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临床试验/NCT04847180
NCT04847180已完成不适用

Study of the Antipodal Capsular Fold and Its Potential Role in Antero-inferior Glenohumeral Instability - Instabio

GCS Ramsay Santé pour l'Enseignement et la Recherche1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年8月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Capsule Aspect

研究概览

简要总结

In schoulders instabilty, the soft tissue has not been the subject of histological studies, as has the "bare area" or zone devoid of cartilage, the exact role of which in glenohumeral biomechanics is unknown. This research is based on the hypothesis that the antipodal lesions are constant, underestimated and that an architectural disorganization at the capsulo-ligament level could contribute to the instability of the shoulder. The aim of this study is therefore to better characterize these lesions which could be the subject of a complementary stabilization procedure even in the absence of a humeral notch

详细描述

Surgery for unstable shoulders sometimes involves repairing lesions that promote instability. These lesions are identified on imaging before surgery and then during the operation, but they are macroscopically inconsistent on genuine unstable shoulders. While the importance of posterior capsuloligamentous structures (soft tissue) in antero-inferior stability has been the subject of biomechanical studies, the soft tissue has not been the subject of histological studies, as has the "bare area" or zone devoid of cartilage, the exact role of which in glenohumeral biomechanics is unknown. However, this research is based on the hypothesis that the antipodal lesions are constant, underestimated and that an architectural disorganization at the capsulo-ligament level could contribute to the instability of the shoulder. The aim of this study is therefore to better characterize these lesions which could be the subject of a complementary stabilization procedure even in the absence of a humeral notch.

研究设计

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

入排标准

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

入选标准

  • •Instability Group
  • •Patient, male or female, over 18 years old and up to 40 years old
  • •Patient operated for antero-inferior shoulder instability
  • •Subject affiliated or beneficiary of a social security scheme
  • •Patient having signed the free and informed consent comparativ group
  • •Patient, male or female, over 18 years old and up to 40 years old
  • •Patient operated for a reason other than unstable shoulder
  • •Subject affiliated or beneficiary of a social security scheme
  • •Patient having signed the free and informed cons

排除标准

  • •History of surgery on the affected shoulder
  • •Capsuloligamentous disease (Ehler Danlos)
  • •History of instability (dislocation, subluxation) in witnesses
  • •Patient participating in another clinical study
  • •Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision;
  • •Pregnant, breastfeeding or parturient woman;
  • •Patient hospitalized without consent.

研究组 & 干预措施

Instability shoulder group

Experimental

Patients operated for an antero-inferior shoulder instability

干预措施: Biopsy (Procedure)

Non instability shoulder group

Other

Patients without shoulder instability, operated for another reason.

干预措施: Biopsy (Procedure)

结局指标

主要结局

Capsule Aspect

时间窗: during biopsy

Normal capsule versus pathological capsule (abnormal capsule with disorganized framework, fragmented fibers, coiled )

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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