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临床试验/NCT04143438
NCT04143438已完成不适用

Assessment of Surgical Correction of Patello-femoral Instability by EOS 3D Kinematics

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2020年6月2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
6
试验地点
1
主要终点
Comparison of patella lateral tilt before and after surgery

研究概览

简要总结

Assessment of surgical correction of patello-femoral instability by EOS 3D kinematics

详细描述

Patella instability induces repetitive patella dislocation, which impairs day-to-day life. Surgery is commonly used to stabilise the patella during knee flexion. However proofs of efficacy of surgery on patello-femoral kinematics have not yet been found. Analysis of the patello-femoral kinematics is crucial to understand, assess et correct the patella instability. The investigators have developed, validated and published a 3D analysis method from biplanar X-rays (EOS 3D imaging). Our aim in this study is to assess the correction of the patello-femoral kinematics after surgery using the EOS 3D imaging method.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age above 15 years and 3 months (minimal age to be allowed for adult orthopedic surgery in the hospital)
  • Patients with patello-femoral instability (at least one patella dislocation)
  • Patients with corrective surgery planned
  • Patients must be covered by public health insurance
  • Signed informed consent form by the patient or by the parents or legal guardian of the patient (if patient is under 18)

排除标准

  • Previous existing surgery for patella instability on the same knee
  • Previous existing surgery on the extensor apparatus of the knee
  • Female patients with pregnancy
  • Patients deprived of liberty by administrative or court order

结局指标

主要结局

Comparison of patella lateral tilt before and after surgery

时间窗: During the presurgery appointment and up to 6 months after surgery

Efficacy of corrective surgery on patello-femoral instability will be assessed by measuring the patella lateral tilt (Ry) with the knee bending at 0, 20 and 45 degrees, before and after surgery. This measurement will be done using the EOS 3D Imaging technique.

次要结局

  • Comparison of patella secondary shifts before and after surgery(During the presurgery appointment and up to 6 months after surgery)
  • Assessment of functional and life quality changes pre- and post-surgery(During the presurgery appointment and up to 6 months after surgery)
  • Comparison of patella secondary rotations before and after surgery(During the presurgery appointment and up to 6 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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