Outcomes of Robotic Total Hip Arthroplasty: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
The objectives of this study are to evaluate the clinical value of robotic-assisted total hip arthroplasty with respect to acetabular cup implantation, and to document the long-term clinical outcome of patients with Total Hip Arthroplasty (THA). IRB approval will be obtained at every study site to evaluate the basic clinical outcomes and post-operative component placement accuracy of each MAKO® THA patient.
The hypothesis is that robotic preparation of the acetabulum will significantly reduce the variability and inaccuracy in the component alignment parameters that lead to post-operative complications, including implant failure.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •20 to 75 years of age
- •Subjects requiring primary total hip replacement
- •Contralateral hip should be relatively free from arthritis for comparison purposes, specifically with less than a grade of 2 on the Kellgren-Lawrence Scale.
- •Subjects diagnosed with osteoarthritis or traumatic arthritis
- •Subjects with avascular necrosis
- •Subjects who demonstrate the ability to return for follow-up for the next 10 years
排除标准
- •Subjects with difficulty understanding protocol for any reason
- •Subjects with a limited life span
- •Subjects with inflammatory hip disease, previous joint infection, or those requiring hip revision surgery
- •Female subjects who are pregnant, or who plan to get pregnant while enrolled in the study
结局指标
主要结局
Adverse Events
时间窗: 10 Years
Protocol deviations, complications, "lost to follow-up"
Survivorship of Components
时间窗: 10 Years
Defined as implant remaining in subject.
次要结局
- Retrieval Analysis of implants from revision surgery(Up to 10 Years)
研究者
Charles R. Bragdon
Research Scientist
Massachusetts General Hospital