- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05995795
Arthroscopic Release Of Shoulder Internal Rotation Contracture In Brachial Plexus Palsy
August 13, 2023 updated by: Mohamed Hamed Mohamed, Assiut University
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.
Study Overview
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 Type
Observational
Enrollment (Estimated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: MOHAMED HAMED, MASTER
- Phone Number: 01146962067
- Email: dr.mohamedelhamed@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
children with brachial plexus injury operated or not with internal rotation contracture
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with failure of initial intervention
Time Frame: 1 year
|
change of improvement of passive and active external rotation of operated shoulder using mallet score
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Mohamed Koteb, phD, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2023
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
May 10, 2023
First Submitted That Met QC Criteria
August 13, 2023
First Posted (Actual)
August 16, 2023
Study Record Updates
Last Update Posted (Actual)
August 16, 2023
Last Update Submitted That Met QC Criteria
August 13, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Arthroscopy in OBBP
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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