Agility LP Ankle Arthroplasty: Clinical and Radiographic Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Assessment of Functional Outcomes Following Agility LP Ankle Replacement
研究概览
简要总结
This is a research study which is being done to determine the outcomes following Agility LP ankle replacement. This implant was approved by the FDA in 2007 and has been used since then with good early results. You are being asked to volunteer for this study because you have undergone Total Ankle Arthroplasty with Agility LP prosthesis. The purpose of the study is to compare the range of motion, level of pain and function during daily living prior to and after your ankle surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over 18 years old
- •Can comprehend and sign the informed consent
- •Patient must have undergone Agility LP ankle replacement between January 2006 to June 2008
排除标准
- •Patient has had following procedures on the study limb within two years of TAA
- •Revision of TAA
- •Ankle arthrodesis
- •Amputation
- •Agility LP arthroplasty was done as a revision procedure for a failed TAA or as a takedown of ankle fusion.
- •Any condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.
结局指标
主要结局
Assessment of Functional Outcomes Following Agility LP Ankle Replacement
时间窗: A Minimum of 2 Years Post Index Procedure
Range of Motion - Combined total of dorsiflexion and plantarflexion. Full range of motion is described as 30 degrees or more. Partial limitation is described as 29 to 15 degrees. Range of motion that is less than 15 degrees is described as severely limited.
次要结局
- Evaluation of Complication and Reoperation Rates(A Minimum of 2 Years Post Index Procedure)
- Radiographic Predictors of Implant Failures and Poor Outcomes(A Minimum of 2 Years Post Index Procedure)
研究者
John G. Anderson, MD
Principal Investigator
Orthopaedic Associates of Michigan, PC