Anatomopathology of the Subscapularis and Infraspinatus Muscles in Children With Brachial Plexus Obstetric Paralysis (POPB)
Primary Purpose
Brachial Obstetrical Palsy
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
arthrolysis
Sponsored by
About this trial
This is an interventional diagnostic trial for Brachial Obstetrical Palsy focused on measuring Brachial obstetrical palsy
Eligibility Criteria
Inclusion Criteria:
- Child with POPB presenting a stiffness in external shoulder rotation after the age of 1 year with a surgical indication of anterior release of shoulder is asked
- Obligation to obtain written informed consent from parents.
Exclusion Criteria:
- Patient with another neuromuscular pathology
- Significant traumatic history of the upper limb (fracture or surgical intervention) or any other pathology affecting the mobility of the joints of the upper limb (either on the pathological side or on the healthy side)
- Patient with a contraindication to surgery (precarious general condition, major coagulation disorders, anesthetic contraindication)
- Child over 10 years old
- Refusal of the patient or family
Sites / Locations
- Chu Montpellier
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Outcomes
Primary Outcome Measures
quantity of fibrosis on tissue muscle
Secondary Outcome Measures
quantity of satellit cells (Pax7, MyoD,Actine) on the muscle detected by PCR
Full Information
NCT ID
NCT03771144
First Posted
November 30, 2018
Last Updated
December 28, 2022
Sponsor
University Hospital, Montpellier
Collaborators
PhyMedExp Inserm U1046
1. Study Identification
Unique Protocol Identification Number
NCT03771144
Brief Title
Anatomopathology of the Subscapularis and Infraspinatus Muscles in Children With Brachial Plexus Obstetric Paralysis
Acronym
POPB
Official Title
Anatomopathology of the Subscapularis and Infraspinatus Muscles in Children With Brachial Plexus Obstetric Paralysis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Investigator's decision
Study Start Date
June 11, 2019 (Actual)
Primary Completion Date
June 23, 2020 (Actual)
Study Completion Date
June 23, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
PhyMedExp Inserm U1046
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brachial Obstetrical Palsy
Keywords
Brachial obstetrical palsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
arthrolysis
Intervention Description
Surgery is performed under general anesthesia. The usual duration of this surgery is on average 1h30. This surgery requires an anterior approach and a posterior approach. The patient is placed in lateral decubitus. The arthroscope of 2.7 is introduced by a posterior route. An anterior instrumental track is made from inside out through the rotator interval.
Primary Outcome Measure Information:
Title
quantity of fibrosis on tissue muscle
Time Frame
1 day
Secondary Outcome Measure Information:
Title
quantity of satellit cells (Pax7, MyoD,Actine) on the muscle detected by PCR
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Child with POPB presenting a stiffness in external shoulder rotation after the age of 1 year with a surgical indication of anterior release of shoulder is asked
Obligation to obtain written informed consent from parents.
Exclusion Criteria:
Patient with another neuromuscular pathology
Significant traumatic history of the upper limb (fracture or surgical intervention) or any other pathology affecting the mobility of the joints of the upper limb (either on the pathological side or on the healthy side)
Patient with a contraindication to surgery (precarious general condition, major coagulation disorders, anesthetic contraindication)
Child over 10 years old
Refusal of the patient or family
Facility Information:
Facility Name
Chu Montpellier
City
Montpellier
ZIP/Postal Code
34000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Anatomopathology of the Subscapularis and Infraspinatus Muscles in Children With Brachial Plexus Obstetric Paralysis
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