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NCT Number: NCT04847180

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

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

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique de l'Union

Saint-Jean, 31240, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Biopsy

Procedure

The biopsy will be performed at the level of the capsular fold located just above the area devoid of cartilage in the postero-superior region of the humeral head, near the area where Hill Sachs notches occur.

Primary outcomes

  1. Capsule Aspect

    Time frame: during biopsy

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

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • Ramsay santé

Registry information

Official study title

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

Acronym: INSTABIO

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2021
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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