Clinical trial NCT03687593: Safety and Performance Using Legion™ CR Oxinium and CoCr Femoral Implants Combined With Legion™/Genesis™ II XLPE High Flex Tibial Inserts
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Total Knee Arthroplasty
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-27
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators will screen all subjects who underwent TKA with the LEGION™ CR Oxinium and CoCR Femoral Implants

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Implant survival 10 years postoperatively
timeFrame: 10 years post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Edina
country: United States
facility: Allina Health Systems
state: Minnesota
city: Reno
country: United States
facility: ROC Foundation
state: Nevada
city: Greenville
country: United States
facility: Hawkins Foundation
state: South Carolina
city: Johnson City
country: United States
facility: Appalachian Orthopedic Associates
state: Tennessee
Study officials:
affiliation: Smith & Nephew, Inc.
name: Karlie Morgan
role: STUDY_DIRECTOR
References: