Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT00883805
Status:
WITHDRAWN
Last Update Posted:
2015-09-17
First Post:
2009-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of Systemic Metal Ion Concentration Following a Ceramic-on-metal Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010014', 'term': 'Osteolysis'}], 'ancestors': [{'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI moved', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'lastUpdateSubmitDate': '2015-09-16', 'studyFirstSubmitDate': '2009-04-17', 'studyFirstSubmitQcDate': '2009-04-17', 'lastUpdatePostDateStruct': {'date': '2015-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'metal ion concentration in urine', 'timeFrame': '1 year post-op'}], 'secondaryOutcomes': [{'measure': 'metal ion concentration in blood', 'timeFrame': '1 year post-op'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metal Ion Concentration', 'Osteolysis'], 'conditions': ['Hip Replacement', 'Hip Implant', 'Total Hip Arthroplasty', 'Orthopaedic Surgery']}, 'descriptionModule': {'briefSummary': 'This is a pilot study to compare systemic concentrations of cobalt and chromium in patients that have previously undergone total hip arthroplasties with ceramic on metal and metal on metal bearing surfaces.', 'detailedDescription': 'This is a pilot study to compare systemic concentrations of cobalt and chromium in patients that have previously undergone total hip arthroplasties with ceramic on metal and metal on metal bearing surfaces. Secondary goals include an assessment of osteolysis on radiographs, potential long term analysis of implant survivability, and cancer rates in the two patient populations.\n\nIncreased metal ion production has been documented in metal-on-metal arthroplasty articulations. There are several concerns over metal ion production. First, even though there is a decreased histiocytic response to metallic debris, a dose dependent cytotoxic response with Interleukin 6, Prostaglandin E2, and Tumor Necrosis Factor alpha persists and may cause osteolysis in the long term. Second, increased levels of cobalt, chromium and nickel has been shown to correlate with increased cancer rates in several animal models, and the carcinogenic risk in humans has not been fully elucidated as yet. Third, hypersensitivity reactions to metal ion develop in up to 25% of these patients, and 60% of patients with poorly functioning hip.\n\nCeramic on metal avoids many of these problems due to the improved wear characteristics. If the level of metal ion production is significantly reduced and the implant survivability is proven in long term studies, this articulation may become the preferred method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects enrolled will have already undergone a total hip arthroplasty with either a metal-on-metal articulation, or a ceramic-on-metal articulation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is 40 - 80, who has undergone a top hip arthroplasty with either metal on metal or ceramic on metal articulation for a diagnosis of non-inflammatory degenerative joint disease. We will also include subjects who have had bilateral hip arthroplasties or a second arthroplasty performed since the initial surgery.\n* Patient must be able to provide consent to participate\n\nExclusion Criteria:\n\n* Diagnosis other than non-inflammatory degenerative joint disease, chronic renal insufficiency, or any systemic inflammatory condition\n* Evidence of active infections\n* Patients whose occupations include welding or metal working\n* A second arthroplasty performed since the initial will not be exclude, but their data will be analyzed as a subpopulation\n* unwillingness to comply with rehabilitation program or inability to return for follow-up visits\n* Any systemic steroid therapy within 3 months of surgery\n* Subjects who are pregnant'}, 'identificationModule': {'nctId': 'NCT00883805', 'briefTitle': 'Investigation of Systemic Metal Ion Concentration Following a Ceramic-on-metal Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Investigation of Systemic Metal Ion Concentration Following a Ceramic-on-metal Total Hip Arthroplasty', 'orgStudyIdInfo': {'id': 'GCRC 0163'}, 'secondaryIdInfos': [{'id': 'IRB# 07-08-105'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Metal-on-Metal Articulations', 'description': 'Subjects will be people who have had metal-on-metal total hip arthroplasties', 'interventionNames': ['Biological: Blood draw', 'Radiation: X-Ray of Hip']}, {'label': 'Ceramic-on-Metal Articulations', 'description': 'Subjects will be people who have had ceramic-on-metal total hip arthroplasties', 'interventionNames': ['Biological: Blood draw', 'Radiation: X-Ray of Hip']}], 'interventions': [{'name': 'Blood draw', 'type': 'BIOLOGICAL', 'description': 'Subjects will give blood for analysis of metal ion concentrations', 'armGroupLabels': ['Ceramic-on-Metal Articulations', 'Metal-on-Metal Articulations']}, {'name': 'X-Ray of Hip', 'type': 'RADIATION', 'description': 'Subject will have x-ray of hip to assessment of osteolysis', 'armGroupLabels': ['Ceramic-on-Metal Articulations', 'Metal-on-Metal Articulations']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Feinstein Institute for Medical Research', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}], 'overallOfficials': [{'name': 'Daniel Grande, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Feinstein Institute for Medical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director:orthopaedic research', 'investigatorFullName': 'Daniel Grande', 'investigatorAffiliation': 'Northwell Health'}}}}