A Retrospective Study of the Navio Robotic-assisted Surgical System

Completed

Conditions: Knee Replacement
Surgical Robotics

Registration Number: NCT03072459

Lead Sponsor: Smith & Nephew, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 128

Inclusion Criteria

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.
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

Subject received the Navio System-assisted UKR on the index joint as a revision for a previously failed UKR.
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).
Subject, in the opinion of the Investigator, had a neuromuscular disorder that prohibited control of the index joint.
Subject, in the opinion of the Investigator, was morbidly obese.
Subject, in the opinion of the Investigator, was contraindicated for UKR.
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.
Subject (prospective subjects only) is a prisoner.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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 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.
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.
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.
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 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.

Trial Locations

Locations (5): Hedley Orthopedics
🇺🇸
Phoenix, Arizona, United States
Rothman Institute
🇺🇸
Philadelphia, Pennsylvania, 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