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

NCT ID: NCT04847180

Last Updated: 2021-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-26

Study Completion Date

2021-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Shoulder Capsulitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Instability shoulder group

Patients operated for an antero-inferior shoulder instability

Group Type EXPERIMENTAL

Biopsy

Intervention Type 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.

Non instability shoulder group

Patients without shoulder instability, operated for another reason.

Group Type OTHER

Biopsy

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ramsay santé

UNKNOWN

Sponsor Role collaborator

Ramsay Générale de Santé

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Régis GUINAND, Dr

Role: PRINCIPAL_INVESTIGATOR

Clinique de l'Union - Ramsay-santé

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinique de l'Union

Saint-Jean, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

JF OUDET

Role: CONTACT

+33683346567

Marie Hélène Barba

Role: CONTACT

+33664888704

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Régis GUINAND

Role: primary

05 61 37 81 81

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ID-RCB : 2019-A00859-48

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Physiotherapy and Capsulitis
NCT01789463 TERMINATED NA
Arthroscopic Subscapularis Augmentation
NCT07292740 NOT_YET_RECRUITING
Value of Capsular Repair for Latarjet
NCT05978362 RECRUITING NA