2019-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Glenosphere Size on Range of Motion in Female Patients Undergoing Reverse Shoulder Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070656', 'term': 'Rotator Cuff Tear Arthropathy'}], 'ancestors': [{'id': 'D002805', 'term': 'Chondrocalcinosis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a randomized trial consisting of female patients undergoing reverse shoulder arthroplasty for rotator cuff tear arthropathy or a massive irreparable rotator cuff tear. The experimental group will receive a 36mm glenosphere and the control group will receive the standard 32mm glenosphere. All other conditions of the surgical procedure will be identical as well as the clinical follow-up.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-16', 'studyFirstSubmitDate': '2019-09-16', 'studyFirstSubmitQcDate': '2019-09-16', 'lastUpdatePostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Active range of motion', 'timeFrame': 'Change from baseline (pre-operative) to 2 years follow-up', 'description': 'Shoulder elevation, abduction, external rotation in abduction, and internal rotation'}, {'measure': 'Passive range of motion', 'timeFrame': 'Change from baseline (pre-operative) to 2 years follow-up', 'description': 'Shoulder elevation and external rotation'}], 'secondaryOutcomes': [{'measure': 'American Shoulder and Elbow Surgeon (ASES) Shoulder Index', 'timeFrame': 'Change from baseline (pre-operative) to 2 years follow-up', 'description': 'Standard functional outcomes questionnaire following shoulder surgery, range 0 - 100 (highest function)'}, {'measure': 'Constant-Murley Shoulder Outcome score', 'timeFrame': 'Change from baseline (pre-operative) to 2 years follow-up', 'description': 'Standard functional outcomes questionnaire following shoulder surgery, range 0 - 100 (highest function)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Rotator Cuff Tear Arthropathy', 'Massive Irreparable Rotator Cuff Tear']}, 'referencesModule': {'references': [{'pmid': '26853756', 'type': 'BACKGROUND', 'citation': 'Mollon B, Mahure SA, Roche CP, Zuckerman JD. Impact of glenosphere size on clinical outcomes after reverse total shoulder arthroplasty: an analysis of 297 shoulders. J Shoulder Elbow Surg. 2016 May;25(5):763-71. doi: 10.1016/j.jse.2015.10.027. Epub 2016 Feb 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to perform a prospective randomized trial among female patients undergoing reverse shoulder arthroplasty (RSA) to determine if a larger glenosphere allows greater range of motion without an impact on complications.', 'detailedDescription': "A current research debate is whether glenosphere size has a significant clinical impact on a patient's range of motion (ROM) following RSA. Some researchers have shown an association between increased glenosphere size and improved ROM, but no study has determined the absolute minimal motion differences that would be recognizable or beneficial by patients. This is mostly attributable to limitations such as small sample sizes as well as the fact that shoulder dynamics are multifactorial in nature. Most studies have shown an increased ROM with larger glenosphere sizes.1 Because smaller patients are often times female and receive smaller implants, female patients may be more susceptible to limited ROM. The purpose of this study is to determine if a larger glenosphere allows for greater ROM in female patients undergoing RSA."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female sex\n* Diagnosis of rotator cuff tear arthropathy or a massive irreparable rotator cuff tear for which the patient has elected to undergo reverse shoulder arthroplasty\n* No history of prior shoulder arthroplasty\n* Consent to study participation by signing the informed consent and the Protected Health Information (PHI) form (Attachment B and C)\n* Ability to speak, read and write English\n\nExclusion Criteria:\n\n* Male sex\n* Any impairment that would prevent answering the surveys\n* No children or adolescents under the age of 18 years old\n* No prisoners, pregnant women, or mentally disabled persons\n* No Workers' Compensation cases"}, 'identificationModule': {'nctId': 'NCT04093804', 'briefTitle': 'Impact of Glenosphere Size on Range of Motion in Female Patients Undergoing Reverse Shoulder Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Fondren Orthopedic Group L.L.P.'}, 'officialTitle': 'Impact of Glenosphere Size on Range of Motion in Female Patients Undergoing Reverse Shoulder Arthroplasty', 'orgStudyIdInfo': {'id': 'TOH183'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '32mm Glenosphere', 'description': 'The control group will receive the standard 32mm glenosphere.', 'interventionNames': ['Device: Glenosphere size for Reverse Shoulder Arthroplasty']}, {'type': 'EXPERIMENTAL', 'label': '36mm Glenosphere', 'description': 'The experimental group will receive a 36mm glenosphere.', 'interventionNames': ['Device: Glenosphere size for Reverse Shoulder Arthroplasty']}], 'interventions': [{'name': 'Glenosphere size for Reverse Shoulder Arthroplasty', 'type': 'DEVICE', 'description': 'Two randomized study groups will be formed with the consented patients (experimental and control). All patients will undergo reverse shoulder arthroplasty by the Principal Investigator. The experimental group patients will receive a 36mm glenosphere and the control group will receive a 32mm glenosphere. All other procedures during the surgery are identical between groups.', 'armGroupLabels': ['32mm Glenosphere', '36mm Glenosphere']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Fondren Orthopedic Group, L.L.P.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Mitzi S Laughlin, PhD', 'role': 'CONTACT', 'email': 'Mitzi.Laughlin@fondren.com', 'phone': '713-794-3408'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondren Orthopedic Group L.L.P.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}