Vanguard Knee Anterior Stabilized Versus Posterior Stabilized Bearing Study (VGASPS)

Zimmer Biomet

Status: Withdrawn

Conditions: Osteoarthritis; Degenerative Arthritis

Treatments: Device: Vanguard Knee System with PS Bearing; Device: Vanguard Knee System with AS Bearing

Study type: Interventional

Funder types: Industry

Identifiers

NCT01308515

090809

Details and patient eligibility

About

The purpose of this study is to compare the performance of two FDA-cleared tibial bearings (replacement for cartilage in the knee) by collecting data on patients through 3 years of follow-up.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria are identical to the indications stated in the FDA approved labeling for the device 510(k) K023546, K033489, and K050222. These indications are stated below:

• 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
• A good nutritional state of the patient
• The patient must have reached full skeletal maturity

Exclusion criteria will be identical to the contraindications stated in the FDA approved labeling for the device 510(k) K023546, K033489, and K050222.

These contraindications 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Posterior Stabilized

Other group

Description:

Patients who received a PS (Posterior Stabilized) Tibial Bearing.

Treatment:

Device: Vanguard Knee System with PS Bearing

Anterior Stablized

Other group

Description:

Patients who received an AS (Anterior Stabilized) Tibial Bearing

Treatment:

Device: Vanguard Knee System with AS Bearing