Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur

Korábbi kezelés

• Has or had inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable

Más betegség

• Has or had an overt infection at the time of implantation
• Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
• Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
• Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
• Has a medical condition, as judged by the Investigator, that would interfere with the subject's ability to comply with the requirements of the protocol

Életkor

• Skeletally immature (less than 21 years of age) at time of implantation

Egyéb

• Has had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques
• Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
• Unwilling or unable to sign the Informed Consent document
• Has documented substance abuse issues
• Currently incarcerated or has impending incarceration

• Has previously undergone or currently has determined to undergo a primary TKA with the specified combination of components: EVOLUTION® CS/CR Porous Femur, EVOLUTION® CS Tibial Insert, and EVOLUTION® BIOFOAM® Tibia and modular keel
• Has previously undergone or currently has determined to undergo a primary TKA for any of the following:
  • non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
  • inflammatory degenerative joint disease including rheumatoid arthritis;
  • correction of functional deformity;
  • willing and able to complete required study visits and assessments through the 10 year postoperative follow-up visit.
• Previously implanted subjects must be enrolled within 3 years (+6 months) of their primary TKA implantation