Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System (GK9B)

Zimmer Biomet

Status: Terminated

Conditions: Post-traumatic Deformity; Lower Limb Deformity; Traumatic Arthritis; Osteoarthritis; Complications, Arthroplasty; Rheumatoid Arthritis

Treatments: Device: Vanguard CR Knee System; Device: Vanguard XP Bicruciate Knee System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02175576

ORTHO.CR.GK9B

Details and patient eligibility

About

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

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Vanguard XP Bicruciate Knee System

Experimental group

Description:

153 patients receive Vanguard XP Bicruciate Knee System

Treatment:

Device: Vanguard XP Bicruciate Knee System

Vanguard CR Knee System

Active Comparator group

Description:

153 patients receive Vanguard CR Knee System

Treatment:

Device: Vanguard CR Knee System