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

Shoulder Capsulitis Clinical Trial

— INSTABIO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04847180
• Other study ID #: ID-RCB : 2019-A00859-48
• Status: Recruiting
• Phase: N/A
• Start date: August 26, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: April 2021
• Source: Ramsay Générale de Santé
• Contact: JF OUDET
• Phone: +33683346567
• Email: jf.oudet[@]ecten.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bursitis
• Shoulder Capsulitis

Intervention

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.

Locations

Country	Name	City	State
France	Clinique de l'Union	Saint-Jean

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	Ramsay santé

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Capsule Aspect	Normal capsule versus pathological capsule (abnormal capsule with disorganized framework, fragmented fibers, coiled )	during biopsy