Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-07 @ 9:11 AM
Study NCT ID:
NCT03227692
Status:
COMPLETED
Last Update Posted:
2020-07-02
First Post:
2017-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Persona TKA With iASSIST Knee System and iASSIST Knee System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'takahito.nakai@zimmerbiomet.com', 'phone': '+81-3-6402-6610', 'title': 'Senior Manager of Clinical Affairs', 'organization': 'Zimmer Biomet G.K.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Surgery to 6 month postoperative visit', 'eventGroups': [{'id': 'EG000', 'title': 'Persona With iASSIST Knee', 'description': 'Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.\n\niAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Persona Without iASSIST Knee', 'description': 'Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 1, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Postoperative Supracondylar Fracture of femur', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Malignant Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Persona With iASSIST Knee', 'description': 'Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.\n\niAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.'}, {'id': 'OG001', 'title': 'Persona Without iASSIST Knee', 'description': 'Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.'}], 'classes': [{'categories': [{'title': 'within 3 degrees', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'outlier', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Postoperative 6 months', 'description': 'Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have CT data at 6 month after surgery were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Alignment Accuracy of the Knee Femoral Components in Sagittal Plain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Persona With iASSIST Knee', 'description': 'Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.\n\niAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.'}, {'id': 'OG001', 'title': 'Persona Without iASSIST Knee', 'description': 'Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.'}], 'classes': [{'categories': [{'title': 'within 3 degrees', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'title': 'outlier', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Postoperative 6 months', 'description': 'Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have CT data at 6 month after surgery were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Alignment Accuracy of the Knee Tibial Components in Coronal Plain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Persona With iASSIST Knee', 'description': 'Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.\n\niAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.'}, {'id': 'OG001', 'title': 'Persona Without iASSIST Knee', 'description': 'Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.'}], 'classes': [{'categories': [{'title': 'within 3 degrees', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': 'outlier', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Postoperative 6 months', 'description': 'Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have CT data at 6 month after surgery were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Persona With iASSIST Knee', 'description': 'Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.\n\niAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.'}, {'id': 'OG001', 'title': 'Persona Without iASSIST Knee', 'description': 'Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.'}], 'classes': [{'categories': [{'title': 'within 3 degrees', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'outlier', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Postoperative 6 months', 'description': 'Ratio of subject, whose knee implant is positioned within 3 degrees from preoperatively determined target angle, is compared between groups by CT data taken at 6 month after surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have CT data at 6 month after surgery were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Surgery Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Persona With iASSIST Knee', 'description': 'Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.\n\niAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.'}, {'id': 'OG001', 'title': 'Persona Without iASSIST Knee', 'description': 'Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.'}], 'classes': [{'categories': [{'measurements': [{'value': '125.1', 'spread': '34.6', 'groupId': 'OG000'}, {'value': '114.2', 'spread': '32.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative, an average of 2 hours', 'description': 'Surgery time from skin incision to closure', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Instrument Trays Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Persona With iASSIST Knee', 'description': 'Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.\n\niAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.'}, {'id': 'OG001', 'title': 'Persona Without iASSIST Knee', 'description': 'Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative', 'description': 'Number of instrument trays used instraoperatively. This number includes number of Total Knee Arthroplasty specific instrument tray, does not include other general surgical instruments/kits.', 'unitOfMeasure': 'trays', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'KSS - Objective Score at 6 Month Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Persona With iASSIST Knee', 'description': 'Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.\n\niAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.'}, {'id': 'OG001', 'title': 'Persona Without iASSIST Knee', 'description': 'Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.8', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '77.2', 'spread': '17.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 month postoperative', 'description': 'KSS-Objective score is physician-derived component and allows for more than 100 points in patients with greater than 125° of flexion and a stable painless knee as outlined below. Lowest possible score is 0.\n\nHigher score means better outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'KSS-Patient Satisfaction at 6 Month Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Persona With iASSIST Knee', 'description': 'Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.\n\niAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.'}, {'id': 'OG001', 'title': 'Persona Without iASSIST Knee', 'description': 'Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.6', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '25.0', 'spread': '8.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 month postoperative', 'description': 'KSS-Patient Satisfaction is patient-derived score and is a five-question 40-point scale that is collected preoperatively and at each follow-up visit. Lowest possible score is 0.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'KSS-function Score at 6 Month Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Persona With iASSIST Knee', 'description': 'Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.\n\niAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.'}, {'id': 'OG001', 'title': 'Persona Without iASSIST Knee', 'description': 'Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.6', 'spread': '23.7', 'groupId': 'OG000'}, {'value': '61.5', 'spread': '18.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 month postoperative', 'description': 'KSS-function score is patient-derived score and composed of four subgroups and has a maximum score of 100.\n\n"Walking and Standing" has a maximum value of 30 points, "Standard Activities" has a maximum of 30 points, "Advanced Activities" has a maximum of 25 points and "Discretionary Activities" has a maximum of 15 points.\n\nLowest possible score is 0. Higher score means better outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'KSS-Patient Expectations at 6 Month Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Persona With iASSIST Knee', 'description': 'Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.\n\niAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.'}, {'id': 'OG001', 'title': 'Persona Without iASSIST Knee', 'description': 'Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 month postoperative', 'description': "KSS-Patient Expectations is patient-derived score and is a three-question fifteen-point scale that is collected pre-operatively and post-operatively. The pre-operative questions reflect the patient's opinion on the extent to which the patient expects that operation will improve knee pain, and ability to perform activities of daily living and recreational activities. The post-operative questions reflect the extent to which postoperative outcome has met the patient's pre-operative expectations with respect to pain and function.\n\nThe score ranges from 3 to 15. Higher score means better outcomes.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Oxford Knee Score at 6 Month Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Persona With iASSIST Knee', 'description': 'Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.\n\niAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.'}, {'id': 'OG001', 'title': 'Persona Without iASSIST Knee', 'description': 'Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.2', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '37.7', 'spread': '6.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 month postoperative', 'description': 'Patient Reported Outcome specific for knee disease. Score range from 0 to 48. Higher score means better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'EQ-5D-3L at 6 Month Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Persona With iASSIST Knee', 'description': 'Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.\n\niAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.'}, {'id': 'OG001', 'title': 'Persona Without iASSIST Knee', 'description': 'Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 month postoperative', 'description': "EQ-5D is patient reported outcome measure to score patient's health related quality of life with minimum score of -0.111 and maximum score of 1.000.\n\nHigher score means better outcomes.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Persona With iASSIST Knee', 'description': 'Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.\n\niAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.'}, {'id': 'FG001', 'title': 'Persona Without iASSIST Knee', 'description': 'Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Persona With iASSIST Knee', 'description': 'Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.\n\niAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.'}, {'id': 'BG001', 'title': 'Persona Without iASSIST Knee', 'description': 'Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.\n\nPersona Knee System: Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.\n\nTotal Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.3', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '76.1', 'spread': '9.0', 'groupId': 'BG001'}, {'value': '74.8', 'spread': '9.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'KSS - Objective Score', 'classes': [{'categories': [{'measurements': [{'value': '34.8', 'spread': '20.2', 'groupId': 'BG000'}, {'value': '36.1', 'spread': '19.8', 'groupId': 'BG001'}, {'value': '35.4', 'spread': '19.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'KSS-Objective score is physician-derived component and allows for more than 100 points in patients with greater than 125° of flexion and a stable painless knee as outlined below. Lowest possible score is 0.\n\nHigher score means better outcomes.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'KSS-Patient Satisfaction', 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '15.1', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '13.9', 'spread': '6.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'KSS-Patient Satisfaction is patient-derived score and is a five-question 40-point scale that is collected preoperatively and at each follow-up visit. Lowest possible score is 0.\n\nHigher score means better outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'KSS-Function Score', 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '39.1', 'spread': '17.6', 'groupId': 'BG001'}, {'value': '38.8', 'spread': '18.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'KSS-function score is patient-derived score and composed of four subgroups and has a maximum score of 100.\n\n"Walking and Standing" has a maximum value of 30 points, "Standard Activities" has a maximum of 30 points, "Advanced Activities" has a maximum of 25 points and "Discretionary Activities" has a maximum of 15 points.\n\nLowest possible score is 0. Higher score means better outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'KSS-Patient Expectation', 'classes': [{'categories': [{'measurements': [{'value': '13.1', 'spread': '2.0', 'groupId': 'BG000'}, {'value': '12.9', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '13.0', 'spread': '1.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "KSS-Patient Expectations is patient-derived score and is a three-question fifteen-point scale that is collected pre-operatively and post-operatively. The pre-operative questions reflect the patient's opinion on the extent to which the patient expects that operation will improve knee pain, and ability to perform activities of daily living and recreational activities. The post-operative questions reflect the extent to which postoperative outcome has met the patient's pre-operative expectations with respect to pain and function.\n\nThe score ranges from 3 to 15. Higher score means better outcomes.", 'unitOfMeasure': 'score on scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Oxford Knee Score', 'classes': [{'categories': [{'measurements': [{'value': '22.0', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '25.0', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '23.5', 'spread': '8.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Patient Reported Outcome specific for knee disease. Score range from 0 to 48. Higher score means better outcome.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'EQ-5D-3L', 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '0.6', 'spread': '0.1', 'groupId': 'BG001'}, {'value': '0.6', 'spread': '0.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "EQ-5D is patient reported outcome measure to score patient's health related quality of life with minimum score of -0.111 and maximum score of 1.000.\n\nHigher score means better outcomes.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-27', 'size': 1536228, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-29T23:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Persona TKA with iASSIST Knee system (Investigational group) or Persona TKA with conventional instrumentation (Control group). The randomization scheme is based on equal numbers per group. The randomization will occur via a random number generator (computer) using blocked randomization procedure. The PI or his/her team does not have influence on the randomization scheme. Sealed opaque envelopes, which will be prepared based on predetermined randomization assignment, will be provided to each study site before study initiation.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'At surgery, intervention group using iASSIST Knee system. At surgery, conventional group not using iASSIST Knee system.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-16', 'studyFirstSubmitDate': '2017-07-20', 'resultsFirstSubmitDate': '2020-03-05', 'studyFirstSubmitQcDate': '2017-07-20', 'lastUpdatePostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-05', 'studyFirstPostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain', 'timeFrame': 'Postoperative 6 months', 'description': 'Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.'}, {'measure': 'Number of Participants With Alignment Accuracy of the Knee Femoral Components in Sagittal Plain', 'timeFrame': 'Postoperative 6 months', 'description': 'Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.'}, {'measure': 'Number of Participants With Alignment Accuracy of the Knee Tibial Components in Coronal Plain', 'timeFrame': 'Postoperative 6 months', 'description': 'Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.'}, {'measure': 'Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain', 'timeFrame': 'Postoperative 6 months', 'description': 'Ratio of subject, whose knee implant is positioned within 3 degrees from preoperatively determined target angle, is compared between groups by CT data taken at 6 month after surgery.'}], 'secondaryOutcomes': [{'measure': 'Surgery Time', 'timeFrame': 'Intraoperative, an average of 2 hours', 'description': 'Surgery time from skin incision to closure'}, {'measure': 'Number of Instrument Trays Used', 'timeFrame': 'Intraoperative', 'description': 'Number of instrument trays used instraoperatively. This number includes number of Total Knee Arthroplasty specific instrument tray, does not include other general surgical instruments/kits.'}, {'measure': 'KSS - Objective Score at 6 Month Postoperatively', 'timeFrame': '6 month postoperative', 'description': 'KSS-Objective score is physician-derived component and allows for more than 100 points in patients with greater than 125° of flexion and a stable painless knee as outlined below. Lowest possible score is 0.\n\nHigher score means better outcomes.'}, {'measure': 'KSS-Patient Satisfaction at 6 Month Postoperatively', 'timeFrame': '6 month postoperative', 'description': 'KSS-Patient Satisfaction is patient-derived score and is a five-question 40-point scale that is collected preoperatively and at each follow-up visit. Lowest possible score is 0.'}, {'measure': 'KSS-function Score at 6 Month Postoperatively', 'timeFrame': '6 month postoperative', 'description': 'KSS-function score is patient-derived score and composed of four subgroups and has a maximum score of 100.\n\n"Walking and Standing" has a maximum value of 30 points, "Standard Activities" has a maximum of 30 points, "Advanced Activities" has a maximum of 25 points and "Discretionary Activities" has a maximum of 15 points.\n\nLowest possible score is 0. Higher score means better outcomes.'}, {'measure': 'KSS-Patient Expectations at 6 Month Postoperatively', 'timeFrame': '6 month postoperative', 'description': "KSS-Patient Expectations is patient-derived score and is a three-question fifteen-point scale that is collected pre-operatively and post-operatively. The pre-operative questions reflect the patient's opinion on the extent to which the patient expects that operation will improve knee pain, and ability to perform activities of daily living and recreational activities. The post-operative questions reflect the extent to which postoperative outcome has met the patient's pre-operative expectations with respect to pain and function.\n\nThe score ranges from 3 to 15. Higher score means better outcomes."}, {'measure': 'Oxford Knee Score at 6 Month Postoperatively', 'timeFrame': '6 month postoperative', 'description': 'Patient Reported Outcome specific for knee disease. Score range from 0 to 48. Higher score means better outcome.'}, {'measure': 'EQ-5D-3L at 6 Month Postoperatively', 'timeFrame': '6 month postoperative', 'description': "EQ-5D is patient reported outcome measure to score patient's health related quality of life with minimum score of -0.111 and maximum score of 1.000.\n\nHigher score means better outcomes."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the accuracy of knee component alignment between patients operated with iASSIST Knee (Investigational group) versus patients operated without iASSIST Knee (Control group) using the same implant system.', 'detailedDescription': 'Objective： To compare the accuracy of knee component alignment between patients operated with iASSIST Knee (Investigational group) versus patients operated without iASSIST Knee (Control group) using the same implant system.\n\nEndpoint： Primary： The alignment accuracy of the knee femoral and tibial components at 6 months for the investigational group compared to the control group.\n\nSecondary：Health Status after TKA, Operating Room efficiency and Complication rate after TKA for the investigational group compared to the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a patient must meet all of the following criteria.\n\n* Knee (either unilateral or bilateral) osteoarthritis (varus deformity only)\n* Male or female\n* At least 20 years of age\n* Patients willing to return for follow-up evaluations.\n\nStudy Specific Requirements for Principal Investigator/Site\n\n* Principal Investigator (PI) must have experience of at least 5 TKAs of iASSIST Knee with Persona and Persona conventional instrument system before any study specific activities.\n* Site has sufficient resources to take limb CT scanning at 6 months follow-up visit.\n\nExclusion Criteria:\n\nAbsolute contraindications include:\n\n* Knee degenerative diseases other than knee osteoarthritis (such as necrosis/rheumatoid arthritis)\n* Too severe OA deformation (FTA: \\> 190 degrees/\\< 175 degrees)\n* Active infection (or within 6 weeks after infection)\n* Sepsis\n* Osteomyelitis\n* Any type of implant is inserted in the affected side of lower extremity\n* Hip and/or foot disease on the affected side\n\nAdditional contraindications include:\n\n* Uncooperative patient or patient with neurologic disorders who are incapable of following directions\n* Diagnosed osteoporosis or osteomalacia\n* Metabolic disorders which may impair bone formation\n* Distant foci of infections which may spread to the implant site\n* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram\n* Vascular insufficiency, muscular atrophy or neuromuscular disease.'}, 'identificationModule': {'nctId': 'NCT03227692', 'briefTitle': 'Persona TKA With iASSIST Knee System and iASSIST Knee System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'Randomized Controlled Study Comparing iASSIST Knee System Versus Conventional Instrumentation', 'orgStudyIdInfo': {'id': 'K.CR.I.AP.16.39'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Persona with iASSIST Knee', 'description': 'Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.', 'interventionNames': ['Device: Persona Knee System', 'Procedure: Total Knee Arthroplasty', 'Device: iAssist Knee']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Persona without iASSIST Knee', 'description': 'Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.', 'interventionNames': ['Device: Persona Knee System', 'Procedure: Total Knee Arthroplasty']}], 'interventions': [{'name': 'Persona Knee System', 'type': 'DEVICE', 'otherNames': ['Persona Knee'], 'description': 'Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.', 'armGroupLabels': ['Persona with iASSIST Knee', 'Persona without iASSIST Knee']}, {'name': 'Total Knee Arthroplasty', 'type': 'PROCEDURE', 'otherNames': ['TKA'], 'description': 'Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.', 'armGroupLabels': ['Persona with iASSIST Knee', 'Persona without iASSIST Knee']}, {'name': 'iAssist Knee', 'type': 'DEVICE', 'description': 'Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.', 'armGroupLabels': ['Persona with iASSIST Knee']}]}, 'contactsLocationsModule': {'locations': [{'zip': '530-0005', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Sumitomo Hopital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '150-8935', 'city': 'Shibuya City', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Japanese Red Cross Medical Center', 'geoPoint': {'lat': 35.6589, 'lon': 139.70665}}, {'zip': '747-8511', 'city': 'Hōfu', 'state': 'Yamaguchi', 'country': 'Japan', 'facility': 'Yamaguchi Prefectural Grand Medical Center', 'geoPoint': {'lat': 34.05, 'lon': 131.56667}}], 'overallOfficials': [{'name': 'Toshihiro Ohdera, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fukuoka Orthopaedic Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}