Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT00962351
Status:
COMPLETED
Last Update Posted:
2015-08-17
First Post:
2009-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metal Ion Release From an FDA-Approved Metal-on-Metal Total Hip Replacement Implant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-14', 'studyFirstSubmitDate': '2009-08-19', 'studyFirstSubmitQcDate': '2009-08-19', 'lastUpdatePostDateStruct': {'date': '2015-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cobalt, chromium, and titanium ion levels in blood and urine', 'timeFrame': 'Pre-op, 6 months, 1 year, 2 years, 3 years, 5 years'}], 'secondaryOutcomes': [{'measure': 'Hip function', 'timeFrame': 'Pre-op, 6 months,1 year, 2 years, 3 years, 5 years'}, {'measure': 'Durability', 'timeFrame': '6 months, 1 year, 2 years, 3 years, 5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['total hip replacement', 'primary cementless total hip arthroplasty', 'metal ion', 'metal-on-metal'], 'conditions': ['Non-inflammatory Degenerative Joint Disease']}, 'referencesModule': {'references': [{'pmid': '18855089', 'type': 'RESULT', 'citation': 'Engh CA Jr, MacDonald SJ, Sritulanondha S, Thompson A, Naudie D, Engh CA. 2008 John Charnley award: metal ion levels after metal-on-metal total hip arthroplasty: a randomized trial. Clin Orthop Relat Res. 2009 Jan;467(1):101-11. doi: 10.1007/s11999-008-0540-9. Epub 2008 Oct 15.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center, randomized study to compare blood and urine cobalt, chromium, and titanium ion levels of a metal-on-metal articular bearing coupled with two different head sizes to that of a conventional metal-on-polyethylene bearing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Undergoing cementless primary total hip replacement\n* Receiving acetabular cup of 52mm or greater\n* Preoperative level of function and pain same as for conventional hip replacement\n* Likelihood of obtaining relief of pain and improved function\n* Full skeletal maturity\n* Ability to follow instructions\n* Good general health\n* Willing to return for follow-up evaluations\n* X-ray evaluation confirming the presence of NIDJD\n* Femoral and acetabular bone stock that is sufficient, regarding strength and shape, and suitable to receive the implants\n\nExclusion Criteria:\n\n* Age less than 40 years or greater than 80 years at time of surgery\n* Patients templated to receive an acetabular component smaller than 52mm in diameter\n* Presence of a previous prosthetic hip replacement device in the hip joint to be operated\n* Previous girdlestone procedure or surgical fusion of the hip to be operated\n* Acute femoral neck fracture\n* Above knee amputation of the contralateral and/or ipsilateral leg\n* Patients with a diagnosis of inflammatory degenerative arthritis\n* Skeletally immature\n* Evidence of active infections that may spread to other areas of the body\n* The presence of a highly communicable disease that may limit follow-up\n* Presence of known active metastatic or neoplastic disease\n* Significant neurologic or musculoskeletal disorders or disease that may adversely affect gait or weightbearing\n* Any previous hip surgery or conditions that may interfere with the total hip replacement's survival or outcome\n* Any patient believed to be unwilling or unable to comply with a rehabilitation program for a cementless total hip replacement or indicates difficulty to return for follow-up\n* Patient is know to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser\n* Any patient who qualifies for inclusion in the study but refuses consent to participate in the study\n* Any steroid therapy, local or systemic, within three months prior to surgery\n* Patient requiring structural bone grafts in order to support the prosthetic components or to shape the bone to receive the implants\n* Patient has known allergies to metal, e.g., jewelry\n* Any patient not meeting all radiographic and clinical parameters for inclusion"}, 'identificationModule': {'nctId': 'NCT00962351', 'briefTitle': 'Metal Ion Release From an FDA-Approved Metal-on-Metal Total Hip Replacement Implant', 'organization': {'class': 'OTHER', 'fullName': 'Anderson Orthopaedic Research Institute'}, 'officialTitle': 'Metal Ion Release From an FDA Approved Metal-on-Metal Hip Replacement Implant: A Multi-Center, Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'AORI2009-0100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Metal-on-Polyethylene', 'interventionNames': ['Procedure: Total Hip Replacement']}, {'type': 'OTHER', 'label': 'Metal-on-Metal, 28mm femoral head', 'interventionNames': ['Procedure: Total Hip Replacement']}, {'type': 'OTHER', 'label': 'Metal-on-Metal, 36mm femoral head', 'interventionNames': ['Procedure: Total Hip Replacement']}], 'interventions': [{'name': 'Total Hip Replacement', 'type': 'PROCEDURE', 'armGroupLabels': ['Metal-on-Metal, 28mm femoral head', 'Metal-on-Metal, 36mm femoral head', 'Metal-on-Polyethylene']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22306', 'city': 'Alexandria', 'state': 'Virginia', 'country': 'United States', 'facility': 'Anderson Orthopaedic Research Institute', 'geoPoint': {'lat': 38.80484, 'lon': -77.04692}}, {'zip': 'N6A5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Department of Orthopaedic Surgery, University of Western Ontario', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'C. Anderson Engh, Jr., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anderson Orthopaedic Research Institute'}, {'name': 'Steven J. MacDonald, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthopaedic Surgery, University of Western Ontario'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anderson Orthopaedic Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Western Ontario, Canada', 'class': 'OTHER'}, {'name': 'DePuy Orthopaedics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopaedic Surgeon', 'investigatorFullName': 'C. Anderson Engh, Jr., MD', 'investigatorAffiliation': 'Anderson Orthopaedic Research Institute'}}}}