Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-01-25 @ 5:49 AM
Study NCT ID:
NCT02539992
Status:
TERMINATED
Last Update Posted:
2024-02-22
First Post:
2015-09-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ShapeMatch Cutting Guide Functional Outcomes Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eric.garling@stryker.com', 'phone': '+31 20 219 2660', 'title': 'Dr. Eric Garling, Director Medical & Scientific Affairs Europe', 'organization': 'Stryker European Operations BV'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Triathlon® CR/Kinematic Alignment', 'description': 'Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.\n\nTriathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Triathlon® CR/Neutral Overall Limb Alignment', 'description': 'Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.\n\nTriathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Triathlon® CR/Conventional Limb Alignment', 'description': 'Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.\n\nTriathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Flexion deficit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mammary Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostatic cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Triathlon® CR/Kinematic Alignment', 'description': 'Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.\n\nTriathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides'}, {'id': 'OG001', 'title': 'Triathlon® CR/Neutral Overall Limb Alignment', 'description': 'Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.\n\nTriathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides'}, {'id': 'OG002', 'title': 'Triathlon® CR/Conventional Limb Alignment', 'description': 'Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.\n\nTriathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation'}], 'classes': [{'title': 'Contact Point Rotation (CPR) Stair Climbing', 'categories': [{'measurements': [{'value': '7.3', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'CPR Chair Rising', 'categories': [{'measurements': [{'value': '12.6', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'CPR Extension-Against-Gravity', 'categories': [{'measurements': [{'value': '12.5', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '5.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': "To demonstrate by means of fluoroscopy that TKR's performed using a kinematic aligned ShapeMatch Cutting Guide provides better short term kinematic and functional performance compared to those TKR's performed with ShapeMatch cutting guides modified to provide neutral overall limb alignment or with conventional instrumentation intended to achieve neutral overall limb alignment.", 'unitOfMeasure': 'Degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Early study termination resulted in limited availability of data for analysis to provide robust, meaningful results. Therefore the fluoroscopic data sets of the Neutral Overall Limb Alignment and Conventional Limb Alignment groups were combined and compared with the Kinematic Alignment group.'}, {'type': 'SECONDARY', 'title': 'Investigation of Clinical Performance and Patient Outcome With the Get-up and go Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Triathlon® CR/Kinematic Alignment', 'description': 'Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.\n\nTriathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides'}, {'id': 'OG001', 'title': 'Triathlon® CR/Neutral Overall Limb Alignment', 'description': 'Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.\n\nTriathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides'}, {'id': 'OG002', 'title': 'Triathlon® CR/Conventional Limb Alignment', 'description': 'Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.\n\nTriathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '6', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '7', 'spread': '2.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Get-up-and-go test uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.\n\nOne source suggests that scores of ten seconds or less indicate normal mobility, 11 - 20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.'}, {'type': 'SECONDARY', 'title': 'Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Triathlon® CR/Neutral Overall Limb Alignment', 'description': 'Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.\n\nTriathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides'}, {'id': 'OG001', 'title': 'Triathlon® CR/Kinematic Alignment', 'description': 'Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.\n\nTriathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides'}, {'id': 'OG002', 'title': 'Triathlon® CR/Conventional Limb Alignment', 'description': 'Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.\n\nTriathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation'}], 'classes': [{'title': 'Symptoms', 'categories': [{'measurements': [{'value': '75', 'spread': '20.0', 'groupId': 'OG000'}, {'value': '84', 'spread': '11.6', 'groupId': 'OG001'}, {'value': '82', 'spread': '11.7', 'groupId': 'OG002'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '88', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '91', 'spread': '12.7', 'groupId': 'OG001'}, {'value': '87', 'spread': '15.2', 'groupId': 'OG002'}]}]}, {'title': 'Daily Living Activities', 'categories': [{'measurements': [{'value': '89', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '92', 'spread': '8.9', 'groupId': 'OG001'}, {'value': '86', 'spread': '13.4', 'groupId': 'OG002'}]}]}, {'title': 'Sport/Recreation', 'categories': [{'measurements': [{'value': '47', 'spread': '25.1', 'groupId': 'OG000'}, {'value': '58', 'spread': '28.3', 'groupId': 'OG001'}, {'value': '64', 'spread': '27.3', 'groupId': 'OG002'}]}]}, {'title': 'Quality of Life', 'categories': [{'measurements': [{'value': '89', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '82', 'spread': '19.9', 'groupId': 'OG001'}, {'value': '76', 'spread': '21.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year follow-up', 'description': 'KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.'}, {'type': 'SECONDARY', 'title': 'Investigation of Clinical Performance and Patient Outcome With the Forgotten Joint Score (FJS) Patient Questionnaire.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Triathlon® CR/Kinematic Alignment', 'description': 'Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.\n\nTriathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides'}, {'id': 'OG001', 'title': 'Triathlon® CR/Neutral Overall Limb Alignment', 'description': 'Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.\n\nTriathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides'}, {'id': 'OG002', 'title': 'Triathlon® CR/Conventional Limb Alignment', 'description': 'Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.\n\nTriathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'spread': '32.1', 'groupId': 'OG000'}, {'value': '82', 'spread': '15.6', 'groupId': 'OG001'}, {'value': '69', 'spread': '27.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year follow-up', 'description': "The FJS consists of 12 questions and focuses on the patients' awareness of their joint replacement during a range of day to day and recreational activities. The score has a range of 0-100. High scores indicate good outcome, i.e., a high degree of being able to forget about the affected joint in daily life.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.'}, {'type': 'SECONDARY', 'title': 'Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Triathlon® CR/Kinematic Alignment', 'description': 'Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.\n\nTriathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides'}, {'id': 'OG001', 'title': 'Triathlon® CR/Neutral Overall Limb Alignment', 'description': 'Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.\n\nTriathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides'}, {'id': 'OG002', 'title': 'Triathlon® CR/Conventional Limb Alignment', 'description': 'Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.\n\nTriathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '0.12', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year follow-up', 'description': 'The EQ-5D index has an upper bound equal to 1 that indicates full health (indicated by "no problem" in all domains), whereas 0 represents death. Negative values are allowed, and the lower bound varies depending on country-specific value set used. UK time Trade Off (UKTTO) indicates the patient status compared to the normal state of the UK population.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.'}, {'type': 'SECONDARY', 'title': 'Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Triathlon® CR/Kinematic Alignment', 'description': 'Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.\n\nTriathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides'}, {'id': 'OG001', 'title': 'Triathlon® CR/Neutral Overall Limb Alignment', 'description': 'Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.\n\nTriathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides'}, {'id': 'OG002', 'title': 'Triathlon® CR/Conventional Limb Alignment', 'description': 'Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.\n\nTriathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation'}], 'classes': [{'title': 'Physikal Function', 'categories': [{'measurements': [{'value': '51', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '47', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '48', 'spread': '6.4', 'groupId': 'OG002'}]}]}, {'title': 'Role Physical', 'categories': [{'measurements': [{'value': '50', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '48', 'spread': '11.3', 'groupId': 'OG001'}, {'value': '48', 'spread': '7.9', 'groupId': 'OG002'}]}]}, {'title': 'Bodily Pain', 'categories': [{'measurements': [{'value': '54', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '46', 'spread': '11.5', 'groupId': 'OG001'}, {'value': '49', 'spread': '8.1', 'groupId': 'OG002'}]}]}, {'title': 'General Health', 'categories': [{'measurements': [{'value': '51', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '50', 'spread': '6.1', 'groupId': 'OG001'}, {'value': '54', 'spread': '7.4', 'groupId': 'OG002'}]}]}, {'title': 'Vitality', 'categories': [{'measurements': [{'value': '57', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '54', 'spread': '7.8', 'groupId': 'OG001'}, {'value': '57', 'spread': '9.1', 'groupId': 'OG002'}]}]}, {'title': 'Social Functioning', 'categories': [{'measurements': [{'value': '50', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '52', 'spread': '7.9', 'groupId': 'OG001'}, {'value': '53', 'spread': '5.7', 'groupId': 'OG002'}]}]}, {'title': 'Role Emotional', 'categories': [{'measurements': [{'value': '50', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '45', 'spread': '6.6', 'groupId': 'OG001'}, {'value': '49', 'spread': '10.2', 'groupId': 'OG002'}]}]}, {'title': 'Mental Health', 'categories': [{'measurements': [{'value': '53', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '50', 'spread': '9.4', 'groupId': 'OG001'}, {'value': '51', 'spread': '11.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year follow-up', 'description': 'The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. 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': 'Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.'}, {'type': 'SECONDARY', 'title': 'Assessment of Better Performance of TKR Using a Kinematic Aligned ShapeMatch Cutting Guide by Functional Evaluation With Knee Society Score (KSS).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Triathlon® CR/Kinematic Alignment', 'description': 'Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.\n\nTriathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides'}, {'id': 'OG001', 'title': 'Triathlon® CR/Neutral Overall Limb Alignment', 'description': 'Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.\n\nTriathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides'}, {'id': 'OG002', 'title': 'Triathlon® CR/Conventional Limb Alignment', 'description': 'Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.\n\nTriathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation'}], 'classes': [{'title': 'Assessment Score', 'categories': [{'measurements': [{'value': '87', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '84', 'spread': '16.1', 'groupId': 'OG001'}, {'value': '82', 'spread': '8.9', 'groupId': 'OG002'}]}]}, {'title': 'Function Score', 'categories': [{'measurements': [{'value': '91', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '89', 'spread': '14.6', 'groupId': 'OG001'}, {'value': '97', 'spread': '4.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year follow-up', '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 potential minimum score of 0 to a maximum score 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': 'Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Triathlon® CR/Kinematic Alignment', 'description': 'Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.\n\nTriathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides'}, {'id': 'FG001', 'title': 'Triathlon® CR/Neutral Overall Limb Alignment', 'description': 'Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.\n\nTriathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides'}, {'id': 'FG002', 'title': 'Triathlon® CR/Conventional Limb Alignment', 'description': 'Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.\n\nTriathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'recruitmentDetails': '56 patients have been screened for study participation. No patient withdrew his/her informed consent.', 'preAssignmentDetails': '12/56 patients received another procedure. Therefore 44 patients were enrolled in 4 centers.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Triathlon® CR/Kinematic Alignment', 'description': 'Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.\n\nTriathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides'}, {'id': 'BG001', 'title': 'Triathlon® CR/Neutral Overall Limb Alignment', 'description': 'Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.\n\nTriathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides'}, {'id': 'BG002', 'title': 'Triathlon® CR/Conventional Limb Alignment', 'description': 'Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.\n\nTriathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69', 'spread': '5.8', 'groupId': 'BG000'}, {'value': '67', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '70', 'spread': '4.8', 'groupId': 'BG002'}, {'value': '69', 'spread': '6.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Forty-four (44) patients were enrolled over an 11 month period in a randomized manner in 4 centers.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'whyStopped': 'Product discontinued in November 2014', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-20', 'studyFirstSubmitDate': '2015-09-01', 'resultsFirstSubmitDate': '2015-09-29', 'studyFirstSubmitQcDate': '2015-09-01', 'lastUpdatePostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-05-13', 'studyFirstPostDateStruct': {'date': '2015-09-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy.', 'timeFrame': '6 months', 'description': "To demonstrate by means of fluoroscopy that TKR's performed using a kinematic aligned ShapeMatch Cutting Guide provides better short term kinematic and functional performance compared to those TKR's performed with ShapeMatch cutting guides modified to provide neutral overall limb alignment or with conventional instrumentation intended to achieve neutral overall limb alignment."}], 'secondaryOutcomes': [{'measure': 'Investigation of Clinical Performance and Patient Outcome With the Get-up and go Test', 'timeFrame': '1 year', 'description': 'Get-up-and-go test uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.\n\nOne source suggests that scores of ten seconds or less indicate normal mobility, 11 - 20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.'}, {'measure': 'Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.', 'timeFrame': '1 year follow-up', 'description': 'KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).'}, {'measure': 'Investigation of Clinical Performance and Patient Outcome With the Forgotten Joint Score (FJS) Patient Questionnaire.', 'timeFrame': '1 year follow-up', 'description': "The FJS consists of 12 questions and focuses on the patients' awareness of their joint replacement during a range of day to day and recreational activities. The score has a range of 0-100. High scores indicate good outcome, i.e., a high degree of being able to forget about the affected joint in daily life."}, {'measure': 'Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).', 'timeFrame': '1 year follow-up', 'description': 'The EQ-5D index has an upper bound equal to 1 that indicates full health (indicated by "no problem" in all domains), whereas 0 represents death. Negative values are allowed, and the lower bound varies depending on country-specific value set used. UK time Trade Off (UKTTO) indicates the patient status compared to the normal state of the UK population.'}, {'measure': 'Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36).', 'timeFrame': '1 year follow-up', 'description': 'The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.'}, {'measure': 'Assessment of Better Performance of TKR Using a Kinematic Aligned ShapeMatch Cutting Guide by Functional Evaluation With Knee Society Score (KSS).', 'timeFrame': '1 year follow-up', '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 potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arthroplasty, Replacement, Knee']}, 'descriptionModule': {'briefSummary': 'Randomized evaluation of the ShapeMatch Cutting Guide for primary total knee replacement (TKR) in a consecutive series of patients who meet the eligibility criteria.', 'detailedDescription': 'This study will be a prospective, randomized evaluation of the ShapeMatch Cutting Guide for primary total knee replacement (TKR) in a consecutive series of patients who meet the eligibility criteria. Forty-eight cases enrolled will receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee. Another forty-eight cases enrolled will receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee. And the last forty-eight cases will receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient has signed an ethic commission approved study specific Informed Patient Consent Form.\n2. Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.\n3. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).\n4. Patient is a candidate for a primary total knee replacement.\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 age ≥ 80.\n3. Patient has a varus or valgus deformity greater than 10 degree or flexion contracture greater than 20 degree.\n4. Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.\n5. Patient has received any orthopaedic surgical intervention to the lower extremities within the past year or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the TKR to be enrolled in this study, within the next year.\n6. Patient requires bilateral total knee replacements, or has a history of contralateral partial or total knee replacement.\n7. Patient has any implanted device that would be incompatible with MRI procedures.\n8. Patient has chronic heart failure (NYHA Stage ≥ 2)\n9. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.\n10. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget"s Disease) leading to progressive bone deterioration.\n11. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \\> 30 days).\n12. Patient requires revision surgery of a previously implanted total knee replacement or knee fusion to the affected joint.\n13. Patient has a known sensitivity to device materials.\n14. Patient is a prisoner.'}, 'identificationModule': {'nctId': 'NCT02539992', 'acronym': 'ShapeMatch', 'briefTitle': 'ShapeMatch Cutting Guide Functional Outcomes Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stryker Orthopaedics'}, 'officialTitle': 'A Prospective, Randomized, Multi-centre Study of the Triathlon Cruciate Retaining Total Knee System Using ShapeMatch Cutting Guides', 'orgStudyIdInfo': {'id': 'K-S-045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Triathlon® CR/Kinematic Alignment', 'description': 'Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.', 'interventionNames': ['Device: Triathlon® CR/Kinematic Alignment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Triathlon® CR/Neutral Overall Limb Alignment', 'description': 'Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.', 'interventionNames': ['Device: Triathlon® CR/Neutral Overall Limb Alignment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Triathlon® CR/Conventional Limb Alignment', 'description': 'Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.', 'interventionNames': ['Device: Triathlon® CR/Conventional Limb Alignment']}], 'interventions': [{'name': 'Triathlon® CR/Kinematic Alignment', 'type': 'DEVICE', 'description': 'Total knee replacement using patient-specific cutting guides', 'armGroupLabels': ['Triathlon® CR/Kinematic Alignment']}, {'name': 'Triathlon® CR/Neutral Overall Limb Alignment', 'type': 'DEVICE', 'description': 'Total knee replacement using patient-specific cutting guides', 'armGroupLabels': ['Triathlon® CR/Neutral Overall Limb Alignment']}, {'name': 'Triathlon® CR/Conventional Limb Alignment', 'type': 'DEVICE', 'description': 'Total knee replacement using traditional instrumentation', 'armGroupLabels': ['Triathlon® CR/Conventional Limb Alignment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '40136', 'city': 'Bologna', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'Istituto Ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '41124', 'city': 'Modena', 'country': 'Italy', 'facility': 'Azienada Ospedaliero-Universitaria di Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': 'EX2 5DW', 'city': 'Exeter', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'Royal Devon and Exeter NHS Foundation Trust', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}], 'overallOfficials': [{'name': 'Fabio Catani, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienada Ospedaliero-Universitaria di Modena'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stryker Orthopaedics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}