Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT04757051
Status:
COMPLETED
Last Update Posted:
2022-08-03
First Post:
2021-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-life Use of BENART TM in Patients With Symptomatic Knee Osteoarthritis
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2021-02-11', 'studyFirstSubmitQcDate': '2021-02-11', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of subjective therapy evaluation (KOOS questionnaire) compared to baseline', 'timeFrame': 'week 1, week 12, week 24, week 36', 'description': 'Knee injury and Osteoarthritis Outcome Score (KOOS) to assess pain, other symptoms, activities of daily living (ADL), function in sport and recreation (Sport/Rec) and knee-related Quality of Life (QoL) on a 5-point Likert scale'}, {'measure': 'Change of pain intensity compared to baseline (visual analogue scale, VAS)', 'timeFrame': 'week 1, week 12, week 24, week 36', 'description': 'Evaluation of pain intensity by the patient on a 10 cm VAS-slider. 10 cm equals the worst pain.'}, {'measure': "Change of patient's global assessment (overall impression of clinical OA severity on a numerical rating scale from 0 to 10)", 'timeFrame': 'week 1, week 12, week 24, week 36', 'description': 'The change of overall subjective symptom severity evaluation on a scale from 0 (very good condition) to 10 (very poor condition).'}, {'measure': 'Change of clinical global impression (overall impression of clinical OA severity of the investigator on a numerical rating scale from 0 to 10)', 'timeFrame': 'week 1, week 12, week 24, week 36', 'description': 'The change of clinical global Impression on a scale from 0 (very good condition) to 10 (very poor condition).'}, {'measure': 'Responder rate according to OMERACT-OARSI criteria', 'timeFrame': 'week 24'}, {'measure': 'Incidence of treatment-emergent Adverse Events', 'timeFrame': 'Up to week 36'}, {'measure': 'Satisfaction scale (subjective satisfaction of patient and investigator with the treatment on a 5 Point likert scale)', 'timeFrame': 'week 1, week 12, week 24, week 36', 'description': 'Subjective satisfaction on a scale from 1 (very satisfied) to 5 (very unsatisfied)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '38498142', 'type': 'DERIVED', 'citation': 'Lynen NA, Eichhorn C, Portelange N, Chausson M, Weyenberg W. Long-Term Efficacy Following Intra-articular Injection of Carboxymethyl-chitosan, a New Product Class for Knee Osteoarthritis: Results from an Observational Study in Germany. Rheumatol Ther. 2024 Jun;11(3):649-662. doi: 10.1007/s40744-024-00661-6. Epub 2024 Mar 18.'}]}, 'descriptionModule': {'briefSummary': 'PMCF study to assess the effectiveness and safety of BENART in the treatment of symptomatic knee OA in a real-life clinical setting when used according to the instructions for use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients between 18 and 99 years with knee osteoarthitis and a recommendation for treatment with BENART TM.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* male or female aged between 18 and 99 years\n* diagnosis of symptomatic knee OA: Kellgren \\& Lawrence grade II/III\n* physician's recommendation to use BENART TM prior to recruitment\n* signed informed consent\n\nExclusion Criteria:\n\n* known allergy or hypersensitivity to any of the BENART TM components\n* infection or skin disease at or around the injection site\n* severe Inflammation, synovitis, or arthritis of the knee joint and/or any other signs of inflammation (e.g. pain causing nocturnal awakenings, knee heat,...)\n* history of autoimmune and crystal diseases (e.g. gout, pseudogout, hereditary hemochromatosis, ...)\n* evidence of lymphatic or venous stasis or serious blood disorders\n* known pregnancy or breast feeding\n* significant joint effusion (confirmed by objective clinical signs and/or ultrasound and/or puncture)\n* individuals who are unable to fully understand all aspects of the study that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response (including persons needing legally designated representatives, illiterate persons or persons with insufficient knowledge of local language)"}, 'identificationModule': {'nctId': 'NCT04757051', 'briefTitle': 'Real-life Use of BENART TM in Patients With Symptomatic Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'TRB Chemedica AG'}, 'officialTitle': 'Real-life Use of BENART TM in Patients With Symptomatic Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'BEN-PMCF-DE-2020'}}, 'contactsLocationsModule': {'locations': [{'zip': '52062', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Praxiszentrum Elisengalerie', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}], 'overallOfficials': [{'name': 'Dr. med. Eichhorn', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Praxiszentrum Elisengalerie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TRB Chemedica AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}