Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-02-24 @ 2:09 PM
Study NCT ID:
NCT05057559
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-05
First Post:
2021-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Clinical Investigation of Arthrosamid in 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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-04', 'studyFirstSubmitDate': '2021-09-16', 'studyFirstSubmitQcDate': '2021-09-16', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse events', 'timeFrame': '5 years', 'description': 'The total number of treatment emergent adverse events'}], 'secondaryOutcomes': [{'measure': 'WOMAC pain subscale', 'timeFrame': '6, 12, 24, 36, 48 and 60 months', 'description': 'change from baseline in WOMAC (WOMAC Osteoarthritis Index) pain subscale'}, {'measure': 'WOMAC stiffness subscale', 'timeFrame': '6, 12, 24, 36, 48 and 60 months', 'description': 'change from baseline in WOMAC (WOMAC Osteoarthritis Index) stiffness subscale'}, {'measure': 'WOMAC physical function subscale', 'timeFrame': '6, 12, 24, 36, 48 and 60 months', 'description': 'change from baseline in WOMAC (WOMAC Osteoarthritis Index) physical function subscale'}, {'measure': "Patient's global assessment of impact of osteoarthritis", 'timeFrame': '6, 12, 24, 36, 48 and 60 months', 'description': 'An eleven point, numeric rating scale (0-10) where 0 =" No impact" and 10 = "Worst imaginable impact"'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This is a prospective, long-term, observational, all-comers, open-label, multi-centre clinical investigation enrolling subjects with knee osteoarthritis who is eligible for treatment with Arthrosamid® according to the Instruction for Use.', 'detailedDescription': 'This is a prospective, long-term, observational, all-comers, open-label, multi-centre clinical investigation enrolling subjects with knee OA who is eligible for treatment with Arthrosamid® according to the Instruction for Use (IFU).\n\nAll subjects will be followed over an observational period of five years with yearly follow-up check points. The first follow-up visit should be six months after the treatment. All follow up visits can be performed as telephone visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruited from participating rheumatology or orthopedic centers.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged ≥ 18 years\n* Clinical diagnosis of knee OA\n\nExclusion Criteria:\n\n* If an active skin disease or infection is present at or near the injection site\n* If the joint is infected or severely inflamed\n* If a degradable intra-articular injectable such as hyaluronic acid is present, it must be expected to be absorbed according to manufacturer's information for the specific product, before injection with Arthrosamid®\n* If the patient has previously received treatment with a different non-absorbable injectable/implant\n* If the patient has received a knee alloplasty or has any foreign material in the knee\n* If the patient has undergone knee arthroscopy within the last 6 months\n* If the patient has haemophilia or is in uncontrolled anticoagulant treatment"}, 'identificationModule': {'nctId': 'NCT05057559', 'acronym': 'LUNA', 'briefTitle': 'Observational Clinical Investigation of Arthrosamid in Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Contura'}, 'officialTitle': 'Prospective, Observational, Open-label, Clinical Investigation of Intra-articular Arthrosamid® Injection in Subjects With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'CON-OA-002'}}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'The Parker Institute', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Odense', 'country': 'Denmark', 'facility': 'Reumatolog i Odense', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'city': 'Marseille', 'country': 'France', 'facility': 'AP-HM hopitaux', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Poissy', 'country': 'France', 'facility': 'Clinique Saint Louis', 'geoPoint': {'lat': 48.92902, 'lon': 2.04952}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'AmBeNet Hausarztpraxis', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'University Medical Center of Johannes Gutenberg-University Mainz (UMC-Mainz)', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Ospedale San Pietro Fatebenefratelli', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'London North West University Healthcare', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Truro', 'country': 'United Kingdom', 'facility': 'Royal Cornwall Hospital', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}], 'overallOfficials': [{'name': 'Dorthe Tvinnemose, DVM.', 'role': 'STUDY_CHAIR', 'affiliation': 'Contura'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Contura', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}