A Prospective Controlled Multi-center Study on Vanguard Complete Knee and Vanguard High Flex RP Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- American Knee Society Knee Score
研究概览
简要总结
The purpose of this study is to compare Vanguard High Flex Rotating Platform to Vanguard Complete Knee System in Asian population in terms of early range of motion (ROM), clinical outcomes, and kinetic and kinematic characteristics in relation to healthy knees.
详细描述
The primary objectives of this clinical study include:
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Evaluate size fit and long term performance of Vanguard Complete Knee ("Fixed") System in Asian and Latino population in comparison to competitor's similar product.
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Evaluate efficacy of Vanguard Complete Knee with Microplasty Tibial Tray.
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Compare Vanguard High Flex Rotating Platform ("High Flex") Knee System to Vanguard Complete Knee System in Asian population in terms of:
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Early ROM
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Clinical outcomes
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Kinetic and Kinematic characteristics in relation to Healthy Knees. o
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Compare current design to new design of Vanguard High Flex Rotating Platform Knee System in terms of :
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Early ROM
-
Clinical outcomes
-
Kinetic and Kinematic characteristics
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Painful and disabled knee joint resulting form 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.
- •Need to obtain pain relief and improve function.
- •Ability and willingness of the patient to follow instructions, including control of weight and activity level.
- •Good nutritional state of the patient.
- •Patient must have reached full skeletal maturity.
排除标准
- •Infection, sepsis, osteomyelitis, and failure of previous joint replacement.
- •Uncooperative patient or patients 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
研究组 & 干预措施
Vanguard Complete Knee
Vanguard Completed Knee with Microplasty Tibial Tray is designed to hold the tibial knee bearings in a microplsty knee procedure. The Co-Cro-Mo trays are designed with a shorter stem.
干预措施: Vanguard Complete Knee (Device)
Vanguard High Flex RP
VGRD High Flex RP knee is an extension to the exsting Vanguard Knee and has been specifically desinged to facilitate greather than 135 degrees of knee flextion as required by certain patients.
干预措施: Vanguard High Flex RP (Device)
结局指标
主要结局
American Knee Society Knee Score
时间窗: 1 Year postop
Including ROM
次要结局
- Gait Lab Analysis(3 yr)
- Kinematic Fluoroscopic Analysis(3 yr)
- EQ5D(3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr)
- Radiographic Assessment(immediate postop, 3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr)