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

A Retrospective Study of the Navio™ Robotic-assisted Surgical System

A retrospective, multi-center, cohort study with prospective follow-up and comparison to historical control

Study Overview

• Status: Completed
• Conditions: Knee Replacement; Surgical Robotics

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.

• Study Type: Observational
• Enrollment (Actual): 128

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Hedley Orthopedics
  • California
    • Santa Barbara, California, United States, 93105
      • Santa Barbara Cottage Hospital
  • Michigan
    • Battle Creek, Michigan, United States, 49015
      • Bronson Orthopedic Specialists
  • Ohio
    • New Albany, Ohio, United States, 43054
      • OrthoNeuro New Albany
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

One hundred twenty-eight (128) subjects, including 10% inflation to allow for attrition

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Preoperative (Baseline) and 24, 48, 72, 96, and 120 weeks postoperatively

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Director: Beate Hanson, MD, PhD, Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2017
• Primary Completion (Actual): November 29, 2017
• Study Completion (Actual): November 29, 2017

Study Registration Dates

• First Submitted: March 2, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 7, 2017

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 16-NPFS-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No