NCT05739240尚未招募不适用
Effects of Preoperative 3D Printing of Distal Intra-articular Radius Fractures on Quality of Fracture Reduction: a Randomized, Single-blinded, Monocentric Clinical Trial
Vilijam Zdravkovic0 个研究点目标入组 80 人开始时间: 2023年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Articular gap of the distal radius joint surface in the postop CAT-scan
研究概览
简要总结
The investigators aim to evaluate the effect of a preoperative 3D printed Model (3PAS) of distal intraarticular radius fractures on quality of fracture reduction. Surgical procedure is equal in the 3PAS and in the conventional group. To evaluate the quality of fracture reduction each patient receives a postoperative CAT-scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Patient older than 18 years
- •Surgery criteria fulfilled
- •Informed consent
- •Intra-articular Fracture of the distal radius (AO 23-B and 23-C) (also including Avulsion of the processus styloideus ulnae AO/OTA 2U3A1.1) in preoperative CAT-Scan
排除标准
- •Patient does not want a surgical treatment
- •Patient does not want to participate
- •Positive history for surgery due to injury of the hurt wrist beforehand
- •Positive history for surgery due to injury of the opposite wrist beforehand
- •Additional injuries to the hand and forearm (except distal ulna fracture AO 2U3A1.1)
- •Pregnancy
- •Vulnerable people
- •Distal ulna fracture (except AO 2U3A1.1)
- •Extraarticular radius fracture (AO 23-A)
- •Concomitant injuries which interfere with the planned aftercare (intubated for a long time, additional elbow or shoulder fracture)
结局指标
主要结局
Articular gap of the distal radius joint surface in the postop CAT-scan
时间窗: 6 weeks
Articular step-off of the distal radius joint surface in the postop CAT-scan
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
Vilijam Zdravkovic
Principal investigator
Cantonal Hospital of St. Gallen
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