Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-26 @ 12:39 AM
Study NCT ID:
NCT00214760
Status:
TERMINATED
Last Update Posted:
2010-02-01
First Post:
2005-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Polymethyl Methacrylate and (PEGT/PBT) Centralizer by the Uncemented BIHAPRO THP
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'whyStopped': 'On of the liners has been taken from the market', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-01-29', 'studyFirstSubmitDate': '2005-09-16', 'studyFirstSubmitQcDate': '2005-09-16', 'lastUpdatePostDateStruct': {'date': '2010-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alignment', 'timeFrame': '0,3,6,12,24 months'}, {'measure': 'Complications', 'timeFrame': 'all time points'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': '0,3,6,12,24 months'}, {'measure': 'Function', 'timeFrame': '0,3,6,12,24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hip prosthesis', 'Centralizer', 'Uncemented'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '10580823', 'type': 'RESULT', 'citation': 'Hernandez-Vaquero D, Murcia-Mazon A, Paz-Jimenez J, Alegre-Mateo R, Martinez-Garcia J, Pena-Vazquez J. Behavior of the femoral stem in the Bihapro hip prosthesis. Orthopedics. 1999 Nov;22(11):1049-53. doi: 10.3928/0147-7447-19991101-13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to analyse if the alignment of the stem and the number of complications of the new resorbable PEGT/PBT centralizer are comparable to the standard PMMA centralizer during the placement of an uncemented Bihapro hip prosthesis.', 'detailedDescription': 'For a correct placement and early fixation of an uncemented hip prosthesis, a centralizer is used. Normally, the centralizer is made of PMMA, the same material as bone cement. When a revision is needed, PMMA is difficult to remove, which is one of the reason not to use a cemented hip prosthesis. With a PMMA centralizer, still PMMA will remain in the bone and needs to be removed in case of a revision. PEGT/PBT is a reabsorbable material, which gives stability during the first month after the placement of the hip prosthesis. However, PEGT/PBT is reabsorped afterwards and, therefore, will not interfere with a revision procedure.\n\nThe goal of this study is to analyse if the PEGT/PBT is as safe as PMMA in terms of alignment, direct postoperative complications and clinical results.\n\nTherefore, 100 patients indicated for a cementless Bihapro hip prosthesis which have signed an informed consent are included and randomised over the used centralizers using a weighted randomisation method. All patients will be treated equally. The patients are examined preoperatively, 1 day, 6 weeks, 3, 6, 12, 24 en 48 months postoperatively using an X-ray, the Harris hip score and a patient questionnaire, the Womac and SF36.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 75 years\n* Diagnosis: Osteoarthritis\n* Indicated for a primary hip prosthesis\n\nExclusion Criteria:\n\n* Previous hip surgery\n* No informed consent\n* Active infection in hip\n* Immature skeleton\n* Rheumatoid arthritis, M. Paget'}, 'identificationModule': {'nctId': 'NCT00214760', 'briefTitle': 'Polymethyl Methacrylate and (PEGT/PBT) Centralizer by the Uncemented BIHAPRO THP', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biomet Nederland BV'}, 'officialTitle': 'Phase 3 Randomised, Prospective Study Comparing the PMMA and the Resorbable PEGT/PBT Centralizer by the Uncemented BIHAPRO Total Hip Prosthesis', 'orgStudyIdInfo': {'id': 'BMBL_2005_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PGET', 'interventionNames': ['Device: PGET']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PMMA', 'interventionNames': ['Device: PMMA']}], 'interventions': [{'name': 'PGET', 'type': 'DEVICE', 'otherNames': ['resolbable liner'], 'description': 'resolbable liner', 'armGroupLabels': ['PGET']}, {'name': 'PMMA', 'type': 'DEVICE', 'otherNames': ['cement liner'], 'description': 'cement liner', 'armGroupLabels': ['PMMA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6401CX', 'city': 'Heerlen', 'country': 'Netherlands', 'facility': 'Atrium medical centre', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}], 'overallOfficials': [{'name': 'Joanne Bloemsaat-Minekus, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Biomet Nederland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biomet Nederland BV', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Atrium Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Meijers', 'oldOrganization': 'Atrium medisch centrum'}}}}