We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Retrospective Study of the Navio Robotic-assisted Surgical System (NAVIO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03072459
Recruitment Status : Completed
First Posted : March 7, 2017
Results First Posted : May 2, 2022
Last Update Posted : May 25, 2022
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Other
Conditions Surgical Robotics
Knee Replacement
Enrollment 128
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Navio Robotic-assisted Surgical System
Hide Arm/Group 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.
Period Title: Overall Study
Started 128
Completed 126
Not Completed 2
Reason Not Completed
Device revised/removed             1
Subject not able to return             1
Arm/Group Title Navio Robotic-assisted Surgical System
Hide Arm/Group 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.
Overall Number of Baseline Participants 128
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 128 participants
64.7  (9.6)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
< 60 years Number Analyzed 128 participants
39
  30.5%
≥ 60 years Number Analyzed 128 participants
89
  69.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants
Female
54
  42.2%
Male
74
  57.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
0
   0.0%
Unknown or Not Reported
128
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   0.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
   3.1%
White
122
  95.3%
More than one race
0
   0.0%
Unknown or Not Reported
1
   0.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 128 participants
128
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Centimeters (cm)
Number Analyzed 127 participants
172.1  (10.8)
[1]
Measure Analysis Population Description: There was one subject with missing height, weight, and BMI information provided from the site, and thus not included in the results.
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 127 participants
89.9  (18.1)
[1]
Measure Analysis Population Description: There was one subject with missing height, weight, and BMI information provided from the site, and thus not included in the results.
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 127 participants
30.3  (5.4)
[1]
Measure Analysis Population Description: There was one subject with missing height, weight, and BMI information provided from the site, and thus not included in the results.
BMI Category   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
< 30 kg/m^2 Number Analyzed 127 participants
66
  52.0%
≥ 30 kg/m^2 Number Analyzed 127 participants
61
  48.0%
[1]
Measure Analysis Population Description: There was one subject with missing height, weight, and BMI information provided from the site, and thus not included in the results.
Smoking Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Current smoker Number Analyzed 128 participants
7
   5.5%
Previous smoker Number Analyzed 128 participants
31
  24.2%
Never smoked Number Analyzed 128 participants
74
  57.8%
Unknown Number Analyzed 128 participants
16
  12.5%
Surgical Approach  
Measure Type: Count of Participants
Unit of measure:  Participants
Medial parapatellar Number Analyzed 128 participants
89
  69.5%
Subvastus / Tissue sparing Number Analyzed 128 participants
18
  14.1%
Midvastus Number Analyzed 128 participants
0
   0.0%
Lateral parapatellar Number Analyzed 128 participants
3
   2.3%
Unknown Number Analyzed 128 participants
0
   0.0%
Other Number Analyzed 128 participants
18
  14.1%
Knee System Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Missing Number Analyzed 128 participants
3
   2.3%
Smith & Nephew Number Analyzed 128 participants
108
  84.4%
Other - Non-Smith & Nephew Number Analyzed 128 participants
17
  13.3%
Unilateral Knee Replacement Type Used  
Measure Type: Count of Participants
Unit of measure:  Participants
Medial Number Analyzed 128 participants
124
  96.9%
Lateral Number Analyzed 128 participants
4
   3.1%
Blood Loss Prevention Method  
Measure Type: Count of Participants
Unit of measure:  Participants
Tourniquet Number Analyzed 128 participants
83
  64.8%
Aquamantus Number Analyzed 128 participants
0
   0.0%
Unknown Number Analyzed 128 participants
45
  35.2%
Other Number Analyzed 128 participants
0
   0.0%
Intra-operative Complications  
Measure Type: Count of Participants
Unit of measure:  Participants
Yes Number Analyzed 128 participants
0
   0.0%
No Number Analyzed 128 participants
128
 100.0%
Duration of Surgery  
Mean (Standard Deviation)
Unit of measure:  Hours
Number Analyzed 128 participants
1.8  (0.4)
1.Primary Outcome
Title Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship
Hide Description Analysis of the absence of device revision (overall survivorship) outcomes assessed from Baseline through 120 weeks post-surgical implantation.
Time Frame Preoperative (Baseline) and 24, 48, 72, 96, and 120 weeks postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Navio Robotic-assisted Surgical System
Hide Arm/Group 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.
Overall Number of Participants Analyzed 128
Measure Type: Number
Unit of Measure: participants
Number of Knees with Revisions : Week 0 Number Analyzed 128 participants
0
Number of Knees with Revisions : Week 24 Number Analyzed 128 participants
0
Number of Knees with Revisions : Week 48 Number Analyzed 127 participants
1
Number of Knees with Revisions : Week 72 Number Analyzed 127 participants
0
Number of Knees with Revisions : Week 96 Number Analyzed 110 participants
0
Number of Knees with Revisions : Week 120 Number Analyzed 69 participants
0
2.Secondary Outcome
Title Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Hide Description

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.

Time Frame Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Navio Robotic-assisted Surgical System
Hide Arm/Group 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.
Overall Number of Participants Analyzed 128
Mean (Full Range)
Unit of Measure: score on a scale
Objective Knee Indicators: Preoperative Number Analyzed 116 participants
48.6
(8 to 92)
Objective Knee Indicators: 6 Months Postoperative Number Analyzed 88 participants
51.6
(4 to 80)
Objective Knee Indicators: 12 Months Postoperative Number Analyzed 51 participants
49.3
(4 to 78)
Objective Knee Indicators: 18 Months Postoperative Number Analyzed 37 participants
49.9
(14 to 72)
Objective Knee Indicators: 24 Months Postoperative Number Analyzed 57 participants
61.9
(14 to 96)
Objective Knee Indicators: 30 Months Postoperative Number Analyzed 52 participants
63.8
(17 to 96)
Objective Knee Indicators: 36 Months Postoperative Number Analyzed 22 participants
60
(11 to 94)
Patient Satisfaction: Preoperative Number Analyzed 45 participants
14.0
(0 to 40)
Patient Satisfaction: 6 Months Postoperative Number Analyzed 15 participants
30.0
(18 to 40)
Patient Satisfaction: 12 Months Postoperative Number Analyzed 23 participants
32
(18 to 40)
Patient Satisfaction: 18 Months Postoperative Number Analyzed 8 participants
32.8
(20 to 40)
Patient Satisfaction: 24 Months Postoperative Number Analyzed 43 participants
34.0
(12 to 40)
Patient Satisfaction: 30 Months Postoperative Number Analyzed 34 participants
33.4
(18 to 40)
Patient Satisfaction: 36 Months Postoperative Number Analyzed 21 participants
34.8
(16 to 40)
Functional Activities: Preoperative Number Analyzed 45 participants
42.8
(0 to 100)
Functional Activities: 6 Months Postoperative Number Analyzed 15 participants
73.3
(30 to 98)
Functional Activities: 12 Months Postoperative Number Analyzed 23 participants
78.2
(42 to 100)
Functional Activities: 18 Months Postoperative Number Analyzed 8 participants
73.9
(43 to 91)
Functional Activities: 24 Months Postoperative Number Analyzed 43 participants
81.9
(39 to 100)
Functional Activities: 30 Months Postoperative Number Analyzed 34 participants
81.1
(43 to 100)
Functional Activities: 36 Months Postoperative Number Analyzed 21 participants
82.6
(55 to 98)
3.Secondary Outcome
Title Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments
Hide 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).

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.

Time Frame Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Navio Robotic-assisted Surgical System
Hide Arm/Group 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.
Overall Number of Participants Analyzed 128
Mean (Full Range)
Unit of Measure: score on a scale
PCS: Preoperative Number Analyzed 44 participants
11.2
(6 to 15)
PCS: 6 Months Postoperative Number Analyzed 25 participants
15.0
(11 to 17)
PCS: 12 Months Postoperative Number Analyzed 25 participants
15.0
(11.4 to 20)
PCS: 18 Months Postoperative Number Analyzed 9 participants
14.9
(12.4 to 17)
PCS: 24 Months Postoperative Number Analyzed 43 participants
14.6
(9 to 19)
PCS: 30 Months Postoperative Number Analyzed 36 participants
15.0
(11.4 to 17)
PCS: 36 Months Postoperative Number Analyzed 22 participants
15.4
(11.4 to 17.4)
MCS: Preoperative Number Analyzed 44 participants
17.3
(10 to 26)
MCS: 6 Months Postoperative Number Analyzed 25 participants
19.7
(11 to 26)
MCS: 12 Months Postoperative Number Analyzed 25 participants
20.0
(16 to 23)
MCS: 18 Months Postoperative Number Analyzed 9 participants
20.1
(18 to 23)
MCS: 24 Months Postoperative Number Analyzed 43 participants
20.4
(13 to 24)
MCS: 30 Months Postoperative Number Analyzed 36 participants
21.1
(16 to 24)
MCS: 36 Months Postoperative Number Analyzed 22 participants
18.6
(2 to 23)
4.Secondary Outcome
Title Preoperative Evaluation of Efficacy Based on Radiographic Findings
Hide Description Changes in radiographic findings (anterior-posterior [AP] and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
Time Frame Preoperative (Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Navio Robotic-assisted Surgical System
Hide Arm/Group 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.
Overall Number of Participants Analyzed 128
Measure Type: Count of Participants
Unit of Measure: Participants
Tibial Osteolysis Yes
0
   0.0%
No
0
   0.0%
Unknown
0
   0.0%
Missing
128
 100.0%
Femoral osteolysis Yes
0
   0.0%
No
0
   0.0%
Unknown
0
   0.0%
Missing
128
 100.0%
Tibial Migration/Subsidence Yes
0
   0.0%
No
0
   0.0%
Unknown
0
   0.0%
Missing
128
 100.0%
Femoral Migration/Subsidence Yes
0
   0.0%
No
0
   0.0%
Unknown
0
   0.0%
Missing
128
 100.0%
Heterotropic Ossification Yes
0
   0.0%
No
0
   0.0%
Unknown
0
   0.0%
Missing
128
 100.0%
Patellar Subluxation Yes
0
   0.0%
No
0
   0.0%
Unknown
0
   0.0%
Missing
128
 100.0%
Patellar Dislocation Yes
0
   0.0%
No
0
   0.0%
Unknown
0
   0.0%
Missing
128
 100.0%
5.Secondary Outcome
Title Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Hide Description Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
Time Frame 6 months postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point.
Arm/Group Title Navio Robotic-assisted Surgical System
Hide Arm/Group 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.
Overall Number of Participants Analyzed 127
Measure Type: Count of Participants
Unit of Measure: Participants
Tibial Osteolysis Yes
0
   0.0%
No
25
  19.7%
Unknown
3
   2.4%
Missing
99
  78.0%
Femoral Osteolysis Yes
0
   0.0%
No
25
  19.7%
Unknown
3
   2.4%
Missing
99
  78.0%
Tibial Migration/Subsidence Yes
0
   0.0%
No
25
  19.7%
Unknown
3
   2.4%
Missing
99
  78.0%
Femoral Migration/Subsidence Yes
0
   0.0%
No
25
  19.7%
Unknown
3
   2.4%
Missing
99
  78.0%
Heterotropic Ossification Yes
0
   0.0%
No
25
  19.7%
Unknown
3
   2.4%
Missing
99
  78.0%
Patellar Subluxation Yes
0
   0.0%
No
25
  19.7%
Unknown
3
   2.4%
Missing
99
  78.0%
Patellar Dislocation Yes
0
   0.0%
No
25
  19.7%
Unknown
3
   2.4%
Missing
99
  78.0%
6.Secondary Outcome
Title Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Hide Description Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
Time Frame 12 months postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point.
Arm/Group Title Navio Robotic-assisted Surgical System
Hide Arm/Group 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.
Overall Number of Participants Analyzed 58
Measure Type: Count of Participants
Unit of Measure: Participants
Tibial Osteolysis Yes
1
   1.7%
No
24
  41.4%
Unknown
3
   5.2%
Missing
30
  51.7%
Femoral Osteolysis Yes
0
   0.0%
No
25
  43.1%
Unknown
3
   5.2%
Missing
30
  51.7%
Tibial Migration/Subsidence Yes
0
   0.0%
No
25
  43.1%
Unknown
3
   5.2%
Missing
30
  51.7%
Femoral Migration/Subsidence Yes
0
   0.0%
No
25
  43.1%
Unknown
3
   5.2%
Missing
30
  51.7%
Heterotropic Ossification Yes
0
   0.0%
No
25
  43.1%
Unknown
3
   5.2%
Missing
30
  51.7%
Patellar Subluxation Yes
0
   0.0%
No
25
  43.1%
Unknown
3
   5.2%
Missing
30
  51.7%
Patellar Dislocation Yes
0
   0.0%
No
25
  43.1%
Unknown
3
   5.2%
Missing
30
  51.7%
7.Secondary Outcome
Title Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Hide Description Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
Time Frame 18 months postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point.
Arm/Group Title Navio Robotic-assisted Surgical System
Hide Arm/Group 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.
Overall Number of Participants Analyzed 41
Measure Type: Count of Participants
Unit of Measure: Participants
Tibial Osteolysis Yes
0
   0.0%
No
27
  65.9%
Unknown
0
   0.0%
Missing
14
  34.1%
Femoral Osteolysis Yes
1
   2.4%
No
26
  63.4%
Unknown
0
   0.0%
Missing
14
  34.1%
Tibial Migration/Subsidence Yes
0
   0.0%
No
27
  65.9%
Unknown
0
   0.0%
Missing
14
  34.1%
Femoral Migration/Subsidence Yes
0
   0.0%
No
27
  65.9%
Unknown
0
   0.0%
Missing
14
  34.1%
Heterotropic Ossification Yes
0
   0.0%
No
27
  65.9%
Unknown
0
   0.0%
Missing
14
  34.1%
Patellar Subluxation Yes
0
   0.0%
No
27
  65.9%
Unknown
0
   0.0%
Missing
14
  34.1%
Patellar Dislocation Yes
0
   0.0%
No
27
  65.9%
Unknown
0
   0.0%
Missing
14
  34.1%
8.Secondary Outcome
Title Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Hide Description Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
Time Frame 24 months postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point.
Arm/Group Title Navio Robotic-assisted Surgical System
Hide Arm/Group 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.
Overall Number of Participants Analyzed 61
Measure Type: Count of Participants
Unit of Measure: Participants
Tibial Osteolysis Yes
1
   1.6%
No
22
  36.1%
Unknown
5
   8.2%
Missing
33
  54.1%
Femoral Osteolysis Yes
0
   0.0%
No
24
  39.3%
Unknown
4
   6.6%
Missing
33
  54.1%
Tibial Migration/Subsidence Yes
0
   0.0%
No
26
  42.6%
Unknown
2
   3.3%
Missing
33
  54.1%
Femoral Migration/Subsidence Yes
0
   0.0%
No
26
  42.6%
Unknown
2
   3.3%
Missing
33
  54.1%
Heterotropic Ossification Yes
0
   0.0%
No
26
  42.6%
Unknown
2
   3.3%
Missing
33
  54.1%
Patellar Subluxation Yes
0
   0.0%
No
26
  42.6%
Unknown
2
   3.3%
Missing
33
  54.1%
Patellar Dislocation Yes
0
   0.0%
No
26
  42.6%
Unknown
2
   3.3%
Missing
33
  54.1%
9.Secondary Outcome
Title Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Hide Description Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
Time Frame 30 months postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point.
Arm/Group Title Navio Robotic-assisted Surgical System
Hide Arm/Group 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.
Overall Number of Participants Analyzed 56
Measure Type: Count of Participants
Unit of Measure: Participants
Tibial Osteolysis Yes
0
   0.0%
No
29
  51.8%
Unknown
1
   1.8%
Missing
26
  46.4%
Femoral Osteolysis Yes
0
   0.0%
No
29
  51.8%
Unknown
1
   1.8%
Missing
26
  46.4%
Tibial Migration/Subsidence Yes
0
   0.0%
No
30
  53.6%
Unknown
0
   0.0%
Missing
26
  46.4%
Femoral Migration/Subsidence Yes
0
   0.0%
No
30
  53.6%
Unknown
0
   0.0%
Missing
26
  46.4%
Heterotropic Ossification Yes
0
   0.0%
No
30
  53.6%
Unknown
0
   0.0%
Missing
26
  46.4%
Patellar Subluxation Yes
0
   0.0%
No
30
  53.6%
Unknown
0
   0.0%
Missing
26
  46.4%
Patellar Dislocation Yes
0
   0.0%
No
30
  53.6%
Unknown
0
   0.0%
Missing
26
  46.4%
10.Secondary Outcome
Title Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Hide Description Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
Time Frame 36 months postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point.
Arm/Group Title Navio Robotic-assisted Surgical System
Hide Arm/Group 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.
Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
Tibial Osteolysis Yes
0
   0.0%
No
13
  56.5%
Unknown
0
   0.0%
Missing
10
  43.5%
Femoral Osteolysis Yes
0
   0.0%
No
13
  56.5%
Unknown
0
   0.0%
Missing
10
  43.5%
Tibial Migration/Subsidence Yes
0
   0.0%
No
13
  56.5%
Unknown
0
   0.0%
Missing
10
  43.5%
Femoral Migration/Subsidence Yes
0
   0.0%
No
13
  56.5%
Unknown
0
   0.0%
Missing
10
  43.5%
Heterotropic Ossification Yes
0
   0.0%
No
13
  56.5%
Unknown
0
   0.0%
Missing
10
  43.5%
Patellar Subluxation Yes
0
   0.0%
No
13
  56.5%
Unknown
0
   0.0%
Missing
10
  43.5%
Patellar Dislocation Yes
0
   0.0%
No
13
  56.5%
Unknown
0
   0.0%
Missing
10
  43.5%
Time Frame Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Navio Robotic-assisted Surgical System
Hide Arm/Group 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.
All-Cause Mortality
Navio Robotic-assisted Surgical System
Affected / at Risk (%)
Total   0/128 (0.00%)    
Hide Serious Adverse Events
Navio Robotic-assisted Surgical System
Affected / at Risk (%) # Events
Total   2/128 (1.56%)    
Vascular disorders   
Deep venous thrombosis (DVT)  [1]  1/128 (0.78%)  1
Lower extremity DVT  [1]  1/128 (0.78%)  1
Indicates events were collected by systematic assessment
[1]
The subject recovered/resolved from the DVT and it was deemed unrelated to the treatment. The subject was not discontinued from the study.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Navio Robotic-assisted Surgical System
Affected / at Risk (%) # Events
Total   28/128 (21.88%)    
Musculoskeletal and connective tissue disorders   
Radiolucency line tibial ML zone   5/128 (3.91%)  5
Knee pain due to mild iliotibial band tendonitis   1/128 (0.78%)  1
Pain in quadriceps   1/128 (0.78%)  1
Knee pain with 50 mL of blood aspiration   1/128 (0.78%)  1
Manipulation under anesthesia   1/128 (0.78%)  1
Soreness/pain   1/128 (0.78%)  1
Stress shielding   1/128 (0.78%)  1
Radiolucent lines   7/128 (5.47%)  7
Femoral osteolysis   1/128 (0.78%)  1
Anterior knee pain and swelling   1/128 (0.78%)  1
Synovial hypertrophy, quadriceps atrophy, and knee pain   1/128 (0.78%)  1
Hamstring irritation and ischial tuberosity bursitis   1/128 (0.78%)  1
Skin and subcutaneous tissue disorders   
Redness, burning, itchiness   1/128 (0.78%)  1
Effusion   1/128 (0.78%)  1
Swelling and discomfort   1/128 (0.78%)  1
Slight swelling and edema   1/128 (0.78%)  1
Possible cellulitis - not life threatening   1/128 (0.78%)  1
Occasional swelling   1/128 (0.78%)  1
Incisional soreness   1/128 (0.78%)  1
Neurodermatitis   1/128 (0.78%)  1
Pin site drainage   1/128 (0.78%)  1
Pimple drainage from pin site   1/128 (0.78%)  1
Incision pain with deep flexion   1/128 (0.78%)  1
Skin irritation over pin site   1/128 (0.78%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Salima Reddy
Organization: Smith & Nephew, Inc.
Phone: 817-916-2233
EMail: salima.reddy@smith-nephew.com
Layout table for additonal information
Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT03072459    
Other Study ID Numbers: 16-NPFS-11
First Submitted: March 2, 2017
First Posted: March 7, 2017
Results First Submitted: July 1, 2019
Results First Posted: May 2, 2022
Last Update Posted: May 25, 2022