Navio With Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03317834
• Other study ID #: 17-NPFS-04
• Status: Completed
• Start date: October 30, 2017
• Est. completion date: October 16, 2021

Study information

• Verified date: September 2022
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: October 16, 2021
• Est. primary completion date: October 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty of Knee
• Total Knee Arthroplasty

Intervention

Device:
• Navio ™ Robotic-assisted Surgical System
Total Knee Replacement

Locations

Country	Name	City	State
United States	OrthoNeuro	Albany	Ohio
United States	Bronson Health	Kalamazoo	Michigan
United States	Hospital for Joint Disease Orthopaedic Institute	New York	New York
United States	Hedley Orthopedics	Phoenix	Arizona
United States	San Diego Orthopaedic	San Diego	California
United States	Orthopaedic Associates of Central Arizona	Scottsdale	Arizona

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	Post-operative Mechanical Alignment	the proportion of subjects achieving post-operative mechanical alignment	1 month
Secondary	Implant survival rate	Did knee survive with no revision through 2 years	2 years
Secondary	Knee Society Score 2011	Patient Reported Outcomes using Knee Society Score 2011 questionnaire	2 years
Secondary	Quality of Life (EQ-5D) 5L	Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D - 3L) questionnaire	2 years
Secondary	Forgotten Joint Score (FJS)	Patient Reported Outcomes using Forgotten Joint Score (FJS) questionnaire	2 years
Secondary	Radiographic Assessments	Mechanical Alignment on Long Leg X-rays,Standard AP, Lateral, and Patellar (Skyline or Merchant) X-rays	at PreOp, 1month, 6 month, 1 year and 2 year visits