Knee Replacement, Surgical Robotics
Conditions
Brief summary
A retrospective, multi-center, cohort study with prospective follow-up and comparison to historical control
Detailed description
Subjects who had previously received the Navio robotic-assisted surgical system for unilateral knee replacement (UKR) were assessed to determine the 2-year safety and effectiveness of the Navio system.
Interventions
None listed
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects ≥ 18 years old (at the time of surgery) who have undergone Navio System-assisted UKR at least 2 years prior to enrollment. This includes UKR procedures with all Unicondylar Knee cemented implant designs. 2. Subject had a primary diagnosis of unicompartmental, non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis, required correction of functional deformity, or required treatment of fractures that were unmanageable using other techniques.
Exclusion criteria
1. Subject received the Navio System-assisted UKR on the index joint as a revision for a previously failed UKR. 2. Subject, in the opinion of the Investigator, had advanced osteoarthritis or joint disease at the time of surgery and was better suited for Total Knee Arthroplasty (TKA). 3. Subject, in the opinion of the Investigator, had a neuromuscular disorder that prohibited control of the index joint. 4. Subject, in the opinion of the Investigator, was morbidly obese. 5. Subject, in the opinion of the Investigator, was contraindicated for UKR. 6. Subject (prospective subjects only), in the opinion of the Investigator, has an emotional or neurological condition including mental illness, mental retardation, drug or alcohol abuse. 7. Subject (prospective subjects only) is a prisoner.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship | Preoperative (Baseline) and 24, 48, 72, 96, and 120 weeks postoperatively | Analysis of the absence of device revision (overall survivorship) outcomes assessed from Baseline through 120 weeks post-surgical implantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments | Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively | 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. |
| Preoperative Evaluation of Efficacy Based on Radiographic Findings | 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. |
| Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | 6 months postoperatively | Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population. |
| Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | 12 months postoperatively | Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population. |
| Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments | Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively | 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. |
| Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | 24 months postoperatively | Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population. |
| Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | 30 months postoperatively | Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population. |
| Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | 36 months postoperatively | Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population. |
| Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | 18 months postoperatively | Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 128 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Device revised/removed | 1 |
| Overall Study | Subject not able to return | 1 |
Baseline characteristics
| Characteristic | Navio Robotic-assisted Surgical System |
|---|---|
| Age, Continuous | 64.7 years STANDARD_DEVIATION 9.6 |
| Age, Customized < 60 years | 39 Participants |
| Age, Customized ≥ 60 years | 89 Participants |
| Blood Loss Prevention Method Aquamantus | 0 Participants |
| Blood Loss Prevention Method Other | 0 Participants |
| Blood Loss Prevention Method Tourniquet | 83 Participants |
| Blood Loss Prevention Method Unknown | 45 Participants |
| BMI | 30.3 kg/m^2 STANDARD_DEVIATION 5.4 |
| BMI Category < 30 kg/m^2 | 66 Participants |
| BMI Category ≥ 30 kg/m^2 | 61 Participants |
| Duration of Surgery | 1.8 hours STANDARD_DEVIATION 0.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 128 Participants |
| Height | 172.1 centimeters (cm) STANDARD_DEVIATION 10.8 |
| Intra-operative Complications No | 128 Participants |
| Intra-operative Complications Yes | 0 Participants |
| Knee System Type Missing | 3 Participants |
| Knee System Type Other - Non-Smith & Nephew | 17 Participants |
| Knee System Type Smith & Nephew | 108 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 122 Participants |
| Region of Enrollment United States | 128 participants |
| Sex: Female, Male Female | 54 Participants |
| Sex: Female, Male Male | 74 Participants |
| Smoking Status Current smoker | 7 Participants |
| Smoking Status Never smoked | 74 Participants |
| Smoking Status Previous smoker | 31 Participants |
| Smoking Status Unknown | 16 Participants |
| Surgical Approach Lateral parapatellar | 3 Participants |
| Surgical Approach Medial parapatellar | 89 Participants |
| Surgical Approach Midvastus | 0 Participants |
| Surgical Approach Other | 18 Participants |
| Surgical Approach Subvastus / Tissue sparing | 18 Participants |
| Surgical Approach Unknown | 0 Participants |
| Unilateral Knee Replacement Type Used Lateral | 4 Participants |
| Unilateral Knee Replacement Type Used Medial | 124 Participants |
| Weight | 89.9 kilograms (kg) STANDARD_DEVIATION 18.1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 128 |
| other Total, other adverse events | 28 / 128 |
| serious Total, serious adverse events | 2 / 128 |
Outcome results
Primary
Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Navio Robotic-assisted Surgical System | Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship | Number of Knees with Revisions : Week 0 | 0 participants |
| Navio Robotic-assisted Surgical System | Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship | Number of Knees with Revisions : Week 24 | 0 participants |
| Navio Robotic-assisted Surgical System | Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship | Number of Knees with Revisions : Week 48 | 1 participants |
| Navio Robotic-assisted Surgical System | Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship | Number of Knees with Revisions : Week 72 | 0 participants |
| Navio Robotic-assisted Surgical System | Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship | Number of Knees with Revisions : Week 96 | 0 participants |
| Navio Robotic-assisted Surgical System | Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship | Number of Knees with Revisions : Week 120 | 0 participants |
Secondary
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments | Functional Activities: Preoperative | 42.8 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments | Objective Knee Indicators: Preoperative | 48.6 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments | Objective Knee Indicators: 6 Months Postoperative | 51.6 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments | Objective Knee Indicators: 12 Months Postoperative | 49.3 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments | Objective Knee Indicators: 18 Months Postoperative | 49.9 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments | Objective Knee Indicators: 24 Months Postoperative | 61.9 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments | Objective Knee Indicators: 30 Months Postoperative | 63.8 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments | Objective Knee Indicators: 36 Months Postoperative | 60 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments | Patient Satisfaction: Preoperative | 14.0 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments | Patient Satisfaction: 6 Months Postoperative | 30.0 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments | Patient Satisfaction: 12 Months Postoperative | 32 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments | Patient Satisfaction: 18 Months Postoperative | 32.8 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments | Patient Satisfaction: 24 Months Postoperative | 34.0 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments | Patient Satisfaction: 30 Months Postoperative | 33.4 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments | Patient Satisfaction: 36 Months Postoperative | 34.8 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments | Functional Activities: 6 Months Postoperative | 73.3 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments | Functional Activities: 12 Months Postoperative | 78.2 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments | Functional Activities: 18 Months Postoperative | 73.9 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments | Functional Activities: 24 Months Postoperative | 81.9 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments | Functional Activities: 30 Months Postoperative | 81.1 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments | Functional Activities: 36 Months Postoperative | 82.6 score on a scale |
Secondary
Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments | PCS: 6 Months Postoperative | 15.0 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments | PCS: Preoperative | 11.2 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments | PCS: 12 Months Postoperative | 15.0 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments | PCS: 18 Months Postoperative | 14.9 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments | PCS: 24 Months Postoperative | 14.6 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments | PCS: 30 Months Postoperative | 15.0 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments | PCS: 36 Months Postoperative | 15.4 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments | MCS: Preoperative | 17.3 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments | MCS: 6 Months Postoperative | 19.7 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments | MCS: 12 Months Postoperative | 20.0 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments | MCS: 18 Months Postoperative | 20.1 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments | MCS: 24 Months Postoperative | 20.4 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments | MCS: 30 Months Postoperative | 21.1 score on a scale |
| Navio Robotic-assisted Surgical System | Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments | MCS: 36 Months Postoperative | 18.6 score on a scale |
Secondary
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
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
Population: The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | Yes | 1 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | No | 24 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | Unknown | 3 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | Missing | 30 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | No | 25 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | Unknown | 3 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | Missing | 30 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | No | 25 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | Unknown | 3 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | Missing | 30 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | No | 25 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | Unknown | 3 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | Missing | 30 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | No | 25 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | Unknown | 3 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | Missing | 30 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | No | 25 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | Unknown | 3 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | Missing | 30 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | No | 25 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | Unknown | 3 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | Missing | 30 Participants |
Secondary
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
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
Population: The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | No | 27 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | Missing | 14 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | Yes | 1 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | No | 26 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | Missing | 14 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | No | 27 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | Missing | 14 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | No | 27 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | Missing | 14 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | No | 27 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | Missing | 14 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | No | 27 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | Missing | 14 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | No | 27 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | Missing | 14 Participants |
Secondary
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
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
Population: The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | Yes | 1 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | No | 22 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | Unknown | 5 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | Missing | 33 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | No | 24 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | Unknown | 4 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | Missing | 33 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | No | 26 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | Unknown | 2 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | Missing | 33 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | No | 26 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | Unknown | 2 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | Missing | 33 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | No | 26 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | Unknown | 2 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | Missing | 33 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | No | 26 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | Unknown | 2 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | Missing | 33 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | No | 26 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | Unknown | 2 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | Missing | 33 Participants |
Secondary
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
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
Population: The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | No | 29 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | Unknown | 1 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | Missing | 26 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | No | 29 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | Unknown | 1 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | Missing | 26 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | No | 30 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | Missing | 26 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | No | 30 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | Missing | 26 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | No | 30 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | Missing | 26 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | No | 30 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | Missing | 26 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | No | 30 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | Missing | 26 Participants |
Secondary
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
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
Population: The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | No | 13 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | Missing | 10 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | No | 13 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | Missing | 10 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | No | 13 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | Missing | 10 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | No | 13 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | Missing | 10 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | No | 13 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | Missing | 10 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | No | 13 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | Missing | 10 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | No | 13 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | Missing | 10 Participants |
Secondary
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
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
Population: The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | No | 25 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | Unknown | 3 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | Missing | 99 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | No | 25 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | Unknown | 3 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Osteolysis | Missing | 99 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | No | 25 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | Unknown | 3 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | Missing | 99 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | No | 25 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | Unknown | 3 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | Missing | 99 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | No | 25 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | Unknown | 3 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | Missing | 99 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | No | 25 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | Unknown | 3 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | Missing | 99 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | No | 25 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | Unknown | 3 Participants |
| Navio Robotic-assisted Surgical System | Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | Missing | 99 Participants |
Secondary
Preoperative Evaluation of Efficacy Based on Radiographic Findings
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)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | No | 0 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Tibial Osteolysis | Missing | 128 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Femoral osteolysis | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Femoral osteolysis | No | 0 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Femoral osteolysis | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Femoral osteolysis | Missing | 128 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | No | 0 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Tibial Migration/Subsidence | Missing | 128 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | No | 0 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Femoral Migration/Subsidence | Missing | 128 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | No | 0 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Heterotropic Ossification | Missing | 128 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | No | 0 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Patellar Subluxation | Missing | 128 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | Yes | 0 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | No | 0 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | Unknown | 0 Participants |
| Navio Robotic-assisted Surgical System | Preoperative Evaluation of Efficacy Based on Radiographic Findings | Patellar Dislocation | Missing | 128 Participants |