NCT05234801Unknown不适用
A Retrospective Data Collection Study of the Internal Fixation and Reconstruction of Bones in the Foot & Ankle Using Various Devices: DARCO Heads; CROSS CHECK 3Di; OrthoLoc 3Di
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年3月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- To demonstrate the safety of the devices concerned.
研究概览
简要总结
A retrospective post-market data collection study of the following implant devices :
- DARCO™ Headed Cannulated Screw
- ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System
- ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module
详细描述
A retrospective post-market data collection study designed to collect safety and performance Standard of Care data on patients who have undergone routine lower limb surgery that involved one of the following implant devices as per the indication for use:
- DARCO™ Headed Cannulated Screw
- ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System
- ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients 18 years or older at the time of index procedure
- •Patients who previously received:
- •the Charlotte™ MUC Screw System in accordance with the indications for use: for fixation of bone fractures or for bone reconstruction.
- •the CROSSCHECKTM in accordance with the indications for use: Stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet.
- •the ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System in accordance with the indications for use: Stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet.
- •a DARCO™ Headed Cannulated Screw in accordance with the indications for use: for bone fracture fixation and bone fragment fixation.
排除标准
- 未提供
结局指标
主要结局
To demonstrate the safety of the devices concerned.
时间窗: 3 months
Device related intra and post operative adverse events
To demonstrate the performance of the devices concerned.
时间窗: 1 year.
Device related intra and post operative adverse events
次要结局
未报告次要终点
研究者
研究点 (1)
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