Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 1:05 AM
Study NCT ID:
NCT05495334
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2022-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Innovations in Genicular Outcomes Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'targetDuration': '18 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2022-07-14', 'studyFirstSubmitQcDate': '2022-08-08', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity and interference scores via NRS (Numeric Rating Scale)', 'timeFrame': '18 months', 'description': 'NRS score from 0(being none)-10(being the worst)'}, {'measure': 'Pain intensity and interference scores via BPI-sf (Brief Pain Inventory-short form)', 'timeFrame': '18 months', 'description': 'Pain intensity and interference scores via BPI-sf 0 to 10, where: 0 = no pain and 10 = pain as bad as you can imagine'}, {'measure': 'Opioid use via pre-and post-treatment analgesic medication use log', 'timeFrame': '18 months', 'description': 'Opioid use via pre-and post-treatment analgesic medication use log'}, {'measure': 'Functional status via KOOS-JR (Knee injury and Osteoarthritis Outcome Score for Joint Replacement)', 'timeFrame': '18 months', 'description': 'Functional status via KOOS-JR. 0(none)-4(extreme)'}, {'measure': 'Functional status via SANE (Single Assessment Numeric Evaluation)', 'timeFrame': '18 months', 'description': 'Functional status via SANE. Percentage of normal (0% to 100% scale with 100% being normal)'}, {'measure': 'Quality of Sleep via PROMIS-SD (PROMIS - Sleep Disturbance - Short Form 8b)', 'timeFrame': '18 months', 'description': 'Quality of Sleep via PROMIS-SD. 1(Best)-5(Worst)'}, {'measure': 'Adverse events related to pain therapies', 'timeFrame': '18 months', 'description': 'Adverse events related to pain therapies'}, {'measure': 'General HRQOL via PROMIS-10 (PROMIS GLOBAL-10)', 'timeFrame': '18 months', 'description': 'General HRQOL via PROMIS-10. 1(Best)-5(Worst)'}, {'measure': 'Patient Satisfaction', 'timeFrame': '18 months', 'description': 'Patient satisfaction with pain management questionnaire (Patient Satisfaction Questionnaire). Two questions assessing satisfaction and benefit.'}, {'measure': 'Physical therapy utilization and work productivity via PT/Work Productivity', 'timeFrame': '18 months', 'description': 'Physical therapy (PT) utilization and work productivity via PT/Work Productivity (WP) questionnaire.'}, {'measure': 'Emergency Department (ED) visits', 'timeFrame': '18 months', 'description': 'Emergency Department (ED) visits'}, {'measure': 'Reimbursement status', 'timeFrame': '18 months', 'description': 'Reimbursement status'}, {'measure': 'Post-operative pain scores NRS (Numeric Rating Scale)', 'timeFrame': '18 months', 'description': 'Post-operative pain scores (NRS) 0(being none)-10(being the worst)'}, {'measure': 'Post-operative opioid consumption (analgesic medication use log)', 'timeFrame': '18 months', 'description': 'Post-operative opioid consumption (analgesic medication use log)'}, {'measure': 'Length of facility stay', 'timeFrame': '18 months', 'description': 'Length of facility stay'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '39691173', 'type': 'DERIVED', 'citation': 'Dasa V, Mihalko W, Rivadeneyra A, Urban J, Wickline A, Rogenmoser D, Concoff A, Spitzer A, Mont MA. Innovations in Genicular Outcomes Registry (IGOR): protocol for a real-world registry study of treatments for knee osteoarthritis. Ther Adv Musculoskelet Dis. 2024 Dec 16;16:1759720X241304193. doi: 10.1177/1759720X241304193. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'The registry will capture prospective data on patients receiving pain management for chronic pain due to knee osteoarthritis (OA) or pain optimization for knee arthroplasty due to knee OA. The OA pain therapies may include cryo nerve block, radiofrequency ablation (RFA), intra-articular (IA) corticosteroids, viscosupplementation, opioids, and others (e.g., non-steroidal anti-inflammatory drugs \\[NSAIDs\\]).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who are planned to receive treatment within 60 days of screening for knee OA pain will be screened, and if eligible, will be approached for participation in the registry.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Planned to receive treatment for knee OA pain including, but not limited to, knee injections, nerve blocking procedures, or knee arthroplasty within 60 days of screening\n2. Able to understand the informed consent and assessment questionnaires and have the ability to complete them in the opinion of the investigator\n3. Have access to a smartphone or internet access with a computer/tablet to complete the questionnaires using the registry application\n\nExclusion Criteria:\n\n1. Actively enrolled in an investigational trial that would preclude patients from receiving the site's standard of care for knee OA pain or knee arthroplasty recovery protocol\n2. Planning to have a surgery other than on the target knee"}, 'identificationModule': {'nctId': 'NCT05495334', 'acronym': 'iGOR', 'briefTitle': 'Innovations in Genicular Outcomes Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pacira Pharmaceuticals, Inc'}, 'officialTitle': 'Innovations in Genicular Outcomes Registry', 'orgStudyIdInfo': {'id': 'IOV-REG-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All participants', 'description': 'Eligible and enrolled subjects with knee OA pain who require treatment on the target knee as a part of pain management.', 'interventionNames': ['Procedure: Treatment for Knee OA']}], 'interventions': [{'name': 'Treatment for Knee OA', 'type': 'PROCEDURE', 'description': 'Pain management treatment for knee OA.', 'armGroupLabels': ['All participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92618', 'city': 'Irvine', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Adam Rivadeneyra, MD', 'role': 'CONTACT'}], 'facility': 'Orthopedic Education and Research Institute of So Ca (Hoag)', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrew Spitzer, MD', 'role': 'CONTACT'}], 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '71301', 'city': 'Alexandria', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Rogenmoser, DO', 'role': 'CONTACT'}], 'facility': 'MidState Orthopedics and Sports Medicine', 'geoPoint': {'lat': 31.31129, 'lon': -92.44514}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vinod Dasa, MD', 'role': 'CONTACT'}], 'facility': 'Louisiana State University /Ochsner', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Mont, MD', 'role': 'CONTACT'}], 'facility': 'Sinai Hospital of Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20889', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Harold Gelfand, MD', 'role': 'CONTACT'}], 'facility': 'Henry M Jackson Foundation for the Advancement of Military Medicine/Walter Reed National Military Medical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '68144', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joshua Urban, MD', 'role': 'CONTACT'}], 'facility': 'OrthoNebraska Clinics', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07302', 'city': 'Jersey City', 'state': 'New Jersey', 'status': 'TERMINATED', 'country': 'United States', 'facility': 'Jersey City Medical Center', 'geoPoint': {'lat': 40.72816, 'lon': -74.07764}}, {'zip': '13413', 'city': 'New Hartford', 'state': 'New York', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Genesee Orthopedics and Plastic Surgery (St. Elizabeth Med Center/ Apex Surgical Center)', 'geoPoint': {'lat': 43.0734, 'lon': -75.28767}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'status': 'TERMINATED', 'country': 'United States', 'facility': 'Blue Nine Systems', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '74137', 'city': 'Tulsa', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarat Kunapuli, DO', 'role': 'CONTACT'}], 'facility': 'Oklahoma Surgical Hospital', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '15824', 'city': 'DuBois', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christopher Varacallo, DO', 'role': 'CONTACT'}], 'facility': 'Penn Highlands DuBois', 'geoPoint': {'lat': 41.11923, 'lon': -78.76003}}, {'zip': '16801', 'city': 'State College', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Thomas Ellis, DO', 'role': 'CONTACT'}], 'facility': 'University Orthopedics Center', 'geoPoint': {'lat': 40.79339, 'lon': -77.86}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'William Mihalko, MD', 'role': 'CONTACT'}], 'facility': 'Campbell Clinic', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}], 'centralContacts': [{'name': 'Kate Fasel, BSN', 'role': 'CONTACT', 'email': 'IGOR@pacira.com', 'phone': '1-520-490-5355'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pacira Pharmaceuticals, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}