Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-01-07 @ 7:44 PM
Study NCT ID:
NCT03072459
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
2017-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Retrospective Study of the Navio Robotic-assisted Surgical System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'salima.reddy@smith-nephew.com', 'phone': '817-916-2233', 'title': 'Salima Reddy', 'organization': 'Smith & Nephew, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'There were no known study limitations.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.', 'eventGroups': [{'id': 'EG000', 'title': 'Navio Robotic-assisted Surgical System', 'description': 'Subjects who had previously received the Navio™ robotic-assisted surgical system for UKR were assessed to determine the 2-year safety and effectiveness of the Navio™ system.', 'otherNumAtRisk': 128, 'deathsNumAtRisk': 128, 'otherNumAffected': 28, 'seriousNumAtRisk': 128, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Radiolucency line tibial ML zone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness, burning, itchiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling and discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Slight swelling and edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Knee pain due to mild iliotibial band tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in quadriceps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Knee pain with 50 mL of blood aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Possible cellulitis - not life threatening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Manipulation under anesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Occasional swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Soreness/pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Incisional soreness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pin site drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pimple drainage from pin site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stress shielding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Radiolucent lines', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Femoral osteolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Incision pain with deep flexion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anterior knee pain and swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Synovial hypertrophy, quadriceps atrophy, and knee pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hamstring irritation and ischial tuberosity bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin irritation over pin site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Deep venous thrombosis (DVT)', 'notes': 'The subject recovered/resolved from the DVT and it was deemed unrelated to the treatment. The subject was not discontinued from the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower extremity DVT', 'notes': 'The subject recovered/resolved from the DVT and it was deemed unrelated to the treatment. The subject was not discontinued from the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Navio Robotic-assisted Surgical System', 'description': 'Subjects who had previously received the Navio™ robotic-assisted surgical system for UKR were assessed to determine the 2-year safety and effectiveness of the Navio™ system.'}], 'classes': [{'title': 'Number of Knees with Revisions : Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Number of Knees with Revisions : Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Number of Knees with Revisions : Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Number of Knees with Revisions : Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Number of Knees with Revisions : Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Number of Knees with Revisions : Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Preoperative (Baseline) and 24, 48, 72, 96, and 120 weeks postoperatively', 'description': 'Analysis of the absence of device revision (overall survivorship) outcomes assessed from Baseline through 120 weeks post-surgical implantation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) population. The SAF population included all subjects who received the study device and were present for follow-up visits at specified time points.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Navio Robotic-assisted Surgical System', 'description': 'Subjects who had previously received the Navio™ robotic-assisted surgical system for UKR were assessed to determine the 2-year safety and effectiveness of the Navio™ system.'}], 'classes': [{'title': 'Objective Knee Indicators: Preoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.6', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '92'}]}]}, {'title': 'Objective Knee Indicators: 6 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51.6', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '80'}]}]}, {'title': 'Objective Knee Indicators: 12 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49.3', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '78'}]}]}, {'title': 'Objective Knee Indicators: 18 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49.9', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '72'}]}]}, {'title': 'Objective Knee Indicators: 24 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61.9', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '96'}]}]}, {'title': 'Objective Knee Indicators: 30 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.8', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '96'}]}]}, {'title': 'Objective Knee Indicators: 36 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '94'}]}]}, {'title': 'Patient Satisfaction: Preoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '40'}]}]}, {'title': 'Patient Satisfaction: 6 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '40'}]}]}, {'title': 'Patient Satisfaction: 12 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '40'}]}]}, {'title': 'Patient Satisfaction: 18 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.8', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '40'}]}]}, {'title': 'Patient Satisfaction: 24 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '40'}]}]}, {'title': 'Patient Satisfaction: 30 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.4', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '40'}]}]}, {'title': 'Patient Satisfaction: 36 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.8', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '40'}]}]}, {'title': 'Functional Activities: Preoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Functional Activities: 6 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '98'}]}]}, {'title': 'Functional Activities: 12 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.2', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': '100'}]}]}, {'title': 'Functional Activities: 18 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.9', 'groupId': 'OG000', 'lowerLimit': '43', 'upperLimit': '91'}]}]}, {'title': 'Functional Activities: 24 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.9', 'groupId': 'OG000', 'lowerLimit': '39', 'upperLimit': '100'}]}]}, {'title': 'Functional Activities: 30 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.1', 'groupId': 'OG000', 'lowerLimit': '43', 'upperLimit': '100'}]}]}, {'title': 'Functional Activities: 36 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.6', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '98'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively', 'description': 'Analysis of KSS from preoperatively (Baseline) up to 36 months postoperatively in 6-months increments to evaluate objective observation, patient satisfaction, and function.\n\nObjective knee indicators: Range 0-100 points; Patient Satisfaction: Range 0-40 points; and Functional Activities: Range 0-100 points.\n\nHigher scores indicated a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The KSS questionnaire assessments were self-reported and not all enrolled subjects completed the questionnaires. See detailed number of participants who completed each response question.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Navio Robotic-assisted Surgical System', 'description': 'Subjects who had previously received the Navio™ robotic-assisted surgical system for UKR were assessed to determine the 2-year safety and effectiveness of the Navio™ system.'}], 'classes': [{'title': 'PCS: Preoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '15'}]}]}, {'title': 'PCS: 6 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '17'}]}]}, {'title': 'PCS: 12 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': '20'}]}]}, {'title': 'PCS: 18 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '12.4', 'upperLimit': '17'}]}]}, {'title': 'PCS: 24 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '19'}]}]}, {'title': 'PCS: 30 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': '17'}]}]}, {'title': 'PCS: 36 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': '17.4'}]}]}, {'title': 'MCS: Preoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.3', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '26'}]}]}, {'title': 'MCS: 6 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '26'}]}]}, {'title': 'MCS: 12 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '23'}]}]}, {'title': 'MCS: 18 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.1', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '23'}]}]}, {'title': 'MCS: 24 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.4', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '24'}]}]}, {'title': 'MCS: 30 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '24'}]}]}, {'title': 'MCS: 36 Months Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '23'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively', 'description': 'Analysis of VR-12 scores preoperatively (Baseline) through 36 months postoperatively in 6 months increments. These scores encompass the individual domains of physical component score (PCS), mental component score (MCS) as well as the sub-domain scores within the PCS (physical functioning, role physical, bodily pain, and general health) and those within the MCS (vitality, social functioning, role emotional, and mental health).\n\nDomain Scores:\n\nPhysical Component Score (PCS): Range 1 to 20 Mental Component Score (MCS): Range 1 to 25\n\nSub-domain Scores:\n\nPhysical Functioning: Range 1 to 6 Role Physical: Range 1 to 4 Bodily Pain: Range 1 to 6 General Health: Range 1 to 6 Vitality: Range 1 to 6 Social Functioning: Range 1 to 6 Role Emotional: Range 1 to 4 Mental Health: Range 1 to 10\n\nTransformation of raw scale scores (range 0-100) = {(actual raw score - lowest possible raw score)/possible raw score range} x100\n\nA higher score indicates a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The VR-12 questionnaire assessments were self-reported and not all enrolled subjects completed the questionnaires. See detailed number of participants who completed each response question.'}, {'type': 'SECONDARY', 'title': 'Preoperative Evaluation of Efficacy Based on Radiographic Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Navio Robotic-assisted Surgical System', 'description': 'Subjects who had previously received the Navio™ robotic-assisted surgical system for UKR were assessed to determine the 2-year safety and effectiveness of the Navio™ system.'}], 'classes': [{'title': 'Tibial Osteolysis', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '128', 'groupId': 'OG000'}]}]}, {'title': 'Femoral osteolysis', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '128', 'groupId': 'OG000'}]}]}, {'title': 'Tibial Migration/Subsidence', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '128', 'groupId': 'OG000'}]}]}, {'title': 'Femoral Migration/Subsidence', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '128', 'groupId': 'OG000'}]}]}, {'title': 'Heterotropic Ossification', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '128', 'groupId': 'OG000'}]}]}, {'title': 'Patellar Subluxation', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '128', 'groupId': 'OG000'}]}]}, {'title': 'Patellar Dislocation', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '128', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Preoperative (Baseline)', 'description': 'Changes in radiographic findings (anterior-posterior \\[AP\\] and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Navio Robotic-assisted Surgical System', 'description': 'Subjects who had previously received the Navio™ robotic-assisted surgical system for UKR were assessed to determine the 2-year safety and effectiveness of the Navio™ system.'}], 'classes': [{'title': 'Tibial Osteolysis', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '25', 'groupId': 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{'title': 'Femoral Osteolysis', 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Tibial Migration/Subsidence', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Femoral Migration/Subsidence', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Missing', 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{'title': 'No', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Patellar Subluxation', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Patellar Dislocation', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 months 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'Patellar Dislocation', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months postoperatively', 'description': 'Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Navio Robotic-assisted Surgical System', 'description': 'Subjects who had previously received the Navio™ robotic-assisted surgical 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'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '122', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '172.1', 'spread': '10.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters (cm)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'There was one subject with missing height, weight, and BMI information provided from the site, and thus not included in the results.'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '89.9', 'spread': '18.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'There was one subject with missing height, weight, and BMI information provided from the site, and thus not included in the results.'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30.3', 'spread': '5.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'There was one subject with missing height, weight, and BMI information provided from the site, and thus not included in the results.'}, {'title': 'BMI Category', 'classes': [{'title': '< 30 kg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}]}]}, {'title': '≥ 30 kg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'There was one subject with missing height, weight, and BMI information provided from the site, and thus not included in the results.'}, {'title': 'Smoking Status', 'classes': [{'title': 'Current smoker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Previous smoker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}, {'title': 'Never smoked', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Surgical Approach', 'classes': [{'title': 'Medial parapatellar', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}]}]}, {'title': 'Subvastus / Tissue sparing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'Midvastus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Lateral parapatellar', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Knee System Type', 'classes': [{'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Smith & Nephew', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}]}]}, {'title': 'Other - Non-Smith & Nephew', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Unilateral Knee Replacement Type Used', 'classes': [{'title': 'Medial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}]}]}, {'title': 'Lateral', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Blood Loss Prevention Method', 'classes': [{'title': 'Tourniquet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}]}]}, {'title': 'Aquamantus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Intra-operative Complications', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Surgery', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'hours', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-05', 'size': 408513, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-12-10T09:03', 'hasProtocol': True}, {'date': '2018-01-29', 'size': 2055887, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-12-10T09:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-02', 'studyFirstSubmitDate': '2017-03-02', 'resultsFirstSubmitDate': '2019-07-01', 'studyFirstSubmitQcDate': '2017-03-02', 'lastUpdatePostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-28', 'studyFirstPostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship', 'timeFrame': 'Preoperative (Baseline) and 24, 48, 72, 96, and 120 weeks postoperatively', 'description': 'Analysis of the absence of device revision (overall survivorship) outcomes assessed from Baseline through 120 weeks post-surgical implantation.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments', 'timeFrame': 'Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively', 'description': 'Analysis of KSS from preoperatively (Baseline) up to 36 months postoperatively in 6-months increments to evaluate objective observation, patient satisfaction, and function.\n\nObjective knee indicators: Range 0-100 points; Patient Satisfaction: Range 0-40 points; and Functional Activities: Range 0-100 points.\n\nHigher scores indicated a better outcome.'}, {'measure': 'Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments', 'timeFrame': 'Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively', 'description': 'Analysis of VR-12 scores preoperatively (Baseline) through 36 months postoperatively in 6 months increments. These scores encompass the individual domains of physical component score (PCS), mental component score (MCS) as well as the sub-domain scores within the PCS (physical functioning, role physical, bodily pain, and general health) and those within the MCS (vitality, social functioning, role emotional, and mental health).\n\nDomain Scores:\n\nPhysical Component Score (PCS): Range 1 to 20 Mental Component Score (MCS): Range 1 to 25\n\nSub-domain Scores:\n\nPhysical Functioning: Range 1 to 6 Role Physical: Range 1 to 4 Bodily Pain: Range 1 to 6 General Health: Range 1 to 6 Vitality: Range 1 to 6 Social Functioning: Range 1 to 6 Role Emotional: Range 1 to 4 Mental Health: Range 1 to 10\n\nTransformation of raw scale scores (range 0-100) = {(actual raw score - lowest possible raw score)/possible raw score range} x100\n\nA higher score indicates a better outcome.'}, {'measure': 'Preoperative Evaluation of Efficacy Based on Radiographic Findings', 'timeFrame': 'Preoperative (Baseline)', 'description': 'Changes in radiographic findings (anterior-posterior \\[AP\\] and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.'}, {'measure': 'Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings', 'timeFrame': '6 months postoperatively', 'description': 'Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.'}, {'measure': 'Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings', 'timeFrame': '12 months postoperatively', 'description': 'Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.'}, {'measure': 'Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings', 'timeFrame': '18 months postoperatively', 'description': 'Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.'}, {'measure': 'Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings', 'timeFrame': '24 months postoperatively', 'description': 'Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.'}, {'measure': 'Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings', 'timeFrame': '30 months postoperatively', 'description': 'Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.'}, {'measure': 'Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings', 'timeFrame': '36 months postoperatively', 'description': 'Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Robotics', 'Knee Replacement']}, 'descriptionModule': {'briefSummary': 'A retrospective, multi-center, cohort study with prospective follow-up and comparison to historical control', 'detailedDescription': 'Subjects who had previously received the Navio robotic-assisted surgical system for unilateral knee replacement (UKR) were assessed to determine the 2-year safety and effectiveness of the Navio system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'One hundred twenty-eight (128) subjects, including 10% inflation to allow for attrition', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female subjects ≥ 18 years old (at the time of surgery) who have undergone Navio System-assisted UKR at least 2 years prior to enrollment. This includes UKR procedures with all Unicondylar Knee cemented implant designs.\n2. Subject had a primary diagnosis of unicompartmental, non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis, required correction of functional deformity, or required treatment of fractures that were unmanageable using other techniques.\n\nExclusion Criteria:\n\n1. Subject received the Navio System-assisted UKR on the index joint as a revision for a previously failed UKR.\n2. Subject, in the opinion of the Investigator, had advanced osteoarthritis or joint disease at the time of surgery and was better suited for Total Knee Arthroplasty (TKA).\n3. Subject, in the opinion of the Investigator, had a neuromuscular disorder that prohibited control of the index joint.\n4. Subject, in the opinion of the Investigator, was morbidly obese.\n5. Subject, in the opinion of the Investigator, was contraindicated for UKR.\n6. Subject (prospective subjects only), in the opinion of the Investigator, has an emotional or neurological condition including mental illness, mental retardation, drug or alcohol abuse.\n7. Subject (prospective subjects only) is a prisoner.'}, 'identificationModule': {'nctId': 'NCT03072459', 'acronym': 'NAVIO', 'briefTitle': 'A Retrospective Study of the Navio Robotic-assisted Surgical System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smith & Nephew, Inc.'}, 'officialTitle': 'A Retrospective Study of the Navio™ Robotic-assisted Surgical System', 'orgStudyIdInfo': {'id': '16-NPFS-11'}}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Hedley Orthopedics', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Santa Barbara Cottage Hospital', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '49015', 'city': 'Battle Creek', 'state': 'Michigan', 'country': 'United States', 'facility': 'Bronson Orthopedic Specialists', 'geoPoint': {'lat': 42.3173, 'lon': -85.17816}}, {'zip': '43054', 'city': 'New Albany', 'state': 'Ohio', 'country': 'United States', 'facility': 'OrthoNeuro New Albany', 'geoPoint': {'lat': 40.08117, 'lon': -82.80879}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rothman Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Beate Hanson, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Smith & Nephew, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smith & Nephew, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}