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临床试验/NCT03835000
NCT03835000Unknown不适用

Medical Imaging of the Musculoskeletal System Before and After Surgery for the Generation of Customized Biomechanical Models

Centre d'Investigation Clinique et Technologique 8051 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年1月19日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Bones volume assessment

研究概览

简要总结

The objective of this study is to design a library of biomechanical musculoskeletal models of patients before and after surgery. These models will be evaluated to analyze the support they can provide for virtual surgical planning in orthopedics.

详细描述

While there are multiple surgical options for the treatment of a specific orthopaedic pathology, the patient is most often operated on according to the preferred method used within a team and not necessarily according to the method that would optimize the functional result. In addition, the variability of morphologies means that some patients, due to their anatomical characteristics, cannot benefit from an intervention that is necessary (incorrectly sized implant, unsuitable equipment). As the orthopaedic surgical procedure is definitive, the investigators believe that it may be useful to perform surgical simulations on a digital clone before performing on the real patient. This would be relevant for the patient, the caregiver, but also the community, as many surgical reopenings or treatment failures can be attributed to the difficulty of properly planning surgery for a functional objective in the long term.

This is a Retrospective study based on patient's record and medical imaging files.

50 patients For 3D medical imaging, the data will be obtained from the examinations performed by the patient before and after his surgery, they will be anonymized. The investigators will use the so-called "DICOM" sequences allowing the reconstruction of 3D models The personal data collected will be taken from the Surgical Report and the pre-surgical check-up (age, sex, height, weight) The patient identifier will be assigned for each subject with the centre number, initials (Surname / First name of the patient) and its inclusion number per centre.

Personal data will be obtained from the department's computerized or paper patient file Medical imaging data will be anonymized by the medical imaging department staff who will be assigned the patient identifier.

The database will be centralized and hosted on a laboratory computer on an encrypted and password-protected session.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Bones volume assessment

时间窗: 20 days

Comparison of volume of bone pieces in mm3

Soft tissue volume assessment

时间窗: 20 days

Volume comparison of soft tissue envelope in mm3

Relative positions of bones

时间窗: 10 days

Comparison of the relative positions of bones relative to each other in degrees

次要结局

  • Biomechanical response(2 days)

研究者

发起方
Centre d'Investigation Clinique et Technologique 805
申办方类型
Other
责任方
Sponsor

研究点 (1)

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