A Retrospective Study of the Navio Robotic-assisted Surgical System

NCT03072459 | Completed Results

• 1 other identifier: 16-NPFS-11
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Surgical Robotics; Knee Replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments

  Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively

• Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments

  Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively

• Preoperative Evaluation of Efficacy Based on Radiographic Findings

  Preoperative (Baseline)

• Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings

  6 months postoperatively

• Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings

  12 months postoperatively

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (5)

Hedley Orthopedics

Phoenix, Arizona, 85016, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

Location

Bronson Orthopedic Specialists

Battle Creek, Michigan, 49015, United States

Location

OrthoNeuro New Albany

New Albany, Ohio, 43054, United States

Location

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Limitations and Caveats

There were no known study limitations.

Results Point of Contact

• Title: Salima Reddy
• Organization: Smith & Nephew, Inc.

salima.reddy@smith-nephew.com

817-916-2233

Study Officials

• Beate Hanson, MD, PhD

  Smith & Nephew, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 7, 2017
• Study Start: July 10, 2017
• Primary Completion: November 29, 2017
• Study Completion: November 29, 2017
• Last Updated: May 25, 2022
• Results First Posted: May 2, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)