Arthroscopic Release Of Shoulder Internal Rotation Contracture In Brachial Plexus Palsy

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05995795

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy periarticular capsuloligamentous arthroscopic release of shoulder internal rotation contracture in brachial plexus palsy without any further intervention as tendon transfer.

Condition or Disease	Intervention/Treatment	Phase
Arthroscopy	Device: ARTHROSCOY

Detailed Description

Obstetrical brachial plexus paralysis (OBPP) refers to complete or partial injury of the brachial plexus produced at the time of birth. OBPP involves most commonly the upper cervical roots (C5, C6) resulting in muscle imbalance between internal and external rotators of the shoulder . Although the majority of the patients (80-90%) recover spontaneously, some have a remaining imbalance causing severe functional impairment . In addition to diminished function, prolonged muscle contractures result in bony deformities in both the glenoid and proximal humerus. Internal rotation contractures due to external rotational weakness are the most common deformity in OBPP. Contracture release, tendon transfers, and rotational osteotomies are surgical methods used, depending on the level of deformity and the patient's age. To achieve functional external rotation of the arm, contracted structures should be released first. Currently, there is a lack of consensus on which procedures over the best outcome for mobility and function, and what are the precise indications for each type of surgery. There is also a large variation of practice between centers

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Arthroscopic Release Of Shoulder Internal Rotation Contracture In Brachial Plexus Palsy

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2025

Outcome Measures

Primary Outcome Measures

Number of participants with failure of initial intervention [1 year]
change of improvement of passive and active external rotation of operated shoulder using mallet score

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

children from 1 year to 15years of age.
all genders
patients with brachial plexus injury operated or not with internal rotation contracture
patient with traumatic brachial plexus injury have residual internal rotation contracture

Exclusion Criteria:

History of septic shoulder
Flail anaethetic limb
glenohumeral posterior sublaxation or dislocation in CT

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

Study Chair: Mohamed Koteb, phD, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Hale HB, Bae DS, Waters PM. Current concepts in the management of brachial plexus birth palsy. J Hand Surg Am. 2010 Feb;35(2):322-31. doi: 10.1016/j.jhsa.2009.11.026.

Responsible Party:

Mohamed Hamed Mohamed, DR.mohamed hamed, Assiut University

ClinicalTrials.gov Identifier:

NCT05995795

Other Study ID Numbers:

Arthroscopy in OBBP

First Posted:

Aug 16, 2023

Last Update Posted:

Aug 16, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Contracture

Study Results

No Results Posted as of Aug 16, 2023