Trial Outcomes & Findings for A Retrospective Study of the Navio Robotic-assisted Surgical System (NCT NCT03072459)
NCT ID: NCT03072459
Last Updated: 2022-05-25
Results Overview
Analysis of the absence of device revision (overall survivorship) outcomes assessed from Baseline through 120 weeks post-surgical implantation.
Recruitment status
COMPLETED
Target enrollment
128 participants
Primary outcome timeframe
Preoperative (Baseline) and 24, 48, 72, 96, and 120 weeks postoperatively
Results posted on
2022-05-25
Participant Flow
Participant milestones
| Measure |
Navio Robotic-assisted Surgical System
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.
|
|---|---|
|
Overall Study
STARTED
|
128
|
|
Overall Study
COMPLETED
|
126
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Navio Robotic-assisted Surgical System
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.
|
|---|---|
|
Overall Study
Device revised/removed
|
1
|
|
Overall Study
Subject not able to return
|
1
|
Baseline Characteristics
There was one subject with missing height, weight, and BMI information provided from the site, and thus not included in the results.
Baseline characteristics by cohort
| Measure |
Navio Robotic-assisted Surgical System
n=128 Participants
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.
|
|---|---|
|
Age, Continuous
|
64.7 years
STANDARD_DEVIATION 9.6 • n=128 Participants
|
|
Age, Customized
< 60 years
|
39 Participants
n=128 Participants
|
|
Age, Customized
≥ 60 years
|
89 Participants
n=128 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=128 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=128 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=128 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=128 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
128 Participants
n=128 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=128 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=128 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=128 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=128 Participants
|
|
Race (NIH/OMB)
White
|
122 Participants
n=128 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=128 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=128 Participants
|
|
Region of Enrollment
United States
|
128 participants
n=128 Participants
|
|
Height
|
172.1 centimeters (cm)
STANDARD_DEVIATION 10.8 • n=127 Participants • There was one subject with missing height, weight, and BMI information provided from the site, and thus not included in the results.
|
|
Weight
|
89.9 kilograms (kg)
STANDARD_DEVIATION 18.1 • n=127 Participants • There was one subject with missing height, weight, and BMI information provided from the site, and thus not included in the results.
|
|
BMI
|
30.3 kg/m^2
STANDARD_DEVIATION 5.4 • n=127 Participants • There was one subject with missing height, weight, and BMI information provided from the site, and thus not included in the results.
|
|
BMI Category
< 30 kg/m^2
|
66 Participants
n=127 Participants • There was one subject with missing height, weight, and BMI information provided from the site, and thus not included in the results.
|
|
BMI Category
≥ 30 kg/m^2
|
61 Participants
n=127 Participants • There was one subject with missing height, weight, and BMI information provided from the site, and thus not included in the results.
|
|
Smoking Status
Current smoker
|
7 Participants
n=128 Participants
|
|
Smoking Status
Previous smoker
|
31 Participants
n=128 Participants
|
|
Smoking Status
Never smoked
|
74 Participants
n=128 Participants
|
|
Smoking Status
Unknown
|
16 Participants
n=128 Participants
|
|
Surgical Approach
Medial parapatellar
|
89 Participants
n=128 Participants
|
|
Surgical Approach
Subvastus / Tissue sparing
|
18 Participants
n=128 Participants
|
|
Surgical Approach
Midvastus
|
0 Participants
n=128 Participants
|
|
Surgical Approach
Lateral parapatellar
|
3 Participants
n=128 Participants
|
|
Surgical Approach
Unknown
|
0 Participants
n=128 Participants
|
|
Surgical Approach
Other
|
18 Participants
n=128 Participants
|
|
Knee System Type
Missing
|
3 Participants
n=128 Participants
|
|
Knee System Type
Smith & Nephew
|
108 Participants
n=128 Participants
|
|
Knee System Type
Other - Non-Smith & Nephew
|
17 Participants
n=128 Participants
|
|
Unilateral Knee Replacement Type Used
Medial
|
124 Participants
n=128 Participants
|
|
Unilateral Knee Replacement Type Used
Lateral
|
4 Participants
n=128 Participants
|
|
Blood Loss Prevention Method
Tourniquet
|
83 Participants
n=128 Participants
|
|
Blood Loss Prevention Method
Aquamantus
|
0 Participants
n=128 Participants
|
|
Blood Loss Prevention Method
Unknown
|
45 Participants
n=128 Participants
|
|
Blood Loss Prevention Method
Other
|
0 Participants
n=128 Participants
|
|
Intra-operative Complications
Yes
|
0 Participants
n=128 Participants
|
|
Intra-operative Complications
No
|
128 Participants
n=128 Participants
|
|
Duration of Surgery
|
1.8 hours
STANDARD_DEVIATION 0.4 • n=128 Participants
|
PRIMARY outcome
Timeframe: Preoperative (Baseline) and 24, 48, 72, 96, and 120 weeks postoperativelyPopulation: 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.
Analysis of the absence of device revision (overall survivorship) outcomes assessed from Baseline through 120 weeks post-surgical implantation.
Outcome measures
| Measure |
Navio Robotic-assisted Surgical System
n=128 Participants
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.
|
|---|---|
|
Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship
Number of Knees with Revisions : Week 0
|
0 participants
|
|
Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship
Number of Knees with Revisions : Week 24
|
0 participants
|
|
Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship
Number of Knees with Revisions : Week 48
|
1 participants
|
|
Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship
Number of Knees with Revisions : Week 72
|
0 participants
|
|
Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship
Number of Knees with Revisions : Week 96
|
0 participants
|
|
Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship
Number of Knees with Revisions : Week 120
|
0 participants
|
SECONDARY outcome
Timeframe: Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperativelyPopulation: 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.
Analysis of KSS from preoperatively (Baseline) up to 36 months postoperatively in 6-months increments to evaluate objective observation, patient satisfaction, and function. Objective knee indicators: Range 0-100 points; Patient Satisfaction: Range 0-40 points; and Functional Activities: Range 0-100 points. Higher scores indicated a better outcome.
Outcome measures
| Measure |
Navio Robotic-assisted Surgical System
n=128 Participants
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.
|
|---|---|
|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Objective Knee Indicators: Preoperative
|
48.6 score on a scale
Interval 8.0 to 92.0
|
|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Objective Knee Indicators: 6 Months Postoperative
|
51.6 score on a scale
Interval 4.0 to 80.0
|
|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Objective Knee Indicators: 12 Months Postoperative
|
49.3 score on a scale
Interval 4.0 to 78.0
|
|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Objective Knee Indicators: 18 Months Postoperative
|
49.9 score on a scale
Interval 14.0 to 72.0
|
|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Objective Knee Indicators: 24 Months Postoperative
|
61.9 score on a scale
Interval 14.0 to 96.0
|
|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Objective Knee Indicators: 30 Months Postoperative
|
63.8 score on a scale
Interval 17.0 to 96.0
|
|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Objective Knee Indicators: 36 Months Postoperative
|
60 score on a scale
Interval 11.0 to 94.0
|
|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Patient Satisfaction: Preoperative
|
14.0 score on a scale
Interval 0.0 to 40.0
|
|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Patient Satisfaction: 6 Months Postoperative
|
30.0 score on a scale
Interval 18.0 to 40.0
|
|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Patient Satisfaction: 12 Months Postoperative
|
32 score on a scale
Interval 18.0 to 40.0
|
|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Patient Satisfaction: 18 Months Postoperative
|
32.8 score on a scale
Interval 20.0 to 40.0
|
|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Patient Satisfaction: 24 Months Postoperative
|
34.0 score on a scale
Interval 12.0 to 40.0
|
|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Patient Satisfaction: 30 Months Postoperative
|
33.4 score on a scale
Interval 18.0 to 40.0
|
|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Functional Activities: Preoperative
|
42.8 score on a scale
Interval 0.0 to 100.0
|
|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Functional Activities: 6 Months Postoperative
|
73.3 score on a scale
Interval 30.0 to 98.0
|
|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Functional Activities: 12 Months Postoperative
|
78.2 score on a scale
Interval 42.0 to 100.0
|
|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Functional Activities: 18 Months Postoperative
|
73.9 score on a scale
Interval 43.0 to 91.0
|
|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Functional Activities: 24 Months Postoperative
|
81.9 score on a scale
Interval 39.0 to 100.0
|
|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Functional Activities: 30 Months Postoperative
|
81.1 score on a scale
Interval 43.0 to 100.0
|
|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Functional Activities: 36 Months Postoperative
|
82.6 score on a scale
Interval 55.0 to 98.0
|
|
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Patient Satisfaction: 36 Months Postoperative
|
34.8 score on a scale
Interval 16.0 to 40.0
|
SECONDARY outcome
Timeframe: Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperativelyPopulation: 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.
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). Domain Scores: Physical Component Score (PCS): Range 1 to 20 Mental Component Score (MCS): Range 1 to 25 Sub-domain Scores: Physical 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 Transformation of raw scale scores (range 0-100) = {(actual raw score - lowest possible raw score)/possible raw score range} x100 A higher score indicates a better outcome.
Outcome measures
| Measure |
Navio Robotic-assisted Surgical System
n=128 Participants
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.
|
|---|---|
|
Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments
PCS: 24 Months Postoperative
|
14.6 score on a scale
Interval 9.0 to 19.0
|
|
Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments
PCS: 30 Months Postoperative
|
15.0 score on a scale
Interval 11.4 to 17.0
|
|
Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments
PCS: 36 Months Postoperative
|
15.4 score on a scale
Interval 11.4 to 17.4
|
|
Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments
MCS: Preoperative
|
17.3 score on a scale
Interval 10.0 to 26.0
|
|
Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments
MCS: 6 Months Postoperative
|
19.7 score on a scale
Interval 11.0 to 26.0
|
|
Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments
PCS: Preoperative
|
11.2 score on a scale
Interval 6.0 to 15.0
|
|
Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments
PCS: 6 Months Postoperative
|
15.0 score on a scale
Interval 11.0 to 17.0
|
|
Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments
PCS: 12 Months Postoperative
|
15.0 score on a scale
Interval 11.4 to 20.0
|
|
Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments
PCS: 18 Months Postoperative
|
14.9 score on a scale
Interval 12.4 to 17.0
|
|
Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments
MCS: 12 Months Postoperative
|
20.0 score on a scale
Interval 16.0 to 23.0
|
|
Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments
MCS: 18 Months Postoperative
|
20.1 score on a scale
Interval 18.0 to 23.0
|
|
Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments
MCS: 24 Months Postoperative
|
20.4 score on a scale
Interval 13.0 to 24.0
|
|
Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments
MCS: 30 Months Postoperative
|
21.1 score on a scale
Interval 16.0 to 24.0
|
|
Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments
MCS: 36 Months Postoperative
|
18.6 score on a scale
Interval 2.0 to 23.0
|
SECONDARY outcome
Timeframe: Preoperative (Baseline)Changes in radiographic findings (anterior-posterior \[AP\] and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
Outcome measures
| Measure |
Navio Robotic-assisted Surgical System
n=128 Participants
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.
|
|---|---|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · Yes
|
0 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · No
|
0 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · Unknown
|
0 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · Missing
|
128 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Femoral osteolysis · Yes
|
0 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Femoral osteolysis · No
|
0 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Femoral osteolysis · Unknown
|
0 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Femoral osteolysis · Missing
|
128 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · Yes
|
0 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · No
|
0 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · Unknown
|
0 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · Missing
|
128 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · Yes
|
0 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · No
|
0 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · Unknown
|
0 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · Missing
|
128 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · Yes
|
0 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · No
|
0 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · Unknown
|
0 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · Missing
|
128 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · Yes
|
0 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · No
|
0 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · Unknown
|
0 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · Missing
|
128 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · Yes
|
0 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · No
|
0 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · Unknown
|
0 Participants
|
|
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · Missing
|
128 Participants
|
SECONDARY outcome
Timeframe: 6 months postoperativelyPopulation: The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point.
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
Outcome measures
| Measure |
Navio Robotic-assisted Surgical System
n=127 Participants
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.
|
|---|---|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · Yes
|
0 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · No
|
25 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · Unknown
|
3 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · Missing
|
99 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · Yes
|
0 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · No
|
25 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · Unknown
|
3 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · Missing
|
99 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · Yes
|
0 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · No
|
25 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · Unknown
|
3 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · Missing
|
99 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · Yes
|
0 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · No
|
25 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · Unknown
|
3 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · Missing
|
99 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · Yes
|
0 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · No
|
25 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · Unknown
|
3 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · Missing
|
99 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · Yes
|
0 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · No
|
25 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · Unknown
|
3 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · Missing
|
99 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · Yes
|
0 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · No
|
25 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · Unknown
|
3 Participants
|
|
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · Missing
|
99 Participants
|
SECONDARY outcome
Timeframe: 12 months postoperativelyPopulation: The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point.
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
Outcome measures
| Measure |
Navio Robotic-assisted Surgical System
n=58 Participants
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.
|
|---|---|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · Yes
|
1 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · No
|
24 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · Unknown
|
3 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · Missing
|
30 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · Yes
|
0 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · No
|
25 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · Unknown
|
3 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · Missing
|
30 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · Yes
|
0 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · No
|
25 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · Unknown
|
3 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · Missing
|
30 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · Yes
|
0 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · No
|
25 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · Unknown
|
3 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · Missing
|
30 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · Yes
|
0 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · No
|
25 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · Unknown
|
3 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · Missing
|
30 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · Yes
|
0 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · No
|
25 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · Unknown
|
3 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · Missing
|
30 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · Yes
|
0 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · No
|
25 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · Unknown
|
3 Participants
|
|
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · Missing
|
30 Participants
|
SECONDARY outcome
Timeframe: 18 months postoperativelyPopulation: The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point.
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
Outcome measures
| Measure |
Navio Robotic-assisted Surgical System
n=41 Participants
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.
|
|---|---|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · Yes
|
0 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · No
|
27 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · Unknown
|
0 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · Missing
|
14 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · Yes
|
1 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · No
|
26 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · Unknown
|
0 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · Missing
|
14 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · Yes
|
0 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · No
|
27 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · Unknown
|
0 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · Missing
|
14 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · Yes
|
0 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · No
|
27 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · Unknown
|
0 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · Missing
|
14 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · Yes
|
0 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · No
|
27 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · Unknown
|
0 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · Missing
|
14 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · Yes
|
0 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · No
|
27 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · Unknown
|
0 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · Missing
|
14 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · Yes
|
0 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · No
|
27 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · Unknown
|
0 Participants
|
|
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · Missing
|
14 Participants
|
SECONDARY outcome
Timeframe: 24 months postoperativelyPopulation: The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point.
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
Outcome measures
| Measure |
Navio Robotic-assisted Surgical System
n=61 Participants
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.
|
|---|---|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · Yes
|
1 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · No
|
22 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · Unknown
|
5 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · Missing
|
33 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · Yes
|
0 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · No
|
24 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · Unknown
|
4 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · Missing
|
33 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · Yes
|
0 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · No
|
26 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · Unknown
|
2 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · Missing
|
33 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · Yes
|
0 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · No
|
26 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · Unknown
|
2 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · Missing
|
33 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · Yes
|
0 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · No
|
26 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · Unknown
|
2 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · Missing
|
33 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · Yes
|
0 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · No
|
26 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · Unknown
|
2 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · Missing
|
33 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · Yes
|
0 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · No
|
26 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · Unknown
|
2 Participants
|
|
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · Missing
|
33 Participants
|
SECONDARY outcome
Timeframe: 30 months postoperativelyPopulation: The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point.
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
Outcome measures
| Measure |
Navio Robotic-assisted Surgical System
n=56 Participants
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.
|
|---|---|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · Yes
|
0 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · No
|
29 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · Unknown
|
1 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · Missing
|
26 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · Yes
|
0 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · No
|
29 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · Unknown
|
1 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · Missing
|
26 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · Yes
|
0 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · No
|
30 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · Unknown
|
0 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · Missing
|
26 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · Yes
|
0 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · No
|
30 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · Unknown
|
0 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · Missing
|
26 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · Yes
|
0 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · No
|
30 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · Unknown
|
0 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · Missing
|
26 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · Yes
|
0 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · No
|
30 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · Unknown
|
0 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · Missing
|
26 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · Yes
|
0 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · No
|
30 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · Unknown
|
0 Participants
|
|
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · Missing
|
26 Participants
|
SECONDARY outcome
Timeframe: 36 months postoperativelyPopulation: The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point.
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
Outcome measures
| Measure |
Navio Robotic-assisted Surgical System
n=23 Participants
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.
|
|---|---|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · Yes
|
0 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · No
|
13 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · Unknown
|
0 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Osteolysis · Missing
|
10 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · Yes
|
0 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · No
|
13 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · Unknown
|
0 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Osteolysis · Missing
|
10 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · Yes
|
0 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · No
|
13 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · Unknown
|
0 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Tibial Migration/Subsidence · Missing
|
10 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · Yes
|
0 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · No
|
13 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · Unknown
|
0 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Femoral Migration/Subsidence · Missing
|
10 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · Yes
|
0 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · No
|
13 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · Unknown
|
0 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Heterotropic Ossification · Missing
|
10 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · Yes
|
0 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · No
|
13 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · Unknown
|
0 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Subluxation · Missing
|
10 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · Yes
|
0 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · No
|
13 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · Unknown
|
0 Participants
|
|
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Patellar Dislocation · Missing
|
10 Participants
|
Adverse Events
Navio Robotic-assisted Surgical System
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Navio Robotic-assisted Surgical System
n=128 participants at risk
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.
|
|---|---|
|
Vascular disorders
Deep venous thrombosis (DVT)
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Vascular disorders
Lower extremity DVT
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
Other adverse events
| Measure |
Navio Robotic-assisted Surgical System
n=128 participants at risk
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.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Radiolucency line tibial ML zone
|
3.9%
5/128 • Number of events 5 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Skin and subcutaneous tissue disorders
Redness, burning, itchiness
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Skin and subcutaneous tissue disorders
Effusion
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Skin and subcutaneous tissue disorders
Swelling and discomfort
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Skin and subcutaneous tissue disorders
Slight swelling and edema
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Musculoskeletal and connective tissue disorders
Knee pain due to mild iliotibial band tendonitis
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Musculoskeletal and connective tissue disorders
Pain in quadriceps
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Musculoskeletal and connective tissue disorders
Knee pain with 50 mL of blood aspiration
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Skin and subcutaneous tissue disorders
Possible cellulitis - not life threatening
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Musculoskeletal and connective tissue disorders
Manipulation under anesthesia
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Skin and subcutaneous tissue disorders
Occasional swelling
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Musculoskeletal and connective tissue disorders
Soreness/pain
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Skin and subcutaneous tissue disorders
Incisional soreness
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Skin and subcutaneous tissue disorders
Pin site drainage
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Skin and subcutaneous tissue disorders
Pimple drainage from pin site
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Musculoskeletal and connective tissue disorders
Stress shielding
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Musculoskeletal and connective tissue disorders
Radiolucent lines
|
5.5%
7/128 • Number of events 7 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Musculoskeletal and connective tissue disorders
Femoral osteolysis
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Skin and subcutaneous tissue disorders
Incision pain with deep flexion
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Musculoskeletal and connective tissue disorders
Anterior knee pain and swelling
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Musculoskeletal and connective tissue disorders
Synovial hypertrophy, quadriceps atrophy, and knee pain
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Musculoskeletal and connective tissue disorders
Hamstring irritation and ischial tuberosity bursitis
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
|
Skin and subcutaneous tissue disorders
Skin irritation over pin site
|
0.78%
1/128 • Number of events 1 • Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place