Prospective Multi-Center Study on Vanguard With E1 Bearing
Prospective Multi-Center Study on Vanguard With E1 Bearing
Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population
E1™ Vitamin E doping of highly cross-linked polyethylene is a proposed method for insuring
 long-term oxidative stability of highly cross-linked ultra-high molecular weight polyethylene
 for use in total joint arthroplasty. In vitro research and development studies have shown
 that this material has improved wear performance, retention of mechanical properties, and a
 high resistance to oxidation due to the anti-oxidative properties of Vitamin E. Biomet Inc,
 has received FDA clearance to market tibial polyethylene components made of E1™ for use in
 the Vanguard total knee replacement system.

 Vanguard Total Knee System™ The Vanguard™ Knee System was designed to incorporate features
 from prior designs, including: ACG, Maxim, & Ascent. The Vanguard Knee includes a streamlined
 design, rounded sagittal profile, and a deeper trochlear groove. The femoral component is
 available in Cruciate Retaining (CR), Posterior Stabilizing (PS), and Super Stabilized (SSK).
 Tibial Bearings are available in various levels of constraint required by the surgeon (CR,
 PS, AS, etc.).

 For this study, ONLY Vanguard with PS Bearing will be used.

 The purpose of the study is to evaluate clinical performance of Vanguard Knee with E1 Bearing
 in TKA in Korean patient population. The clinical performance will be evaluated based on
 patient outcomes, radiographic assessment and survivorship.
Inclusion Criteria:

 Patients will be included in this study if they received Vanguard knee with E1 Bearing per
 the approved indications for use for Vanguard Knee. Specifically

 -  Painful and disabled knee joint resulting from osteoarthritis or traumatic arthritis
 where one or more compartments are involved

 -  Correction of varus, valgus, or posttraumatic deformity

 -  Correction or revision of unsuccessful osteotomy

 Exclusion Criteria:

 Exclusion Criteria for this study should comply with the stated contraindications on
 package inserts of Vanguard™ Knee and the E1™ Tibial Bearing. These indications are stated
 below:

 Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a
 previous joint replacement

 Relative contraindications include:

 -  Uncooperative patient or patient with neurologic disorders who are incapable of
 following 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 on roentgenogram

 -  Vascular insufficiency, muscular atrophy, neuromuscular disease

 -  Incomplete or deficient soft tissue surrounding the knee