Clinical trial NCT04847180: Study of the Antipodal Capsular Fold and Its Potential Role in Antero-inferior Glenohumeral Instability
Official title: Study of the Antipodal Capsular Fold and Its Potential Role in Antero-inferior Glenohumeral Instability - Instabio
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Capsulitis
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: Ramsay santé
First posted: 2021-04-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Capsule Aspect
timeFrame: during biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Jean
country: France
facility: Clinique de l'Union
Study officials:
affiliation: Clinique de l'Union - Ramsay-santé
name: Régis GUINAND, Dr
role: PRINCIPAL_INVESTIGATOR
References: