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

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

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

Study Overview

• Status: Completed
• Conditions: Shoulder Capsulitis
• Intervention / Treatment: Procedure: Biopsy

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Jean, France, 31240
    • Clinique de l'Union

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Instability shoulder group; Patients operated for an antero-inferior shoulder instability	Procedure: Biopsy; 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.
Other: Non instability shoulder group; Patients without shoulder instability, operated for another reason.	Procedure: Biopsy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Capsule Aspect	Normal capsule versus pathological capsule (abnormal capsule with disorganized framework, fragmented fibers, coiled )	during biopsy

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: Ramsay santé
• Investigators: Principal Investigator: Régis GUINAND, Dr, Clinique de l'Union - Ramsay-santé

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2020
• Primary Completion (Actual): January 12, 2024
• Study Completion (Actual): February 11, 2024

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Cytological Techniques; Cytodiagnosis; Diagnostic Techniques, Surgical; Biopsy
• Other Study ID Numbers: ID-RCB : 2019-A00859-48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No