Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-03-04 @ 10:28 AM
Study NCT ID:
NCT03879434
Status:
COMPLETED
Last Update Posted:
2024-10-09
First Post:
2019-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Routine Application of Ostenil® Mini in Patients with Rhizarthrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2019-03-15', 'studyFirstSubmitQcDate': '2019-03-15', 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Pain Intensity compared to Baseline (VAS-slider)', 'timeFrame': 'Day 7, Day 14, Day 84 after last injection, Day 168 after last injection', 'description': 'Evaluation of Pain Intensity by the Patient on a 10 cm VAS-slider. (10 cm equal the worst pain)'}, {'measure': 'Change of Subjective Therapy Evaluation (FIHOA Questionnaire, 4 grade scale) compared to Baseline', 'timeFrame': 'Day 7, Day 14, Day 84 after last injection, Day 168 after last injection', 'description': 'Functional Index for Hand OsteoArthritis (FIHOA) to assess hand-OA related functional impairment on a 4-grade scale'}, {'measure': 'Change of Subjective Quality of Life Evaluation (Questionnaire with 5 Point Likert scale) compared to Baseline', 'timeFrame': 'Day 7, Day 14, Day 84 after last injection, Day 168 after last injection', 'description': 'Questionnaire to assess hand-OA related Quality of Life on a 5-grade scale'}, {'measure': 'Change of Subjective Symptom Evaluation (Overall Impression on a scale from 1 to 5)', 'timeFrame': 'Day 7, Day 14, Day 84 after last injection, Day 168 after last injection', 'description': 'The Change of Overall Subjective Symptom Evaluation on a scale from 1 (much improved) to 5 (much worse)'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'Up to Day 252 after the last injection'}, {'measure': 'Change of Key Pinch Strength compared to Baseline (Pinch Gauge)', 'timeFrame': 'Day 7, Day 14, Day 84 after last injection, Day 168 after last injection', 'description': 'Measurement of Key Pinch in kilograms with a Pinch Gauge'}, {'measure': 'Change of Tip Pinch Strength compared to Baseline (Pinch Gauge)', 'timeFrame': 'Day 7, Day 14, Day 84 after last injection, Day 168 after last injection', 'description': 'Measurement of Tip Pinch in kilograms with a Pinch Gauge'}, {'measure': 'Change of Palmar Pinch Strength compared to Baseline (Pinch Gauge)', 'timeFrame': 'Day 7, Day 14, Day 84 after last injection, Day 168 after last injection', 'description': 'Measurement of Palmar Pinch in kilograms with a Pinch Gauge'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rhizarthrosis']}, 'descriptionModule': {'briefSummary': 'PMCF study to observe the routine application of Ostenil® Mini in the treatment of pain and restricted mobility in degenerative and traumatic changes of the CMC joint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult Patients with Rhizarthrosis and a Recommendation for Treatment with Ostenil® Mini.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects ≥ 18 years of age and in good general health condition\n* Signed informed consent\n* Existing Ostenil® Mini recommendation for the treatment of rhizarthrosis\n\nExclusion Criteria:\n\n* Known hypersensitivity to one of the Ostenil® Mini components\n* Known pregnancy or lactating females\n* Presence of coagulation disorder\n* Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts\n* Subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and / or non completion of the study according to investigator's judgement (e.g. illiteracy, insufficient knowledge of local language)"}, 'identificationModule': {'nctId': 'NCT03879434', 'briefTitle': 'Routine Application of Ostenil® Mini in Patients with Rhizarthrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'TRB Chemedica AG'}, 'officialTitle': 'Routine Application of Ostenil® Mini in Patients with Rhizarthrosis', 'orgStudyIdInfo': {'id': 'OSTCMC-PMCF-DE-2018-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ostenil® Mini', 'description': '1-3 injections of sodium hyaluronate 1.0 % (10 milligrams (mg) / 1,0 millilitres (ml)) in weekly interval.', 'interventionNames': ['Device: Ostenil® Mini']}], 'interventions': [{'name': 'Ostenil® Mini', 'type': 'DEVICE', 'description': 'Ostenil® Mini is a CE-certified viscoelastic solution for injection into the Joint cavity, containing 1.0 % sodium hyaluronate from fermentation', 'armGroupLabels': ['Ostenil® Mini']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10789', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Orthopädie am Tauentzien', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10711', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Praxis für Orthopädie und Unfallchirurgie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12555', 'city': 'Berlin', 'country': 'Germany', 'facility': 'MVZ Berlin Freiheit 1', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13589', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Orthopädie am Kiesteich', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14052', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Wirbelsäulen Gelenk Zentrum Westend', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14109', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Orthopädie Wannsee', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TRB Chemedica AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}