Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT01787812
Status:
UNKNOWN
Last Update Posted:
2013-07-04
First Post:
2013-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
California Joint Replacement Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'lastUpdateSubmitDate': '2013-07-02', 'studyFirstSubmitDate': '2013-02-01', 'studyFirstSubmitQcDate': '2013-02-07', 'lastUpdatePostDateStruct': {'date': '2013-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients with Total Hip Replacement', 'timeFrame': '3 months, 6 months, every year up to 5 years'}, {'measure': 'Number of Patients with Partial Hip Replacement', 'timeFrame': '3 months, 6 months, every year up to 5 years'}, {'measure': 'Number of Patients with Hip Revision', 'timeFrame': '3 months, 6 months, every year up to 5 years'}, {'measure': 'Number of Patients with Total Knee Replacement', 'timeFrame': '3 months, 6 months, every year up to 5 years'}, {'measure': 'Number of Patients with Knee Revision', 'timeFrame': '3 months, 6 months, every year up to 5 years'}], 'secondaryOutcomes': [{'measure': 'Number and Type of Adverse Events as a Measure of Patient Safety', 'timeFrame': '3 months', 'description': 'Adverse Events:\n\n* Would infection\n* Fracture\n* Excessive bleeding\n* DVT proximal\n* DVT\n* PE\n* Congestive heart\n* Arrhythmia\n* Renal failure\n* Nerve injury\n* MI'}, {'measure': 'Number and Type of Readmissions as a Measure of Surgical Quality', 'timeFrame': '3 months, 6 months, every year up to 5 years'}, {'measure': 'Number of Revisions as a Measure of Surgical Quality', 'timeFrame': '3 months, 6 months, every year up to 5 years'}, {'measure': 'Health-Related Quality of Life Score on the SF-12', 'timeFrame': '3 months, 6 months, every year up to 5 years'}, {'measure': 'Pain Score on the WOMAC', 'timeFrame': '3 months, 6 months, every year up to 5 years'}, {'measure': 'Stiffness Score on the WOMAC', 'timeFrame': '3 months, 6 months, every year up to 5 years'}, {'measure': 'Physical Function Score on the WOMAC', 'timeFrame': '3 months, 6 months, every year up to 5 years'}, {'measure': 'Activity Level Score on the UCLA Activity Index', 'timeFrame': '3 months, 6 months, every year up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hip and Knee Replacement Surgeries']}, 'descriptionModule': {'briefSummary': "The California Joint Replacement Registry (CJRR) was created to meet the need for comprehensive, scientific assessment of devices, treatment protocols, surgical approaches, and patient factors influencing the results of hip and knee replacement surgeries. Importantly, it is a Level 3 registry, meaning it collects and incorporates clinical information and direct feedback from patients about the outcomes of hip and knee replacement surgeries. It is one of only a small number of registries in the United States to do so.\n\nThe CJRR's goals are to:\n\n* Collect and report scientifically valid data on the results of hip and knee replacements performed in California, including device safety and effectiveness, post-operative complication and revision rates, and patient-reported outcomes; and\n* Promote the use of performance information regarding hip and knee replacements to guide physician and patient decisions and to support programs for provider recognition and reward.\n\nSpecifically the CJRR is designed to:\n\n* Minimize burden on participants by using electronic data sources, rather than manual data entry or chart review.\n* Compile reports assessing the outcomes associated with different devices and surgical techniques.\n* Create benchmarking reports for physicians and hospitals that detail performance data and compare it to statewide averages.\n* Transmit safety alerts on devices with short-term results that provoke concern.\n* Shape a measurement and reporting system for total hip and total knee replacement surgeries.\n\nThe CJRR was developed by the California HealthCare Foundation (CHCF), the Pacific Business Group on Health (PBGH), and the California Orthopaedic Association (COA). PBGH manages the day-to-day operations of the CJRR.\n\nCJRR's data elements are aligned with other major orthopedic registries. The CJRR is a member of the International Consortium of Orthopedic Registries (ICOR) and the International Society of Arthroscopic Registries (ISAR)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Californians, 18+ years of age, receiving hip or knee replacement surgery in California.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving hip or knee replacement surgery in California.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01787812', 'acronym': 'CJRR', 'briefTitle': 'California Joint Replacement Registry', 'organization': {'class': 'NETWORK', 'fullName': 'California Joint Replacement Registry'}, 'officialTitle': 'California Joint Replacement Registry', 'orgStudyIdInfo': {'id': 'CJRR-2013'}}, 'contactsLocationsModule': {'locations': [{'zip': '92618', 'city': 'Irvine', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kanoelani Allen, MSN-CNS, PHN, RN', 'role': 'CONTACT', 'email': 'kallen@hoag.org', 'phone': '949.517.3138'}, {'name': 'James Caillouette, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hoag Orthopedic Institute', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}], 'centralContacts': [{'name': 'Rachel Brodie', 'role': 'CONTACT', 'email': 'rbrodie@pbgh.org', 'phone': '415.786.2204'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'California Joint Replacement Registry', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}