A Retrospective Study of the Navio Robotic-assisted Surgical System

Smith & Nephew, Inc.128 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

128

Conditions

Surgical Robotics Knee Replacement

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Hedley Orthopedics

Phoenix, Arizona, United States

Santa Barbara Cottage Hospital

Santa Barbara, California, United States

Bronson Orthopedic Specialists

Battle Creek, Michigan, United States

OrthoNeuro New Albany

New Albany, Ohio, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

Preoperative Evaluation of Efficacy Based on Radiographic Findings

Data from ClinicalTrials.gov

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