NCT05995795

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

May 10, 2023

Last Update Submit

August 13, 2023

Conditions

Arthroscopy

Outcome Measures

Primary Outcomes (1)

  • Number of participants with failure of initial intervention

    change of improvement of passive and active external rotation of operated shoulder using mallet score

    1 year

Interventions

ARTHROSCOYDEVICE

arthroscopy

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children with brachial plexus injury operated or not with internal rotation contracture

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 20141905BACKGROUND

Study Officials

  • Mohamed Koteb, phD

    Assiut University

    STUDY CHAIR

Central Study Contacts

MOHAMED HAMED, MASTER

CONTACT

01146962067dr.mohamedelhamed@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR.mohamed hamed

Study Record Dates

First Submitted

May 10, 2023

First Posted

August 16, 2023

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

September 1, 2025

Last Updated

August 16, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share