VGRDE1: Prospective Multi-Center Study on Vanguard With E1 Bearing
Study Details
Study Description
Brief Summary
Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Vanguard with E1 PS Bearing 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
Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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
- Knee Society Score [5 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
- KOOS [1 Year]
Knee injuries & Osteoarthritis Outcome Score
- KOOS [3 Years]
Knee injuries & Osteoarthritis Outcome Score
- KOOS [5 Years]
Knee injuries & Osteoarthritis Outcome Score
- EQ5D [6 Months]
standardised instrument for use as a measure of health outcome.
- EQ5D [1 Year]
standardised instrument for use as a measure of health outcome.
- EQ5D [3 Years]
standardised instrument for use as a measure of health outcome.
- EQ5D [5 Years]
standardised instrument for use as a measure of health outcome.
- 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.
- Modified University of California Los Angeles (UCLA) Activity Score [1 Year]
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.
- Modified University of California Los Angeles (UCLA) Activity Score [3 Years]
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.
- Modified University of California Los Angeles (UCLA) Activity Score [5 Years]
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
- Radiographic Assessment [6 Months]
Radiographic Evaluation
- Radiographic Assessment [1 Year]
Radiographic Evaluation
- Radiographic Assessment [3 Years]
Radiographic Evaluation
- Radiographic Assessment [5 Years]
Radiographic Evaluation
Eligibility Criteria
Criteria
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
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Painful and disabled knee joint resulting from osteoarthritis or traumatic arthritis where one or more compartments are involved
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Correction of varus, valgus, or posttraumatic deformity
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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:
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Uncooperative patient or patient with neurologic disorders who are incapable of following directions,
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Osteoporosis
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Metabolic disorders which may impair bone formation
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Osteomalacia
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Distant foci of infections which may spread to the implant site
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Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
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Vascular insufficiency, muscular atrophy, neuromuscular disease
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Incomplete or deficient soft tissue surrounding the knee
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kangwon Nat'l Univ. Hospital | Chuncheon | Korea, Republic of | ||
| 2 | Chungnam Nat'l Univ. Hospital | Daejeon | Korea, Republic of | ||
| 3 | Gacheon Gil Univ. Gil Medical Center | Incheon | Korea, Republic of | ||
| 4 | Chonbuk Nat'l Univ. Hospital | Jeonju | Korea, Republic of |
Sponsors and Collaborators
- Zimmer Biomet
Investigators
- Principal Investigator: Young Mo Kim, Ph.D, Chungnam Nat'l Univ. Hospital
- Principal Investigator: Kye Young Han, Ph.D, Kangwon Nat'l Univ. Hospital
- Principal Investigator: Jae Ang Shim, Ph.D, Gacheon Uni. Gil Medical Center
- Principal Investigator: Joo Hong Lee, Ph. D, Chonbuk Nat'l Univ. Hospital
Study Documents (Full-Text)
More Information
Publications
None provided.- INT.CR.GK4