Comparative Clinical Study of the Vanguard® Knee System Using Signature™ Custom Guides & Conventional Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Patient dissatisfaction following primary total knee replacement.
研究概览
简要总结
The purpose of this study is to determine the surgical and clinical outcomes of patients receiving total knee replacement with the same implant using two different types of cutting guides during surgery:
- Standard knee cutting guides;
- MRI generated patient specific custom cutting guides.
Both types of cutting guides used in this study are registered with the U.S. Food and Drug Administration (FDA) and are routinely used for knee replacement surgery. However, it is unknown if one type of cutting guide has risks or benefits over the other.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 75
- •Diagnosis of osteoarthritis of the knee and qualify for surgery, as indicated by one of the following:
- •Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved;
- •Correction of varus or valgus.
- •Willing to participate and return for follow-up study visits.
排除标准
- •Infection
- •Osteomyelitis
- •Uncooperative patient or patient with neurologic disorders who is 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
- •Previous osteotomy
- •Diagnosis of rheumatoid arthritis
- •Previous patella fracture or surgery
- •Previous healed tibia or femur fractures
- •Previous joint replacement surgery
- •Cannot have an MRI
- •Patients receiving single-stage bilateral total knee arthroplasty (TKA)
研究组 & 干预措施
Standard knee cutting guides
Standard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod.
干预措施: Instrument (Other)
MRI generated patient specific custom cutting guides
Patient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone.
干预措施: Instrument (Other)
结局指标
主要结局
Patient dissatisfaction following primary total knee replacement.
时间窗: Preoperatively, intraoperatively, and at four to six weeks, three months, six months, and one year postoperatively.
次要结局
- Postoperative recovery time following primary total knee replacement.(Immediate postoperative period (prior to discharge) and at four to six weeks, three months, six months, and one year postoperatively.)