Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-02 @ 7:52 AM
Study NCT ID:
NCT04364295
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-04-04
First Post:
2020-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stronger Together Global Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013122', 'term': 'Spinal Diseases'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2285}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-30', 'studyFirstSubmitDate': '2020-04-23', 'studyFirstSubmitQcDate': '2020-04-24', 'lastUpdatePostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of product failure', 'timeFrame': '12 months post-operative', 'description': 'Product failure is defined as product fracture, loosening, gross migration and/or dissociation.'}], 'secondaryOutcomes': [{'measure': 'Incidence of product-related Serious Adverse Events (SAEs) related to the spine, fusion or bone healing, and intraoperative and postoperative unanticipated adverse device effects', 'timeFrame': 'Intra-operative to 24 months', 'description': 'Product-related SAEs related to the spine, fusion, or bone will be collected for this outcome measure.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Spinal Disease']}, 'descriptionModule': {'briefSummary': 'A global, prospective, non-randomized, multicenter, observational, post-market, medical record review registry evaluating real-world evidence for SeaSpine products.', 'detailedDescription': 'To gain observational, prospective, real-world clinical, and radiographic data in order to evaluate continued safety and performance following the implantation of SeaSpine products.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Approximately 2285 patients who were previously implanted with SeaSpine products', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have been treated with at least one SeaSpine product.\n* Have obtained radiographic imaging, as part of the standard of care, at the following time points: preoperative and postoperative.\n* Have obtained at least one preoperative patient-reported outcome measure, as part of the standard of care.\n* Patient is planned, per standard of care, to be assessed with radiographic imaging and consistent patient-reported outcome measure(s) from preoperative through at least two scheduled follow-up visits.\n\nExclusion Criteria:\n\n* Was not implanted with at least one SeaSpine product during operation\n* Any other condition that the Investigator determines is unacceptable for enrollment into this registry'}, 'identificationModule': {'nctId': 'NCT04364295', 'briefTitle': 'Stronger Together Global Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'SeaSpine, Inc.'}, 'officialTitle': 'Evaluating Real-World Spine Outcomes for Spinal and Orthobiologics Products From Around the World', 'orgStudyIdInfo': {'id': 'SS-GR-1902'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Implanted with SeaSpine spinal or orthobiologics product', 'description': 'Standard of Care Registry- Patients must have been implanted with at least one SeaSpine product', 'interventionNames': ['Device: Spinal Surgery with SeaSpine product']}], 'interventions': [{'name': 'Spinal Surgery with SeaSpine product', 'type': 'DEVICE', 'description': 'Implanted with SeaSpine spinal or orthobiologic product', 'armGroupLabels': ['Implanted with SeaSpine spinal or orthobiologics product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81301', 'city': 'Durango', 'state': 'Colorado', 'country': 'United States', 'facility': 'Spine Colorado', 'geoPoint': {'lat': 37.27528, 'lon': -107.88007}}, {'zip': '43054', 'city': 'New Albany', 'state': 'Ohio', 'country': 'United States', 'facility': 'OrthoNeuro', 'geoPoint': {'lat': 40.08117, 'lon': -82.80879}}], 'overallOfficials': [{'name': 'Frank Vizesi, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SeaSpine Orthopedics Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SeaSpine, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}