Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-04-11 @ 4:57 AM
Study NCT ID:
NCT02422667
Status:
WITHDRAWN
Last Update Posted:
2023-12-05
First Post:
2015-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iCORE: Collaborative Orthopedics Outcomes Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Study cancelled - no results', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-01', 'studyFirstSubmitDate': '2015-04-14', 'studyFirstSubmitQcDate': '2015-04-16', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality Improvement', 'timeFrame': '10 years'}, {'measure': 'Treatment Patterns', 'timeFrame': '5 years'}, {'measure': 'Healthcare Utilization', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Humanistic Outcomes', 'timeFrame': '10 years'}, {'measure': 'Economic Outcomes', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Orthopedics', 'Outcome Assessment'], 'conditions': ['Arthroplasty, Replacement, Hip', 'Arthroplasty, Replacement, Knee']}, 'descriptionModule': {'briefSummary': 'The goal of this registry is to review the data collected and research ways to improve patient safety, quality of care, and medical decision-making, reduce medical spending, and help advance orthopedic science and bioengineering.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients 18 years and older who undergo hip and/or knee arthroplasty. Patient must have the ability to understand the nature of the registry and give written informed consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Patients requested to be seen by an orthopedic surgeon participating in the iCORE Registry.\n* Patient must have the ability to understand the nature of the registry and give written informed consent.\n\nExclusion Criteria:\n\n* There are no exclusion criteria for this Outcomes Registry.'}, 'identificationModule': {'nctId': 'NCT02422667', 'acronym': 'iCORE', 'briefTitle': 'iCORE: Collaborative Orthopedics Outcomes Registry', 'organization': {'class': 'OTHER', 'fullName': 'SCRI Development Innovations, LLC'}, 'officialTitle': 'iCORE: Collaborative Orthopedics Outcomes Registry', 'orgStudyIdInfo': {'id': 'SCRI HEOR_03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Patient Registry', 'type': 'OTHER', 'description': 'Orthopedic Data Registry'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'SCRI', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'David K DeBoer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SJRI/SCRI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SCRI Development Innovations, LLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}