Evaluation of Outcomes of the Triathlon Hinge Knee (THK) System

Inclusion Criteria:

• The subject undergoes a primary or revision procedure implanting at least theRevision Baseplate portion of the Triathlon Hinge Knee System in accordance with theIndications for Use.

• The subject has signed an IRB/EC-approved, study-specific Informed Consent Form (ICF).

• The subject is a male or non-pregnant female at the time of enrollment.

• The subject agrees to comply with the protocol-mandated clinical evaluations.

Exclusion Criteria:

• Any active or suspected latent infection in or about the knee joint; overtinfection;

• Distant foci of infection which may cause hematogenous spread to the implant site;rapid disease progression as manifested by joint destruction or bone resorptionapparent on roentgenogram;

• skeletally immature patients;

• Severe instability of the knee joint secondary to the absence of collateral ligamentintegrity and function.

• Bone stock compromised by disease, infection or prior implantation which cannotprovide adequate support and/or fixation to the prosthesis.

• Known or suspected sensitivity and/or allergy to any material in the device.

• Conditions presenting an increased risk of failure include:

• uncooperative patient or patient with neurologic disorder, incapable of followinginstructions;

• osteoporosis;

• metabolic disorders which may impair bone formation or cause bone loss;

• osteomalacia; and,

• previous arthrodesis.

• A higher incidence of implant failure has also occurred in paraplegics, cerebralpalsy and patients with Parkinson's disease.

• Any mental or neuromuscular disorder which would create an unacceptable risk ofprosthesis instability, prosthesis fixation failure, or complications inpostoperative care.

• The subject is a prisoner