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

Primary Purpose

Shoulder Capsulitis

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Biopsy

About this trial

This is an interventional diagnostic trial for Shoulder Capsulitis

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Clinique de l'UnionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Instability shoulder group

Non instability shoulder group

Arm Description

Patients operated for an antero-inferior shoulder instability

Patients without shoulder instability, operated for another reason.

Outcomes

Primary Outcome Measures

Capsule Aspect

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04847180

First Posted

April 12, 2021

Last Updated

April 14, 2021

Sponsor

Ramsay Générale de Santé

Collaborators

Ramsay santé

1. Study Identification

Unique Protocol Identification Number

NCT04847180

Brief Title

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

Acronym

INSTABIO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 26, 2020 (Actual)

Primary Completion Date

September 30, 2021 (Anticipated)

Study Completion Date

September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ramsay Générale de Santé

Collaborators

Ramsay santé

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Capsulitis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Instability shoulder group

Arm Type

Experimental

Arm Description

Patients operated for an antero-inferior shoulder instability

Arm Title

Non instability shoulder group

Arm Type

Other

Arm Description

Patients without shoulder instability, operated for another reason.

Intervention Type

Procedure

Intervention Name(s)

Biopsy

Intervention Description

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 Outcome Measure Information:

Title

Capsule Aspect

Description

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

Time Frame

during biopsy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

JF OUDET

Phone

+33683346567

jf.oudet@ecten.eu

First Name & Middle Initial & Last Name or Official Title & Degree

Marie Hélène Barba

Phone

+33664888704

mh.barba@ecten.eu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Régis GUINAND, Dr

Organizational Affiliation

Clinique de l'Union - Ramsay-santé

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinique de l'Union

City

Saint-Jean

ZIP/Postal Code

31240

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Régis GUINAND

Phone

05 61 37 81 81

regis.guinand@epaule-toulouse.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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