Ignite Creation Date:
2024-05-06 @ 12:30 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03771144
Status:
TERMINATED
Last Update Posted:
2022-12-29
First Post:
2018-11-30
Brief Title:
Anatomopathology of the Subscapularis and Infraspinatus Muscles in Children With Brachial Plexus Obstetric Paralysis
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Anatomopathology of the Subscapularis and Infraspinatus Muscles in Children With Brachial Plexus Obstetric Paralysis
Status:
TERMINATED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigators decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POPB
Brief Summary:
POPB is a consequence of the stretching of the nerve roots C5 C6 C7 C8 or T1 of the brachial plexus at birth One third of patients will have sequelae The most common is the appearance of a deficit of passive and active mobilities in the movements in external rotation of the shoulder especially in external rotation RE elbow to the body despite daily rehabilitation At present this stiffness is attributed to an imbalance between the external rotator muscles mainly infraspinatus that would be atrophied and the internal rotator muscles subscapularis pectoralis major latissimus dorsi that would be slightly affected In case of no or negative RE from the age of 1 year there is a surgical indication to operate these children At present surgery to lift internal retractions is the only therapy used but despite this surgery and intensive rehabilitation in some patients mobility deficits re-occur in a few years Thus some teams systematically perform a muscle transfer to strengthen the outer rotator muscles deficit during the initial operation Other teams of which principal investigator is part do this transfer only secondarily and in some patients Investigators lack objective and scientific criteria for the indication of this second muscle transfer surgery and the etiology of retractions is not clearly defined
In humans subscapularis is innervated by the C5 and C6 roots which are constantly affected in POPB It can be assumed that subscapularis may have an atrophy in POPB patients To date no anatomopathological study has been performed on the internal external rotator muscles of patients with POPB that can give indications on recurrences
Based on our clinical observations and literature data the main hypothese is there is amyotrophy of subscapularis and or infraspinatus in POPB patients with shoulder stiffness
In humans subscapularis is innervated by the C5 and C6 roots which are constantly affected in POPB It can be assumed that subscapularis may have an atrophy in POPB patients To date no anatomopathological study has been performed on the internal external rotator muscles of patients with POPB that can give indications on recurrences
Based on our clinical observations and literature data the main hypothese is there is amyotrophy of subscapularis and or infraspinatus in POPB patients with shoulder stiffness
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None