Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2026-01-01 @ 5:25 AM
Study NCT ID:
NCT05364606
Status:
RECRUITING
Last Update Posted:
2024-11-07
First Post:
2022-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Specific Talus Spacer Post Approval Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010020', 'term': 'Osteonecrosis'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal 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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2029-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-05', 'studyFirstSubmitDate': '2022-02-04', 'studyFirstSubmitQcDate': '2022-05-02', 'lastUpdatePostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Additional Analyses at 5 Years Post Operative compared to Baseline for Foot and Outcome Score FAOS', 'timeFrame': '5 Years Post Procedure compared to baseline', 'description': 'Additional analyses will be performed to observe improvement at 5-years post-procedure compared to baseline on Foot and Ankle Outcome Score (FAOS - which include Pain, Other Symptoms, Sport and Recreation Function, Activities of Daily Living (ADL) and Foot and Ankle related Quality of Life (QOL). This is a series of questions for each sub section that the subject will answer at the subjects visits.'}], 'primaryOutcomes': [{'measure': 'Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS)', 'timeFrame': 'At 5 years compared to Baseline', 'description': 'Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS) at 5 years compared to baseline on the 0 to 100mm scale. A lower score will indicate an improvement in pain.'}, {'measure': "A lack Secondary Subsequent Surgical Intervention at 5 years Post Operative assessed during the subject's visits", 'timeFrame': 'A patient will achieve the primary probable benefit endpoint only is they do not undergo a Secondary Subsequent Surgical Intervention at 5 years Post Operative as assessed during the subjects visits for the study.', 'description': 'A lack Secondary Subsequent Surgical Intervention (SSSI) at 5 years Post Operative'}], 'secondaryOutcomes': [{'measure': 'Additional Analyses at 5 years Post Operative compared to baseline, Range of Motion of the Ankle.', 'timeFrame': '5 Years Post Procedure compared to baseline.', 'description': 'Additional analyses will be performed to observe improvement at 5-years post-procedure compared to baseline on ankle range of motion (ROM) as assessed by the surgeon at each follow up visit through 5 years Post Operative.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Avascular Necrosis', 'Talus', 'Ankle'], 'conditions': ['Avascular Necrosis of the Talus']}, 'descriptionModule': {'briefSummary': 'Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.', 'detailedDescription': "This is a Humanitarian Device Exemption (HDE) approved device called the Patient Specific Talus Spacer. This is a post approval study to determine the safety and probable benefit of the Patient Specific Talus Spacer in commercial use. The Patient Specific Talus Spacer is a solid polished replica of the patient's bone to allow the patient to regain motion and reduce pain."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Avascular Necrosis of the Ankle Joint.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject plans to undergo implantation of the Patient Specific Talus Spacer for avascular necrosis of the ankle joint independent of this research protocol;\n2. Avascular necrosis of the ankle joint;\n3. Age 21 years old or older;\n4. Subject has good general health; and\n5. Subject signs a written informed consent form (ICF) prior to the surgical procedure.\n\nExclusion Criteria:\n\n1. Presence of any contraindication identified in the device Instructions for Use;\n2. Surgeon determines that the patient is not appropriate for the Talus Spacer procedure based on the device IFU (including the enumerated Warnings and Precautions);\n3. Based on the medical opinion of the surgeon, the patient is not appropriate for the Talus Spacer procedure;\n4. For female subjects, pregnancy;\n5. Active systemic disease, such as AIDS, HIV, or active infection;\n6. Active infection or the skin is compromised at the surgical site; and\n7. Systemic disease that would affect the subject's welfare;\n8. Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results;\n9. Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the time course of follow-up.\n10. If the Sponsor has notified the site that 30 subjects have been enrolled in the study with a Cobalt Chromium Patient Specific Talus Spacer, and the surgeon believes that a Cobalt Chromium Patient Specific Talus Spacer is the best option for the patient.\n11. If the Sponsor has notified the site that 30 subjects have been enrolled in the study with a Titanium (Ti6Al4V) with Titanium Nitride (TiN) coating Patient Specific Talus Spacer, and the surgeon believes that a Titanium (Ti6Al4V) with Titanium Nitride (TiN) coating Patient Specific Talus Spacer is the best option for the patient."}, 'identificationModule': {'nctId': 'NCT05364606', 'briefTitle': 'Patient Specific Talus Spacer Post Approval Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Paragon 28'}, 'officialTitle': 'Patient Specific Talus Spacer Post Approval Study', 'orgStudyIdInfo': {'id': 'AOPSTSPAS'}}, 'armsInterventionsModule': {'armGroups': [{'label': '50 Subjects', 'description': '50 Subjects Receiving the Patient Specific Talus Spacer.', 'interventionNames': ['Device: Patient Specific Talus Spacer']}], 'interventions': [{'name': 'Patient Specific Talus Spacer', 'type': 'DEVICE', 'description': "Patient Specific Talus Spacer is a solid polished replica of the patient's bone.", 'armGroupLabels': ['50 Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95403', 'city': 'Santa Rosa', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Thomas Chang, DPM', 'role': 'CONTACT', 'phone': '707-544-3400'}, {'name': 'Thomas Chang, DMP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Redwood Orthopaedics', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Faith Etherington, PA-C', 'role': 'CONTACT', 'phone': '260-436-8686'}, {'name': 'Matthew Beuchel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fort Wayne Orthopedics', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '21202', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maggie Manchester', 'role': 'CONTACT', 'email': 'mmanches@mdmercy.com'}, {'name': 'Patrick Maloney, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Clifford Jeng, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lew Schon, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rebecca Cerrato, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Mercy Institute for Foot & Ankle Reconstruction', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '27560', 'city': 'Morrisville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kalynn Purnell', 'role': 'CONTACT', 'email': 'kalyn.purnell@duke.edu', 'phone': '919-681-6035'}, {'name': 'Andrew Hanselman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mark Easley, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Samuel Adams, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Duke Orthopeadics Arringdon', 'geoPoint': {'lat': 35.82348, 'lon': -78.82556}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Josh Morningstar', 'role': 'CONTACT', 'email': 'morninjo@musc.edu'}, {'name': 'Christoper Gross, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Daniel Scott, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77584', 'city': 'Pearland', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jordan Harmon', 'role': 'CONTACT', 'email': 'jordan.j.harmon@uth.tmc.edu', 'phone': '713-962-9954'}, {'name': 'Taggart Gauvain, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UT Physicians Orthopedics - Pearland', 'geoPoint': {'lat': 29.56357, 'lon': -95.28605}}], 'centralContacts': [{'name': 'Jacy Legue', 'role': 'CONTACT', 'email': 'jlegue@paragon28.com', 'phone': '720-399-3400'}, {'name': 'Caleigh Bates', 'role': 'CONTACT', 'email': 'cbates@paragon28.com', 'phone': '720-399-3400'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': "After study completion and data analysis, results of the study will be shared with the Investigator's who participated. Individual Patient Identifiers will not be provided. Only specific numbers from the statistical analysis will be shared."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paragon 28', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}