Safety and Performance Using Legion™ CR Oxinium and CoCr Femoral Implants Combined With Legion™/Genesis™ II XLPE High Flex Tibial Inserts

Running, not enrolling

Conditions studied: Total Knee Arthroplasty

In brief

The purpose of this research is to collect data on patients that had the Legion CR Oxinium and CoCr Femoral Implant and the Legion/Genesis II XLPE High Flex Tibial Inserts implanted in the past. Smith \& Nephew will evaluate the safety and performance of these implants.

Key facts

Study ID

NCT03687593

Run by

Smith & Nephew, Inc.

People needed

126

Starts

2018-08-26

Expected to finish

2028-04-01

Last updated by the study team

2026-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject received primary TKA with the Legion™ CR Femoral Implant (either Oxinium or CoCr) with Legion™/Genesis™ II XLPE Hi-flex Tibial Insert, due to degenerative joint disease (primary diagnosis of osteoarthritis, post-traumatic arthritis, degenerative arthritis, or rheumatoid arthritis).
• Subject received primary TKA between 24 and 66 months prior to the time of consent.
• Subject agrees to consent 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 must be available through ten (10) years postoperative follow-up.

You may not qualify if…

• Subject had Body Mass Index (BMI) > 40 at time of surgery.
• Subject received the Legion™ CR Femoral Implant with Legion™/Genesis™ II XLPE Hi-flex Tibial Insert as a revision surgery.
• Subject has a condition that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).
• Subject has a known allergy to one or more of its components of the study device.
• Subject, in the opinion of the Principal Investigator (PI), has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.
• Subject is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days.
• Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits.

Where it is running

• Allina Health Systems — Edina, Minnesota, United States
• ROC Foundation — Reno, Nevada, United States
• Hawkins Foundation — Greenville, South Carolina, United States
• Appalachian Orthopedic Associates — Johnson City, Tennessee, United States

Full record on ClinicalTrials.gov

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