A Clinical Investigation of the Vanguard™ Complete Knee System

Inclusion criteria:

• Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis,traumatic arthritis where one or more compartments are involved.

• Correction of varus, valgus, or posttraumatic deformity

• Correction or revision of unsuccessful osteotomy, or arthrodesis

Patient selection factors to be considered include:

• Need to obtain pain relief and improve function

• Ability and willingness of the patient to follow instructions

• Including control of weight and activity level

• Good nutritional state of the patient

• Patient must have reached full skeletal maturity

Exclusion criteria:

Absolute contraindications include:

• Infection

• Sepsis

• Osteomyelitis

• Failure of a previous joint replacement

Relative contraindications include:

• Uncooperative patient or patient with neurologic disorders who are incapable offollowing directions

• Osteoporosis

• Metabolic disorders which may impair bone formation

• Osteomalacia

• Distant foci of infections which may spread to the implant site

• Rapid joint destruction, marked bone loss or bone resorption apparent onroentgenogram

• Vascular insufficiency, Muscular atrophy, Neuromuscular disease

• Incomplete or deficient soft tissue surrounding the knee

Additional exclusion criteria includes: failure of a previous joint replacement