Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-06 @ 5:49 AM
Study NCT ID:
NCT03317834
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2017-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Navio With Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Helena.Kyriakou@smith-nephew.com', 'phone': '+1 8186995700', 'title': 'Helena Kyriakou', 'organization': 'Smith+Nephew, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).', 'description': 'The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.', 'eventGroups': [{'id': 'EG000', 'title': 'Study Population', 'description': 'Total Knee Replacement with Navio Surgical Systems\n\nNavio ™ Robotic-assisted Surgical System: Total Knee Replacement', 'otherNumAtRisk': 122, 'deathsNumAtRisk': 122, 'otherNumAffected': 12, 'seriousNumAtRisk': 122, 'deathsNumAffected': 2, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Tooth abcess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound complication due to suture reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in left knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in right knee, effusion right knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Iliotibial band friction syndrome - left knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left knee pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in left hip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right knee pain, lumbar sprain / strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Recurrent dislocation, right hip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Quadricep tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Delayed wound healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthrofibrosis of total knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthrofibrosis right knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Instability of internal left knee prosthesis, init. encounter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Patellar tendon tear right knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostate cancer (reoccurence)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deceased, unknown cause', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rt knee effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischemic stroke in left MCA region', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GI bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary atelectasis J98.11', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Periprosthetic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Macular Pucker with surgical repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cataracts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right knee pain, lumbar sprain / strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in left knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall causing torn tendon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection right knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acquired instability, left knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthrofibrosis (R) knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left stiffness of knee with history of replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthrofibrosis left knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in right knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Count of Participants With Post-operative Mechanical Alignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Population', 'description': 'Total Knee Replacement with Navio Surgical Systems\n\nNavio ™ Robotic-assisted Surgical System: Total Knee Replacement'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '106', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month', 'description': 'The number of participants achieving post-operative mechanical alignment within ±3 degrees from target with "Yes" indicating mechanical alignment was achieved and "No" indicating mechanical alignment was not achieved.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Participants Analyzed indicates the data available for the time frame specified.'}, {'type': 'SECONDARY', 'title': 'Count of Participants With Implant Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Population', 'description': 'Total Knee Replacement with Navio Surgical Systems\n\nNavio ™ Robotic-assisted Surgical System: Total Knee Replacement'}], 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '117', 'groupId': 'OG000'}]}, {'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Number of participants with implant survivorship where "No" indicates a revision surgery was not required and "Yes" indicates a revision surgery was required by the 2 year postoperative visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Knee Society Score 2011', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Population', 'description': 'Total Knee Replacement with Navio Surgical Systems\n\nNavio ™ Robotic-assisted Surgical System: Total Knee Replacement'}], 'classes': [{'title': 'Patient Expectation: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.21', 'spread': '1.627', 'groupId': 'OG000'}]}]}, {'title': 'Patient Expectation: 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.42', 'spread': '2.819', 'groupId': 'OG000'}]}]}, {'title': 'Patient Expectation: 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.78', 'spread': '3.391', 'groupId': 'OG000'}]}]}, {'title': 'Patient Expectation: 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.39', 'spread': '3.040', 'groupId': 'OG000'}]}]}, {'title': 'Patient Expectation: 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.97', 'spread': '2.485', 'groupId': 'OG000'}]}]}, {'title': 'Functional Activity: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.13', 'spread': '15.914', 'groupId': 'OG000'}]}]}, {'title': 'Functional Activity: 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.55', 'spread': '16.155', 'groupId': 'OG000'}]}]}, {'title': 'Functional Activity: 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '72.28', 'spread': '15.819', 'groupId': 'OG000'}]}]}, {'title': 'Functional Activity: 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.35', 'spread': '15.775', 'groupId': 'OG000'}]}]}, {'title': 'Functional Activity: 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.42', 'spread': '14.931', 'groupId': 'OG000'}]}]}, {'title': 'Objective: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49.40', 'spread': '21.382', 'groupId': 'OG000'}]}]}, {'title': 'Objective: 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.02', 'spread': '17.250', 'groupId': 'OG000'}]}]}, {'title': 'Objective: 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.98', 'spread': '15.867', 'groupId': 'OG000'}]}]}, {'title': 'Objective: 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.10', 'spread': '14.339', 'groupId': 'OG000'}]}]}, {'title': 'Objective: 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84.51', 'spread': '13.463', 'groupId': 'OG000'}]}]}, {'title': 'Patient Satisfaction: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.93', 'spread': '6.310', 'groupId': 'OG000'}]}]}, {'title': 'Patient Satisfaction: 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.64', 'spread': '7.028', 'groupId': 'OG000'}]}]}, {'title': 'Patient Satisfaction: 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.42', 'spread': '8.358', 'groupId': 'OG000'}]}]}, {'title': 'Patient Satisfaction: 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.19', 'spread': '7.110', 'groupId': 'OG000'}]}]}, {'title': 'Patient Satisfaction: 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.42', 'spread': '5.941', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 month, 6 months, 1 year, and 2 years', 'description': 'The Functional Knee Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities in Total Knee Arthroplasty (TKA) participants. The 2011 Knee Society Score consists of 4 separate subscales with a higher number indicating a better outcome:\n\n* A Patient Expectation Score (5items: 15 points, range 0-15)\n* A Functional Activity Score (19 items: 100 points, range 0-100)\n* An "Objective" Knee Score (7 items: 100 points, range 0-100)\n* A Patient Satisfaction Score (5 items: 40 points, range 0-40)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Participants Analyzed indicates the data available for the time frame specified.'}, {'type': 'SECONDARY', 'title': 'Quality of Life EQ-5D-5L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Population', 'description': 'Total Knee Replacement with Navio Surgical Systems\n\nNavio ™ Robotic-assisted Surgical System: Total Knee Replacement'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.44', 'spread': '16.643', 'groupId': 'OG000'}]}]}, {'title': '1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.01', 'spread': '12.251', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.44', 'spread': '13.462', 'groupId': 'OG000'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.82', 'spread': '10.012', 'groupId': 'OG000'}]}]}, {'title': '2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84.18', 'spread': '9.364', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 Month, 6 Months, 1 Year, 2 Years', 'description': 'Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D-5L) was graded on a scale of 0 to 100, with 100 being the best health you can imagine and 0 indicating the worst.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Participants Analyzed indicates the data available for the time frame specified.'}, {'type': 'SECONDARY', 'title': 'Forgotten Joint Score (FJS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Population', 'description': 'Total Knee Replacement with Navio Surgical Systems\n\nNavio ™ Robotic-assisted Surgical System: Total Knee Replacement'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.84', 'spread': '12.084', 'groupId': 'OG000'}]}]}, {'title': '1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.31', 'spread': '19.603', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51.45', 'spread': '25.377', 'groupId': 'OG000'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.31', 'spread': '26.598', 'groupId': 'OG000'}]}]}, {'title': '2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.56', 'spread': '26.095', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 month, 6 months, 1 year, 2 years', 'description': 'Forgotten Joint Score (FJS) is a patient-reported outcome measure intended to determine a patient\'s ability to "forget" about their affected joint after surgery or treatment. The Forgotten Joint Score consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Participants Analyzed indicates the data available for the time frame specified.'}, {'type': 'SECONDARY', 'title': 'Hospital Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Population', 'description': 'Total Knee Replacement with Navio Surgical Systems\n\nNavio ™ Robotic-assisted Surgical System: Total Knee Replacement'}], 'classes': [{'categories': [{'measurements': [{'value': '2.04', 'spread': '0.837', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During hospitalization, up to 6 days', 'description': 'Hospital length of stay measured in days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Operative Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Population', 'description': 'Total Knee Replacement with Navio Surgical Systems\n\nNavio ™ Robotic-assisted Surgical System: Total Knee Replacement'}], 'classes': [{'categories': [{'measurements': [{'value': '90.48', 'spread': '29.316', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During surgery, up to 235 minutes', 'description': 'Operative time taken for the surgery measured in minutes.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Radiographic Assessment - Anteroposterior (AP) Angle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Population', 'description': 'Total Knee Replacement with Navio Surgical Systems\n\nNavio ™ Robotic-assisted Surgical System: Total Knee Replacement'}], 'classes': [{'title': 'Femoral Flexion: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65.39', 'spread': '40.711', 'groupId': 'OG000'}]}]}, {'title': 'Femoral Flexion: 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.77', 'spread': '37.265', 'groupId': 'OG000'}]}]}, {'title': 'Femoral Flexion: 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.10', 'spread': '38.357', 'groupId': 'OG000'}]}]}, {'title': 'Femoral Flexion: 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.41', 'spread': '35.754', 'groupId': 'OG000'}]}]}, {'title': 'Femoral Flexion: 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '72.89', 'spread': '36.198', 'groupId': 'OG000'}]}]}, {'title': 'Tibial Angle: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '62.34', 'spread': '38.578', 'groupId': 'OG000'}]}]}, {'title': 'Tibial Angle: 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '69.07', 'spread': '37.639', 'groupId': 'OG000'}]}]}, {'title': 'Tibial Angle: 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.59', 'spread': '38.915', 'groupId': 'OG000'}]}]}, {'title': 'Tibial Angle: 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.51', 'spread': '36.435', 'groupId': 'OG000'}]}]}, {'title': 'Tibial Angle: 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.16', 'spread': '36.760', 'groupId': 'OG000'}]}]}, {'title': 'Total Valgus Angle: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '126.46', 'spread': '79.078', 'groupId': 'OG000'}]}]}, {'title': 'Total Valgus Angle: 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '140.15', 'spread': '74.310', 'groupId': 'OG000'}]}]}, {'title': 'Total Valgus Angle: 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '136.63', 'spread': '77.309', 'groupId': 'OG000'}]}]}, {'title': 'Total Valgus Angle: 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '143.89', 'spread': '71.527', 'groupId': 'OG000'}]}]}, {'title': 'Total Valgus Angle: 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '143.05', 'spread': '72.249', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 month, 6 months, 1 year, and 2 years', 'description': 'AP Angle mechanical alignment of femoral flexion, tibial angle, and total valgus angle', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Participants Analyzed indicates the data available for the time frame specified.'}, {'type': 'SECONDARY', 'title': 'Radiographic Assessment - Lateral Angle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Population', 'description': 'Total Knee Replacement with Navio Surgical Systems\n\nNavio ™ Robotic-assisted Surgical System: Total Knee Replacement'}], 'classes': [{'title': 'Lateral Angle Femoral Flexion: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.12', 'spread': '2.233', 'groupId': 'OG000'}]}]}, {'title': 'Lateral Angle Femoral Flexion: 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.68', 'spread': '2.600', 'groupId': 'OG000'}]}]}, {'title': 'Lateral Angle Femoral Flexion: 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.41', 'spread': '2.499', 'groupId': 'OG000'}]}]}, {'title': 'Lateral Angle Femoral Flexion: 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.10', 'spread': '9.465', 'groupId': 'OG000'}]}]}, {'title': 'Lateral Angle Femoral Flexion: 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.31', 'spread': '9.763', 'groupId': 'OG000'}]}]}, {'title': 'Tibial Angle: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.18', 'spread': '19.654', 'groupId': 'OG000'}]}]}, {'title': 'Tibial Angle: 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.30', 'spread': '37.277', 'groupId': 'OG000'}]}]}, {'title': 'Tibial Angle: 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.79', 'spread': '38.965', 'groupId': 'OG000'}]}]}, {'title': 'Tibial Angle: 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.56', 'spread': '38.965', 'groupId': 'OG000'}]}]}, {'title': 'Tibial Angle: 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.84', 'spread': '37.326', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 month, 6 months, 1 year, and 2 years', 'description': 'Lateral Angle mechanical alignment of femoral flexion and tibial angle.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Participants Analyzed indicates the data available for the time frame specified.'}, {'type': 'SECONDARY', 'title': 'Radiographic Assessment - Count of Participant Displacements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Population', 'description': 'Total Knee Replacement with Navio Surgical Systems\n\nNavio ™ Robotic-assisted Surgical System: Total Knee Replacement'}], 'classes': [{'categories': [{'title': 'No Displacement', 'measurements': [{'value': '62', 'groupId': 'OG000'}]}, {'title': 'Displacement', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Number of participants with either no displacement or displacement observed at the 6-month follow-up visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Participants Analyzed indicates the data available for the time frame specified.'}, {'type': 'SECONDARY', 'title': 'Radiographic Assessment - Displacement Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Population', 'description': 'Total Knee Replacement with Navio Surgical Systems\n\nNavio ™ Robotic-assisted Surgical System: Total Knee Replacement'}], 'classes': [{'categories': [{'measurements': [{'value': '3.95', 'spread': '2.663', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Degree of displacement measured in millimeters (mm) for participants with displacement observed at the 6-month follow-up visit.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Participants that showed displacement with data available for the time frame specified.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study Population', 'description': 'Total Knee Replacement with Navio Surgical Systems\n\nNavio ™ Robotic-assisted Surgical System: Total Knee Replacement'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Device Revision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}]}], 'recruitmentDetails': 'The enrollment for this study was conducted between 13 November 2017 and 27 May 2021 across six investigative sites.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Population', 'description': 'Total Knee Replacement with Navio Surgical Systems\n\nNavio ™ Robotic-assisted Surgical System: Total Knee Replacement'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.51', 'spread': '8.683', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age Category', 'categories': [{'title': '< 60 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': '>=60 years', 'measurements': [{'value': '109', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '74', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Black', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '107', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '31.32', 'spread': '5.102', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-19', 'size': 538112, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-23T12:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-27', 'studyFirstSubmitDate': '2017-10-18', 'resultsFirstSubmitDate': '2023-06-14', 'studyFirstSubmitQcDate': '2017-10-18', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-27', 'studyFirstPostDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Count of Participants With Post-operative Mechanical Alignment', 'timeFrame': '1 month', 'description': 'The number of participants achieving post-operative mechanical alignment within ±3 degrees from target with "Yes" indicating mechanical alignment was achieved and "No" indicating mechanical alignment was not achieved.'}], 'secondaryOutcomes': [{'measure': 'Count of Participants With Implant Survival', 'timeFrame': '2 years', 'description': 'Number of participants with implant survivorship where "No" indicates a revision surgery was not required and "Yes" indicates a revision surgery was required by the 2 year postoperative visit.'}, {'measure': 'Knee Society Score 2011', 'timeFrame': 'Baseline, 1 month, 6 months, 1 year, and 2 years', 'description': 'The Functional Knee Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities in Total Knee Arthroplasty (TKA) participants. The 2011 Knee Society Score consists of 4 separate subscales with a higher number indicating a better outcome:\n\n* A Patient Expectation Score (5items: 15 points, range 0-15)\n* A Functional Activity Score (19 items: 100 points, range 0-100)\n* An "Objective" Knee Score (7 items: 100 points, range 0-100)\n* A Patient Satisfaction Score (5 items: 40 points, range 0-40)'}, {'measure': 'Quality of Life EQ-5D-5L', 'timeFrame': 'Baseline, 1 Month, 6 Months, 1 Year, 2 Years', 'description': 'Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D-5L) was graded on a scale of 0 to 100, with 100 being the best health you can imagine and 0 indicating the worst.'}, {'measure': 'Forgotten Joint Score (FJS)', 'timeFrame': 'Baseline, 1 month, 6 months, 1 year, 2 years', 'description': 'Forgotten Joint Score (FJS) is a patient-reported outcome measure intended to determine a patient\'s ability to "forget" about their affected joint after surgery or treatment. The Forgotten Joint Score consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities.'}, {'measure': 'Hospital Length of Stay', 'timeFrame': 'During hospitalization, up to 6 days', 'description': 'Hospital length of stay measured in days'}, {'measure': 'Operative Time', 'timeFrame': 'During surgery, up to 235 minutes', 'description': 'Operative time taken for the surgery measured in minutes.'}, {'measure': 'Radiographic Assessment - Anteroposterior (AP) Angle', 'timeFrame': 'Baseline, 1 month, 6 months, 1 year, and 2 years', 'description': 'AP Angle mechanical alignment of femoral flexion, tibial angle, and total valgus angle'}, {'measure': 'Radiographic Assessment - Lateral Angle', 'timeFrame': 'Baseline, 1 month, 6 months, 1 year, and 2 years', 'description': 'Lateral Angle mechanical alignment of femoral flexion and tibial angle.'}, {'measure': 'Radiographic Assessment - Count of Participant Displacements', 'timeFrame': '6 months', 'description': 'Number of participants with either no displacement or displacement observed at the 6-month follow-up visit.'}, {'measure': 'Radiographic Assessment - Displacement Measurement', 'timeFrame': '6 months', 'description': 'Degree of displacement measured in millimeters (mm) for participants with displacement observed at the 6-month follow-up visit.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Total Knee Arthroplasty', 'Arthroplasty of Knee']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate superior accuracy with the Navio ™ Robotic-assisted Surgical System in achieving desired post-operative mechanical alignment, compared to TKA procedures using standard instruments. An additional study purpose is to document clinical and patient-reported outcomes in subjects receiving TKA with the Navio ™ system.', 'detailedDescription': 'Total Knee Arthroplasty (TKA) has become an effective and reliable treatment for arthritis of the knee (1). TKA is associated with low morbidity and mortality, and its effectiveness in reducing joint pain and improving range of motion is well established. In 2014, over 750,000 knee replacements were performed in the US (2).\n\nA significant innovation in TKA has been the introduction of computer navigation and robotic-assisted surgery (3). One such technology is the Navio™ Robotic-assisted Surgical System. This system is a semi-autonomous image-free system. During the surgery, the surgeon maps the condylar landmarks and determines alignment indices to define the volume and orientation of bone to be removed. The tools to remove the bone and place the implants are controlled and manipulated by the surgeon with the guidance of a 3-dimensional digital map of the surgical surface.\n\nOriginally the Navio™ system was launched for use in unicondylar knee replacement only. To date, there have been over 1000 unicondylar knee replacement surgeries using the system. In 2017, Smith \\& Nephew Inc. expanded the indications for the Navio™ system to include TKA. The purpose of this multicenter, prospective study is to evaluate outcomes associated with this new indication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'To eliminate the potential for selection bias, Investigators should screen all subjects undergoing a Navio™ assisted TKA. In order to do so, only the existing information obtained per standard routine medical procedures will be used. No study-specific screening procedures, activities or questionnaires will be performed during pre-screening.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject requires primary total knee arthroplasty with the Journey II BCS or Cruciate-Retraining (CR) Systems due to degenerative joint disease (primary diagnosis of osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis.\n2. Subject was considered skeletally mature at the time of cone implantation (at least 18 years or older.)\n3. Subject agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form) by signing the IRB/EC approved informed consent form.\n4. Subject plans to be available through two (2) years postoperative follow-up.\n\nExclusion Criteria:\n\n1. Subject has BMI ≥ 40.\n2. Subject has condition(s) that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease, or an active, local infection).\n3. Subject is deemed by investigator to require a constrained or deep dish tibial insert.\n4. Subject has inadequate bone stock to support the device (severe osteopenia, history of severe osteoporosis or severe osteopenia).\n5. Subject has mental or neurologic condition(s) that may pre-empt the ability or willingness to restrict activities.\n6. Subject is 80 years of age or older.\n7. Subject is a prisoner or impending incarceration."}, 'identificationModule': {'nctId': 'NCT03317834', 'briefTitle': 'Navio With Total Knee Arthroplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smith & Nephew, Inc.'}, 'officialTitle': 'Clinical, Radiographic and Patient-reported Outcomes Associated With the Use of the Navio™ Robotic-assisted Surgical System in Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '17-NPFS-04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Population', 'description': 'Total Knee Replacement with Navio Surgical Systems', 'interventionNames': ['Device: Navio ™ Robotic-assisted Surgical System']}], 'interventions': [{'name': 'Navio ™ Robotic-assisted Surgical System', 'type': 'DEVICE', 'description': 'Total Knee Replacement', 'armGroupLabels': ['Study Population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Hedley Orthopedics', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '86305', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Orthopaedic Associates of Central Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Orthopaedic', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '49006', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Bronson Health', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Joint Disease Orthopaedic Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43054', 'city': 'Albany', 'state': 'Ohio', 'country': 'United States', 'facility': 'OrthoNeuro', 'geoPoint': {'lat': 39.22757, 'lon': -82.20237}}], 'overallOfficials': [{'name': 'Julie Lankiewicz', 'role': 'STUDY_CHAIR', 'affiliation': 'Smith & Nephew, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smith & Nephew, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}