Prospective, Multicentre Evaluation of the Vanguard Rocc Rotating Platform Knee Prosthesis - Clinical and Radiographic Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 450
- 试验地点
- 9
- 主要终点
- Functional outcomes assessment
研究概览
简要总结
The objective of this project is to obtain prospective, multi-center, long term (10 year) clinical data on the Vanguard Rocc knee prosthesis. Patient and knee function will be collected along with knee stability, the knee motion, functional recuperation, radiographic and survivorship data.
详细描述
The Vanguard rotating platform knee prosthesis (Vanguard ROCC) was launched in March 2009. Therefore there is a need to show the safety and performance of the Vanguard ROCC at long term.
A maximum of 10 sites will be involved in this study. This number of clinical centers will permit assessment of consistency among a multitude of investigators.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria should be in accordance with Indications for Use for Vanguard-ROCC® Knee
- •System specifically:
- •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, or arthrodesis.
- •Additional inclusion criteria include:
- •Male or female.
- •18 years of age or older
- •Subjects willing to return for follow-up evaluations
排除标准
- •Exclusion criteria should be in accordance with Absolute and Relative Contraindications for Use for Vanguard-ROCC Knee system: 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.
结局指标
主要结局
Functional outcomes assessment
时间窗: 10 years
The American Knee Society Clinical Rating System (original method) : Evaluation of the knee joint and functional assessment of patients. Subscale knee assessment: judgement of pain (50 points), stability (25 points)and range of motion (25 points (5 degrees is 1 point). Flexion contracture, extension lag and malalignment should be dealt with as deductions. Maximum Knee score of 100 points. Subscale functional assessment: assessment of patient function for walking distance (50 points)and stair climbing (50points), with deductions for walking aids. Maximum Function score is 100 points.
次要结局
- Radiographic outcomes assessment(10 years)
- Assesment of health-related quality of life using the EQ-5D score(10 years)
- Safety and performance of the device by recording all adverse events(10 years)
- Calculation of survivorship using revision of prosthesis as the failure event(10 years)