跳至主要内容
临床试验/NCT05123456
NCT05123456Unknown不适用

Risk of Osteoarthritis of the Knee at Least 5 Years After ACL Reconstruction: Comparative Study Between an Isolated ACL Reconstruction and a Reconstruction Combining ACL and ALL

Ramsay Générale de Santé2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2020年4月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
180
试验地点
2
主要终点
Assessment of the prevalence of femoro-tibial osteoarthritis

研究概览

简要总结

The main objective of this study is to compare, with a minimum follow-up of 5 years, the prevalence of femoro-tibial osteoarthritis after an isolated ACL ligamentoplasty or after an ACL ligamentoplasty combining ACL and ALL.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
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

入选标准

  • Patients who underwent an isolated Anterior Cruciate Ligament (ACL) reconstruction or a combined ACL and anterolateral ligament reconstruction (Extra Articular Plasty) between January 1, 2011 and March 31,
  • Patients affiliated or beneficiaries of a social security scheme
  • Patients who have given their express consent.

排除标准

  • Patients with pediatric ACL reconstruction technique
  • Patients with a complex associated gesture such as osteotomy or ligamentoplasty other than extra articular plastic surgery.
  • Contraindication to a radio control (pregnancy)
  • Patient's refusal to participate in the study
  • Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; Pregnant, breastfeeding or parturient woman; Hospitalized without consent.

结局指标

主要结局

Assessment of the prevalence of femoro-tibial osteoarthritis

时间窗: 1 day

The prevalence of femoro-tibial osteoarthritis will be assessed by the percentage of patients with cartilage damage to the femoro-tibial compartments on a single X-ray of the face compared to 30 °of flexion.

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 (2)

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