Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2026-01-03 @ 2:31 AM
Study NCT ID:
NCT00116051
Status:
COMPLETED
Last Update Posted:
2009-07-07
First Post:
2005-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Two Surface Materials (Tantalum Versus Titanium Fiber Mesh) of Acetabular Components in Hip Arthroplasty
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2006-04'}, 'lastUpdateSubmitDate': '2009-07-06', 'studyFirstSubmitDate': '2005-06-26', 'studyFirstSubmitQcDate': '2005-06-26', 'lastUpdatePostDateStruct': {'date': '2009-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acetabular component migration evaluated by RSA'}], 'secondaryOutcomes': [{'measure': 'BMD in the surrounding bone of the acetabular implant'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['RSA', 'DEXA', 'Osteoarthritis', 'Hip arthroplasty'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two surface materials (tantalum versus titanium fiber mesh) of acetabular components in hip arthroplasty.', 'detailedDescription': 'In younger patients, acetabulum components are most often implanted without the use of cement. A direct ingrowth of bone to the implant is crucial to the attainment of good results in those cases where cement is not employed. A new implant material (tantalum) has shown better properties than the implant material which is in use today (titanium). The advantages of tantalum implants are greater porosity, reduced stiffness and a higher friction coefficient than with titanium implants.\n\nHypothetically, the higher porosity of tantalum should enhance bone ingrowth due to better osteoconductivity in terms of:\n\n1. less migration of the acetabulum component, as evaluated by RSA;\n2. increased BMD in the bone surrounding acetabulum components;\n3. fewer postoperative complaints on the Harris Hip Score and visual analog scale scores.\n\nThe migration of acetabulum components will be evaluated by RSA. The follow-up RSA will be scheduled for week 1, as well as 3 months, 12 months and 2 years after surgery. Bone mineral density around the implanted femoral component will be examined by DEXA scan at week 1, as well as 1 year and 2 years after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with primary arthritis in the hip.\n* Patients with sufficient bone density to allow uncemented implantation of a femoral component.\n* Informed patient consent in writing.\n\nExclusion Criteria:\n\n* Patients with neuromuscular or vascular disease in the affected leg.\n* Patients found upon operation to be unsuited for uncemented acetabulum component.\n* Patients who regularly take non-steroid anti-inflammatory drugs (NSAID) and cannot interrupt intake for the postoperative phase of the study.\n* Patients with fracture sequelae.\n* Female patients of childbearing capacity.\n* Hip joint dysplasia.\n* Sequelae to previous hip joint disorder in childhood.'}, 'identificationModule': {'nctId': 'NCT00116051', 'briefTitle': 'A Comparison of Two Surface Materials (Tantalum Versus Titanium Fiber Mesh) of Acetabular Components in Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'A Comparison of Two Surface Materials (Tantalum Versus Titanium Fiber Mesh) of Acetabular Components in Hip Arthroplasty', 'orgStudyIdInfo': {'id': '200330159'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Acetabular implant, Monoblock cup', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Orthopaedic Center, Aarhus University Hospital,', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Kjeld Søballe, MD., Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aalborg University Hospital', 'class': 'OTHER'}, {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Professor Kjeld Soballe', 'oldOrganization': 'Aarhus University Hospital, Tage-Hansens Gade 2, 8000 Aarhus C'}}}}