CT-based Evaluation of the Intraoperative Implementation Accuracy of 3D-planned Osteotomies of the Hand and Forearm Performed With Patient-specific Instruments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- 3D difference between preoperative plan and surgery
研究概览
简要总结
Target of the study is to evaluate the reduction accuracy of 3D computer-planned osteotomies that are performed with patient-specific instruments.
Due to the higher accuracy achieved it is expected that complaints can be resolved or effectively revealed. The Research hypothesis to prove is "The medical product permits the surgical reduction of deformed bones of the hand and forearm (radius, ulna, distal humerus, carpal, metacarpal, and finger bones) by corrective osteotomy within an accuracy of 2 mm and 2º. Secondary outcome is an assessment of the surgical outcome using the "Disabilities of the Arm, Shoulder and Hand" (DASH) and the "Patient related wrist Evaluation" (PRWE) scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 99 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Posttraumatic or congenital bone deformity or pseudoarthrosis in the field of hand Surgery requiring correction by corrective osteotomy
- •Clinical indication for a computer tomography scan of the forearms
- •> 18 years old
- •written informed consent
排除标准
- •pregnant or nursing women
- •other clinical significant accompanying symptoms (Tumor, infection)
- •non-compliance of the patient to follow the clinical study protocol, drug or alcohol abuse
- •Participation in a different clinical trial within the last 30 days before inclusion or during the study
研究组 & 干预措施
Interventional
3D-planned osteotomies with patient-specific guides
干预措施: EUDAMED CIV-14-03-011940 (Device)
结局指标
主要结局
3D difference between preoperative plan and surgery
时间窗: 42 month
For each reduced fragment the 3D difference in all 6 degrees of freedom (3xrotation, 3xtranslation) is quantified by comparing pre- and postoperative CT.
次要结局
- Surgical Outcome(42 month)
