Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2026-01-30 @ 11:12 PM
Study NCT ID:
NCT02831595
Status:
TERMINATED
Last Update Posted:
2019-10-23
First Post:
2016-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Titanium Niobium Nitride Coating in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Enrollment stopped for missing availability of the site', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-21', 'studyFirstSubmitDate': '2016-06-29', 'studyFirstSubmitQcDate': '2016-07-08', 'lastUpdatePostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline plasma metal ion concentrations (Co, Cr, Ni) at 12 months', 'timeFrame': 'Preoperative and at 12 months follow-up'}], 'secondaryOutcomes': [{'measure': 'Number of patients with metal sensitivity at 1 year tested by patch-testing', 'timeFrame': '1 year follow-up'}]}, 'conditionsModule': {'conditions': ['Knee Arthritis']}, 'descriptionModule': {'briefSummary': 'Modern knee implants combine several types of metal and therefore potentially expose patients to different metal ions.\n\nTitanium niobium nitride coating (TiNbN) acts like a physical barrier against the corrosion process and the metallic ions release towards the surrounding biologic environment, thus, making TiNbN-coated prostheses possible to be safety implanted in metal sensitized patients.\n\nThe aim of the study is to verify that the postoperative plasma metal concentrations at 1 year are not different than preoperative values.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosis of knee osteoarthritis scheduled for unilateral TKA', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients candidate for unilateral primary total knee arthroplasty\n\nExclusion Criteria:\n\n* Existing orthopaedic metal implants\n* A history of hypersensitivity to metals\n* Preoperative patch-test positivity to Co, Cr, Ni and Ti\n* Malignancies\n* Renal insufficiency\n* Severe illnesses that would impair participation in this study'}, 'identificationModule': {'nctId': 'NCT02831595', 'briefTitle': 'Effectiveness of Titanium Niobium Nitride Coating in Total Knee Arthroplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Permedica spa'}, 'orgStudyIdInfo': {'id': 'VCG-30-2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing unilateral TKA', 'interventionNames': ['Device: GKS Prime Flex Bioloy by Permedica, a TiNbN coated fixed-bearing cruciate-retaining total knee prosthesis']}], 'interventions': [{'name': 'GKS Prime Flex Bioloy by Permedica, a TiNbN coated fixed-bearing cruciate-retaining total knee prosthesis', 'type': 'DEVICE', 'armGroupLabels': ['Patients undergoing unilateral TKA']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nicola Ursino, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Istituto Ortopedico Galeazzi Milano, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Permedica spa', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}