Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-25 @ 8:33 PM
Study NCT ID:
NCT04817969
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-24
First Post:
2021-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Persona Ti-Nidium Post-Market Clinical Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D010020', 'term': 'Osteonecrosis'}], 'ancestors': [{'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': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2034-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-22', 'studyFirstSubmitDate': '2021-03-23', 'studyFirstSubmitQcDate': '2021-03-23', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2034-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxford Knee Score (OKS)', 'timeFrame': '10 years', 'description': 'A patient reported functional outcome score for knee arthroplasty. This score ranges from 0-48, with higher scores indicating a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Knee Society Score (KSS) Expectations (pre and post op)', 'timeFrame': '10 years', 'description': "This is a 3 question form regarding a patient's expectations of the total knee replacement. The pre-op form assesses the patient's expectations of the knee replacement, and the post-op form addresses how the replacement is meeting said expectations. The score ranges from 3-15, with higher scores indicating a better outcome."}, {'measure': 'EuroQol Five Dimension Five Level (EQ-5D-5L) Outcomes Measure', 'timeFrame': '10 years', 'description': 'A questionnaire completed by the patient and assesses his/her general health status. This score ranges from -0.573 to 1, with higher recorded scores indicating better overall health.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'Rheumatoid Arthritis', 'Total Knee Arthroplasty'], 'conditions': ['Knee Pain Chronic', 'Osteoarthritis', 'Rheumatoid Arthritis', 'Traumatic Arthritis', 'Polyarthritis', 'Varus Deformity', 'Valgus Deformity', 'Flexion Deformity of the Knee', 'Avascular Necrosis', 'Patellofemoral Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The main objectives of this study are to evaluate overall clinical performance and safety of the Persona Ti-Nidium implant in total knee arthroplasty.', 'detailedDescription': 'The study design is a prospective, multicenter data collection model of the 510(k) cleared Persona Ti-Nidium Total Knee System. The study will require each site to obtain institutional review board (IRB) approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.\n\nAll study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. Investigators will collect clinical data for a required 10 years. Follow-up clinical visits include Early Post-op, 6 months, 1 year, 2, 3, 5, 7 and 10 years post-operatively.\n\nThe objective of this study is to evaluate clinical performance, benefits and safety of the Persona Ti-Nidium implant in total knee arthroplasty.\n\nSpecific assessments include:\n\n1. Confirming the long-term safety, performance and clinical benefits of the Persona Ti-Nidium total knee system and instrumentation in primary and revision TKA.\n2. Verifying that, under normal use, the performance and clinical benefits of this device and its instrumentation conform to those intended by the manufacturer by recording patient-reported clinical outcomes measures (PROMs) and radiographic outcomes (if available).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient is of legal age and skeletally mature\n2. Patient is willing and able to provide written Informed Consent by signing and dating the IRB-approved Informed Consent document\n3. Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol\n4. Patient qualifies for total knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the Persona Ti-Nidium Knee System and Vivacit-E polyethylene articulating surface\n5. Independent of study participation, patient is a candidate for the commercially available Persona Ti-Nidium Knee and Vivacit-E polyethylene articulating surface, implanted in accordance with product labeling\n\nStudy Device Inclusion Criteria:\n\nThe Persona Ti-Nidium Total Knee is intended for patients with severe pain and disability due to the following:\n\n1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.\n2. Collagen disorders, and/or avascular necrosis of the femoral condyle.\n3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.\n4. Moderate valgus, varus, or flexion deformities.\n\nExclusion Criteria:\n\n1. Patient is unwilling to sign the Informed Consent\n2. Patient is currently participating in any other surgical intervention or pain management study\n3. Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)\n4. Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions\n5. Patient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the study\n6. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation\n\nStudy Device Exclusion Criteria\n\n1. Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint\n2. Insufficient bone stock on femoral or tibial surfaces\n3. Skeletal immaturity\n4. Neuropathic arthropathy\n5. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb\n6. A stable, painless arthrodesis in a satisfactory functional position\n7. Severe instability secondary to the absence of collateral ligament integrity\n8. Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin\n9. The kinematic alignment surgical technique is contraindicated for patients with greater than 5° valgus deformity with medial collateral ligament (MCL) insufficiency'}, 'identificationModule': {'nctId': 'NCT04817969', 'acronym': 'TKA', 'briefTitle': 'Persona Ti-Nidium Post-Market Clinical Follow-up', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'Persona® Ti-Nidium® Personalized Total Knee System A Post-Market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data Using the Persona Ti-Nidium Total Knee System and Instrumentation', 'orgStudyIdInfo': {'id': 'CMG2020-05K'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Persona Ti-Nidium', 'description': 'Primary total knee arthroplasty subjects that receive the Zimmer Biomet Persona Ti-Nidium Total Knee System', 'interventionNames': ['Device: Zimmer Biomet Persona Ti-Nidium Total Knee System']}], 'interventions': [{'name': 'Zimmer Biomet Persona Ti-Nidium Total Knee System', 'type': 'DEVICE', 'description': 'Primary Knee Total Arthroplasty', 'armGroupLabels': ['Persona Ti-Nidium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80134', 'city': 'Parker', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Hip & Knee, Inc.', 'geoPoint': {'lat': 39.5186, 'lon': -104.76136}}, {'zip': '20782', 'city': 'Hyattsville', 'state': 'Maryland', 'country': 'United States', 'facility': 'MedStar Health Research Institute', 'geoPoint': {'lat': 38.95594, 'lon': -76.94553}}, {'zip': '39202', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Mississippi Sports Medicine and Orthopaedic Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '87110', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'New Mexico Orthopaedic Associates', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '27708', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rothman Orthopaedic Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Monument Health Rapid City Hospital, Inc.', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}], 'overallOfficials': [{'name': 'Hillary Overholser', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zimmer Biomet Assoc Director'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}