Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-02-27 @ 11:18 AM
Study NCT ID:
NCT02084693
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2014-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COMPREHENSIVE® REVERSE SHOULDER Mini BasePlate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070656', 'term': 'Rotator Cuff Tear Arthropathy'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D010018', 'term': 'Osteomalacia'}], 'ancestors': [{'id': 'D002805', 'term': 'Chondrocalcinosis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012279', 'term': 'Rickets'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093182', 'term': 'Comprehensive Metabolic Panel'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-07-31', 'size': 1770434, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-06-24T21:10', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-03', 'studyFirstSubmitDate': '2014-03-05', 'studyFirstSubmitQcDate': '2014-03-10', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survivorship', 'timeFrame': '1 year', 'description': 'The primary objective of this prospective clinical data collection is to evaluate survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.'}], 'secondaryOutcomes': [{'measure': 'Adverse Events (including dislocation)', 'timeFrame': '3 year', 'description': 'Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes'}, {'measure': 'Constant-Murley Shoulder Score', 'timeFrame': '3 year', 'description': 'Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes'}, {'measure': 'Radiographic Evaluation (Plain X-ray and CT)', 'timeFrame': '3 year', 'description': 'Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes'}, {'measure': 'Scapular Notching', 'timeFrame': '3 year', 'description': 'Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes'}, {'measure': 'Constant-Murley Shoulder Score', 'timeFrame': '1 year', 'description': 'Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes'}, {'measure': 'Constant-Murley Shoulder Score', 'timeFrame': '6 Months', 'description': 'Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes'}, {'measure': 'Radiographic Evaluation', 'timeFrame': '1 year', 'description': 'Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes'}, {'measure': 'Radiographic Evaluation', 'timeFrame': '6 Weeks', 'description': 'Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rotator Cuff Tear Arthropathy', 'Osteoporosis', 'Osteomalacia', 'Joint; Destruction, Sacroiliac']}, 'descriptionModule': {'briefSummary': 'Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.', 'detailedDescription': 'The primary objective of this prospective clinical data collection is to evaluate survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate. Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes including adverse events, scapular notching, and Constant Score.\n\nAll shoulders on which data will be collected are legally marketed and none of the devices are investigational or experimental. FDA has cleared this device via Premarket Notification 510(k) K080642. This data collection effort will document the clinical outcomes of the Comprehensive® Reverse shoulders. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Therefore, patients / cases to be included in this study shall utilize the following inclusion criteria:\n\n1. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.\n2. Grossly deficient rotator cuff with severe arthropathy and/or\n\n * Previously failed shoulder joint replacement with a grossly deficient rotator cuff.\n * Primary total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or\n * Fracture total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or\n * Revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients / cases to be included in this study shall utilize the following inclusion criteria:\n\n1. Comprehensive Reverse Shoulder Mini Base Plate and Mini Stem in a reverse shoulder configuration.\n2. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.\n3. Grossly deficient rotator cuff with severe arthropathy and/or\n\n 1. Previously failed shoulder joint replacement with a grossly deficient rotator cuff.\n 2. Primary total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or\n 3. Fracture total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or\n 4. Revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.\n\nExclusion Criteria:\n\n* The exclusion criteria are the same as the indications stated in the cleared labeling for the device:\n\nAbsolute contraindications include infection, sepsis, and osteomyelitis.\n\nRelative contraindications include:\n\n1. Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.\n2. Osteoporosis.\n3. Metabolic disorders which may impair bone formation.\n4. Osteomalacia.\n5. Distant foci of infections which may spread to the implant site.\n6. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.'}, 'identificationModule': {'nctId': 'NCT02084693', 'briefTitle': 'COMPREHENSIVE® REVERSE SHOULDER Mini BasePlate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.', 'orgStudyIdInfo': {'id': 'INT.CR.GE1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COMPREHENSIVE', 'description': 'Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.', 'interventionNames': ['Device: COMPREHENSIVE']}], 'interventions': [{'name': 'COMPREHENSIVE', 'type': 'DEVICE', 'description': 'Comprehensive® Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.', 'armGroupLabels': ['COMPREHENSIVE']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seongnam-si', 'state': 'Seongnam', 'country': 'South Korea', 'facility': "Bunndang Seoul Nat'l Univ. Hospital", 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans University Mokdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee Univ Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Joo Han Oh, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Bundang Seoul Nat'l University Hospital"}, {'name': 'Sang Jin Shin, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ewha Womans University Mokdong Hospital'}, {'name': 'Jae Chul Yoo, Ph. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}, {'name': 'Yong Girl Rhee, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyung Hee Univ. Hospital'}, {'name': 'Kyu Chul Noh, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gangnam Sacred Heart Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}