A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 255
- 试验地点
- 12
- 主要终点
- AMERICAN KNEE SOCIETY KNEE SCORE
研究概览
简要总结
The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship.
详细描述
This investigation is being conducted on a new complete revision knee system, Vanguard 360, which incorporates:
- Fixed Bearing Knee - Vanguard SSK360 with PS Bearing and PSC Bearing
- Fixed Bearing Knee - Vanguard SSK360 TiNbN Femur with PS Bearing and PSC Bearing
- Mobile Bearing Knee - Vanguard DA360 (only being collected in Europe)
The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship.
The efficacy and performance of the devices will be assessed by improvement of pain, function, range of motion and patient satisfaction measured pre-operatively and post-operatively. Secondary performance and safety will be determined by radiographic investigation, incidence of complications and revision rates.
Surgical techniques and patient care are to be standard for the surgeon participating in the protocol. There will be no experimental or investigational devices used. There will be no experimental or investigational surgical techniques used. The devices and products will be used in accordance with their instructions for use and/or approved labeling.
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
- •Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
- •Correction of varus, valgus or post-traumatic deformity
- •Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure
- •Ability and willingness of the patient to attend follow-up visit.
- •Willing to give written informed consent
- •Patients are at least 18 years of age, no upper age limit, must have reached full skeletal maturity.
排除标准
- •infection
- •osteomyelitis
- •Relative Contraindications:
- •An uncooperative patient or a patient with neurologic disorders who is incapable of following directions
- •Osteoporosis
- •Metabolic disorders which may impair brain function
- •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
- •Additional research-related exclusion criteria: patients who have a history of or current infection in the affected knee.
结局指标
主要结局
AMERICAN KNEE SOCIETY KNEE SCORE
时间窗: 24 months postoperative
Improvement of American Knee Society Knee Score between pre-operative and 2 years post-operative follow up
次要结局
- Survivorship(10 years postoperative)