Multicenter Post Approval Study of the Trilogy AB(R) Acetabular System
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Harris Hip Score
研究概览
简要总结
This is a post-approval study with prospective enrollment in the United States and a retrospective enrollment outside the United States to obtain functional, quality of life and radiographic data, which will facilitate assessment of the clinical performance of the Zimmer Trilogy AB Acetabular Hip System.
详细描述
To obtain functional, quality of life and radiographic data to evaluate the clinical performance of the Zimmer Trilogy AB Acetabular Hip System in primary total hip replacement surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-obese patients
- •The patient is a good candidate for a primary hip arthroplasty using the Zimmer Trilogy AB Acetabular Hip System.
- •Patient is willing and able to give informed consent to participate in the follow-up program.
- •Patient is suitable for surgery and able to participate in the follow-up program.
排除标准
- •Skeletally immature
- •Rheumatoid arthritis
- •Osteoradionecrosis
- •Infection
- •Nerve or muscle disease that may have a negative affect on gait or weight bearing
- •Loss of abductor musculature in the affected limb
- •Poor bone stock
- •Poor skin coverage around the hip joint
- •Rapid disease progression as obvious by joint destruction or bone absorption seen on x-ray
- •Previous total or cemented hemi-arthroplasty of the affected hip
- •Previous pinning or plating of the affected hip
- •Patients with heavy labor jobs or extreme activity levels
- •Patients who participate in sports activities or require deep flexion
- •Patients who are obese
- •Patients who have other disabilities
- •Patients who are unwilling or unable to give consent, or to comply with the protocol and follow-up program.
结局指标
主要结局
Harris Hip Score
时间窗: Pre-op, 3 Month Post-Op and Annual Post-Op visits through 5 Years
The Harris Hip Score was developed to assess hip disabilities and methods of treatment and has been in use for decades. It evaluates patients on the basis of pain, function, absence of deformity and range of motion. The Harris Hip Score could range from 0 to 100. Scores less then 70 are poor, scores 70 to 79 are fair, scores 80 to 89 are good, and scores 90 to 100 are excellent.
次要结局
- Continued Assessment of Implant Survivorship and Incidences of Adverse Events.(At all follow-up visits through 5 Years and postcard follow-up 6 - 10 Years)