Evaluation Der Intraoperativen Umsetzung Von 3D Geplanten Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen Durch Eine Quantitative Postoperative Erfolgskontrolle
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- 3D difference between preoperative plan and surgery
研究概览
简要总结
Goal of this study is to evaluate the accuracy of 3D computer-planned fracture fixation with patient-specific instruments for clavicle, upper extremity, lower extremity and pelvis fractures compared with the standard procedure of fracture fixation.
详细描述
The research hypothesis is: The medical product permits the fracture fixation of clavicle, upper extremity, lower extremity and pelvis fractures to be more accurate compared with standard procedures of fracture fixation. Accuracy is evaluated by calculating translation and rotation comparing the postoperative 3D model versus the preoperative 3D plan.
Secondary outcome is an assessment of the surgical outcome using validated outcome instruments for each fractured body part like "Patient related wrist Evaluation" (PRWE) scores for distal radial fractures, as well as evaluation of range of motion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •fracture of clavicle, upper extremity, lower extremity or pelvis,tibia, fibula,Femur, with indication for fracture Fixation
- •clinical indication for a computed tomography of the fractured bone
- •>18 years of Age
- •Patient is able to give informed consent
排除标准
- •pregnancy or nursing women
- •non-compliance of the patient to follow the clinical study protocol, drug abuse or alcohol abuse
- •participation in a different clinical Trial within the last 30 days before inclusion or during the study
- •allergy to Polyamid PA 2200
- •no available technique for fracture Fixation which could be performed, in case of applying the medical device is not possible.
- •Applying the medical device is not possible, because of technical or anatomical reasons.
- •other clinical significant accompanying symptoms (tumor, infection)
结局指标
主要结局
3D difference between preoperative plan and surgery
时间窗: 12 months
For each surgery the discrepancy of the postoperative result compared to the preoperative planning is calculated by measuring all 6 degrees of freedom (3xrotation, 3xtranslation). The discrepancy between a simulated perfect postoperative result and the actual postoperative result is assessed in degree (rotation) and millimeters (translation). These measures are used to compare the outcome of the two different study Groups.
次要结局
- range of motion(12 months)
- surgical outcome assesed by validated outcome instruments(12 months)