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临床试验/NCT02625038
NCT02625038已完成不适用

CT-based Evaluation of the Intraoperative Implementation Accuracy of 3D-planned Osteotomies of the Hand and Forearm Performed With Patient-specific Instruments

Balgrist University Hospital2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2014年9月1日最近更新:
适应症
干预措施

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

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

Experimental

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)

研究者

发起方
Balgrist University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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