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

NCT04847180 | Unknown

• 1 other identifier: ID-RCB : 2019-A00859-48
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Shoulder Capsulitis

Outcome Measures

Primary Outcomes (1)

• Capsule Aspect

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

  during biopsy

Study Arms (2)

Instability shoulder group

EXPERIMENTAL

Patients operated for an antero-inferior shoulder instability

Procedure: Biopsy

Non instability shoulder group

OTHER

Patients without shoulder instability, operated for another reason.

Procedure: Biopsy

Interventions

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.

Instability shoulder group; Non instability shoulder group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• Ramsay santé: collaborator

Study Sites (1)

Clinique de l'Union

Saint-Jean, 31240, France

RECRUITING

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Régis GUINAND, Dr

  Clinique de l'Union - Ramsay-santé

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JF OUDET

CONTACT

+33683346567; jf.oudet@ecten.eu

Marie Hélène Barba

CONTACT

+33664888704; mh.barba@ecten.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 19, 2021
• Study Start: August 26, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

FR (1)