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



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:3/28/2019
Start Date:September 30, 2018
End Date:January 1, 2030
Contact:Mia Ashe-Randolph
Email:Mia.Asherandolph@smith-nephew.com
Phone:817-916-1449

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

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.


Inclusion Criteria:

1. 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).

2. Subject received primary TKA between 24 and 66 months prior to the time of consent.

3. 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.

4. Subject must be available through ten (10) years postoperative follow-up.

Exclusion Criteria:

1. Subject had Body Mass Index (BMI) > 40 at time of surgery.

2. Subject received the Legion™ CR Femoral Implant with Legion™/Genesis™ II XLPE Hi-flex
Tibial Insert as a revision surgery.

3. 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).

4. Subject has a known allergy to one or more of its components of the study device.

5. 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.

6. Subject is entered in another drug, biologic, or device study or has been treated with
an investigational product in the past 30 days.

7. Subject is known to be at risk for loss to follow-up, or failure to return for
scheduled visits.
We found this trial at
3
sites
Greenville, South Carolina 29615
Principal Investigator: Brayton Shirley, MD
Phone: 864-454-7458
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Greenville, SC
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Edina, Minnesota 55439
Principal Investigator: Robert W. Tuttle, MD
Phone: 952-914-8594
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Edina, MN
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Reno, Nevada 89503
Principal Investigator: Eric Boyden, MD
Phone: 775-333-7862
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Reno, NV
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