Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT06087705
Status:
UNKNOWN
Last Update Posted:
2023-10-18
First Post:
2023-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device
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': 'ESTIMATED', 'count': 134}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-13', 'studyFirstSubmitDate': '2023-02-06', 'studyFirstSubmitQcDate': '2023-10-13', 'lastUpdatePostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'device performance', 'timeFrame': '6 months', 'description': 'evolution of the pain sub-score of the WOMAC (universities of Western Ontario and McMaster) index (A). The higher the score, the more the knee osteoarthritis has a functional impact.'}], 'secondaryOutcomes': [{'measure': 'Complication', 'timeFrame': '1 year', 'description': 'complication rate'}, {'measure': 'recovery of autonomy', 'timeFrame': '1 year', 'description': 'Evolution of the disability according to the patient (Likert scale 0-10, higher scores mean better outcome)'}, {'measure': 'Evolution of the pain', 'timeFrame': '1 year', 'description': 'Evolution of the pain sub-score (WOMAC A)(universities of Western Ontario and McMaster) index (A). (Higher scores mean worse outcome)'}, {'measure': 'Stiffness', 'timeFrame': '1 year', 'description': 'Evolution of the stiffness sub-score (WOMAC B) (universities of Western Ontario and McMaster) index (B). (Higher scores mean worse outcome)'}, {'measure': 'Function', 'timeFrame': '1 year', 'description': 'Evolution of the function sub-score (WOMAC C) (universities of Western Ontario and McMaster) index (C). (Higher scores mean worse outcome)'}, {'measure': 'responder patients', 'timeFrame': '1 year', 'description': 'Rate of responder patients according to the OMERACT-OARSI criteria (to the treatment, in knee osteoarthritis) (0% (no responder) to 100% (all responder))'}, {'measure': 'Impact of the injection on concomitant treatments', 'timeFrame': '1 year', 'description': 'Recording of the consumption of analgesics and NSAIDs'}, {'measure': 'long-term performance of the SYNOVIUM HCS device', 'timeFrame': '1 year', 'description': 'Rate of patients having reached 1 year, without intervention on the knee concerned'}, {'measure': "Investigator's general assessment", 'timeFrame': '1 year', 'description': 'General assessment by the investigator at the end of the study. (Likert scale 0-3, higher scores mean better outcome)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hyaluronic acid'], 'conditions': ['Gonarthrosis']}, 'descriptionModule': {'briefSummary': 'Patients who are to benefit from an injection of SYNOVIUM HCS as part of their care will be offered to participate in this study. Patients will need to sign a consent form to participate. Prior to SYNOVIUM HCS injection, patients will be asked a series of questions regarding their pain and disability. Data collected during follow-up visits can be compared to pre-injection data.', 'detailedDescription': 'Inclusion period: 6 months\n\nFollow-up period:\n\n* 6-month follow-up, after intra-articular injection with extension\n\n * 1 single syringe of SYNOVIUM HCS (3 mL),\n * Controls scheduled at 1 week, 1, 3, 6 months and up to 1 year\n * Additional control (single) in the event of leaving the study if this takes place outside the scheduled visit dates and before 1 year, for medical reasons\n* Duration of the study: Overall time estimated at 18 months\n* In this open-label CI, the group itself is used as a control, by comparing the scores on inclusion with those of the various control visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with knee osteoarthritis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient\n* Patient with radiologically characterized gonarthrosis (stages Kellgren \\& Lawrence grades I to III)\n* Patient with walking pain (WOMAC A1) at least equal to 2 on the Likert scale 0-4\n* Patient to benefit from an injection of SYNOVIUM HCS as part of his treatment\n* Patient agreeing to participate in the study\n* Patient affiliated to a social security scheme or benefiting from such a scheme\n\nExclusion Criteria:\n\n* Viscosupplementation less than 6 months old\n* Intra-articular corticosteroid injection less than 2 months old\n* Inflammatory arthritis or active infectious of the knee studied\n* History of surgery of the lower limb concerned\n* Kellgren \\& Lawrence grades not defined\n* Known hypersensitivity to hyaluronic acid or chondroitin sulfate\n* Pregnant or breastfeeding women\n* Patient under guardianship, curatorship or judicial safeguard\n* Patient participating in another clinical investigation, at the time of inclusion'}, 'identificationModule': {'nctId': 'NCT06087705', 'acronym': 'YNOVIUM', 'briefTitle': 'Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'LCA Pharmaceutical'}, 'officialTitle': 'Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device', 'orgStudyIdInfo': {'id': 'YNOVIUM'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Intra-articular injection of hyaluronic acid', 'type': 'DEVICE', 'description': 'The injection must necessarily be performed by a practitioner in compliance with the rules of asepsis.\n\nProcedure of use:\n\n* Before the injection, a rigorous prior disinfection of the area to be treated will be carried out.\n* Check the integrity of the sterility protector.\n* Take the syringe and remove the protective tip.\n* Hold the syringe body and insert a sterile intra-articular injection needle into the Luer-Lock system.\n* Gently turn the needle clockwise to secure the needle in the Luer-Lock system.\n* A visual check of the attachment of the needle will be carried out.\n* Remove the needle cap.\n* Inject slowly.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '22000', 'city': 'Saint-Brieuc', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dominique BARON', 'role': 'CONTACT', 'email': 'DBARON@ch-lannion.fr', 'phone': '02 96 05 65 61'}], 'facility': 'CRRF en Milieu Marin de Trestel', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}], 'centralContacts': [{'name': 'Patrice VINCENT', 'role': 'CONTACT', 'email': 'pvin@lca-pharma.com', 'phone': '02 37 33 39 30', 'phoneExt': '+033'}], 'overallOfficials': [{'name': 'Dominique BARON', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CRRF en Milieu Marin de Trestel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LCA Pharmaceutical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'EVAMED', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}