A Retrospective Study of the Navio Robotic-assisted Surgical System

Knee Replacement Clinical Trial

— NAVIO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03072459
• Other study ID #: 16-NPFS-11
• Status: Completed
• Start date: July 10, 2017
• Est. completion date: November 29, 2017

Study information

• Verified date: December 2021
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: November 29, 2017
• Est. primary completion date: November 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Replacement
• Surgical Robotics

Locations

Country	Name	City	State
United States	Bronson Orthopedic Specialists	Battle Creek	Michigan
United States	OrthoNeuro New Albany	New Albany	Ohio
United States	Rothman Institute	Philadelphia	Pennsylvania
United States	Hedley Orthopedics	Phoenix	Arizona
United States	Santa Barbara Cottage Hospital	Santa Barbara	California

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Preoperative (Baseline) and 24, 48, 72, 96, and 120 weeks postoperatively
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.	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.	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.	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.	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.	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.	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.	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.	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.	36 months postoperatively