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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04847180
Other study ID # ID-RCB : 2019-A00859-48
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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