Radlinik GPS Provide a Valid Intra-operative Assessment of Acetabular Inclination and Anteversion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Comparison of intra-op values for acetabular inclination and ante version, limb length using Radlink with those obtained and 4-8 weeks postop digital films.
研究概览
简要总结
Evaluate the accuracy of Radlink System in determining acetabular cup placement and limb length evaluation during Anterior hip replacement as measured intraoperative with C-Arm visualization and confirmed with digital x-ray at 4-6 weeks postoperatively.
详细描述
Evaluate the accuracy of Radlink System in determining acetabular cup placement and limb length evaluation during Anterior hip replacement as measured intraoperative with C-Arm visualization and confirmed with digital x-ray at 4-6 weeks postoperatively.
GPS may improve total hip replacement by allowing surgeons to measure the exact position of components placed during surgery and there is a question whether RADLINK helps surgeons place the acetabular cup (the part that goes into the hip bone) component in a precise position. The objective of the study is to determine whether GPS gives surgeons reliable, valid information about the orientation of the cup component. The surgeons need to collect data to help clarify this issue.
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
- •Both: both female and male participants are being studied.
- •Minimum Age: Age of participants is between 20 years - 75 years.
- •Accepts: Persons who are in need of a total hip replacement
- •Exclusion Critieria:
- •Has an existing condition that would compromise participation
- •Had previous surgery on affected hip
排除标准
- 未提供
结局指标
主要结局
Comparison of intra-op values for acetabular inclination and ante version, limb length using Radlink with those obtained and 4-8 weeks postop digital films.
时间窗: 4-8 weeks
次要结局
- Accuracy of cup placement/limb length with Radlink to a predetermined value and what surgeon obtains with Radlink guidance.(4-8 weeks)
研究者
William Barrett, M.D.
William P. Barrett, MD
Barrett, William, M.D.