Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT04997005
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-08
First Post:
2021-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Medacta International AMIStem-P Post-Marketing Surveillance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D006618', 'term': 'Hip Dislocation, Congenital'}, {'id': 'D005271', 'term': 'Femur Head Necrosis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D000082602', 'term': 'Developmental Dysplasia of the Hip'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 550}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2021-08-04', 'studyFirstSubmitQcDate': '2021-08-04', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival rate', 'timeFrame': '10 years', 'description': 'Kaplan Meier method'}], 'secondaryOutcomes': [{'measure': 'Harris Hip Score', 'timeFrame': '3/6 months, 1, 3, 5 and 10 years', 'description': 'Harris Hip Score \\[min = 0 (worst clinical outcome), max = 100 (best clinical outcome)\\]'}, {'measure': 'Oxford Hip Score', 'timeFrame': '3/6 months, 1, 3, 5 and 10 years', 'description': 'Oxford Hip Score \\[min = 0 (worst functional outcome), max = 48 (best functional outcome)\\]'}, {'measure': 'Radiographic performance of the implants', 'timeFrame': '3/6 months, 1, 3, 5 and 10 years', 'description': 'Presence of radiolucencies, migration, loosening, subsidence, tilt'}, {'measure': 'Quality of life - Euroqol questionnaire', 'timeFrame': '3/6 months, 1, 3, 5 and 10 years', 'description': 'EQ-5D-5L score \\[min = -0.59 (worst functional outcome), max = 1 (best functional outcome)\\]'}, {'measure': 'Adverse events', 'timeFrame': 'intraop, 3/6 months, 1, 3, 5 and 10 years', 'description': 'Intraoperative and postoperative adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthrosis', 'Traumatic Arthritis', 'Rheumatoid Polyarthritis', 'Congenital Hip Dysplasia', 'Avascular Necrosis of the Femoral Head']}, 'descriptionModule': {'briefSummary': 'This is a Post-Market Surveillance study of AMIStem-P femoral stem prosthesis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients requiring Total Hip Arthroplasty and who are suitable to receive Medacta AMIStem-P femoral stem will be proposed to take part to the current post-market surveillance study during their pre-operative visit.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a disease (primary coxarthrosis, inflammatory arthritis of the hip, necrosis of the femoral head, etc.) requiring a total hip replacement\n* Patient eligible to receive an uncemented AMIStem-P femoral stem\n* Patient agreeing to comply with the study requirements\n* Patient willing to provide written informed consent\n* Patient affiliated to a social security system\n* Patients between 18 and 85 years old\n\nExclusion Criteria:\n\n* Participation in biomedical research\n* Patients younger than 18 years old\n* Vulnerable adult patients according to article L1121-6 of the French Public Health Code\n* Pregnant or breastfeeding women\n* Patients unable to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT04997005', 'briefTitle': 'The Medacta International AMIStem-P Post-Marketing Surveillance Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medacta International SA'}, 'officialTitle': 'Prospective, Multicentre, Open Study Evaluating the Performance and Stability of the AMIStem-P Femoral Stem', 'orgStudyIdInfo': {'id': 'P01.001.16'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AMIStem-P', 'type': 'DEVICE', 'description': 'Performance of Total Hip Arthroplasty (THA) with AMIStem-P femoral stem implant'}]}, 'contactsLocationsModule': {'locations': [{'zip': '62575', 'city': 'Blendecques', 'country': 'France', 'facility': 'Clinique de Saint Omer', 'geoPoint': {'lat': 50.71843, 'lon': 2.28601}}, {'zip': '81108', 'city': 'Castres', 'country': 'France', 'facility': 'Hôpital Castres', 'geoPoint': {'lat': 43.60527, 'lon': 2.24088}}, {'zip': '33270', 'city': 'Floirac', 'country': 'France', 'facility': 'Nouvelle Clinique Bordeaux Tondu', 'geoPoint': {'lat': 44.83061, 'lon': -0.52675}}, {'zip': '84100', 'city': 'Orange', 'country': 'France', 'facility': "Clinique d'Orange", 'geoPoint': {'lat': 44.13806, 'lon': 4.81025}}, {'zip': '12000', 'city': 'Rodez', 'country': 'France', 'facility': 'Hôpital Jacques-Puel', 'geoPoint': {'lat': 44.35258, 'lon': 2.57338}}], 'overallOfficials': [{'name': 'Alexandru Nebunescu-Schirliu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Jacques-Puel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medacta International SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}