Viewing Study NCT02527161

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Ignite Creation Date: 2025-12-24 @ 12:03 PM
Ignite Modification Date: 2025-12-27 @ 10:43 PM
Study NCT ID: NCT02527161
Status: COMPLETED
Last Update Posted: 2020-09-18
First Post: 2015-08-03
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using ShapeMatch® Cutting Guides: Sub-Study B
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.fulker@stryker.com', 'phone': '+61 2 9467 1072', 'title': 'David Fulker', 'organization': 'Stryker SP'}, 'certainAgreement': {'otherDetails': 'Discloser must give at least 40 days notice to Sponsor including a copy of the proposed publication. The Sponsor can then provide comments (which Discloser is not bound to follow), request delay of publication by no more than 120 days to allow for Sponsor to protect its intellectual property, or request that the Discloser remove certain proprietary or confidential information from the study (other than the results of the study).', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '5 years', 'eventGroups': [{'id': 'EG000', 'title': 'ShapeMatch Cutting Guides With Triathlon', 'description': 'Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.', 'otherNumAtRisk': 96, 'deathsNumAtRisk': 96, 'otherNumAffected': 47, 'seriousNumAtRisk': 96, 'deathsNumAffected': 1, 'seriousNumAffected': 48}], 'otherEvents': [{'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 32, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Non-Operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 15, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-Operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Operative Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 38, 'numAffected': 28}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 11, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 38, 'numAffected': 22}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative side', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Implant Location/Assessment of Alignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ShapeMatch Cutting Guides With Triathlon', 'description': 'Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.'}], 'classes': [{'title': 'Femoral deviation pre-op to post-op', 'categories': [{'measurements': [{'value': '1.70', 'spread': '1.46', 'groupId': 'OG000'}]}]}, {'title': 'Tibial deviation pre-op to post-op', 'categories': [{'measurements': [{'value': '1.91', 'spread': '1.58', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '3 months Post-Operatively', 'description': 'Implant location and limb alignment is assessed using CT scan 3 months after surgery. The mean deviation of the postoperative femoral and tibial alignment from the preoperative plan is measured in degrees.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data. Participants=knees.'}, {'type': 'SECONDARY', 'title': 'Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ShapeMatch Cutting Guides With Triathlon', 'description': 'Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.'}], 'classes': [{'title': 'Pre-op KOOS Pain score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.18', 'spread': '17.64', 'groupId': 'OG000'}]}]}, {'title': '6 weeks KOOS Pain score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.23', 'spread': '16.88', 'groupId': 'OG000'}]}]}, {'title': '3 months KOOS Pain score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74.96', 'spread': '18.55', 'groupId': 'OG000'}]}]}, {'title': '6 months KOOS Pain score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.03', 'spread': '18.12', 'groupId': 'OG000'}]}]}, {'title': '1 year KOOS Pain score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.11', 'spread': '16.69', 'groupId': 'OG000'}]}]}, {'title': '2 years KOOS Pain score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.00', 'spread': '18.18', 'groupId': 'OG000'}]}]}, {'title': '5 years KOOS Pain score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.58', 'spread': '14.24', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Change from preoperative to 6 weeks KOOS Pain', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0013', 'groupIds': ['OG000'], 'groupDescription': 'Change from 6 weeks to 3 months KOOS Pain', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.3316', 'groupIds': ['OG000'], 'groupDescription': 'Change from 3 months to 6 months KOOS Pain', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3366', 'groupIds': ['OG000'], 'groupDescription': 'Change from 6 months to 1 year KOOS Pain', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9826', 'groupIds': ['OG000'], 'groupDescription': 'Change from 1 year to 2 year KOOS Pain', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9276', 'groupIds': ['OG000'], 'groupDescription': 'Change from 2 year to 5 year KOOS Pain', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative to 5 years post-operative', 'description': 'KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data. Participants=knees.'}, {'type': 'SECONDARY', 'title': 'Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ShapeMatch Cutting Guides With Triathlon', 'description': 'Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.'}], 'classes': [{'title': 'Pre-op KOOS Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.94', 'spread': '20.85', 'groupId': 'OG000'}]}]}, {'title': '6 weeks KOOS Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.78', 'spread': '16.01', 'groupId': 'OG000'}]}]}, {'title': '3 months KOOS Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.12', 'spread': '18.60', 'groupId': 'OG000'}]}]}, {'title': '6 months KOOS Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.16', 'spread': '18.54', 'groupId': 'OG000'}]}]}, {'title': '1 year KOOS Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.12', 'spread': '15.33', 'groupId': 'OG000'}]}]}, {'title': '2 years KOOS Symptoms score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84.49', 'spread': '17.07', 'groupId': 'OG000'}]}]}, {'title': '5 years KOOS Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.90', 'spread': '13.13', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Change from preoperative to 6 weeks KOOS Symptoms', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0736', 'groupIds': ['OG000'], 'groupDescription': 'Change from 6 weeks to 3 months KOOS Symptoms', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4675', 'groupIds': ['OG000'], 'groupDescription': 'Change from 3 months to 6 months KOOS Symptoms', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0229', 'groupIds': ['OG000'], 'groupDescription': 'Change from 6 months to 1 year KOOS Symptoms', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9968', 'groupIds': ['OG000'], 'groupDescription': 'Change from 1 year to 2 year KOOS Symptoms', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7761', 'groupIds': ['OG000'], 'groupDescription': 'Change from 2 year to 5 year KOOS Symptoms', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative to 5 years post-operative', 'description': 'KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data. Participants=knees'}, {'type': 'SECONDARY', 'title': 'Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ShapeMatch Cutting Guides With Triathlon', 'description': 'Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.'}], 'classes': [{'title': 'Pre-op KOOS ADL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38.08', 'spread': '20.12', 'groupId': 'OG000'}]}]}, {'title': '6 weeks KOOS ADL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.98', 'spread': '17.58', 'groupId': 'OG000'}]}]}, {'title': '3 months KOOS ADL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.75', 'spread': '18.20', 'groupId': 'OG000'}]}]}, {'title': '6 months KOOS ADL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.37', 'spread': '17.90', 'groupId': 'OG000'}]}]}, {'title': '1 year KOOS ADL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.14', 'spread': '14.39', 'groupId': 'OG000'}]}]}, {'title': '2 years KOOS ADL score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.60', 'spread': '15.46', 'groupId': 'OG000'}]}]}, {'title': '5 years KOOS ADL score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.80', 'spread': '15.09', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Change from preoperative to 6 weeks KOOS ADL', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0212', 'groupIds': ['OG000'], 'groupDescription': 'Change from 6 weeks to 3 months KOOS ADL', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7173', 'groupIds': ['OG000'], 'groupDescription': 'Change from 3 months to 6 months KOOS ADL', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1834', 'groupIds': ['OG000'], 'groupDescription': 'Change from 6 months to 1 year KOOS ADL', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9957', 'groupIds': ['OG000'], 'groupDescription': 'Change from 1 year to 2 year KOOS ADL', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9999', 'groupIds': ['OG000'], 'groupDescription': 'Change from 6 months to 1 year KOOS ADL', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative to 5 years post-operative', 'description': 'KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data. Participants=knees.'}, {'type': 'SECONDARY', 'title': 'Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ShapeMatch Cutting Guides With Triathlon', 'description': 'The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.\n\nThey are intended for single use only.\n\nShapeMatch Cutting Guides with Triathlon: All participants will undergo medical imaging assessment using Magnetic Resonance Imaging (MRI) of the affected lower limb.These images will be used to manufacture the patient-specific cutting guides for preparation of the bones prior to implantation of the total knee replacement (Pre-operatively). Patients will undergo primary total knee arthroplasty with the Triathlon® Total Knee System (Stryker Orthopaedics, Mahwah, NJ USA) using the Shapematch cutting guides to guide the bone resection. Patients will follow the standard postoperative rehabilitation program established by the investigator at each site.'}], 'classes': [{'title': 'Pre-op KOOS S&R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.45', 'spread': '20.98', 'groupId': 'OG000'}]}]}, {'title': '1 year KOOS S&R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65.05', 'spread': '25.48', 'groupId': 'OG000'}]}]}, {'title': '2 years KOOS S&R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65.92', 'spread': '27.28', 'groupId': 'OG000'}]}]}, {'title': '5 years KOOS S&R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.78', 'spread': '27.00', 'groupId': 'OG000'}]}]}, {'title': '6 weeks KOOS S&R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39.06', 'spread': '32.49', 'groupId': 'OG000'}]}]}, {'title': '3 months KOOS S&R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.58', 'spread': '28.74', 'groupId': 'OG000'}]}]}, {'title': '6 months KOOS S&R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58.70', 'spread': '29.09', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Change from preoperative to 6 weeks KOOS S\\&R', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0522', 'groupIds': ['OG000'], 'groupDescription': 'Change from 6 weeks to 3 months KOOS S\\&R', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1696', 'groupIds': ['OG000'], 'groupDescription': 'Change from 3 months to 6 months KOOS S\\&R', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6942', 'groupIds': ['OG000'], 'groupDescription': 'Change from 6 months to 1 year KOOS S\\&R', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>0.9999', 'groupIds': ['OG000'], 'groupDescription': 'Change from 1 year to 2 year KOOS S\\&R', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>0.9999', 'groupIds': ['OG000'], 'groupDescription': 'Change from 2 year to 5 year KOOS S\\&R', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative to 5 years Post-Operative', 'description': 'KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data. Participants=knees'}, {'type': 'SECONDARY', 'title': 'Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ShapeMatch Cutting Guides With Triathlon', 'description': 'Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.'}], 'classes': [{'title': 'Pre-op KOOS QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.92', 'spread': '17.63', 'groupId': 'OG000'}]}]}, {'title': '6 weeks KOOS QOL score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51.87', 'spread': '22.12', 'groupId': 'OG000'}]}]}, {'title': '3 months KOOS QOL score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61.51', 'spread': '21.14', 'groupId': 'OG000'}]}]}, {'title': '6 months KOOS QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '69.44', 'spread': '25.39', 'groupId': 'OG000'}]}]}, {'title': '1 year KOOS QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.09', 'spread': '20.78', 'groupId': 'OG000'}]}]}, {'title': '2 years KOOS QOL score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.82', 'spread': '22.53', 'groupId': 'OG000'}]}]}, {'title': '5 years KOOS QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.19', 'spread': '21.73', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Change from preoperative to 6 weeks KOOS QoL', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0135', 'groupIds': ['OG000'], 'groupDescription': 'Change from 6 weeks to 3 months KOOS QoL', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0829', 'groupIds': ['OG000'], 'groupDescription': 'Change from 3 months to 6 months KOOS QoL', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1729', 'groupIds': ['OG000'], 'groupDescription': 'Change from 6 months to 1 year KOOS QoL', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9687', 'groupIds': ['OG000'], 'groupDescription': 'Change from 1 year to 2 year KOOS QoL', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>0.9999', 'groupIds': ['OG000'], 'groupDescription': 'Change from 2 year to 5 year KOOS QoL', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative to 5 years post-operative', 'description': 'KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.)', 'unitOfMeasure': 'unit of a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data. Participants=knees.'}, {'type': 'SECONDARY', 'title': 'Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ShapeMatch Cutting Guides With Triathlon', 'description': 'Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.'}], 'classes': [{'title': 'SF12 PCS Preop', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.36', 'spread': '7.69', 'groupId': 'OG000'}]}]}, {'title': 'SF12 PCS 6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.27', 'spread': '6.98', 'groupId': 'OG000'}]}]}, {'title': 'SF12 PCS 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45.99', 'spread': '8.09', 'groupId': 'OG000'}]}]}, {'title': 'SF12 PCS 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47.35', 'spread': '8.89', 'groupId': 'OG000'}]}]}, {'title': 'SF12 PCS 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.27', 'spread': '8.88', 'groupId': 'OG000'}]}]}, {'title': 'SF12 PCS 2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49.90', 'spread': '8.64', 'groupId': 'OG000'}]}]}, {'title': 'SF12 PCS 5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.96', 'spread': '8.66', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Change from preoperative to 6 weeks SF-12 PCS', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Change from 6 weeks to 3 months SF-12 PCS', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8189', 'groupIds': ['OG000'], 'groupDescription': 'Change from 3 months to 6 months SF-12 PCS', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9845', 'groupIds': ['OG000'], 'groupDescription': 'Change from 6 months to 1 year SF-12 PCS', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7500', 'groupIds': ['OG000'], 'groupDescription': 'Change from 1 year to 2 year SF-12 PCS', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1376', 'groupIds': ['OG000'], 'groupDescription': 'Change from 2 year to 5 year SF-12 PCS', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative to 5 years Post-Operative', 'description': 'SF-12 provides a summary measure of health status after combining the physical health score (PCS) and mental health score (MCS). The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data. Participants=knees.'}, {'type': 'SECONDARY', 'title': 'VAS Pain at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ShapeMatch Cutting Guides With Triathlon', 'description': 'Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.'}], 'classes': [{'title': 'VAS pain at rest_Preop', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.78', 'spread': '2.49', 'groupId': 'OG000'}]}]}, {'title': 'VAS pain at rest_6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.09', 'spread': '2.56', 'groupId': 'OG000'}]}]}, {'title': 'VAS pain at rest_3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.02', 'spread': '2.14', 'groupId': 'OG000'}]}]}, {'title': 'VAS pain at rest_6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.45', 'spread': '1.98', 'groupId': 'OG000'}]}]}, {'title': 'VAS pain at rest_ 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.22', 'spread': '1.84', 'groupId': 'OG000'}]}]}, {'title': 'VAS pain at rest_ 2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.09', 'spread': '1.82', 'groupId': 'OG000'}]}]}, {'title': 'VAS pain at rest_ 5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.04', 'spread': '1.65', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Change from preoperative to 6 week VAS Rest', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0031', 'groupIds': ['OG000'], 'groupDescription': 'Change from 6 weeks to 3 months VAS Rest', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2990', 'groupIds': ['OG000'], 'groupDescription': 'Change from 3 months to 6 months VAS Rest', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9832', 'groupIds': ['OG000'], 'groupDescription': 'Change from 6 months to 1 year VAS Rest', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9991', 'groupIds': ['OG000'], 'groupDescription': 'Change from 1 year to 2 year VAS Rest', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>0.9999', 'groupIds': ['OG000'], 'groupDescription': 'Change from 2 year to 5 year VAS Rest', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Operative to 5 years Post-Operative', 'description': 'Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data. Participants=knees.'}, {'type': 'SECONDARY', 'title': 'VAS Pain Mobilised', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ShapeMatch Cutting Guides With Triathlon', 'description': 'Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.'}], 'classes': [{'title': 'VAS pain during mobilization_Preop', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.28', 'spread': '2.07', 'groupId': 'OG000'}]}]}, {'title': 'VAS pain during mobilization_6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.47', 'spread': '2.74', 'groupId': 'OG000'}]}]}, {'title': 'VAS pain during mobilization_3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.39', 'spread': '2.48', 'groupId': 'OG000'}]}]}, {'title': 'VAS pain during mobilization_6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.83', 'spread': '2.23', 'groupId': 'OG000'}]}]}, {'title': 'VAS pain during mobilization_1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.43', 'spread': '1.99', 'groupId': 'OG000'}]}]}, {'title': 'VAS pain during mobilization_2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.41', 'spread': '2.19', 'groupId': 'OG000'}]}]}, {'title': 'VAS pain during mobilization_5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.22', 'spread': '1.92', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Change from preoperative to 6 weeks VAS Mob', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0062', 'groupIds': ['OG000'], 'groupDescription': 'Change from 6 weeks to 3 months VAS Mob', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3730', 'groupIds': ['OG000'], 'groupDescription': 'Change from 3 months to 6 months VAS Mob', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8499', 'groupIds': ['OG000'], 'groupDescription': 'Change from 6 months to 1 year VAS Mob', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>0.9999', 'groupIds': ['OG000'], 'groupDescription': 'Change from 1 year to 2 year VAS Mob', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9958', 'groupIds': ['OG000'], 'groupDescription': 'Change from 2 year to 5 year VAS Mob', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Operative to 5 years post-operative', 'description': 'Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.', 'unitOfMeasure': 'units of a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data. Participants=knees.'}, {'type': 'SECONDARY', 'title': 'Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ShapeMatch Cutting Guides With Triathlon', 'description': 'Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.'}], 'classes': [{'title': 'SF12 MCS Preop', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47.02', 'spread': '12.49', 'groupId': 'OG000'}]}]}, {'title': 'SF12 MCS 6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49.91', 'spread': '10.56', 'groupId': 'OG000'}]}]}, {'title': 'SF12 MCS 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.18', 'spread': '9.96', 'groupId': 'OG000'}]}]}, {'title': 'SF12 MCS 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.58', 'spread': '9.15', 'groupId': 'OG000'}]}]}, {'title': 'SF12 MCS 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.93', 'spread': '9.28', 'groupId': 'OG000'}]}]}, {'title': 'SF12 MCS 2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.78', 'spread': '9.27', 'groupId': 'OG000'}]}]}, {'title': 'SF12 MCS 5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.95', 'spread': '10.39', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.3493', 'groupIds': ['OG000'], 'groupDescription': 'Change from preoperative to 6 weeks SF-12 MCS', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4800', 'groupIds': ['OG000'], 'groupDescription': 'Change from 6 weeks to 3 months SF-12 MCS', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>0.9999', 'groupIds': ['OG000'], 'groupDescription': 'Change from 3 months to 6 months SF-12 MCS', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>0.9999', 'groupIds': ['OG000'], 'groupDescription': 'Change from 6 months to 1 year SF-12 MCS', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>0.9999', 'groupIds': ['OG000'], 'groupDescription': 'Change from 1 year to 2 year SF-12 MCS', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>0.9999', 'groupIds': ['OG000'], 'groupDescription': 'Change from 2 year to 5 year SF-12 MCS', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative to 5 years Post-Operative', 'description': 'SF-12 provides a summary measure of health status after combining the physical health score (PCS) and mental health score (MCS). The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data. Participants=knees.'}, {'type': 'SECONDARY', 'title': 'Knee Society Clinical Rating System (KSS) Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ShapeMatch Cutting Guides With Triathlon', 'description': 'Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.'}], 'classes': [{'title': 'KSS Pain Preop', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.95', 'spread': '14.06', 'groupId': 'OG000'}]}]}, {'title': 'KSS Pain 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '69.05', 'spread': '18.46', 'groupId': 'OG000'}]}]}, {'title': 'KSS Pain 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.36', 'spread': '15.21', 'groupId': 'OG000'}]}]}, {'title': 'KSS Pain 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '76.75', 'spread': '16.53', 'groupId': 'OG000'}]}]}, {'title': 'KSS Pain 2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.04', 'spread': '16.32', 'groupId': 'OG000'}]}]}, {'title': 'KSS Pain 5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.60', 'spread': '13.96', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Change from preoperative to 6 weeks KSS Pain', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9465', 'groupIds': ['OG000'], 'groupDescription': 'Change from 3 months to 6 months KSS Pain', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1215', 'groupIds': ['OG000'], 'groupDescription': 'Change from 6 months to 1 year KSS Pain', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9912', 'groupIds': ['OG000'], 'groupDescription': 'Change from 1 year to 2 years KSS Pain', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8952', 'groupIds': ['OG000'], 'groupDescription': 'Change from 2 year to 5 year KSS Pain', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative to 5 years Post-Operative', 'description': 'The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 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', 'populationDescription': 'Participants with available data. Participants=knees.'}, {'type': 'SECONDARY', 'title': 'Knee Society Clinical Rating System (KSS) Functional Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ShapeMatch Cutting Guides With Triathlon', 'description': 'Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.'}], 'classes': [{'title': 'KSS functional Preop', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43.45', 'spread': '19.25', 'groupId': 'OG000'}]}]}, {'title': 'KSS functional 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.82', 'spread': '20.07', 'groupId': 'OG000'}]}]}, {'title': 'KSS functional 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.45', 'spread': '20.28', 'groupId': 'OG000'}]}]}, {'title': 'KSS functional 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '76.99', 'spread': '19.79', 'groupId': 'OG000'}]}]}, {'title': 'KSS functional 2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74.82', 'spread': '23.62', 'groupId': 'OG000'}]}]}, {'title': 'KSS functional 5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.44', 'spread': '25.47', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Change from preoperative to 3 months KSS Function', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0266', 'groupIds': ['OG000'], 'groupDescription': 'Change from 3 months to 6 months KSS Function', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9880', 'groupIds': ['OG000'], 'groupDescription': 'Change from 6 months to 1 year KSS Function', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9699', 'groupIds': ['OG000'], 'groupDescription': 'Change from 1 year to 2 years KSS Function', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8575', 'groupIds': ['OG000'], 'groupDescription': 'Change from 2 year to 5 years KSS Function', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative to 5 years Post-Operative', 'description': 'The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 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', 'populationDescription': 'Participants with available data. Participants=knees.'}, {'type': 'SECONDARY', 'title': 'Knee Society Clinical Rating System (KSS) Range of Motion Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ShapeMatch Cutting Guides With Triathlon', 'description': 'Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.'}], 'classes': [{'title': 'KSS ROM Preop', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '108.59', 'spread': '16.74', 'groupId': 'OG000'}]}]}, {'title': 'KSS ROM 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '110.40', 'spread': '14.38', 'groupId': 'OG000'}]}]}, {'title': 'KSS ROM 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '112.71', 'spread': '12.71', 'groupId': 'OG000'}]}]}, {'title': 'KSS ROM 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '115.30', 'spread': '12.36', 'groupId': 'OG000'}]}]}, {'title': 'KSS ROM 2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '115.09', 'spread': '12.40', 'groupId': 'OG000'}]}]}, {'title': 'KSS ROM 5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '119.11', 'spread': '13.06', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.8581', 'groupIds': ['OG000'], 'groupDescription': 'Change from preoperative to 3 months KSS Range of Motion', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7664', 'groupIds': ['OG000'], 'groupDescription': 'Change from 3 months to 6 months KSS Range of Motion', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7022', 'groupIds': ['OG000'], 'groupDescription': 'Change from 6 months to 1 year KSS Range of Motion', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>0.9999', 'groupIds': ['OG000'], 'groupDescription': 'Change from 1 year to 2 year KSS Range of Motion', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2943', 'groupIds': ['OG000'], 'groupDescription': 'Change from 2 year to 5 year KSS Range of Motion', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative to 5 years Post-Operative', 'description': 'The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 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', 'populationDescription': 'Participants with available data. Participants=knees.'}, {'type': 'SECONDARY', 'title': 'Forgotten Joint Score (FJS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ShapeMatch Cutting Guides With Triathlon', 'description': 'Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.'}], 'classes': [{'title': 'FJS 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.48', 'spread': '30.58', 'groupId': 'OG000'}]}]}, {'title': 'FJS 2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.28', 'spread': '30.08', 'groupId': 'OG000'}]}]}, {'title': 'FJS 5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68.82', 'spread': '31.17', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0161', 'groupIds': ['OG000'], 'groupDescription': 'Change from 1 year to 2 year Forgotten Joint Score', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Change from 2 year to 5 year Forgotten Joint Score', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '1 to 5 years Post-Operative', 'description': 'The Forgotten Joint Score is a newly-developed twelve-item, self-reported assessment of how aware recipients of hip and knee joint replacement are of their joint in everyday life. The total score for the FJS is summed, averaged then multiplied by 25 (never = 0 points; almost never = 1 point; seldom = 2 points; sometimes = 3 points; mostly = 4 points). Total score range of 0 to 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data. Participants=knees.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ShapeMatch® Cutting Guides With Triathlon®', 'description': 'Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'All results are reported by knee throughout record. Participant=knee.', 'groupId': 'FG000', 'numSubjects': '205'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed/Not completed counts are for knees at the 5 year outcome interval.', 'groupId': 'FG000', 'numSubjects': '73'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}]}], 'dropWithdraws': [{'type': 'Failed MRI', 'reasons': [{'groupId': 'FG000', 'numSubjects': '52'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Delay in or unfit for surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'MRI contraindication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Consent violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Only Recruited to Part A', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Patients were assessed and then placed in either Part A or Part B. Patients in Part B were invited to participate in the extension follow-up to 5-years.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ShapeMatch Cutting Guides With Triathlon', 'description': 'Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.04', 'spread': '8.30', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline measurements are only available for participants who were invited and consented to the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-08-21', 'size': 353693, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-28T02:55', 'hasProtocol': True}, {'date': '2016-09-06', 'size': 104737, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-08-28T02:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 205}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-16', 'studyFirstSubmitDate': '2015-08-03', 'resultsFirstSubmitDate': '2015-09-29', 'studyFirstSubmitQcDate': '2015-08-16', 'lastUpdatePostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-09-29', 'studyFirstPostDateStruct': {'date': '2015-08-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant Location/Assessment of Alignment', 'timeFrame': '3 months Post-Operatively', 'description': 'Implant location and limb alignment is assessed using CT scan 3 months after surgery. The mean deviation of the postoperative femoral and tibial alignment from the preoperative plan is measured in degrees.'}], 'secondaryOutcomes': [{'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain', 'timeFrame': 'Pre-operative to 5 years post-operative', 'description': 'KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.)'}, {'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms', 'timeFrame': 'Pre-operative to 5 years post-operative', 'description': 'KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.)'}, {'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL', 'timeFrame': 'Pre-operative to 5 years post-operative', 'description': 'KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.)'}, {'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R', 'timeFrame': 'Pre-operative to 5 years Post-Operative', 'description': 'KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.)'}, {'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL', 'timeFrame': 'Pre-operative to 5 years post-operative', 'description': 'KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.)'}, {'measure': 'Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS)', 'timeFrame': 'Pre-operative to 5 years Post-Operative', 'description': 'SF-12 provides a summary measure of health status after combining the physical health score (PCS) and mental health score (MCS). The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state.'}, {'measure': 'VAS Pain at Rest', 'timeFrame': 'Pre-Operative to 5 years Post-Operative', 'description': 'Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.'}, {'measure': 'VAS Pain Mobilised', 'timeFrame': 'Pre-Operative to 5 years post-operative', 'description': 'Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.'}, {'measure': 'Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS)', 'timeFrame': 'Pre-operative to 5 years Post-Operative', 'description': 'SF-12 provides a summary measure of health status after combining the physical health score (PCS) and mental health score (MCS). The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state.'}, {'measure': 'Knee Society Clinical Rating System (KSS) Pain Scores', 'timeFrame': 'Pre-operative to 5 years Post-Operative', 'description': 'The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.'}, {'measure': 'Knee Society Clinical Rating System (KSS) Functional Scores', 'timeFrame': 'Pre-operative to 5 years Post-Operative', 'description': 'The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.'}, {'measure': 'Knee Society Clinical Rating System (KSS) Range of Motion Scores', 'timeFrame': 'Pre-operative to 5 years Post-Operative', 'description': 'The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.'}, {'measure': 'Forgotten Joint Score (FJS)', 'timeFrame': '1 to 5 years Post-Operative', 'description': 'The Forgotten Joint Score is a newly-developed twelve-item, self-reported assessment of how aware recipients of hip and knee joint replacement are of their joint in everyday life. The total score for the FJS is summed, averaged then multiplied by 25 (never = 0 points; almost never = 1 point; seldom = 2 points; sometimes = 3 points; mostly = 4 points). Total score range of 0 to 100.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arthroplasties, Replacement, Knee']}, 'descriptionModule': {'briefSummary': 'This is a prospective, non-randomized, longitudinal study of the clinical outcomes of participants that receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using ShapeMatch® Cutting Guides.\n\nHealth status and functional outcome measures will be recorded to quantify functional status of subjects before surgery and at each follow-up interval. This sub-study involved the assessment of the placement of the ShapeMatch® Cutting Guides intraoperatively and post-operatively. An assessment of post-operative patient outcomes compared to pre-operative status was also analysed.', 'detailedDescription': 'Protocol Attached in documentation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient is a male or non-pregnant female between the ages of 50-90.\n* The patient requires a primary total knee replacement and is indicated for computer-assisted surgery.\n* The patient has a primary diagnosis of osteoarthritis (OA).\n* The patient has intact collateral ligaments.\n* The patient is able to undergo MRI scanning of the affected limb.\n* The patient has signed the study specific, HREC-approved, Informed Consent document.\n* The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.\n\nExclusion Criteria:\n\n* The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint.\n* The patient has had a high tibial osteotomy or femoral osteotomy.\n* The patient is morbidly obese (BMI ≥ 40).\n* The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.\n* The patient has a varus/valgus malalignment ≥ 15° (relative to mechanical axis).\n* The patient has a fixed flexion deformity ≥ 15°.\n* The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.\n* The patient has a systemic or metabolic disorder leading to progressive bone deterioration.\n* The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.\n* The patient has a cognitive impairment, an intellectual disability or a mental illness.\n* The patient is pregnant.\n* The patient has metal hardware present in the region of the hip, knee or ankle (as this is known to create geometrical distortion in the region of the implant).\n* The patient has any known contraindications for undergoing assessment by MRI (e.g. ferrous implants, metallic clips, magnetically activated implanted devices such as cardiac pacemakers, etc).'}, 'identificationModule': {'nctId': 'NCT02527161', 'briefTitle': 'Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using ShapeMatch® Cutting Guides: Sub-Study B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stryker South Pacific'}, 'officialTitle': 'A Prospective, Non-randomized, Longitudinal Study of the Clinical Outcomes of Participants That Receive the Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using ShapeMatch® Cutting Guides: Sub-Study B', 'orgStudyIdInfo': {'id': 'TriShapeMatch-10_SubStudyB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ShapeMatch Cutting Guides with Triathlon', 'description': 'The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.\n\nThey are intended for single use only.', 'interventionNames': ['Device: ShapeMatch Cutting Guides with Triathlon']}], 'interventions': [{'name': 'ShapeMatch Cutting Guides with Triathlon', 'type': 'DEVICE', 'description': 'All participants will undergo medical imaging assessment using Magnetic Resonance Imaging (MRI) of the affected lower limb.These images will be used to manufacture the patient-specific cutting guides for preparation of the bones prior to implantation of the total knee replacement (Pre-operatively). Patients will undergo primary total knee arthroplasty with the Triathlon® Total Knee System (Stryker Orthopaedics, Mahwah, NJ USA) using the Shapematch cutting guides to guide the bone resection. Patients will follow the standard postoperative rehabilitation program established by the investigator at each site.', 'armGroupLabels': ['ShapeMatch Cutting Guides with Triathlon']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stryker South Pacific', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}