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A retrospective, multi-center, cohort study with prospective follow-up and comparison to historical control
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Navioâ„¢ 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. | Preoperative (Baseline) and 24, 48, 72, 96, and 120 weeks postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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One hundred twenty-eight (128) subjects, including 10% inflation to allow for attrition
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| Name | Affiliation | Role |
|---|---|---|
| Beate Hanson, MD, PhD | Smith & Nephew, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hedley Orthopedics | Phoenix | Arizona | 85016 | United States | ||
| Santa Barbara Cottage Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Navio Robotic-assisted Surgical System | Subjects who had previously received the Navioâ„¢ robotic-assisted surgical system for UKR were assessed to determine the 2-year safety and effectiveness of the Navioâ„¢ system. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Navio Robotic-assisted Surgical System | Subjects who had previously received the Navioâ„¢ robotic-assisted surgical system for UKR were assessed to determine the 2-year safety and effectiveness of the Navioâ„¢ system. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluate the Navioâ„¢ 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. | 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. | Posted | Number | participants | Preoperative (Baseline) and 24, 48, 72, 96, and 120 weeks postoperatively |
|
Adverse events (AEs) were collected from Study Day 1 until up to 2 years postoperatively (+/- 3 months) at End of Study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Navio Robotic-assisted Surgical System | Subjects who had previously received the Navioâ„¢ robotic-assisted surgical system for UKR were assessed to determine the 2-year safety and effectiveness of the Navioâ„¢ system. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep venous thrombosis (DVT) | Vascular disorders | Systematic Assessment | The subject recovered/resolved from the DVT and it was deemed unrelated to the treatment. The subject was not discontinued from the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Radiolucency line tibial ML zone | Musculoskeletal and connective tissue disorders | Systematic Assessment |
There were no known study limitations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Salima Reddy | Smith & Nephew, Inc. | 817-916-2233 | salima.reddy@smith-nephew.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 5, 2017 | Dec 10, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 29, 2018 | Dec 10, 2018 | SAP_001.pdf |
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| Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively |
| 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. | Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively |
| 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. | Preoperative (Baseline) |
| 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. | 6 months postoperatively |
| 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. | 12 months postoperatively |
| 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. | 18 months postoperatively |
| 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. | 24 months postoperatively |
| 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. | 30 months postoperatively |
| 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. | 36 months postoperatively |
| Santa Barbara |
| California |
| 93105 |
| United States |
| Bronson Orthopedic Specialists | Battle Creek | Michigan | 49015 | United States |
| OrthoNeuro New Albany | New Albany | Ohio | 43054 | United States |
| Rothman Institute | Philadelphia | Pennsylvania | 19107 | United States |
| years |
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| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | There was one subject with missing height, weight, and BMI information provided from the site, and thus not included in the results. | Mean | Standard Deviation | centimeters (cm) |
|
| Weight | There was one subject with missing height, weight, and BMI information provided from the site, and thus not included in the results. | Mean | Standard Deviation | kilograms (kg) |
|
| BMI | There was one subject with missing height, weight, and BMI information provided from the site, and thus not included in the results. | Mean | Standard Deviation | kg/m^2 |
|
| BMI Category | There was one subject with missing height, weight, and BMI information provided from the site, and thus not included in the results. | Count of Participants | Participants |
|
| Smoking Status | Count of Participants | Participants |
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| Surgical Approach | Count of Participants | Participants |
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| Knee System Type | Count of Participants | Participants |
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| Unilateral Knee Replacement Type Used | Count of Participants | Participants |
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| Blood Loss Prevention Method | Count of Participants | Participants |
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| Intra-operative Complications | Count of Participants | Participants |
|
| Duration of Surgery | Mean | Standard Deviation | hours |
|
| Units | Counts |
|---|---|
| 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. | 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. | Posted | Mean | Full Range | score on a scale | Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively |
|
|
|
| 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. | 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. | Posted | Mean | Full Range | score on a scale | Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively |
|
|
|
| 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. | Posted | Count of Participants | Participants | Preoperative (Baseline) |
|
|
|
| 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. | The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point. | Posted | Count of Participants | Participants | 6 months postoperatively |
|
|
|
| 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. | The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point. | Posted | Count of Participants | Participants | 12 months postoperatively |
|
|
|
| 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. | The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point. | Posted | Count of Participants | Participants | 18 months postoperatively |
|
|
|
| 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. | The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point. | Posted | Count of Participants | Participants | 24 months postoperatively |
|
|
|
| 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. | The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point. | Posted | Count of Participants | Participants | 30 months postoperatively |
|
|
|
| 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. | The data presented for this outcome are based upon the number of participants who returned for evaluation at this specific time point. | Posted | Count of Participants | Participants | 36 months postoperatively |
|
|
|
| 0 |
| 128 |
| 2 |
| 128 |
| 28 |
| 128 |
|
| Lower extremity DVT | Vascular disorders | Systematic Assessment | The subject recovered/resolved from the DVT and it was deemed unrelated to the treatment. The subject was not discontinued from the study. |
|
| Redness, burning, itchiness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Effusion | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Swelling and discomfort | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Slight swelling and edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Knee pain due to mild iliotibial band tendonitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in quadriceps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Knee pain with 50 mL of blood aspiration | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Possible cellulitis - not life threatening | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Manipulation under anesthesia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Occasional swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Soreness/pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Incisional soreness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Neurodermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pin site drainage | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pimple drainage from pin site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Stress shielding | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Radiolucent lines | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Femoral osteolysis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Incision pain with deep flexion | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Anterior knee pain and swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Synovial hypertrophy, quadriceps atrophy, and knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hamstring irritation and ischial tuberosity bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Skin irritation over pin site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| Objective Knee Indicators: 12 Months Postoperative |
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| Objective Knee Indicators: 18 Months Postoperative |
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| Objective Knee Indicators: 24 Months Postoperative |
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| Objective Knee Indicators: 30 Months Postoperative |
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| Objective Knee Indicators: 36 Months Postoperative |
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| Patient Satisfaction: Preoperative |
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| Patient Satisfaction: 6 Months Postoperative |
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| Patient Satisfaction: 12 Months Postoperative |
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| Patient Satisfaction: 18 Months Postoperative |
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| Patient Satisfaction: 24 Months Postoperative |
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| Patient Satisfaction: 30 Months Postoperative |
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| Patient Satisfaction: 36 Months Postoperative |
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| Functional Activities: Preoperative |
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| Functional Activities: 6 Months Postoperative |
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| Functional Activities: 12 Months Postoperative |
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| Functional Activities: 18 Months Postoperative |
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| Functional Activities: 24 Months Postoperative |
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| Functional Activities: 30 Months Postoperative |
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| Functional Activities: 36 Months Postoperative |
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| PCS: 12 Months Postoperative |
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| PCS: 18 Months Postoperative |
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| PCS: 24 Months Postoperative |
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| PCS: 30 Months Postoperative |
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| PCS: 36 Months Postoperative |
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| MCS: Preoperative |
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| MCS: 6 Months Postoperative |
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| MCS: 12 Months Postoperative |
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| MCS: 18 Months Postoperative |
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| MCS: 24 Months Postoperative |
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| MCS: 30 Months Postoperative |
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| MCS: 36 Months Postoperative |
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| Missing |
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| Femoral osteolysis |
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| Tibial Migration/Subsidence |
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| Femoral Migration/Subsidence |
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| Heterotropic Ossification |
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| Patellar Subluxation |
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| Patellar Dislocation |
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| Missing |
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| Femoral Osteolysis |
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| Tibial Migration/Subsidence |
|
| Femoral Migration/Subsidence |
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| Heterotropic Ossification |
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| Patellar Subluxation |
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| Patellar Dislocation |
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| Missing |
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| Femoral Osteolysis |
|
| Tibial Migration/Subsidence |
|
| Femoral Migration/Subsidence |
|
| Heterotropic Ossification |
|
| Patellar Subluxation |
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| Patellar Dislocation |
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| Missing |
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| Femoral Osteolysis |
|
| Tibial Migration/Subsidence |
|
| Femoral Migration/Subsidence |
|
| Heterotropic Ossification |
|
| Patellar Subluxation |
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| Patellar Dislocation |
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| Missing |
|
| Femoral Osteolysis |
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| Tibial Migration/Subsidence |
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| Femoral Migration/Subsidence |
|
| Heterotropic Ossification |
|
| Patellar Subluxation |
|
| Patellar Dislocation |
|
| Missing |
|
| Femoral Osteolysis |
|
| Tibial Migration/Subsidence |
|
| Femoral Migration/Subsidence |
|
| Heterotropic Ossification |
|
| Patellar Subluxation |
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| Patellar Dislocation |
|
| Missing |
|
| Femoral Osteolysis |
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| Tibial Migration/Subsidence |
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| Femoral Migration/Subsidence |
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| Heterotropic Ossification |
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| Patellar Subluxation |
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| Patellar Dislocation |
|