Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT05721859
Status:
RECRUITING
Last Update Posted:
2025-05-08
First Post:
2023-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
M-Vizion™ Macroscopic Radiographic Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2023-01-27', 'studyFirstSubmitQcDate': '2023-02-08', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'subsidence', 'timeFrame': '6 weeks post-op visit (± 2 weeks)', 'description': 'Occurrence of subsidence \\>5mm'}, {'measure': 'subsidence', 'timeFrame': '6 Months post-op visit (± 2 months)', 'description': 'Occurrence of subsidence \\>5mm'}, {'measure': 'subsidence', 'timeFrame': '1 year post-op visit (± 4 months)', 'description': 'Occurrence of subsidence \\>5mm'}, {'measure': 'subsidence', 'timeFrame': '2 year post-op visit (± 6 months)', 'description': 'Occurrence of subsidence \\>5mm'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['revision', 'hip', 'arthroplasty'], 'conditions': ['Revision Hip Arthroplasty']}, 'descriptionModule': {'briefSummary': "Study of the patient's subsidence after revision hip arthroplasty by assessing gross stem subsidence in the femoral canal.", 'detailedDescription': 'The aim of this study is to evaluate the M-Vizion modular stem performance in patients who undergo total hip replacement according to the standard practice. It is expected that subjects receiving revision hip arthroplasty with the Medacta M-Vizion™ modular hip stem will have less than 5mm of stem subsidence at 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients listed for revision THA receiving a M-Vizion femoral component and meeting all inclusion/ exclusion criteria at a research site,', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF).\n* Ability to understand and provide written authorization for use and disclosure of personal health information.\n* Subjects who are able and willing to comply with the study protocol and follow-up visits.\n* Patients requiring a revision total hip replacement.\n* Subjects undergoing revision THA who will receive an M-Vizion femoral component according to the indications for use.\n* Male and female patients ages 21 - 80 years of age at the time of surgery.\n\nExclusion Criteria:\n\n* Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.\n* Patients with a systemic or metabolic disorder leading to progressive bone deterioration.\n* Patients bone stock is compromised by disease or infection, which could possibly prevent adequate support and/or fixation to the prosthesis.\n* Patients with an active or suspected latent infection in or about the hip joint.\n* Patients that are incarcerated.'}, 'identificationModule': {'nctId': 'NCT05721859', 'briefTitle': 'M-Vizion™ Macroscopic Radiographic Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medacta USA'}, 'officialTitle': 'Medacta M-Vizion™ Macroscopic Radiographic Study, Multi-center, Post-Market Outcomes Study', 'orgStudyIdInfo': {'id': 'MUSA-H-MV-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'revision hip arthroplasty', 'type': 'DEVICE', 'description': 'revision hip arthroplasty'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melissa Shauver', 'role': 'CONTACT', 'email': 'melissa.shauver1@nm.org'}, {'name': 'Megan VanDyke', 'role': 'CONTACT', 'email': 'megan.vandyke@nm.org'}, {'name': 'Kevin Hardt, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northwestern Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02120', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael McTague', 'role': 'CONTACT', 'email': 'mmctague@bidmc.harvard.edu', 'phone': '617-754-6609'}, {'name': 'Eric Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New England Baptist Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julia Aguiar', 'role': 'CONTACT', 'email': 'hjaguiar2@bidmc.harvard.edu', 'phone': '0000000000'}, {'name': 'Michael Baratz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Holly Symonds', 'role': 'CONTACT', 'email': 'holly.b.symonds@hitchcock.org'}, {'name': 'Wayne Moschetti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dartmouth Health', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexis Ready', 'role': 'CONTACT', 'email': 'Alexis.Ready@orthocarolina.com'}, {'name': 'Caleb Michalek', 'role': 'CONTACT', 'email': 'caleb.michalek@orthocarolina.com'}, {'name': 'Bradley Ellison, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'OrthoCarolina Research Institute, Inc.', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yagiz Ozdag, MD', 'role': 'CONTACT', 'email': 'yozdag@geisinger.edu', 'phone': '0000000000'}, {'name': 'John Mercuri, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Geisinger Medical Center', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brenna Blackburn, PhD, MPH', 'role': 'CONTACT', 'email': 'brenna.blackburn@hsc.utah.edu', 'phone': '801-213-7154'}, {'name': 'Claire Kepron', 'role': 'CONTACT', 'phone': '801-213-7154'}, {'name': 'Lucas Anderson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jeremy Gililland, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Utah Department of Orthopaedics', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Emily Hord, CCRP', 'role': 'CONTACT', 'email': 'ehord@medacta.us.com', 'phone': '331-208-4284'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medacta USA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}