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临床试验/NCT05131126
NCT05131126Unknown不适用

Influence of an Anterior Latarjet-type Abutment Operation on Scapular Dyskinesia and the Muscular Stabilization Mechanisms of the Scapula (DyScapLat)

Ramsay Générale de Santé2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年5月22日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Difference in position of the scapula (tilt, rotation and bell) between the pre and post-test measured in the control group

研究概览

简要总结

The aim of this study is to assess the influence of anterior abutment surgery using the Latarjet method on the kinematics of the scapula. The sub-objectives will be to show that Latarjet-type surgery does not lead to scapular dyskinesia and modification of muscle activity compared to a control group that has not undergone an operation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Patient Group:
  • Male between 18 and 40 years-old
  • Practice a regular sports activity before the injury (s) requiring surgery
  • Present the clinical criteria leading to anterior abutment surgery using the Latarjet method
  • Surgery performed by surgeons from the Jean-Mermoz Private Hospital (69008 Lyon)
  • Have followed a post-surgery self-rehabilitation program
  • Control group:
  • Male between 18 and 40 years-old
  • Practice a regular sports activity
  • Both group:
  • oPatient having signed an informed consent o Subject affiliated or beneficiary of a social security scheme

排除标准

  • Patient group:
  • Have another shoulder pathology on the side of the operated limb or on the contralateral side
  • Present a constitutional hyper laxity
  • Have stiffness or recurrence of dislocation of the shoulder post-surgery
  • Have a body mass index greater than 30 kg / m² (to ensure sufficient accuracy to measure the movements of the scapula)
  • Wear a pacemaker or any other metal device (e.g. patch with metal material)
  • Present a contraindication to the use of measuring devices (intolerance to a weak electromagnetic field)
  • Control group:
  • Present during the study or have presented in the past any musculoskeletal pathology in the right or left shoulder (WOSI or WORC score greater than 250).
  • Have a body mass index greater than 30 kg / m² (to ensure sufficient accuracy to measure the movements of the scapula)
  • Wear a pacemaker or any other metal device (e.g. patch with metal material)
  • Present a contraindication to the use of measuring devices (intolerance to a weak electromagnetic field)
  • Both group :
  • o Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

结局指标

主要结局

Difference in position of the scapula (tilt, rotation and bell) between the pre and post-test measured in the control group

时间窗: 4 months

For electromyographic analysis, the signals will be filtered, smoothed and normalized to obtain a percentage of activation relative to that measured during submaximal voluntary contractions.

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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