Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-01 @ 10:57 AM
Study NCT ID:
NCT06546332
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-11
First Post:
2024-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Market Clinical Follow-Up KeriFuse®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 97}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2024-08-06', 'studyFirstSubmitQcDate': '2024-08-06', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain and radiological assessment', 'timeFrame': '3 months', 'description': 'At 3 months postoperatively, the proportion of patients with a pain level ≤ 3 on VAS (ranking from 0 to 10 cm) and with a fused DIP or IP joint (radiological assessment)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthritis']}, 'descriptionModule': {'briefSummary': 'The general objective of this study is to evaluate the performances and the safety related to the KeriFuse® intramedullary arthrodesis implant and associated instrumentation used in accordance with their approved labelling and instruction for use. Performance and safety of KeriFuse® intramedullary arthrodesis implant will be established on short and middle-terms in regards to the implant life-cycle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The intended target population for the KeriFuse® and associated instruments is an adult population requiring a surgical treatment claimed by the device and presenting bone quality deemed satisfactory by the surgeon.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years,\n* Patients that will have a surgery using a KeriFuse® implant in accordance with the approved labelling and IFU.\n\nExclusion Criteria:\n\n* Pregnant or nursing women,\n* Patients with intellectual disabilities who cannot follow the instructions of their surgeon,\n* Patients with a contraindication to surgery and more specifically to the implantation of KeriFuse®,\n* Patients with acute or chronic infections, local or systemic,\n* Patients with sensitivities or allergies to the implant components (Nickel, Titanium).'}, 'identificationModule': {'nctId': 'NCT06546332', 'briefTitle': 'Post Market Clinical Follow-Up KeriFuse®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Keri Medical SA'}, 'officialTitle': 'Effectiveness and Safety of the KeriFuse® Intramedullary Arthrodesis Implant and Associated Instruments in the Treatment of IP or DIP Arthritis: a Post Market Clinical Follow-up.', 'orgStudyIdInfo': {'id': '2021-A03148-33'}}, 'armsInterventionsModule': {'interventions': [{'name': 'KeriFuse®', 'type': 'DEVICE', 'description': 'The intramedullary arthrodesis Implant (KeriFuse®) is indicated for consolidation or bone fusion (arthrodesis) of degraded or arthritic distal interphalangeal (DIP) of hand digits or interphalangeal (IP) joint of the hand thumb.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13090', 'city': 'Aix-en-Provence', 'country': 'France', 'facility': "Centre de la main du Pays d'Aix", 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '63110', 'city': 'Beaumont', 'country': 'France', 'facility': 'Clinique de la Chataigneraie', 'geoPoint': {'lat': 45.75165, 'lon': 3.08294}}, {'zip': '38300', 'city': 'Bourgoin', 'country': 'France', 'facility': 'Centre Ostéo Articulaire Fleming', 'geoPoint': {'lat': 45.59889, 'lon': 5.27236}}, {'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'Clinique Saint François', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '66000', 'city': 'Perpignan', 'country': 'France', 'facility': 'Clinique Mutualiste Catalane', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'zip': '24000', 'city': 'Périgueux', 'country': 'France', 'facility': 'Clinique du Parc', 'geoPoint': {'lat': 45.18691, 'lon': 0.71439}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keri Medical SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}