Vanguard Knee Anterior Stabilized Versus Posterior Stabilized Bearing Study

Study Overview
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Brief Summary
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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.

Official Title
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A Comparative Clinical Evaluation of the Vanguard Knee System's Anterior Stabilized & Posterior Stabilized Tibial Bearings

Conditions
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Osteoarthritis, Degenerative Arthritis

Intervention / Treatment
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* Device: Vanguard Knee System with AS Bearing
* Device: Vanguard Knee System with PS Bearing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Posterior Stabilized<br>Patients who received a PS (Posterior Stabilized) Tibial Bearing. | Device: Vanguard Knee System with PS Bearing<br>* FDA cleared Tibial bearing that stabilizes the knee with a post that articulates with the FDA cleared Vanguard PS(Posterior Stabilizing) Femoral Component.<br>|
| Other: Anterior Stablized<br>Patients who received an AS (Anterior Stabilized) Tibial Bearing | Device: Vanguard Knee System with AS Bearing<br>* FDA cleared Tibial bearing that stabilizes the knee with an anterior lip, and is used with FDA cleared Vanguard CR (Cruciate Retaining) Femoral Component.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Knee Score | Average objective knee score; includes a combination of range of motion and pain scores. | 1 Year Post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score | Average total knee score. Includes the objective and functional aspects of the knee score. | 3 Years | 
| Dislocation | Rate of Dislocation as reported by patients in a complication. | 3 Years | 
| Survivorship | Reports surivival of implant. | 3 Years | 
| Reports of Radiographic Loosening via Complication Form | A more specific survivorship element; will indicate rate of loosening if it occurs. | 3 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee, osteoarthritis, joint, replacement, knee surgery