Prospective Multi-Center Study on Vanguard With E1 Bearing

Study Overview
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Brief Summary
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Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population

Detailed Description
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E1™ Vitamin E doping of highly cross-linked polyethylene is a proposed method for insuring long-term oxidative stability of highly cross-linked ultra-high molecular weight polyethylene for use in total joint arthroplasty. In vitro research and development studies have shown that this material has improved wear performance, retention of mechanical properties, and a high resistance to oxidation due to the anti-oxidative properties of Vitamin E. Biomet Inc, has received FDA clearance to market tibial polyethylene components made of E1™ for use in the Vanguard total knee replacement system. Vanguard Total Knee System™ The Vanguard™ Knee System was designed to incorporate features from prior designs, including: ACG, Maxim, & Ascent. The Vanguard Knee includes a streamlined design, rounded sagittal profile, and a deeper trochlear groove. The femoral component is available in Cruciate Retaining (CR), Posterior Stabilizing (PS), and Super Stabilized (SSK). Tibial Bearings are available in various levels of constraint required by the surgeon (CR, PS, AS, etc.). For this study, ONLY Vanguard with PS Bearing will be used. The purpose of the study is to evaluate clinical performance of Vanguard Knee with E1 Bearing in TKA in Korean patient population. The clinical performance will be evaluated based on patient outcomes, radiographic assessment and survivorship.

Official Title
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Evaluate Clinical Performance of Vanguard Knee With E1 Bearing in Korean Patient Population

Conditions
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Varus Deformity, Valgus Deformity, Posttraumatic Deformity, Osteoarthritis, Knee, Unspecified Disorder of Knee Joint

Intervention / Treatment
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* Device: Vanguard with E1 PS Bearing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be included in this study if they received Vanguard knee with E1 Bearing per the approved indications for use for Vanguard Knee. Specifically Painful and disabled knee joint resulting from osteoarthritis or traumatic arthritis where one or more compartments are involved Correction of varus, valgus, or posttraumatic deformity Correction or revision of unsuccessful osteotomy Exclusion Criteria: Exclusion Criteria for this study should comply with the stated contraindications on package inserts of Vanguard™ Knee and the E1™ Tibial Bearing. These indications 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: 20 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vanguard with E1 PS Bearing<br>E1™ Vitamin E doping of highly cross-linked polyethylene is a proposed method for insuring long-term oxidative stability of highly cross-linked ultra-high molecular weight polyethylene for use in total joint arthroplasty. Vanguard Total Knee System™ The Vanguard™ Knee System was designed to incorporate features from prior designs, including: ACG, Maxim, & Ascent. | Device: Vanguard with E1 PS Bearing<br>* Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score | scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Sociey Score | scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA | 6 Months | 
| Knee Society Score | scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA | 3 Years | 
| Knee Society Score | scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA | 5 Years | 
| KOOS | Knee injuries & Osteoarthritis Outcome Score | 6 Months | 
| KOOS | Knee injuries & Osteoarthritis Outcome Score | 1 Year | 
| KOOS | Knee injuries & Osteoarthritis Outcome Score | 3 Years | 
| KOOS | Knee injuries & Osteoarthritis Outcome Score | 5 Years | 
| EQ5D | standardised instrument for use as a measure of health outcome. | 6 Months | 
| EQ5D | standardised instrument for use as a measure of health outcome. | 1 Year | 
| EQ5D | standardised instrument for use as a measure of health outcome. | 3 Years | 
| EQ5D | standardised instrument for use as a measure of health outcome. | 5 Years | 
| Modified University of California Los Angeles (UCLA) Activity Score | It asks patients to rate their activity level from 1 to 10, with 1 defined as no physical activity and 10 defined as regular participation in impact sports. The UCLA scale has demonstrated construct validity, excellent reliability, and the best completion rates. | 6 Months | 
| Modified University of California Los Angeles (UCLA) Activity Score | It asks patients to rate their activity level from 1 to 10, with 1 defined as no physical activity and 10 defined as regular participation in impact sports. The UCLA scale has demonstrated construct validity, excellent reliability, and the best completion rates. | 1 Year | 
| Modified University of California Los Angeles (UCLA) Activity Score | It asks patients to rate their activity level from 1 to 10, with 1 defined as no physical activity and 10 defined as regular participation in impact sports. The UCLA scale has demonstrated construct validity, excellent reliability, and the best completion rates. | 3 Years | 
| Modified University of California Los Angeles (UCLA) Activity Score | It asks patients to rate their activity level from 1 to 10, with 1 defined as no physical activity and 10 defined as regular participation in impact sports. The UCLA scale has demonstrated construct validity, excellent reliability, and the best completion rates. | 5 Years | 
| Radiographic Assessment | Radiographic Evaluation | Immediate Post-op(2 - 4 Weeks) | 
| Radiographic Assessment | Radiographic Evaluation | 6 Months | 
| Radiographic Assessment | Radiographic Evaluation | 1 Year | 
| Radiographic Assessment | Radiographic Evaluation | 3 Years | 
| Radiographic Assessment | Radiographic Evaluation | 5 Years |