Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT06012656
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2023-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Study for the Evaluation of the Cementless Anatomic Femoral Stem Minimax -Launay
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D006618', 'term': 'Hip Dislocation, Congenital'}, {'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System 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': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2031-01-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2023-07-26', 'studyFirstSubmitQcDate': '2023-08-22', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival Rate', 'timeFrame': '10 years', 'description': 'Kaplan Meier method'}], 'secondaryOutcomes': [{'measure': 'Functional evaluation', 'timeFrame': 'Pre-op, 3 months, 1, 3, 5, 10 years', 'description': 'Harris Hip Score (HHS): the HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: \\<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.'}, {'measure': 'Evaluation of patient satisfaction', 'timeFrame': 'Pre-op, 3 months, 1, 3, 5, 10 years', 'description': "HOOS (hip disability and osteoarthritis outcome score) questionnaire: HOOS is a questionnaire intended to be used to assess patient's opinion about their hip and associated problems, and to evaluate their symptoms and functional limitations during a therapeutic process.The interval score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health."}, {'measure': 'Evaluation of the stem fixation', 'timeFrame': 'Pre-op, 3 months, 1, 3, 5, 10 years', 'description': 'Radiographic evaluation to assess the osteointegration of the stem, the implant positioning, radiolucent lines.'}, {'measure': 'Evaluation of the general and thigh pain', 'timeFrame': 'Pre-op, 3 months, 1, 3, 5, 10 years', 'description': 'Echelle Visuelle Analogique (EVA) and pain location. Interpretation of the EVA scale: no pain 0, low pain 1-3, moderate pain 4-6, severe pain 7-9, extreme pain 10.'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Surgery, Immediate post-op, 3 months, 1, 3, 5, 10 years', 'description': 'Intraoperative and postoperative complications'}, {'measure': 'Evaluation of the stability of the stem', 'timeFrame': 'Pre-op, 3 months, 1, 3, 5, 10 years', 'description': 'Radiographic evaluation to assess the osteointegration of the stem, the implant positioning, radiolucent lines.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Osteoarthritis', 'Secondary Osteoarthritis', 'Traumatic Arthritis', 'Rheumatoid Arthritis', 'Congenital Hip Dysplasia', 'Avascular Necrosis', 'Fracture; Femur, Head']}, 'descriptionModule': {'briefSummary': 'This is a post-marketing surveillance on MiniMAX Stem'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The sample size of 100 patients has been defined based on the literature data to guarantee a sufficient number of patients for the evaluation of the performance of the prosthesis, taking into account a 10% of lost patients (dead or lost at follow-up).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient with a clinical condition requiring THA\n2. Patient receiving a MiniMAX® stem\n3. Patient aged more than 18 years\n4. Patient having a Social Insurance or a similar protection regime\n5. Patient eligible for an AMIS procedure\n6. Patient able to follow the study requirements\n7. Patients who are willing to give informed written consent\n\nExclusion Criteria:\n\n1. Patient with local or systemic infection\n2. Participation to biomedical research\n3. Patient whose BMI exceeds 40\n4. Patient with less than 18 years\n5. Protected adults\n6. Vulnerable person according to article L1121-6 of the Code de la Santè Publique.\n7. Pregnant or lactating woman\n8. Patient unable to express his/ her opinion about the participation to the study'}, 'identificationModule': {'nctId': 'NCT06012656', 'briefTitle': 'Prospective Study for the Evaluation of the Cementless Anatomic Femoral Stem Minimax -Launay', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medacta International SA'}, 'officialTitle': 'Prospective, Multricentre, Non Controlled, Non-randomized, Open Study for the Evaluation of the Cementless Anatomic Femoral Stem MiniMAX', 'orgStudyIdInfo': {'id': 'P01.005.10'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MiniMAX', 'type': 'DEVICE', 'description': 'Total or Partial Hip Arthroplasty'}]}, 'contactsLocationsModule': {'locations': [{'zip': '16800', 'city': 'Soyaux', 'state': 'France', 'country': 'France', 'facility': 'Centre Clinical Angouleme Soyaux', 'geoPoint': {'lat': 45.64052, 'lon': 0.19752}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medacta International SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}