Status:
COMPLETED
Navio With Total Knee Arthroplasty
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Total Knee Arthroplasty
Arthroplasty of Knee
Eligibility:
All Genders
Up to 80 years
Brief 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 usi...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 13 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 27 2021
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT03317834
Start Date
November 13 2017
End Date
May 27 2021
Last Update
October 8 2024
Active Locations (6)
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1
Hedley Orthopedics
Phoenix, Arizona, United States, 85016
2
Orthopaedic Associates of Central Arizona
Scottsdale, Arizona, United States, 86305
3
San Diego Orthopaedic
San Diego, California, United States, 92103
4
Bronson Health
Kalamazoo, Michigan, United States, 49006