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

Exclusion Criteria

• •Any active or suspected latent infection in or about the knee joint; overt infection;
• •Distant foci of infection which may cause hematogenous spread to the implant site; rapid disease progression as manifested by joint destruction or bone resorption apparent on roentgenogram;
• •skeletally immature patients;
• •Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
• •Bone stock compromised by disease, infection or prior implantation which cannot provide 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 following instructions;
• •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, cerebral palsy and patients with Parkinson's disease.
• •Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
• •The subject is a prisoner