Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-25 @ 4:59 PM
Study NCT ID:
NCT02195557
Status:
COMPLETED
Last Update Posted:
2014-07-22
First Post:
2014-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Follow-up Study of Synvisc® in Patients With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C049816', 'term': 'hylan'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-21', 'studyFirstSubmitDate': '2014-07-18', 'studyFirstSubmitQcDate': '2014-07-18', 'lastUpdatePostDateStruct': {'date': '2014-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reason for prescription', 'timeFrame': 'at least 3 years before start of observation period'}, {'measure': 'Number of other treatments per patient', 'timeFrame': 'at least 3 years of observation', 'description': 'antalgics, non-steroid anti-inflammatory drugs (NSAIDs), steroid anti-inflammatory drugs (SAIDs), specific symptomatic treatments and surgery'}, {'measure': 'Time between two treatments', 'timeFrame': 'at least 3 years of observation'}]}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Retrospective collection of data, aimed at a better knowledge of the use of Synvisc® among the patients with knee osteoarthritis (OA) since at least three years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'rheumatological practice', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with knee osteoarthritis using Synvisc® since at least three years\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02195557', 'briefTitle': 'Retrospective Follow-up Study of Synvisc® in Patients With Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Synvisc® in Knee Osteoarthritis: Retrospective Follow-up in Treated Patients Since at Least Three Years', 'orgStudyIdInfo': {'id': '1139.6'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Synvisc®', 'interventionNames': ['Drug: Synvisc®']}], 'interventions': [{'name': 'Synvisc®', 'type': 'DRUG', 'armGroupLabels': ['Synvisc®']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}