跳至主要内容
临床试验/NCT06996145
NCT06996145已完成不适用

Study of the Isometry of the Anterior Cruciate Ligament From the Center of the Native MRI Insertion Reported on Dynamic Scanner

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
variation in length of the ACL

研究概览

简要总结

In anterior cruciate ligament (ACL) reconstruction, navigation and robotic assistance now provide the possibility of precise positioning of the tunnels.

The challenge is therefore to carry out isometric preoperative planning which can be carried out with robotic or navigation assistance.

In the classic reconstruction technique this isometry is assumed by positioning the tunnels on the center of the native ACL footprints. However, studies cast doubt on this hypothesis.

In this work, the investigators will study the isometry of the center of the native footprints on a dynamic 4D scanner in order to obtain the variation in the distance between the centers of the native footprints during a knee flexion cycle.

This study is part of a larger project. the objective is, if the absence of isometry of the center of the native impressions is confirmed, to develop software assistance which will help the surgeon plan preoperatively an isometric reconstruction. The hypothesis is that the techniques based on the center of the native footprints does not allow isometric reconstruction.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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
是

入选标准

  • •Healthy volunteers aged 18 or older
  • •Signed informed consent
  • •Affiliation to a social security system
  • •Negative pregnancy test for women of childbearing age

排除标准

  • •Volunteer having already undergone knee ligament reconstruction or having peri- or intra-articular knee fractures
  • •Volunteers for whom ligamentoplasty would not have been the therapeutic option chosen in the event of an ACL rupture
  • •Pregnant woman
  • •Volunteer under guardianship or curators, under the protection of justice or deprived of public law.
  • •Minor volunteer
  • •Contraindication to MRI or scanner

结局指标

主要结局

variation in length of the ACL

时间窗: 15 days

Study of the variation in length of the ACL (isometry) during knee flexion in 4D imaging calculated from the center of the natural footprints of the ACL.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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