Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System



Status:Active, not recruiting
Conditions:Arthritis, Osteoarthritis (OA), Rheumatoid Arthritis, Women's Studies
Therapuetic Areas:Rheumatology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:6/23/2018
Start Date:October 2014
End Date:October 2026

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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
We found this trial at
6
sites
Rochester Hills, Michigan 48307
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Rochester Hills, MI
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Chicago, IL
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1100 Virginia Avenue
Columbia, Missouri 65212
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Columbia, MO
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New Albany, Ohio 43054
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New Albany, OH
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Plano, TX
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Salt Lake City, Utah 84108
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Salt Lake City, UT
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