NCT07727161招募中不适用
Impact of 3D Printed Models on Preoperative Planing in Thoracic and Lumbar Spine Trauma
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2026年7月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Blood Loss
研究概览
简要总结
Case series of 16 patients with lower lumbar or lower thoracic traumatic injuries treated with pedicle screw fixation. Patients were divided into two groups (n≈8 per group). The control group underwent standard fluoroscopy-controlled pedicle screw fixation with conventional preoperative CT planning. The experimental group underwent identical fluoroscopy-controlled fixation with preoperative planning using a patient-specific 3D-printed model.
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single vertebra AO A2-A4 thoracic or lumbar spine fracture indicated for spine fixation.
排除标准
- •Neurological impairment caused by the fracture.
结局指标
主要结局
Blood Loss
时间窗: Peroperative (during surgery)
The amount of blood lost during the surgical procedure, measured in mililitres (mL). This outcome measure has no fixed upper limit and can vary widely, typically between 10 and 1,000 mL.
次要结局
- Surgical duration(Peroperative (during surgery))
- Pedicle screw placement accuracy(The parameter will be measured once on the first postoperative day)
- Incision length(This parameter will be assessed during the postoperative period, specifically on the day of suture removal, which is typically on day 10-14 after surgery.)
研究者
研究点 (1)
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