Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-01-03 @ 6:47 PM
Study NCT ID:
NCT04658459
Status:
UNKNOWN
Last Update Posted:
2020-12-08
First Post:
2020-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Results of the Tactys Implant in Proximal Interphalangeal Joint Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-07', 'studyFirstSubmitDate': '2020-11-17', 'studyFirstSubmitQcDate': '2020-12-07', 'lastUpdatePostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'range of motion in degrees', 'timeFrame': 'minimal one year post-operative', 'description': 'measurement of range of motion in degrees'}, {'measure': 'force in kilograms', 'timeFrame': 'minimal one year post-operative', 'description': 'measurement of force with jamar and pinch tests in kilograms'}, {'measure': 'pain with the digital pain scale', 'timeFrame': 'minimal one year post-operative', 'description': 'measurement of pain with the digital pain scale to zero to ten'}, {'measure': 'functional score with the Quick DASH', 'timeFrame': 'minimal one year post-operative', 'description': 'measurement of the quick-DASH functional score to zeo to hundred'}], 'secondaryOutcomes': [{'measure': 'register the complication and their apparition in time', 'timeFrame': 'minimal one year post-operative'}, {'measure': 'assess satisfaction', 'timeFrame': 'minimal one year post-operative', 'description': "assess the patient's satisfaction : very satisfied, satisfied, moderate, not satisfied"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tactys prosthesis'], 'conditions': ['Interphalangeal; Osteoarthritis, Proximal (Bouchard)']}, 'descriptionModule': {'briefSummary': 'Study at middle term of the functional and radiographic results of proximal interphalangeal joint arthroplasty with the Tactys prothesis. The aim is to evaluate if the short term results are maintained in time.', 'detailedDescription': 'The inclusion criteria is any patient who has undergone a proximal interphalangeal joint arthroplasty with the Tactys prothesis between january 2015 to january 2020 in the Centre Chirurgical Emile Gallé in Nancy.\n\nThe functional results evaluated are range of motion, force, pain, functional score as Quick DASH and the radiological one are clinodactyly, periprosthetic ossifications and loosening, dislocation and implant subsidence.\n\nData is registered from the medical folder of every patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who have undergone a proximal interphalangeal joint arthroplasty with the Tactys prosthesis between january 2015 and january 2020 in the Chirugie de la main service in the Centre chirurgical Emile Gallé in Nancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* one or more proximal interphalangeal joint arthroplasty of long fingers with the Tactys prosthesis\n* between january 2015 to january 2020\n* major\n* centre chirurgical emile gallé, centre hospitalier régional universitaire de Nancy\n\nExclusion Criteria:\n\n* minor'}, 'identificationModule': {'nctId': 'NCT04658459', 'briefTitle': 'Results of the Tactys Implant in Proximal Interphalangeal Joint Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Proximal Interphalangeal Joint Arthroplasty With the TACTYS® Prosthesis : Clinical and Radiographic Results at Medium Term.', 'orgStudyIdInfo': {'id': '2020PI110'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Results at short term follow up', 'description': 'Functional and Radiological results at short-term follow up (one year at least)', 'interventionNames': ['Procedure: Proximal Interphalangeal Joint Arthroplasty with the Tactys Prosthesis']}, {'label': 'Results at middle term follow up', 'description': 'Functional and Radiological results at the last follow up of the patient (2 years at least)', 'interventionNames': ['Procedure: Proximal Interphalangeal Joint Arthroplasty with the Tactys Prosthesis']}], 'interventions': [{'name': 'Proximal Interphalangeal Joint Arthroplasty with the Tactys Prosthesis', 'type': 'PROCEDURE', 'armGroupLabels': ['Results at middle term follow up', 'Results at short term follow up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'state': 'Meurthe ET Moselle', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aude LOZANO, resident', 'role': 'CONTACT', 'email': 'a.lozano@chru-nancy.fr', 'phone': '0611434813'}], 'facility': 'Centre Hospitalier Régional Universitaire', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'centralContacts': [{'name': 'Aude LOZANO, resident', 'role': 'CONTACT', 'email': 'a.lozano@chru-nancy.fr', 'phone': '0611434813'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}