NCT05231304已完成不适用
Retrospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement
Restor3D2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年4月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Improvement in pain from pre-operative baseline
研究概览
简要总结
This study is a retrospective analysis of patients who underwent surgery using a total talus replacement (TTR) implant with or without concurrent total ankle replacement and/or subtalar fusion. This study seeks to analyze the clinical and radiographic outcomes of TTR implant recipients and generate additional data on the safety and benefit of the TTR implant.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 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
- 否
入选标准
- •>18 Years of Age
- •Patient underwent surgery involving a total talus replacement implant between 1/1/2019 and 01/28/2022.
排除标准
- •No available postoperative data
结局指标
主要结局
Improvement in pain from pre-operative baseline
时间窗: 12-months
Primary probable benefit endpoint is improvement in pain at 12 months from preoperative baseline.
次要结局
- Improvement in Patient Reported Outcomes(36 months)
研究者
研究点 (2)
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