A Prospective Munti-center Study on VANGUARD™ PS Total Knee Replacement System

Study Overview
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Brief Summary
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The primary objectives of this pilot clinical study include: Evaluate clinical outcomes and quality of life on patients who received Vanguard PS Total Knee in Korean population Evaluate safety of Vanguard PS Total Knee in Korean population

Detailed Description
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This study is a prospective, single cohort, multi-center study of Vanguard PS system and will be conducted in Korea with 2 institutions. The study will be conducted over a period of 10 years. Patients will be followed at immediate post-op, 6 weeks, 6 months and 1 year, 3 years. Total of 2 sites will be involved in this study. 50 cases on each sites and total of 100 subjects will be enrolled in the study. Primary end-point will be KSS at 1 year post op and secondary end-points are Survivorship of the product, KSS, EQ5D, High-Flexion Knee Score, Radiographic Assessment, and any kind of complication including lost to follow up.

Official Title
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A Prospective Munti-center Study on VANGUARD™ PS Total Knee Replacement System

Conditions
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Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Posttraumatic Deformity

Participation Criteria
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Eligibility Criteria
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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, arthrodesis, or failure of previous joint replacement procedure 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, and The patient must have reached full skeletal maturity (at least 18 years old). Exclusion Criteria: infection sepsis osteomyelitis 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

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Knee Society Score | Primary Endpoint: Knee Society Score (KSS) at 1 Year Postop | 1 year Post Op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship | To access the number of patients with implants | 3 years post op | 
| EQ-5D | Quality of life on patients | 3 year post op | 
| Radiographic Assessment | Access on subsidence, migration, and radiolucency | 3 year Post Op | 
| Complications | Any AEs to patients | 3 year Post Op |