Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-10 @ 1:40 AM
Study NCT ID:
NCT06699134
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2024-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hi-Fatigue G Bone Cement Retrospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}, {'id': 'D019644', 'term': 'Arthroplasty, Replacement, Hip'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2024-11-19', 'studyFirstSubmitQcDate': '2024-11-19', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic evaluation', 'timeFrame': 'From enrollment to the 5 year post-op follow up.', 'description': 'Detection of radiolucent lines around the implant components (tibial, femoral, acetabular) at 5 years (in accordance with the hospital standard of care).'}], 'secondaryOutcomes': [{'measure': 'Survivorship', 'timeFrame': 'From enrollment to the 5 year post-op follow up.', 'description': 'Evaluation of implant survivorship and safety by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.'}, {'measure': 'Patient reported outcome measures (PROM)', 'timeFrame': 'From enrollment to the 5 year post-op follow up.', 'description': 'Evaluation of PROMs, collected in accordance with the hospital standard of care.'}, {'measure': 'Cement Information', 'timeFrame': 'From enrollment to the 5 year post-op follow up.', 'description': 'Obtain information regarding the cementing technique and handling of the cement, if available'}]}, 'conditionsModule': {'keywords': ['Bone Cement', 'Knee Arthroplasty', 'Hip Arthroplasty'], 'conditions': ['Total Hip and Knee Arthroplasties']}, 'descriptionModule': {'briefSummary': 'The objective of this retrospective monocentric study is to collect survivorship and clinical data confirming safety, performance and clinical benefits for the Hi-Fatigue G Bone Cement.\n\nThe assessments will include:\n\n* Radiological analysis performed at different time points according to the standard of care of the hospital\n* Implant survivorship and safety based on removal of a study device\n* Patient reported outcome measures (PROMs)\n\nPrimary endpoint:\n\nAssessment of radiolucent lines around the components (tibial, femoral, acetabular) at 5 years (in accordance with the hospital standard of care).\n\nSecondary endpoints:\n\n* Evaluation of implant survivorship and safety by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.\n* Evaluation of PROMs\n* Obtain information regarding the cementing technique and handling of the cement, if available'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients operated with primary total knee or hip replacement using Hi-Fatigue G Bone Cement, a Zimmer Biomet implant, and who meet the inclusion / exclusion criteria for study participation.\n\nTwo consecutive groups of patients that underwent cemented TKA or THA according to the instructions for use of both the respective implant and of Hi-Fatigue G Bone Cement.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject qualified for cemented TKA or THA with a Zimmer Biomet implant\n* Subject is willing and able to give written informed consent for retrospective data collection and undergo interim and final evaluation (X-Ray \\& Scores completion)\n* Subject \\> 18 years old\n\nExclusion Criteria:\n\n* Muscle wasting\n* Neuromuscular compromise in the affected limb\n* Known hypersensitivity to any of the cement constituents\n* Subjects with severe renal failure\n* Bilateral interventions\n* Subject is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, known alcohol or drug abuser, anticipated to be non-compliant)'}, 'identificationModule': {'nctId': 'NCT06699134', 'briefTitle': 'Hi-Fatigue G Bone Cement Retrospective Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'Evaluation of Hi-Fatigue G Bone Cement With Gentamicin A Retrospective Data Collection', 'orgStudyIdInfo': {'id': 'CME2020-38C'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with TKA', 'description': 'Patients with primary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant', 'interventionNames': ['Device: Total knee arthroplasty']}, {'label': 'Patients with THA', 'description': 'Patients with primary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant', 'interventionNames': ['Device: Total Hip arthroplasty']}], 'interventions': [{'name': 'Total knee arthroplasty', 'type': 'DEVICE', 'description': 'Primary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant', 'armGroupLabels': ['Patients with TKA']}, {'name': 'Total Hip arthroplasty', 'type': 'DEVICE', 'description': 'Primary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant', 'armGroupLabels': ['Patients with THA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92637', 'city': 'Weiden', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christian von Rüden', 'role': 'CONTACT', 'email': 'christian.vonrueden@kno.ag', 'phone': '00490961 303-0'}], 'facility': 'Klinikum Weiden', 'geoPoint': {'lat': 49.67682, 'lon': 12.15613}}], 'centralContacts': [{'name': 'Miguel Correa-Tapia', 'role': 'CONTACT', 'email': 'Miguel.CorreaTapia@zimmerbiomet.com', 'phone': '+41791522905'}, {'name': 'Linda Meijer', 'role': 'CONTACT', 'email': 'linda.meijer@zimmer.com', 'phone': '+31657933741'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}