Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-04-20 @ 6:25 PM
Study NCT ID:
NCT02748408
Status:
RECRUITING
Last Update Posted:
2025-09-29
First Post:
2016-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Medacta International SMS 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': 'RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2032-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2016-04-11', 'studyFirstSubmitQcDate': '2016-04-21', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2032-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'survivorship of the Medacta SMS femoral stem', 'timeFrame': '10-year'}], 'secondaryOutcomes': [{'measure': 'clinical performance', 'timeFrame': '3, 5, 7 and 10 years', 'description': 'Harris Hip Score'}, {'measure': 'radiographic performance', 'timeFrame': '3, 5, 7 and 10 years', 'description': 'presence of radiolucencies'}, {'measure': 'Evaluate the patient satisfaction', 'timeFrame': '6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years', 'description': 'Oxford score'}, {'measure': 'Evaluate the quality of life', 'timeFrame': '6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years', 'description': 'EQ-5D'}, {'measure': 'pattern of bone remodeling', 'timeFrame': '6 weeks, 6 months, 1 year', 'description': 'Dual Energy X ray Absorptiometry (DEXA)'}, {'measure': 'stem migration', 'timeFrame': '6 weeks, 6 months, 1 and 2 years', 'description': 'Radiostereometric Analysis (RSA)'}, {'measure': 'Adverse events', 'timeFrame': 'up to 10 years', 'description': 'record of adverse event'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arthrosis', 'Traumatic Arthritis', 'Rheumatoid Polyarthritis', 'Congenital Hip Dysplasia', 'Avascular Necrosis of the Femoral Head']}, 'descriptionModule': {'briefSummary': 'This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals suitable for hip replacement using the Medacta SMS femoral stem', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Individuals with a severely painful and/or disabling hip joint with osteoarthritis, traumatic arthritis or developmental dysplasia of the hip or avascular necrosis of the femoral head.\n* In order to take part in this study, all study participants must be between the ages of 18 and 75 years of age, at the time of surgery.\n* Scheduled for a primary total hip replacement.\n\nExclusion Criteria:\n\n* Active infection\n* Pregnancy\n* Mental illness where the known condition is likely to compromise the patient's ability to consent, affect the patient's assessment of their progress or complete the 10 year cycle of follow-up appointments and reviews\n* Grossly distorted anatomy (surgeon's discretion)\n* Osteomalacia where uncemented implant fixation is contraindicated\n* Active rheumatoid arthritis.\n* Osteoporosis\n* Metabolic disorders which may impair bone formation where uncemented implant fixation is contraindicated\n* Muscular atrophy or neuromuscular disease\n* Allergy to implant material\n* Any patient who cannot or will not provide informed consent for participation in the study\n* Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems"}, 'identificationModule': {'nctId': 'NCT02748408', 'briefTitle': 'The Medacta International SMS Post-Marketing Surveillance Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medacta International SA'}, 'officialTitle': 'The Medacta SMS Femoral Stem Component. A Multi-National, Multi-Centre, Clinical Surveillance Study', 'orgStudyIdInfo': {'id': 'P01.019.01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SMS femoral stem', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1030', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Maximilian Walther, Dr', 'role': 'CONTACT'}], 'facility': 'Herz-Jesu Krankenhaus', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '20161', 'city': 'Milan', 'state': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Peretti, Prof.', 'role': 'CONTACT'}], 'facility': 'Istituto Ortopedico Galezzi', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': 'CH-4500', 'city': 'Solothurn', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Näder Helmy, PD Dr.', 'role': 'CONTACT'}], 'facility': 'Bürgerspital Solothurn', 'geoPoint': {'lat': 47.20791, 'lon': 7.53714}}, {'zip': 'KT18 7EG', 'city': 'Epsom', 'state': 'Surrey', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Richard Field, PhD FRCS', 'role': 'CONTACT', 'email': 'richardefield@aol.com'}], 'facility': 'The Elective Orthopaedic Centre (EOC)', 'geoPoint': {'lat': 51.3305, 'lon': -0.27011}}], 'centralContacts': [{'name': 'Mara Colombo, Eng', 'role': 'CONTACT', 'email': 'colombo@medacta.ch', 'phone': '0041 91 6966060'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medacta International SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}