Osteoarthritis, Knee, Posttraumatic Deformity, Unspecified Disorder of Knee Joint, Valgus Deformity, Varus Deformity
Conditions
Brief summary
Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population
Detailed description
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.
Interventions
DEVICEVanguard with E1 PS Bearing
Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population
Sponsors
Zimmer Biomet
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score | 1 year | scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score | 3 Years | scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA |
| KOOS | 6 Months | Knee injuries & Osteoarthritis Outcome Score |
| Knee Sociey Score | 6 Months | scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA |
| Modified University of California Los Angeles (UCLA) Activity Score | 6 Months | 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. |
| Radiographic Assessment | Immediate Post-op(2 - 4 Weeks) | Radiographic Evaluation |
| EQ5D | 6 Months | standardised instrument for use as a measure of health outcome. |
Countries
South Korea
Outcome results
None listed