Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT03495232
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2018-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Persona Cohort Nordic Multicenter Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2018-03-20', 'studyFirstSubmitQcDate': '2018-04-10', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-04-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate patient reported outcome measures following primary total knee replacement using Persona Total Knee system', 'timeFrame': '2 years', 'description': 'Evaluate patient reported outcome measures following primary total knee replacement using Persona Total Knee system as measured by Oxford knee score (OKS); a 12-item patient-reported Patient Reported Outcomes specifically designed and developed to assess function and pain after total knee replacement surgery. Score ranging from 0 (most severe symptoms/problems) to 48 (least severe).'}], 'secondaryOutcomes': [{'measure': 'Evaluate patient reported physical activity level following primary total knee replacement using Persona Total Knee system. An 8-item patient-reported outcome. Score ranging from 0 (most severe symptoms/problems) to 32 (least severe).', 'timeFrame': '2 years', 'description': 'Oxford knee score Activity \\& Participation Questionnaire (OKS, APQ)'}, {'measure': 'Evaluate patient quality of life following primary total knee replacement using Persona Total Knee system', 'timeFrame': '2 years', 'description': 'EuroQol Group (EQ5D) standardized measure of health status. Measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Overall health status rated by the patient using the visual analogue scale (EQ-VAS).'}, {'measure': 'Evaluate patient satisfaction following primary total knee replacement using Persona Total Knee system', 'timeFrame': '2 years', 'description': 'Anchoring questions. Focusing on Patient perception of their knee and their satisfaction with the knee after their knee surgery'}, {'measure': 'Evaluate patient reported awareness of their knee following primary total knee replacement using Persona Total Knee system', 'timeFrame': '2 years', 'description': 'Forgotten Joint Score (FJS)'}, {'measure': 'Evaluate intraoperative and postoperative complications', 'timeFrame': '10 years', 'description': 'Register adverse events including intraoperative complications and revisions at any postoperative time point.'}, {'measure': 'Evaluate implant positioning following primary total knee replacement using Persona Total Knee system', 'timeFrame': '2 years', 'description': 'Measure radiolucency and osteolysis using conventional radiographs in anterior posterior (AP) and lateral views.'}, {'measure': 'Evaluate longer term survivorship following primary total knee replacement using Persona Total Knee system', 'timeFrame': '10 years', 'description': 'Survival of the implant through registries'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Total Knee Arthroplasty', 'Persona knee system', 'osteoarthrosis', 'Knee'], 'conditions': ['Knee Arthropathy']}, 'descriptionModule': {'briefSummary': 'In this project the investigators wish to:\n\nEvaluate intra-operative and postop complications, longer term survivorship and patient reported outcome measures (PROMs) following primary total knee replacement using Persona Total Knee system.\n\nThis project is carried out as prospective cohort study. Recruitment of participants to this project is expected to begin in October 2016 or as soon as permission from the Regional Ethics Committee and the local Data Protection Agency is obtained as required. A total of 700 participants (including 155 participants from a randomized controlled trial (RCT) investigating the Persona and the Nexgen total knee systems, which is separately submitted to the ethics committee) are to be included at several centers in the nordic region. Recruitment is expected complete after a period of 1,5 years per site. The patient follow-up visits are expected to be completed 2 years after recruitment of the last participant. Survivorship will be collected until 10 years after the recruitment of the last participant.\n\nParticipants are seen on an outpatient basis at 3 months and 1 and 2 years postoperatively.\n\nAfter the 2 year follow-up visit the patients recruited in the Scandinavian sites will be followed for survivorship through the National Knee Arthroplasty Registries at 5, 7 and 10 years postoperatively. Since France does not have a national registry, the French site will also perform 5 year follow-up visits.', 'detailedDescription': "The investigators will retain the subject data sources, case report forms (CRFs) and electronic-CRFs in accordance with local laws and regulations.\n\nThe enrollment is competitive between the participating centers. Project information and consent according to local requirements before surgery is completed.\n\nSurgery is performed as described in the manufacturer's surgical technique. A senior surgeon dedicated to total knee arthroplasty surgery will perform all operations with an assistant.\n\nParticipants will receive standard pain treatment and rehabilitation until discharge."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Any patient planned for primary total knee arthroplasty (TKA) on orthopedic surgeons' waiting list may be asked and selected for the study.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical and radiological osteoarthritis of the knee set to receive a primary unilateral total knee replacement\n\nExclusion Criteria:\n\n* Patients who are unwilling or unable to give consent, or to comply with the follow-up program.\n* Patients that meet any contraindications listed in the Instruction for Use'}, 'identificationModule': {'nctId': 'NCT03495232', 'briefTitle': 'Persona Cohort Nordic Multicenter Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'A Multicenter Prospective Cohort Study on Persona Total Knee System', 'orgStudyIdInfo': {'id': 'K.CR.I.EU.15.13 Cohort'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Zimmer Biomet Persona total knee system', 'type': 'DEVICE', 'description': 'Product manufactured by Zimmer Biomet used to replace the knee joint.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital, Hvidovre', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '35760', 'city': 'Saint-Grégoire', 'country': 'France', 'facility': "Institute Locomoteur de L'Ouest", 'geoPoint': {'lat': 48.15101, 'lon': -1.68579}}, {'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}, {'city': 'Motala', 'country': 'Sweden', 'facility': 'Ortopedic Clinic, Motala Specialist Care Capio AB', 'geoPoint': {'lat': 58.53706, 'lon': 15.03649}}], 'overallOfficials': [{'name': 'Anders Troelsen, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Copenhagen University Hospital, Hvidovre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}