Vanguard Knee Anterior Stabilized Versus Posterior Stabilized Bearing Study

NCT ID: NCT01308515

Last Updated: 2017-06-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2010-09-30

Brief Summary

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.

Conditions

Osteoarthritis; Degenerative Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Posterior Stabilized

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

Group Type: OTHER

Vanguard Knee System with PS Bearing

Intervention Type: DEVICE

FDA cleared Tibial bearing that stabilizes the knee with a post that articulates with the FDA cleared Vanguard PS(Posterior Stabilizing) Femoral Component.

Anterior Stablized

Patients who received an AS (Anterior Stabilized) Tibial Bearing

Group Type: OTHER

Vanguard Knee System with AS Bearing

Intervention Type: DEVICE

FDA cleared Tibial bearing that stabilizes the knee with an anterior lip, and is used with FDA cleared Vanguard CR (Cruciate Retaining) Femoral Component.

Interventions

Vanguard Knee System with AS Bearing

FDA cleared Tibial bearing that stabilizes the knee with an anterior lip, and is used with FDA cleared Vanguard CR (Cruciate Retaining) Femoral Component.

Intervention Type: DEVICE

Vanguard Knee System with PS Bearing

FDA cleared Tibial bearing that stabilizes the knee with a post that articulates with the FDA cleared Vanguard PS(Posterior Stabilizing) Femoral Component.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ken Beres, MD

Role: STUDY_DIRECTOR

Biomet (no investigators were selected for this study)

Other Identifiers

090809

Identifier Type: -

Identifier Source: org_study_id