Navio With Total Knee Arthroplasty

Completed

Conditions studied: Total Knee Arthroplasty, Arthroplasty of Knee

In brief

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.

Key facts

Study ID

NCT03317834

Run by

Smith & Nephew, Inc.

People needed

122

Starts

2017-11-13

Expected to finish

2021-05-27

Last updated by the study team

2024-10-08

Who can join

Age: any, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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