Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-31 @ 11:34 AM
Study NCT ID:
NCT00588861
Status:
TERMINATED
Last Update Posted:
2017-01-27
First Post:
2007-12-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nicholas.higdon@biomet.com', 'phone': '1-800-348-9500', 'title': 'Nick Higdon, Clinical Research Specialist', 'phoneExt': '3047', 'organization': 'Biomet Manufacturing'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can conduct a pre-publication review of articles, papers, or presentations which the PI desires to publish. Any such review must be completed by sponsor within thirty (30)days of the submission of the request. The PI must include whatever credits the sponsor deems necessary or appropriate to disclose its proprietary interest to the material disclosed in the article, paper or presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Study was terminated prematurely after sponsor no longer distributed the products involved and follow-up failed to produce sufficient data to be analyzed.'}}, 'adverseEventsModule': {'timeFrame': '8 Years', 'eventGroups': [{'id': 'EG000', 'title': 'Answer Stem Utilizing Simplex Cement', 'description': 'Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics', 'otherNumAtRisk': 202, 'otherNumAffected': 0, 'seriousNumAtRisk': 202, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Answer Stem Utilizing Palacos Cement', 'description': 'Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.', 'otherNumAtRisk': 200, 'otherNumAffected': 0, 'seriousNumAtRisk': 200, 'seriousNumAffected': 8}], 'seriousEvents': [{'term': 'Dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 31, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Femoral loosening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep infection < 6 weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep infection > 6 weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Femoral, acetabular loosening and instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Revision with all components removed and re-implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'I&D, exchange of poly liner', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Harris Hip Score Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Answer Stem Utilizing Simplex Cement', 'description': 'Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics'}, {'id': 'OG001', 'title': 'Answer Stem Utilizing Palacos Cement', 'description': 'Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.'}], 'classes': [{'title': 'Pre-Operative Harris Hip Score Pain', 'categories': [{'measurements': [{'value': '15.89', 'spread': '7.64', 'groupId': 'OG000'}, {'value': '14.74', 'spread': '7.78', 'groupId': 'OG001'}]}]}, {'title': '6 Month Harris Hip Score Pain', 'categories': [{'measurements': [{'value': '39.78', 'spread': '4.06', 'groupId': 'OG000'}, {'value': '36.25', 'spread': '9.69', 'groupId': 'OG001'}]}]}, {'title': '1 Year Harris Hip Score Pain', 'categories': [{'measurements': [{'value': '37.89', 'spread': '9.54', 'groupId': 'OG000'}, {'value': '37.76', 'spread': '9.24', 'groupId': 'OG001'}]}]}, {'title': '2 Year Harris Hip Score Pain', 'categories': [{'measurements': [{'value': '36.93', 'spread': '9.47', 'groupId': 'OG000'}, {'value': '34.59', 'spread': '10.54', 'groupId': 'OG001'}]}]}, {'title': '4 Year Harris Hip Score Pain', 'categories': [{'measurements': [{'value': '38.38', 'spread': '9.78', 'groupId': 'OG000'}, {'value': '41.27', 'spread': '4.22', 'groupId': 'OG001'}]}]}, {'title': '6 Year Harris Hip Score Pain', 'categories': [{'measurements': [{'value': '44.00', 'spread': '0', 'groupId': 'OG000'}, {'value': '42.00', 'spread': '2.83', 'groupId': 'OG001'}]}]}, {'title': '8 Year Harris Hip Score Pain', 'categories': [{'measurements': [{'value': '37.00', 'spread': '9.90', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No patients were analyzed at this time interval', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year', 'description': 'Harris Hip Score Pain is detailed below as mean score for the Harris Hip Score Pain question. 44 being the highest score, and 0 being the lowest score. 44 is considered "None/Ignores." 40 is considered "Slight/Occasional." 30 is considered "Mild." 20 is considered "Moderate." 10 is considered "Marked." 0 is considered "Totally Disabled."', 'unitOfMeasure': 'Mean Hip Pain', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This population represents patients that returned for follow-up per protocol.'}, {'type': 'PRIMARY', 'title': 'Harris Hip Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Answer Stem Utilizing Simplex Cement', 'description': 'Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics'}, {'id': 'OG001', 'title': 'Answer Stem Utilizing Palacos Cement', 'description': 'Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.'}], 'classes': [{'title': 'Score of 90-100'}, {'title': 'Score of 80-89'}, {'title': 'Score of 70-79'}, {'title': 'Score of <70'}], 'timeFrame': '10 Years Post-Operative', 'description': 'The Harris Hip Score is detailed below as a range. 100 being the highest score, and 0 being the lowest score. 90-100 is considered "Excellent." 80-89 is considered "Good." 70-79 is considered "Fair." Less than 70 is considered "Poor."', 'reportingStatus': 'POSTED', 'populationDescription': 'This population represents patients that returned for follow-up per protocol. Because no patients returned at the primary outcome measure time frame (10 years), 0 patients were analyzed at 10 years.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Answer Stem Utilizing Simplex Cement', 'description': 'Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics'}, {'id': 'FG001', 'title': 'Answer Stem Utilizing Palacos Cement', 'description': 'Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.'}], 'periods': [{'title': 'Pre-Operative', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '202 Patients were enrolled, however only 107 contributed preop data.', 'groupId': 'FG000', 'numSubjects': '202'}, {'comment': '200 patients were enrolled, however only 114 contributed preop data.', 'groupId': 'FG001', 'numSubjects': '200'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '86'}]}], 'dropWithdraws': [{'type': 'Patients Did Not Complete Preop Data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '86'}]}]}, {'title': '6 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '107 cases were due at 6 Months, however only 9 returned for follow-up.', 'groupId': 'FG000', 'numSubjects': '107'}, {'comment': '114 cases were due at 6 Months, however only 41 returned for follow-up.', 'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '73'}]}], 'dropWithdraws': [{'type': 'Patients did not return for follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '73'}]}]}, {'title': '1 Year', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '107 cases were due at 1 Year, however only 18 returned for follow-up.', 'groupId': 'FG000', 'numSubjects': '107'}, {'comment': '114 cases were due at 1 Year, however only 32 returned for follow-up.', 'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '82'}]}], 'dropWithdraws': [{'type': 'Patients did not return for follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '82'}]}]}, {'title': '2 Years', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '107 cases were due at 2 Years, however only 15 returned for follow-up.', 'groupId': 'FG000', 'numSubjects': '107'}, {'comment': '114 cases were due at 2 Years, however only 27 returned for follow-up.', 'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '87'}]}], 'dropWithdraws': [{'type': 'Patients did not return for follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '87'}]}]}, {'title': '4 Years', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '107 cases were due at 4 Years, however only 16 returned for follow-up.', 'groupId': 'FG000', 'numSubjects': '107'}, {'comment': '114 cases were due at 4 Years, however only 11 returned for follow-up.', 'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '103'}]}], 'dropWithdraws': [{'type': 'Patients did not return for follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '103'}]}]}, {'title': '6 Years', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '107 cases were due at 6 Years, however only 3 returned for follow-up.', 'groupId': 'FG000', 'numSubjects': '107'}, {'comment': '114 cases were due at 6 Years, however only 5 returned for follow-up.', 'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '109'}]}], 'dropWithdraws': [{'type': 'Patients did not return for follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '109'}]}]}, {'title': '8 Years', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '107 cases were due at 8 Years, however only 2 returned for follow-up.', 'groupId': 'FG000', 'numSubjects': '107'}, {'comment': '114 cases were due at 8 Years, however no patients returned for follow-up.', 'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '114'}]}], 'dropWithdraws': [{'type': 'Patients did not return for follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '114'}]}]}, {'title': '10 Years', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '107 cases were due at 10 Years, however no patients returned for follow-up.', 'groupId': 'FG000', 'numSubjects': '107'}, {'comment': '114 cases were due at 10 Years, however no patients returned for follow-up.', 'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '114'}]}], 'dropWithdraws': [{'type': 'Incomplete due to study termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '114'}]}]}], 'recruitmentDetails': 'Patients were recruited by the investigator based on the FDA cleared inclusion/exclusion criteria in the protocol.', 'preAssignmentDetails': 'The patients were assigned to each group according to the bone cement used with the implant.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '402', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Answer Stem Utilizing Simplex Cement', 'description': 'Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics'}, {'id': 'BG001', 'title': 'Answer Stem Utilizing Palacos Cement', 'description': 'Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000', 'lowerLimit': '46', 'upperLimit': '93'}, {'value': '76', 'groupId': 'BG001', 'lowerLimit': '54', 'upperLimit': '95'}, {'value': '75', 'groupId': 'BG002', 'lowerLimit': '46', 'upperLimit': '95'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '269', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'whyStopped': 'Study was terminated due to insufficient data and lack of patient follow-up', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-26', 'studyFirstSubmitDate': '2007-12-19', 'resultsFirstSubmitDate': '2010-06-14', 'studyFirstSubmitQcDate': '2008-01-02', 'lastUpdatePostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-01-12', 'studyFirstPostDateStruct': {'date': '2008-01-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Harris Hip Score', 'timeFrame': '10 Years Post-Operative', 'description': 'The Harris Hip Score is detailed below as a range. 100 being the highest score, and 0 being the lowest score. 90-100 is considered "Excellent." 80-89 is considered "Good." 70-79 is considered "Fair." Less than 70 is considered "Poor."'}], 'secondaryOutcomes': [{'measure': 'Harris Hip Score Pain', 'timeFrame': 'Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year', 'description': 'Harris Hip Score Pain is detailed below as mean score for the Harris Hip Score Pain question. 44 being the highest score, and 0 being the lowest score. 44 is considered "None/Ignores." 40 is considered "Slight/Occasional." 30 is considered "Mild." 20 is considered "Moderate." 10 is considered "Marked." 0 is considered "Totally Disabled."'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Hip', 'Traumatic Arthritis of Hip']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to document the clinical outcomes of several devices used in total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular shell, and Simplex® or Palacos® bone cement.', 'detailedDescription': 'The purpose of this study is to document the clinical outcomes of several devices used in total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular shell, and Simplex® or Palacos® bone cement. It was desirable to see if there were any differences in the outcomes of two different types of bone cement in application.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis\n* Rheumatoid arthritis\n* Correction of functional deformity\n* Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques\n\nExclusion Criteria:\n\n* Infection, sepsis, and osteomyelitis'}, 'identificationModule': {'nctId': 'NCT00588861', 'briefTitle': 'Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Acetabular Shell Using Simplex® or Palacos® Bone Cement', 'orgStudyIdInfo': {'id': '101-U-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Answer® hip stem with Simplex Cement', 'description': 'Femoral stem replacement with Answer® hip stem \\& Simplex Bone Cement', 'interventionNames': ['Device: Answer® hip stem']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Answer® hip stem with Palacos Cement', 'description': 'Femoral stem replacement with Answer® hip stem \\& Palacos Bone Cement', 'interventionNames': ['Device: Answer® hip stem']}], 'interventions': [{'name': 'Answer® hip stem', 'type': 'DEVICE', 'otherNames': ['Answer Hip Stem', 'Simplex Bone Cement'], 'description': 'Total hip replacement using Palacos® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.', 'armGroupLabels': ['Answer® hip stem with Palacos Cement', 'Answer® hip stem with Simplex Cement']}, {'name': 'Answer® hip stem', 'type': 'DEVICE', 'otherNames': ['Answer Hip Stem', 'Palacos Bone Cement'], 'description': 'Total hip replacement using Simplex® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.', 'armGroupLabels': ['Answer® hip stem with Palacos Cement', 'Answer® hip stem with Simplex Cement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46581', 'city': 'Warsaw', 'state': 'Indiana', 'country': 'United States', 'facility': 'Biomet Orthopedics, LLC', 'geoPoint': {'lat': 41.2381, 'lon': -85.85305}}], 'overallOfficials': [{'name': 'Ken Beres, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zimmer Biomet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biomet Orthopedics, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}