Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:18 AM
Study NCT ID:
NCT06151834
Status:
RECRUITING
Last Update Posted:
2025-02-13
First Post:
2023-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2023-11-14', 'studyFirstSubmitQcDate': '2023-11-21', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fusion time of bone in distal interphalangeal arthrodesis of the fingers', 'timeFrame': 'day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery', 'description': 'Fusion time of bone (in weeks) will be measure by X-ray,'}], 'secondaryOutcomes': [{'measure': 'Mid-term efficacy of arthrodesis in pain decrease', 'timeFrame': 'day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery', 'description': 'Evaluation of pain with analogic visual scale'}, {'measure': 'Evaluation of arthrosis degree', 'timeFrame': 'day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery', 'description': 'Evaluation fo arthrosis degree according to Kellgren-Lawrence scale'}, {'measure': 'Patient satisfaction', 'timeFrame': 'D5 - W4 - W6 - W8 - W10 - W12 - Y2 after surgery', 'description': 'Evaluation of patient satisfaction according to Likert scale'}, {'measure': 'Evaluation of global hand function', 'timeFrame': 'day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery', 'description': 'Evaluation by the patient using functional score Quick DASH'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis Finger', 'Osteoarthritis Thumb']}, 'descriptionModule': {'briefSummary': 'Arthrodesis of a distal interphalangeal joint of the finger (DIP) is mainly performed for a degenerated and painful joint. Various stabilization methods have been used to provide compression at the arthrodesis site such as pins, steel wires, compression screws, headless compression screws, bioresorbable implants and intramedullary staples.\n\nAlthough with complications such as implant fractures or dorsal cortical erosion, intramedullary arthrodesis staples provide reliable pain relief and a consistent fusion rate while inevitably scarring the finger pulp or nail dystrophy.\n\nThe aim of this study is to evaluate the bone fusion time during an arthrodesis performed with the Kerifuse shape memory implant.', 'detailedDescription': 'Arthrodesis of a distal interphalangeal joint of the finger (DIP) is mainly performed for a degenerated and painful joint. Various stabilization methods have been used to provide compression at the arthrodesis site such as pins, steel wires, compression screws, headless compression screws, bioresorbable implants and intramedullary staples.\n\nAlthough with complications such as implant fractures or dorsal cortical erosion, intramedullary arthrodesis staples provide reliable pain relief and a consistent fusion rate while inevitably scarring the finger pulp or nail dystrophy.\n\nThe aim of this study is to evaluate the bone fusion time during an arthrodesis performed with the Kerifuse shape memory implant.\n\nMain objective is to evaluate the bone fusion time in arthrodesis performed with the Kerifuse shape memory implant.\n\nSecondary objectives are :\n\n* to evaluate the fusion rate and its associated healing time\n* to evaluate patient satisfaction, including aesthetic aspect\n* to assess overall hand function\n* to evaluate the radiological evolution of the KeriFuse® implant and its implantation site\n* To evaluate the radiological evolution of the arthrodesis angle between the post-operative situation and the final fusion position'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Eligible patients with osteoarthritis of finger for an interphalangeal arthrodesis with KeriFuse implant\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding patient\n* Patient with an intellectual disability and who therefore cannot follow the surgeon's instructions\n* Patients with contraindications to surgery\n* Patients with acute or chronic, local or systemic infections\n* Patients with sensitivities or allergies to device components (Nickel, Titanium)"}, 'identificationModule': {'nctId': 'NCT06151834', 'acronym': 'KF23', 'briefTitle': 'Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device', 'organization': {'class': 'OTHER', 'fullName': 'Clinique Saint François, Nice, France'}, 'officialTitle': 'Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device KF 23)', 'orgStudyIdInfo': {'id': '2023-A02072-43'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients', 'description': 'Patients older than 18 years-old, with a surgical indication of interphalangeal arthrodesis of finger', 'interventionNames': ['Procedure: KeriFuse implant implantation']}], 'interventions': [{'name': 'KeriFuse implant implantation', 'type': 'PROCEDURE', 'description': 'The surgery is an arthrodesis of finger or thumb (for patients with finger osteoarthritis) and involves implanting the KeriFuse implant.', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Valentine Lammens', 'role': 'CONTACT', 'email': 'vlammens@vivalto-sante.com', 'phone': '+334.93.13.65.00'}], 'facility': 'Clinique Saint François', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Nicolas DREANT, MD', 'role': 'CONTACT', 'email': 'nicolas.dreant@sfr.fr', 'phone': '+334 93 13 68 31'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Saint François, Nice, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}