Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-01-04 @ 5:36 PM
Study NCT ID:
NCT00579059
Status:
TERMINATED
Last Update Posted:
2017-07-17
First Post:
2007-12-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Maxim® Knee Pop-Top® Tibia vs. Regular Maxim® Knee Tibia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'megan.lawson@biomet.com', 'phone': '1-800-348-9500', 'title': 'Megan Lawson, Clinical Research Specialist', 'phoneExt': '1183', 'organization': 'Biomet, LLC'}, 'certainAgreement': {'otherDetails': 'Biomet owns copyright to database.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Study was terminated after enrollment failed to produce sufficient data to be analyzed.'}}, 'adverseEventsModule': {'timeFrame': 'Not applicable - no adverse events were reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Maxim® Pop-Top® Tibia', 'description': 'tibia with removable polyethylene', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Maxim® Regular Tibia', 'description': 'Tibia with Modular Polyethylene', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Knee Society Function Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maxim® Pop-Top® Tibia', 'description': 'tibia with removable polyethylene'}, {'id': 'OG001', 'title': 'Maxim® Regular Tibia', 'description': 'Tibia with Modular Polyethylene'}], 'classes': [{'title': '90-100', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '60-89', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '30-59', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '0-29', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 Year', 'description': 'The function score is detailed below as a Range; 100 being the highest score, and 0 being the lowest score. 90-100 is considered "Excellent," 60-89 is considered "Good," 30-59 is considered "fair," and 0-29 is considered "poor."', 'unitOfMeasure': 'knees', 'reportingStatus': 'POSTED', 'populationDescription': 'This population represents patients that returned for follow-up at 1-year post-op per protocol.'}, {'type': 'SECONDARY', 'title': 'Range of Motion - Flexion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maxim® Pop-Top® Tibia', 'description': 'tibia with removable polyethylene'}, {'id': 'OG001', 'title': 'Maxim® Regular Tibia', 'description': 'Tibia with Modular Polyethylene'}], 'classes': [{'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '130'}, {'value': '113', 'groupId': 'OG001', 'lowerLimit': '105', 'upperLimit': '120'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Year', 'description': 'This represents how far the patients were able to flex the knee in the clinic at 1-year.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This population represents patients that returned for follow-up at 1-year post-op per protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Maxim® Pop-Top® Tibia', 'description': 'tibia with removable polyethylene'}, {'id': 'FG001', 'title': 'Maxim® Regular Tibia', 'description': 'Tibia with Modular Polyethylene'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Enrollment was incomplete due to study cancellation.', 'groupId': 'FG000', 'numSubjects': '21'}, {'comment': 'Enrollment was incomplete due to study cancellation.', 'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Immediate Post-Op', 'achievements': [{'comment': "1 Patient didn't return for follow-up.", 'groupId': 'FG000', 'numSubjects': '20'}, {'comment': "1 Patient didn't return for follow-up.", 'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': '6 Months', 'achievements': [{'comment': "10 Patients didn't return for follow-up.", 'groupId': 'FG000', 'numSubjects': '11'}, {'comment': "6 patients didn't return for follow-up.", 'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': '1 Year', 'achievements': [{'comment': "13 patients didn't return for follow-up.", 'groupId': 'FG000', 'numSubjects': '8'}, {'comment': "7 patients didn't return for follow-up.", 'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': '3 Years', 'achievements': [{'comment': 'Incomplete due to study closure at 1-year of follow-up.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Incomplete due to study closure at 1-year of follow-up.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': '5 Years', 'achievements': [{'comment': 'Incomplete due to study closure at 1-year of follow-up.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Incomplete due to study closure at 1-year of follow-up.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'No Patients completed through 5 years due to study closure at 1-year of follow-up.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'No Patients completed through 5 years due to study closure at 1-year of follow-up.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Study Canceled at 1 Year', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'Patients were recruited by the investigator.', 'preAssignmentDetails': 'There were no pre-assignment details to report.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Maxim® Pop-Top® Tibia', 'description': 'tibia with removable polyethylene'}, {'id': 'BG001', 'title': 'Maxim® Regular Tibia', 'description': 'Tibia with Modular Polyethylene'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68', 'spread': '8', 'groupId': 'BG000', 'lowerLimit': '53', 'upperLimit': '82'}, {'value': '62', 'spread': '6', 'groupId': 'BG001', 'lowerLimit': '54', 'upperLimit': '75'}, {'value': '65', 'groupId': 'BG002', 'lowerLimit': '53', 'upperLimit': '82'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31.0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'whyStopped': 'The study sponsor canceled the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-19', 'studyFirstSubmitDate': '2007-12-17', 'resultsFirstSubmitDate': '2009-05-20', 'studyFirstSubmitQcDate': '2007-12-20', 'lastUpdatePostDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-05-20', 'studyFirstPostDateStruct': {'date': '2007-12-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Society Function Score', 'timeFrame': '1 Year', 'description': 'The function score is detailed below as a Range; 100 being the highest score, and 0 being the lowest score. 90-100 is considered "Excellent," 60-89 is considered "Good," 30-59 is considered "fair," and 0-29 is considered "poor."'}], 'secondaryOutcomes': [{'measure': 'Range of Motion - Flexion', 'timeFrame': '1 Year', 'description': 'This represents how far the patients were able to flex the knee in the clinic at 1-year.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis', 'Rheumatoid Arthritis', 'Traumatic Arthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective clinical data collection is to compare the outcomes of two different tibial bearings: the Maxim® Pop-Top® Tibia and Maxim® Modular Tibia.', 'detailedDescription': "The purpose of this prospective clinical data collection is to document and compare the performance and clinical outcomes between the Maxim® Knee System with Removable Molded Poly Tibia and the Maxim® Knee System with Modular Tibial Bearing as two treatment groups.\n\nFDA has cleared these devices via Premarket Notification 510(k)'s K991753, K984623, K993159, K010027. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts and answer potential questions from reimbursement agencies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nIdentical to the indications stated in the FDA approved labeling for the device (cleared in 510(k) K991753,\n\nK984623, K993159, K010027). These indications are stated below:\n\n* Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.\n* Correction of varus, valgus, or posttraumatic deformity.\n* Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.\n\nPatient selection factors to be considered include:\n\n* need to obtain pain relief and improve function,\n* ability and willingness of the patient to follow instructions, including control of weight and activity level,\n* a good nutritional state of the patient,\n* the patient must have reached full skeletal maturity.\n* Porous coated knee joint replacement prostheses have not been approved for non-cemented applications in the United States.\n\nExclusion Criteria:\n\nIdentical to the contraindications stated in the FDA approved labeling for the device (cleared in 510(k) K991753, K984623, K993159, K010027's). These contraindications are stated below:\n\nAbsolute contraindications include:\n\n* infection,\n* sepsis\n* osteomyelitis.\n\nRelative contraindications include:\n\n* uncooperative patient or patient with neurologic disorders who are incapable of following directions,\n* Osteoporosis,\n* metabolic disorders which may impair bone formation,\n* osteomalacia,\n* distant foci of infections which may spread to the implant site,\n* rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,\n* vascular insufficiency, muscular atrophy, neuromuscular disease,\n* incomplete or deficient soft tissue surrounding the knee."}, 'identificationModule': {'nctId': 'NCT00579059', 'briefTitle': 'Maxim® Knee Pop-Top® Tibia vs. Regular Maxim® Knee Tibia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'A Randomized Data Collection of the Maxim® Knee System With Removable Molded Polyethylene Tibia and the Regular Maxim® Knee System', 'orgStudyIdInfo': {'id': '62-U-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Maxim® Pop-Top® Tibia', 'interventionNames': ['Device: Maxim® Knee System with Removable Molded Polyethylene Tibia']}, {'type': 'OTHER', 'label': '2', 'description': 'Maxim® Regular Tibia', 'interventionNames': ['Device: Regular Maxim® Knee System']}], 'interventions': [{'name': 'Maxim® Knee System with Removable Molded Polyethylene Tibia', 'type': 'DEVICE', 'otherNames': ['Maxim® Pop-Top® Tibia'], 'description': 'Used for total knee replacements', 'armGroupLabels': ['1']}, {'name': 'Regular Maxim® Knee System', 'type': 'DEVICE', 'otherNames': ['Modular Tibia'], 'description': 'Used for total knee replacements', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46581', 'city': 'Warsaw', 'state': 'Indiana', 'country': 'United States', 'facility': 'Biomet Orthopedics, LLC', 'geoPoint': {'lat': 41.2381, 'lon': -85.85305}}], 'overallOfficials': [{'name': 'Russell Wagner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harris Methodist Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biomet Orthopedics, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}