Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System

Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System

Randomized Controlled Study to determine if preservation of ligaments provides increased functional ability post-operatively in comparison to traditional TKA which sacrifices soft tissue.

Randomized Controlled Study to compare clinical and patient reported outcomes of the Vanguard XP Bicruciate Total Knee System to the Vanguard CR Knee System through 10 years of follow-up.

Inclusion Criteria:

• cemented application of components
• bilateral subjects randomized by knee
• patients with pre-existing contralateral knee surgery
• painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved
• correction of varus, valgus, or posttraumatic deformity
• sufficient soft tissue surrounding the knee, including the Anterior Cruciate Ligament

Exclusion Criteria:

• cementless application of components
• BMI greater than or equal to 40
• use of Anterior Stabilized Bearings
• patients with severe pre-operative varus or valgus deformity greater than or equal to 15 degrees
• correction or revision of previous joint replacement procedure on index knee
• infection
• sepsis
• osteomyelitis

Relative exclusion criteria:

• uncooperative patient or patient with neurological disorders who is 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, including the anterior cruciate ligament