Navio With Total Knee Arthroplasty

Clinical, Radiographic and Patient-reported Outcomes Associated With the Use of the Navio™ Robotic-assisted Surgical System in Total Knee Arthroplasty

The purpose of this study is to demonstrate superior accuracy with the Navio ™ Robotic-assisted Surgical System in achieving desired post-operative mechanical alignment, compared to TKA procedures using standard instruments. An additional study purpose is to document clinical and patient-reported outcomes in subjects receiving TKA with the Navio ™ system.

Study Overview

• Status: Completed
• Conditions: Total Knee Arthroplasty; Arthroplasty of Knee
• Intervention / Treatment: Device: Navio ™ Robotic-assisted Surgical System

Detailed Description

Total Knee Arthroplasty (TKA) has become an effective and reliable treatment for arthritis of the knee (1). TKA is associated with low morbidity and mortality, and its effectiveness in reducing joint pain and improving range of motion is well established. In 2014, over 750,000 knee replacements were performed in the US (2).

A significant innovation in TKA has been the introduction of computer navigation and robotic-assisted surgery (3). One such technology is the Navio™ Robotic-assisted Surgical System. This system is a semi-autonomous image-free system. During the surgery, the surgeon maps the condylar landmarks and determines alignment indices to define the volume and orientation of bone to be removed. The tools to remove the bone and place the implants are controlled and manipulated by the surgeon with the guidance of a 3-dimensional digital map of the surgical surface.

Originally the Navio™ system was launched for use in unicondylar knee replacement only. To date, there have been over 1000 unicondylar knee replacement surgeries using the system. In 2017, Smith & Nephew Inc. expanded the indications for the Navio™ system to include TKA. The purpose of this multicenter, prospective study is to evaluate outcomes associated with this new indication.

• Study Type: Observational
• Enrollment (Actual): 122

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Hedley Orthopedics
    • Scottsdale, Arizona, United States, 86305
      • Orthopaedic Associates of Central Arizona
  • California
    • San Diego, California, United States, 92103
      • San Diego Orthopaedic
  • Michigan
    • Kalamazoo, Michigan, United States, 49006
      • Bronson Health
  • New York
    • New York, New York, United States, 10003
      • Hospital for Joint Disease Orthopaedic Institute
  • Ohio
    • Albany, Ohio, United States, 43054
      • OrthoNeuro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 76 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

To eliminate the potential for selection bias, Investigators should screen all subjects undergoing a Navio™ assisted TKA. In order to do so, only the existing information obtained per standard routine medical procedures will be used. No study-specific screening procedures, activities or questionnaires will be performed during pre-screening.

Description

Inclusion Criteria:

1. Subject requires primary total knee arthroplasty with the Journey II BCS or Cruciate-Retraining (CR) Systems due to degenerative joint disease (primary diagnosis of osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis.
2. Subject was considered skeletally mature at the time of cone implantation (at least 18 years or older.)
3. Subject agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form) by signing the IRB/EC approved informed consent form.
4. Subject plans to be available through two (2) years postoperative follow-up.

Exclusion Criteria:

1. Subject has BMI ≥ 40.
2. Subject has condition(s) that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease, or an active, local infection).
3. Subject is deemed by investigator to require a constrained or deep dish tibial insert.
4. Subject has inadequate bone stock to support the device (severe osteopenia, history of severe osteoporosis or severe osteopenia).
5. Subject has mental or neurologic condition(s) that may pre-empt the ability or willingness to restrict activities.
6. Subject is 80 years of age or older.
7. Subject is a prisoner or impending incarceration.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Population; Total Knee Replacement with Navio Surgical Systems	Device: Navio ™ Robotic-assisted Surgical System; Total Knee Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Count of Participants With Post-operative Mechanical Alignment	The number of participants achieving post-operative mechanical alignment within ±3 degrees from target with "Yes" indicating mechanical alignment was achieved and "No" indicating mechanical alignment was not achieved.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Count of Participants With Implant Survival	Number of participants with implant survivorship where "No" indicates a revision surgery was not required and "Yes" indicates a revision surgery was required by the 2 year postoperative visit.	2 years
Knee Society Score 2011	The Functional Knee Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities in Total Knee Arthroplasty (TKA) participants. The 2011 Knee Society Score consists of 4 separate subscales with a higher number indicating a better outcome: A Patient Expectation Score (5items: 15 points, range 0-15); A Functional Activity Score (19 items: 100 points, range 0-100); An "Objective" Knee Score (7 items: 100 points, range 0-100); A Patient Satisfaction Score (5 items: 40 points, range 0-40)	Baseline, 1 month, 6 months, 1 year, and 2 years
Quality of Life EQ-5D-5L	Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D-5L) was graded on a scale of 0 to 100, with 100 being the best health you can imagine and 0 indicating the worst.	Baseline, 1 Month, 6 Months, 1 Year, 2 Years
Forgotten Joint Score (FJS)	Forgotten Joint Score (FJS) is a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment. The Forgotten Joint Score consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities.	Baseline, 1 month, 6 months, 1 year, 2 years
Hospital Length of Stay	Hospital length of stay measured in days	During hospitalization, up to 6 days
Operative Time	Operative time taken for the surgery measured in minutes.	During surgery, up to 235 minutes
Radiographic Assessment - Anteroposterior (AP) Angle	AP Angle mechanical alignment of femoral flexion, tibial angle, and total valgus angle	Baseline, 1 month, 6 months, 1 year, and 2 years
Radiographic Assessment - Lateral Angle	Lateral Angle mechanical alignment of femoral flexion and tibial angle.	Baseline, 1 month, 6 months, 1 year, and 2 years
Radiographic Assessment - Count of Participant Displacements	Number of participants with either no displacement or displacement observed at the 6-month follow-up visit.	6 months
Radiographic Assessment - Displacement Measurement	Degree of displacement measured in millimeters (mm) for participants with displacement observed at the 6-month follow-up visit.	6 months

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Chair: Julie Lankiewicz, Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2017
• Primary Completion (Actual): October 25, 2018
• Study Completion (Actual): May 27, 2021

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 17-NPFS-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes