Anatomopathology of the Subscapularis and Infraspinatus Muscles in Children With Brachial Plexus Obstetric Paralysis (POPB)

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.

Study Overview

• Status: Terminated
• Conditions: Brachial Obstetrical Palsy
• Intervention / Treatment: Procedure: arthrolysis

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marion DELPONT, PhD; Phone Number: 0467339581; Email: m-delpont@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34000
    • CHU Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental	Procedure: arthrolysis; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
quantity of fibrosis on tissue muscle	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
quantity of satellit cells (Pax7, MyoD,Actine) on the muscle detected by PCR	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: PhyMedExp Inserm U1046

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2019
• Primary Completion (Actual): June 23, 2020
• Study Completion (Actual): June 23, 2020

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: December 7, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Estimate): December 29, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Brachial obstetrical palsy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Infant, Newborn, Diseases; Birth Injuries; Paralysis; Paralysis, Obstetric
• Other Study ID Numbers: UF7640

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No