Trial Outcomes & Findings for Navio With Total Knee Arthroplasty (NCT NCT03317834)
NCT ID: NCT03317834
Last Updated: 2024-10-08
Results Overview
The number of participants achieving post-operative mechanical alignment within ±3 degrees from target with "Yes" indicating mechanical alignment was achieved and "No" indicating mechanical alignment was not achieved.
Recruitment status
COMPLETED
Target enrollment
122 participants
Primary outcome timeframe
1 month
Results posted on
2024-10-08
Participant Flow
The enrollment for this study was conducted between 13 November 2017 and 27 May 2021 across six investigative sites.
Participant milestones
| Measure |
Study Population
Total Knee Replacement with Navio Surgical Systems
Navio ™ Robotic-assisted Surgical System: Total Knee Replacement
|
|---|---|
|
Overall Study
STARTED
|
122
|
|
Overall Study
COMPLETED
|
89
|
|
Overall Study
NOT COMPLETED
|
33
|
Reasons for withdrawal
| Measure |
Study Population
Total Knee Replacement with Navio Surgical Systems
Navio ™ Robotic-assisted Surgical System: Total Knee Replacement
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Device Revision
|
5
|
|
Overall Study
Withdrawal by Subject
|
13
|
|
Overall Study
Lost to Follow-up
|
13
|
Baseline Characteristics
Navio With Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Study Population
n=122 Participants
Total Knee Replacement with Navio Surgical Systems
Navio ™ Robotic-assisted Surgical System: Total Knee Replacement
|
|---|---|
|
Age, Continuous
|
69.51 years
STANDARD_DEVIATION 8.683 • n=5 Participants
|
|
Age, Customized
Age Category · < 60 years
|
13 Participants
n=5 Participants
|
|
Age, Customized
Age Category · >=60 years
|
109 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
107 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
122 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
31.32 kg/m^2
STANDARD_DEVIATION 5.102 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Number of Participants Analyzed indicates the data available for the time frame specified.
The number of participants achieving post-operative mechanical alignment within ±3 degrees from target with "Yes" indicating mechanical alignment was achieved and "No" indicating mechanical alignment was not achieved.
Outcome measures
| Measure |
Study Population
n=115 Participants
Total Knee Replacement with Navio Surgical Systems
Navio ™ Robotic-assisted Surgical System: Total Knee Replacement
|
|---|---|
|
Count of Participants With Post-operative Mechanical Alignment
Yes
|
106 Participants
|
|
Count of Participants With Post-operative Mechanical Alignment
No
|
9 Participants
|
SECONDARY outcome
Timeframe: 2 yearsNumber of participants with implant survivorship where "No" indicates a revision surgery was not required and "Yes" indicates a revision surgery was required by the 2 year postoperative visit.
Outcome measures
| Measure |
Study Population
n=122 Participants
Total Knee Replacement with Navio Surgical Systems
Navio ™ Robotic-assisted Surgical System: Total Knee Replacement
|
|---|---|
|
Count of Participants With Implant Survival
No
|
117 Participants
|
|
Count of Participants With Implant Survival
Yes
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 6 months, 1 year, and 2 yearsPopulation: Number of Participants Analyzed indicates the data available for the time frame specified.
The Functional Knee Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities in Total Knee Arthroplasty (TKA) participants. The 2011 Knee Society Score consists of 4 separate subscales with a higher number indicating a better outcome: * A Patient Expectation Score (5items: 15 points, range 0-15) * A Functional Activity Score (19 items: 100 points, range 0-100) * An "Objective" Knee Score (7 items: 100 points, range 0-100) * A Patient Satisfaction Score (5 items: 40 points, range 0-40)
Outcome measures
| Measure |
Study Population
n=122 Participants
Total Knee Replacement with Navio Surgical Systems
Navio ™ Robotic-assisted Surgical System: Total Knee Replacement
|
|---|---|
|
Knee Society Score 2011
Patient Expectation: Baseline
|
14.21 score on a scale
Standard Deviation 1.627
|
|
Knee Society Score 2011
Patient Expectation: 1 Month
|
8.42 score on a scale
Standard Deviation 2.819
|
|
Knee Society Score 2011
Patient Expectation: 6 Months
|
9.78 score on a scale
Standard Deviation 3.391
|
|
Knee Society Score 2011
Patient Expectation: 1 Year
|
9.39 score on a scale
Standard Deviation 3.040
|
|
Knee Society Score 2011
Patient Expectation: 2 Years
|
9.97 score on a scale
Standard Deviation 2.485
|
|
Knee Society Score 2011
Functional Activity: Baseline
|
42.13 score on a scale
Standard Deviation 15.914
|
|
Knee Society Score 2011
Functional Activity: 1 Month
|
46.55 score on a scale
Standard Deviation 16.155
|
|
Knee Society Score 2011
Functional Activity: 6 Months
|
72.28 score on a scale
Standard Deviation 15.819
|
|
Knee Society Score 2011
Functional Activity: 1 Year
|
79.35 score on a scale
Standard Deviation 15.775
|
|
Knee Society Score 2011
Functional Activity: 2 Years
|
83.42 score on a scale
Standard Deviation 14.931
|
|
Knee Society Score 2011
Objective: Baseline
|
49.40 score on a scale
Standard Deviation 21.382
|
|
Knee Society Score 2011
Objective: 1 Month
|
63.02 score on a scale
Standard Deviation 17.250
|
|
Knee Society Score 2011
Objective: 6 Months
|
78.98 score on a scale
Standard Deviation 15.867
|
|
Knee Society Score 2011
Objective: 1 Year
|
82.10 score on a scale
Standard Deviation 14.339
|
|
Knee Society Score 2011
Objective: 2 Years
|
84.51 score on a scale
Standard Deviation 13.463
|
|
Knee Society Score 2011
Patient Satisfaction: Baseline
|
10.93 score on a scale
Standard Deviation 6.310
|
|
Knee Society Score 2011
Patient Satisfaction: 1 Month
|
22.64 score on a scale
Standard Deviation 7.028
|
|
Knee Society Score 2011
Patient Satisfaction: 6 Months
|
29.42 score on a scale
Standard Deviation 8.358
|
|
Knee Society Score 2011
Patient Satisfaction: 1 Year
|
32.19 score on a scale
Standard Deviation 7.110
|
|
Knee Society Score 2011
Patient Satisfaction: 2 Years
|
33.42 score on a scale
Standard Deviation 5.941
|
SECONDARY outcome
Timeframe: Baseline, 1 Month, 6 Months, 1 Year, 2 YearsPopulation: Number of Participants Analyzed indicates the data available for the time frame specified.
Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D-5L) was graded on a scale of 0 to 100, with 100 being the best health you can imagine and 0 indicating the worst.
Outcome measures
| Measure |
Study Population
n=122 Participants
Total Knee Replacement with Navio Surgical Systems
Navio ™ Robotic-assisted Surgical System: Total Knee Replacement
|
|---|---|
|
Quality of Life EQ-5D-5L
Baseline
|
73.44 score on a scale
Standard Deviation 16.643
|
|
Quality of Life EQ-5D-5L
1 Month
|
75.01 score on a scale
Standard Deviation 12.251
|
|
Quality of Life EQ-5D-5L
6 Months
|
78.44 score on a scale
Standard Deviation 13.462
|
|
Quality of Life EQ-5D-5L
1 Year
|
81.82 score on a scale
Standard Deviation 10.012
|
|
Quality of Life EQ-5D-5L
2 Years
|
84.18 score on a scale
Standard Deviation 9.364
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 6 months, 1 year, 2 yearsPopulation: Number of Participants Analyzed indicates the data available for the time frame specified.
Forgotten Joint Score (FJS) is a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment. The Forgotten Joint Score consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities.
Outcome measures
| Measure |
Study Population
n=122 Participants
Total Knee Replacement with Navio Surgical Systems
Navio ™ Robotic-assisted Surgical System: Total Knee Replacement
|
|---|---|
|
Forgotten Joint Score (FJS)
Baseline
|
11.84 score on a scale
Standard Deviation 12.084
|
|
Forgotten Joint Score (FJS)
1 Month
|
17.31 score on a scale
Standard Deviation 19.603
|
|
Forgotten Joint Score (FJS)
6 Months
|
51.45 score on a scale
Standard Deviation 25.377
|
|
Forgotten Joint Score (FJS)
1 Year
|
66.31 score on a scale
Standard Deviation 26.598
|
|
Forgotten Joint Score (FJS)
2 Years
|
78.56 score on a scale
Standard Deviation 26.095
|
SECONDARY outcome
Timeframe: During hospitalization, up to 6 daysHospital length of stay measured in days
Outcome measures
| Measure |
Study Population
n=122 Participants
Total Knee Replacement with Navio Surgical Systems
Navio ™ Robotic-assisted Surgical System: Total Knee Replacement
|
|---|---|
|
Hospital Length of Stay
|
2.04 days
Standard Deviation 0.837
|
SECONDARY outcome
Timeframe: During surgery, up to 235 minutesOperative time taken for the surgery measured in minutes.
Outcome measures
| Measure |
Study Population
n=122 Participants
Total Knee Replacement with Navio Surgical Systems
Navio ™ Robotic-assisted Surgical System: Total Knee Replacement
|
|---|---|
|
Operative Time
|
90.48 minutes
Standard Deviation 29.316
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 6 months, 1 year, and 2 yearsPopulation: Number of Participants Analyzed indicates the data available for the time frame specified.
AP Angle mechanical alignment of femoral flexion, tibial angle, and total valgus angle
Outcome measures
| Measure |
Study Population
n=115 Participants
Total Knee Replacement with Navio Surgical Systems
Navio ™ Robotic-assisted Surgical System: Total Knee Replacement
|
|---|---|
|
Radiographic Assessment - Anteroposterior (AP) Angle
Femoral Flexion: Baseline
|
65.39 degrees
Standard Deviation 40.711
|
|
Radiographic Assessment - Anteroposterior (AP) Angle
Femoral Flexion: 1 Month
|
71.77 degrees
Standard Deviation 37.265
|
|
Radiographic Assessment - Anteroposterior (AP) Angle
Femoral Flexion: 6 Months
|
70.10 degrees
Standard Deviation 38.357
|
|
Radiographic Assessment - Anteroposterior (AP) Angle
Femoral Flexion: 1 Year
|
73.41 degrees
Standard Deviation 35.754
|
|
Radiographic Assessment - Anteroposterior (AP) Angle
Femoral Flexion: 2 Years
|
72.89 degrees
Standard Deviation 36.198
|
|
Radiographic Assessment - Anteroposterior (AP) Angle
Tibial Angle: Baseline
|
62.34 degrees
Standard Deviation 38.578
|
|
Radiographic Assessment - Anteroposterior (AP) Angle
Tibial Angle: 1 Month
|
69.07 degrees
Standard Deviation 37.639
|
|
Radiographic Assessment - Anteroposterior (AP) Angle
Tibial Angle: 6 Months
|
66.59 degrees
Standard Deviation 38.915
|
|
Radiographic Assessment - Anteroposterior (AP) Angle
Tibial Angle: 1 Year
|
70.51 degrees
Standard Deviation 36.435
|
|
Radiographic Assessment - Anteroposterior (AP) Angle
Tibial Angle: 2 Years
|
70.16 degrees
Standard Deviation 36.760
|
|
Radiographic Assessment - Anteroposterior (AP) Angle
Total Valgus Angle: Baseline
|
126.46 degrees
Standard Deviation 79.078
|
|
Radiographic Assessment - Anteroposterior (AP) Angle
Total Valgus Angle: 1 Month
|
140.15 degrees
Standard Deviation 74.310
|
|
Radiographic Assessment - Anteroposterior (AP) Angle
Total Valgus Angle: 6 Months
|
136.63 degrees
Standard Deviation 77.309
|
|
Radiographic Assessment - Anteroposterior (AP) Angle
Total Valgus Angle: 1 Year
|
143.89 degrees
Standard Deviation 71.527
|
|
Radiographic Assessment - Anteroposterior (AP) Angle
Total Valgus Angle: 2 Years
|
143.05 degrees
Standard Deviation 72.249
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 6 months, 1 year, and 2 yearsPopulation: Number of Participants Analyzed indicates the data available for the time frame specified.
Lateral Angle mechanical alignment of femoral flexion and tibial angle.
Outcome measures
| Measure |
Study Population
n=107 Participants
Total Knee Replacement with Navio Surgical Systems
Navio ™ Robotic-assisted Surgical System: Total Knee Replacement
|
|---|---|
|
Radiographic Assessment - Lateral Angle
Lateral Angle Femoral Flexion: Baseline
|
6.12 degrees
Standard Deviation 2.233
|
|
Radiographic Assessment - Lateral Angle
Lateral Angle Femoral Flexion: 1 Month
|
2.68 degrees
Standard Deviation 2.600
|
|
Radiographic Assessment - Lateral Angle
Lateral Angle Femoral Flexion: 6 Months
|
2.41 degrees
Standard Deviation 2.499
|
|
Radiographic Assessment - Lateral Angle
Lateral Angle Femoral Flexion: 1 Year
|
3.10 degrees
Standard Deviation 9.465
|
|
Radiographic Assessment - Lateral Angle
Lateral Angle Femoral Flexion: 2 Years
|
3.31 degrees
Standard Deviation 9.763
|
|
Radiographic Assessment - Lateral Angle
Tibial Angle: Baseline
|
80.18 degrees
Standard Deviation 19.654
|
|
Radiographic Assessment - Lateral Angle
Tibial Angle: 1 Month
|
66.30 degrees
Standard Deviation 37.277
|
|
Radiographic Assessment - Lateral Angle
Tibial Angle: 6 Months
|
63.79 degrees
Standard Deviation 38.965
|
|
Radiographic Assessment - Lateral Angle
Tibial Angle: 1 Year
|
66.56 degrees
Standard Deviation 38.965
|
|
Radiographic Assessment - Lateral Angle
Tibial Angle: 2 Years
|
66.84 degrees
Standard Deviation 37.326
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Number of Participants Analyzed indicates the data available for the time frame specified.
Number of participants with either no displacement or displacement observed at the 6-month follow-up visit.
Outcome measures
| Measure |
Study Population
n=86 Participants
Total Knee Replacement with Navio Surgical Systems
Navio ™ Robotic-assisted Surgical System: Total Knee Replacement
|
|---|---|
|
Radiographic Assessment - Count of Participant Displacements
No Displacement
|
62 Participants
|
|
Radiographic Assessment - Count of Participant Displacements
Displacement
|
24 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Number of Participants that showed displacement with data available for the time frame specified.
Degree of displacement measured in millimeters (mm) for participants with displacement observed at the 6-month follow-up visit.
Outcome measures
| Measure |
Study Population
n=22 Participants
Total Knee Replacement with Navio Surgical Systems
Navio ™ Robotic-assisted Surgical System: Total Knee Replacement
|
|---|---|
|
Radiographic Assessment - Displacement Measurement
|
3.95 millimeters
Standard Deviation 2.663
|
Adverse Events
Study Population
Serious events: 26 serious events
Other events: 12 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Study Population
n=122 participants at risk
Total Knee Replacement with Navio Surgical Systems
Navio ™ Robotic-assisted Surgical System: Total Knee Replacement
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Recurrent dislocation, right hip
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Musculoskeletal and connective tissue disorders
Quadricep tendon rupture
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Blood and lymphatic system disorders
Delayed wound healing
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Musculoskeletal and connective tissue disorders
Arthrofibrosis of total knee arthroplasty
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Musculoskeletal and connective tissue disorders
Arthrofibrosis right knee
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Musculoskeletal and connective tissue disorders
Instability of internal left knee prosthesis, init. encounter
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Musculoskeletal and connective tissue disorders
Patellar tendon tear right knee
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Reproductive system and breast disorders
Prostate cancer (reoccurence)
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Investigations
Deceased, unknown cause
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Musculoskeletal and connective tissue disorders
Rt knee effusion
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Cardiac disorders
Ischemic stroke in left MCA region
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Gastrointestinal disorders
GI bleed
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Skin and subcutaneous tissue disorders
Pulmonary atelectasis J98.11
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Respiratory, thoracic and mediastinal disorders
Right ankle fracture
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Blood and lymphatic system disorders
Periprosthetic infection
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Eye disorders
Macular Pucker with surgical repair
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Eye disorders
Cataracts
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Musculoskeletal and connective tissue disorders
Right knee pain, lumbar sprain / strain
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Musculoskeletal and connective tissue disorders
Pain in left knee
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Musculoskeletal and connective tissue disorders
Fall causing torn tendon
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Blood and lymphatic system disorders
Infection right knee
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Musculoskeletal and connective tissue disorders
Acquired instability, left knee
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Musculoskeletal and connective tissue disorders
Arthrofibrosis (R) knee
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Musculoskeletal and connective tissue disorders
Left stiffness of knee with history of replacement
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Musculoskeletal and connective tissue disorders
Arthrofibrosis left knee
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Musculoskeletal and connective tissue disorders
Pain in right knee
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
Other adverse events
| Measure |
Study Population
n=122 participants at risk
Total Knee Replacement with Navio Surgical Systems
Navio ™ Robotic-assisted Surgical System: Total Knee Replacement
|
|---|---|
|
Gastrointestinal disorders
Tooth abcess
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Blood and lymphatic system disorders
Wound complication due to suture reaction
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Blood and lymphatic system disorders
Wound dehiscence
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Musculoskeletal and connective tissue disorders
Pain in left knee
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Musculoskeletal and connective tissue disorders
Pain in right knee, effusion right knee
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Musculoskeletal and connective tissue disorders
Iliotibial band friction syndrome - left knee
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Musculoskeletal and connective tissue disorders
Left knee pain
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Musculoskeletal and connective tissue disorders
Pain in left hip
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
|
Musculoskeletal and connective tissue disorders
Right knee pain, lumbar sprain / strain
|
0.82%
1/122 • Number of events 1 • Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up).
The Intent-to-Treat (ITT) population used for safety analyses and included all consented participants enrolled in the study that received Total Knee Replacement with NAVIO ™ Robotic-assisted Surgical System.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place