Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-03 @ 3:48 AM
Study NCT ID:
NCT02155712
Status:
TERMINATED
Last Update Posted:
2023-11-14
First Post:
2014-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Triathlon Tritanium Knee Outcomes Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'StrykerJRClinical@stryker.com', 'phone': '201-831-5000', 'title': 'Stryker JR Clinical Research', 'organization': 'Stryker Orthopaedics'}, 'certainAgreement': {'otherDetails': "Each investigator shall have privileges for their own center's results at the completion of the study.These manuscripts \\& abstracts will be delayed until after the multi-center publication is submitted.All publications shall be submitted to the sponsor for review at least 60 days prior to the submission for publication.The sponsor shall not edit or otherwise influence the publications other than to ensure that confidential information is not disclosed and that the data is accurately represented.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data is provided from enrollment through the 8-year postoperative interval for the cementless Cohort 1 with a mean of 4.4 years. For the cemented Cohort 2, the period was from enrollment to the 5.6 years postoperative interval with a mean of 3.1 years.', 'description': 'All operative site events occurring at any time, as well as all serious adverse events (SAEs) occurring in the perioperative period (intraoperative to hospital discharge), are collected. Specific Adverse Event terms are not used for all Adverse Events.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1 Cementless', 'description': 'Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.\n\nTriathlon Tritanium Knee: Cementless', 'otherNumAtRisk': 319, 'deathsNumAtRisk': 319, 'otherNumAffected': 69, 'seriousNumAtRisk': 319, 'deathsNumAffected': 12, 'seriousNumAffected': 28}, {'id': 'EG001', 'title': 'Cohort 2 Cemented', 'description': 'Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.\n\nTriathlon Knee: Cemented', 'otherNumAtRisk': 134, 'deathsNumAtRisk': 134, 'otherNumAffected': 12, 'seriousNumAtRisk': 134, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Operative site', 'notes': 'Events include arthrofibrosis, excessive knee pain, patellar fracture, soft tissue trauma, superficial wound infection, wound hematoma, tendinitis, IT band syndrome, effusion, swelling, bursitis, neuroma, lesion, bruising, incision dehiscence, etc.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 89, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Non-operative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Knees With Cementless Application That Had Successful Primary Total Knee Replacement With the Triathlon Tritanium Total Knee System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'Knees', 'counts': [{'value': '373', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 Cementless', 'description': 'Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.'}, {'id': 'OG001', 'title': 'Cohort 2 Cemented', 'description': 'Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.'}], 'classes': [{'categories': [{'measurements': [{'value': '373', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Success is defined as freedom from Triathlon Tritanium Tibial Baseplate revision for aseptic loosening.', 'unitOfMeasure': 'Successful Knees', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Knees', 'denomUnitsSelected': 'Knees', 'populationDescription': 'The primary objective analysis only includes cementless, Cohort 1 participants. All Cohort 2 participants received cemented primary total knee replacements and are not included in the primary objective analysis.'}, {'type': 'SECONDARY', 'title': 'Implant Survivorship (Baseplate and Patella)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'Knees', 'counts': [{'value': '373', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 Cementless', 'description': 'Subjects enrolled in the Cohort 1 (cementless) eligible to receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.\n\nTriathlon Tritanium Knee: Cementless'}, {'id': 'OG001', 'title': 'Cohort 2 Cemented', 'description': 'Subjects enrolled in Cohort 2 (cemented) that began upon completion of Cohort 1 (cementless) enrollment, that were eligible to receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.\n\nTriathlon Knee: Cemented'}], 'classes': [{'title': '1-year KM survival rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'Knees', 'counts': [{'value': '373', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.42', 'groupId': 'OG000', 'lowerLimit': '97.71', 'upperLimit': '99.86'}]}]}, {'title': '3-year KM survival rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'Knees', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.74', 'groupId': 'OG000', 'lowerLimit': '96.67', 'upperLimit': '99.53'}]}]}, {'title': '5-year KM survival rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'Knees', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.74', 'groupId': 'OG000', 'lowerLimit': '96.67', 'upperLimit': '99.53'}]}]}, {'title': '7-year KM survival rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'Knees', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.05', 'groupId': 'OG000', 'lowerLimit': '95.06', 'upperLimit': '99.24'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 years', 'description': 'This secondary outcome measure is a statistical estimation on the number of cases at risk at 1-year, 3-years, 5-years and 7-years postoperative in the cementless cohort 1 only, per protocol. The final 10-year results were not done due to early study termination.', 'unitOfMeasure': 'percentage of cementless knees', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Knees', 'denomUnitsSelected': 'Knees', 'populationDescription': 'Results below are for the participants/knees that were measured and analyzed at 1-year, 3-year, 5-year, 7-year postoperative on Cohort 1 cementless only as per protocol. The final 10 year was not analyzed due to early study termination.'}, {'type': 'SECONDARY', 'title': 'Compare 2011 Knee Society Score (KSS) Scores Between Both Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}, {'units': 'Knees', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 Cementless', 'description': 'Subjects enrolled in the Cohort 1 (cementless) eligible to receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.\n\nTriathlon Tritanium Knee: Cementless'}, {'id': 'OG001', 'title': 'Cohort 2 Cemented', 'description': 'Subjects enrolled in Cohort 2 (cemented) that began upon completion of Cohort 1 (cementless) enrollment, that were eligible to receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.\n\nTriathlon Knee: Cemented'}], 'classes': [{'title': 'Objective Knee Score', 'categories': [{'measurements': [{'value': '94.90', 'spread': '6.48', 'groupId': 'OG000'}, {'value': '91.75', 'spread': '9.40', 'groupId': 'OG001'}]}]}, {'title': 'Function Score KSS', 'categories': [{'measurements': [{'value': '80.85', 'spread': '15.56', 'groupId': 'OG000'}, {'value': '75.41', 'spread': '18.81', 'groupId': 'OG001'}]}]}, {'title': 'Patient Satisfaction Score', 'categories': [{'measurements': [{'value': '35.29', 'spread': '6.76', 'groupId': 'OG000'}, {'value': '33.08', 'spread': '8.06', 'groupId': 'OG001'}]}]}, {'title': 'Patient Expectation Score', 'categories': [{'measurements': [{'value': '10.60', 'spread': '3.04', 'groupId': 'OG000'}, {'value': '10.06', 'spread': '2.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'The 2011 Knee Society Score System is comprised of 4 distinct sub-scores: Objective, Functional, Patient Satisfaction and Expectations. The Objective and Functional sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. The Patient Satisfaction sub-score ranges from a potential minimum score of 0 to a maximum score of 40 points. The Subject Expectations sub-score ranges from a potential minimum score of 0 to a maximum score of 15 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Knees', 'denomUnitsSelected': 'Knees', 'populationDescription': 'Participants with available data at 2 years are presented for both cohorts.'}, {'type': 'SECONDARY', 'title': 'Compare Oxford Knee Score (OKS) Scores Between Both Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}, {'units': 'Knees', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 Cementless', 'description': 'Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.\n\nTriathlon Tritanium Knee: Cementless'}, {'id': 'OG001', 'title': 'Cohort 2 Cemented', 'description': 'Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.\n\nTriathlon Knee: Cemented'}], 'classes': [{'categories': [{'measurements': [{'value': '42.59', 'spread': '5.91', 'groupId': 'OG000'}, {'value': '40.66', 'spread': '7.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'The OKS questionnaire consists of 12 questions that cover function and pain of the knee. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Knees', 'denomUnitsSelected': 'Knees', 'populationDescription': 'Participants with available data at 2 years are presented for both cohorts.'}, {'type': 'SECONDARY', 'title': 'Compare Short Form-12 (SF-12) Scores Between Both Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}, {'units': 'Knees', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 Cementless', 'description': 'Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.\n\nTriathlon Tritanium Knee: Cementless'}, {'id': 'OG001', 'title': 'Cohort 2 Cemented', 'description': 'Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.\n\nTriathlon Knee: Cemented'}], 'classes': [{'title': 'SF-12 Physical Component Score', 'categories': [{'measurements': [{'value': '49.07', 'spread': '8.36', 'groupId': 'OG000'}, {'value': '46.24', 'spread': '9.37', 'groupId': 'OG001'}]}]}, {'title': 'SF-12 Mental Component Score', 'categories': [{'measurements': [{'value': '56.10', 'spread': '7.46', 'groupId': 'OG000'}, {'value': '54.28', 'spread': '8.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'The SF-12 Health Survey is a 12-item patient quality-of-life questionnaire to measure general health and well-being. It is comprised of two distinct scores (physical and mental component score). They are both calculated on a scale ranging from 0 points to 100 points, with low values representing a poor health state and high values representing a good health state.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Knees', 'denomUnitsSelected': 'Knees', 'populationDescription': 'Participants with available data at 2 years are presented for both cohorts.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1 Cementless', 'description': 'Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.\n\nIt should be noted that Cohort 1 over-enrolled by 17 cases for a total of 373 cases.'}, {'id': 'FG001', 'title': 'Cohort 2 Cemented', 'description': 'Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '397'}, {'groupId': 'FG001', 'numSubjects': '216'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '397'}, {'groupId': 'FG001', 'numSubjects': '179'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Revision of device', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Site termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Sponsor terminated study early', 'reasons': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Missed final 5-year protocol visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'Censored because surgery cancelled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Censored because study device was not implanted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'Censored because of inclusion/exclusion violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': 'Cohort 1: 397 participants/451 knees - 78 cases censored leaving 319 participants/373 knees.\n\nCohort 2: 216 participants/229 knees - 82 cases censored leaving 134 participants/147 knees.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '453', 'groupId': 'BG002'}]}, {'units': 'Knees', 'counts': [{'value': '373', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '520', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1 Cementless', 'description': 'Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.\n\nTriathlon Tritanium Knee: Cementless'}, {'id': 'BG001', 'title': 'Cohort 2 Cemented', 'description': 'Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.\n\nTriathlon Knee: Cemented'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.12', 'spread': '7.19', 'groupId': 'BG000'}, {'value': '63.18', 'spread': '7.71', 'groupId': 'BG001'}, {'value': '62.42', 'spread': '7.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '241', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '299', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '319', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '453', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Knees', 'populationDescription': 'Includes all participants who received the Triathlon Knee System and were not censored from analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-01-30', 'size': 4625443, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2018-10-25T10:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 680}}, 'statusModule': {'whyStopped': 'Due to the pandemic, multiple sites were unable to complete patient visits resulting in less-than-optimal postoperative follow-up occurred. Therefore, study objectives were not met and the decision was made to close the study early.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-24', 'studyFirstSubmitDate': '2014-06-02', 'resultsFirstSubmitDate': '2019-04-04', 'studyFirstSubmitQcDate': '2014-06-02', 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-25', 'studyFirstPostDateStruct': {'date': '2014-06-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Knees With Cementless Application That Had Successful Primary Total Knee Replacement With the Triathlon Tritanium Total Knee System', 'timeFrame': '2 years', 'description': 'Success is defined as freedom from Triathlon Tritanium Tibial Baseplate revision for aseptic loosening.'}], 'secondaryOutcomes': [{'measure': 'Implant Survivorship (Baseplate and Patella)', 'timeFrame': '10 years', 'description': 'This secondary outcome measure is a statistical estimation on the number of cases at risk at 1-year, 3-years, 5-years and 7-years postoperative in the cementless cohort 1 only, per protocol. The final 10-year results were not done due to early study termination.'}, {'measure': 'Compare 2011 Knee Society Score (KSS) Scores Between Both Groups', 'timeFrame': '2 years', 'description': 'The 2011 Knee Society Score System is comprised of 4 distinct sub-scores: Objective, Functional, Patient Satisfaction and Expectations. The Objective and Functional sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. The Patient Satisfaction sub-score ranges from a potential minimum score of 0 to a maximum score of 40 points. The Subject Expectations sub-score ranges from a potential minimum score of 0 to a maximum score of 15 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.'}, {'measure': 'Compare Oxford Knee Score (OKS) Scores Between Both Groups', 'timeFrame': '2 years', 'description': 'The OKS questionnaire consists of 12 questions that cover function and pain of the knee. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes.'}, {'measure': 'Compare Short Form-12 (SF-12) Scores Between Both Groups', 'timeFrame': '2 years', 'description': 'The SF-12 Health Survey is a 12-item patient quality-of-life questionnaire to measure general health and well-being. It is comprised of two distinct scores (physical and mental component score). They are both calculated on a scale ranging from 0 points to 100 points, with low values representing a poor health state and high values representing a good health state.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Arthroplasty, Replacement, Knee']}, 'descriptionModule': {'briefSummary': 'The success of the Triathlon Tritanium Knee will be determined by comparing the rate of absence of revision for aseptic loosening of the tibial baseplate at 2 years with the rates reported in the literature.', 'detailedDescription': "Cases are to be enrolled at five to ten centers. The same center may be included in both arms. Conversely, a center may choose to participate in only a single arm. The enrollment goal is approximately 36 - 72 cases per center for Cohort 1 (cementless) and 15 - 30 cases per center for Cohort 2 (cemented) , and will vary dependent upon the number of participating centers. Although a goal is presented, there is no maximum limit to the number of cases that a center may enroll. In the event that a center far exceeds the enrollment goal, Stryker may ask the center to cease enrollment so as not to skew the data. All participating centers will comply with the federal regulations regarding patient informed consent and Institutional Review Board (IRB) or Ethics Committee (EC) approval. Non-compliance of a study center may result in termination of the center's participation in the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved; study specific Informed Patient Consent Form.\n2. Patient is a male or non-pregnant female age 18-75 years at time of study device implantation.\n3. Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).\n4. Patient is a candidate for primary cementless total knee replacement, including a resurfaced patella.\n5. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.\n\nExclusion Criteria:\n\n1. Patient has a Body Mass Index (BMI) \\> 40.\n2. Patient has a diagnosis of avascular necrosis or inflammatory arthritis.\n3. Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.\n4. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.\n5. Subject is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.\n6. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \\> 30 days).\n7. Patient is diagnosed with lumbar radicular pain.\n8. Patient has a known sensitivity to device materials.\n9. Patient is a prisoner."}, 'identificationModule': {'nctId': 'NCT02155712', 'briefTitle': 'Triathlon Tritanium Knee Outcomes Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stryker Orthopaedics'}, 'officialTitle': 'Triathlon Tritanium Knee Outcomes Study', 'orgStudyIdInfo': {'id': '74'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Triathlon Tritanium Knee', 'description': 'Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.', 'interventionNames': ['Device: Triathlon Tritanium Knee']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Triathlon Knee', 'description': 'Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.', 'interventionNames': ['Device: Triathlon Knee']}], 'interventions': [{'name': 'Triathlon Tritanium Knee', 'type': 'DEVICE', 'description': 'Cementless', 'armGroupLabels': ['Triathlon Tritanium Knee']}, {'name': 'Triathlon Knee', 'type': 'DEVICE', 'description': 'Cemented', 'armGroupLabels': ['Triathlon Knee']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'OrthoArizona', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85741', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tucson Orthopaedic Institute', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Heekin Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '70605', 'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Imperial Health', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}, {'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sinai Hospital of Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48197', 'city': 'Ypsilanti', 'state': 'Michigan', 'country': 'United States', 'facility': 'St. Joseph Mercy Health System', 'geoPoint': {'lat': 42.24115, 'lon': -83.61299}}, {'zip': '08234', 'city': 'Egg Harbor', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rothman Orthopaedic Institute', 'geoPoint': {'lat': 39.38646, 'lon': -74.60361}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mission Hospital Research Institute', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '27703', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '17821', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Orthopaedic Institute', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}], 'overallOfficials': [{'name': 'Edward Petrow, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tucson Orthopaedic Institute'}, {'name': 'Alvin Ong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rothman Orthopaedic Institute'}, {'name': 'David Heekin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heekin Clinic'}, {'name': 'Kipling Sharpe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OrthoArizona'}, {'name': 'Marcus Barnett, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mission Hospital Research Institute'}, {'name': 'John Noble, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial Health'}, {'name': 'Michael Masini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Joseph Mercy Health System'}, {'name': 'Samuel Wellman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Ronald Delanois, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sinai Hospital of Baltimore'}, {'name': 'Thomas Bowen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Geisinger Orthopaedic Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stryker Orthopaedics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}