Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty

Inclusion criteria

• Subject received primary TKA with the LEGION Porous HA Tibial Baseplates (either with holes or without holes) and/or the LEGION Porous HA CR Femoral Component, due to degenerative joint disease (primary diagnosis of osteoarthritis, post-traumatic arthritis, or degenerative arthritis).
• Subject received primary TKA between 24 and 60 months prior to the time of consent.

Inclusion criteria

for prospective follow-up (subjects must meet criteria 1 & 2 from above and criteria 3,4 and 5 below):

• Subject agrees to consent and to follow the prospective study visit schedule (as defined in the study protocol and informed consent form) by signing the IRB/IEC approved informed consent form.
• Subject must be available through ten (10) years postoperative follow-up.
• Subject is able to read, understand, and communicate responses to Patient Reported Outcome assessments in English.

Exclusion criteria

Exclusion criteria

for retrospective chart review - Any one (1) of the following criteria will disqualify a potential subject from participation in the retrospective chart review:

• Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty
• Subject has ipsilateral hip arthritis resulting in flexion contracture.
• At the time of enrollment, subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator: Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty; Contralateral primary total knee or unicondylar knee arthroplasty.
• Subject has a condition that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, lupus, 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 is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days.

Exclusion criteria

for prospective follow-up - Any one (1) of the criteria from 1-6 above will disqualify a potential subject from participation in the prospective follow-up) as will any one (1) of the below criteria 7, 8 and 9:

• 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 known to be at risk for loss to follow-up, or failure to return for scheduled visits.
• Subject is found to have had a revision of the study device(s).