Navio With Total Knee Arthroplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Total Knee Arthroplasty, Arthroplasty of Knee

Intervention / Treatment
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* Device: Navio ™ Robotic-assisted Surgical System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Subject was considered skeletally mature at the time of cone implantation (at least 18 years or older.) 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. Subject plans to be available through two (2) years postoperative follow-up. Exclusion Criteria: Subject has BMI ≥ 40. 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). Subject is deemed by investigator to require a constrained or deep dish tibial insert. Subject has inadequate bone stock to support the device (severe osteopenia, history of severe osteoporosis or severe osteopenia). Subject has mental or neurologic condition(s) that may pre-empt the ability or willingness to restrict activities. Subject is 80 years of age or older. Subject is a prisoner or impending incarceration.

Ages Eligible for Study
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Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Population<br>Total Knee Replacement with Navio Surgical Systems | Device: Navio ™ Robotic-assisted Surgical System<br>* Total Knee Replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Mechanical Alignment | the proportion of subjects achieving post-operative mechanical alignment | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival rate | Did knee survive with no revision through 2 years | 2 years | 
| Knee Society Score 2011 | Patient Reported Outcomes using Knee Society Score 2011 questionnaire | 2 years | 
| Quality of Life (EQ-5D) 5L | Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D - 3L) questionnaire | 2 years | 
| Forgotten Joint Score (FJS) | Patient Reported Outcomes using Forgotten Joint Score (FJS) questionnaire | 2 years | 
| 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 |