Viewing Study NCT04428125



Ignite Creation Date: 2024-05-06 @ 2:47 PM
Last Modification Date: 2024-10-26 @ 1:37 PM
Study NCT ID: NCT04428125
Status: UNKNOWN
Last Update Posted: 2020-06-11
First Post: 2020-06-09

Brief Title: CFD Analysis and Risk of TOS in Sport
Sponsor: University of Catanzaro
Organization: University of Catanzaro

Study Overview

Official Title: Computational Fluid Dynamics Analysis for the Risk of Thoracic Outlet Syndrome in Sporty Subjects
Status: UNKNOWN
Status Verified Date: 2020-06
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: COFLUTOSPO
Brief Summary: Thoracic outlet syndrome TOS may complicate the activities of sporty subjects that participate in sports that involves upper extremities activities such as baseball tennis swimming rowing volleyball rugby football and weightlifting Disability and postintervention recovery related to TOS treatment and possible surgery may have a significant impact in the overall performance abilities of athletes This study aims to detect the early predisposition of athletes to TOS onset by means of computational fluid dynamics CFD analysis of thoracic outlet region
Detailed Description: Repetitive upper extremity use in athletes may be associated with the development of neurogenic and vascular thoracic outlet syndrome TOS which typically presents as upper extremity symptoms caused by compression of the neurovascular structures in the area of the neck above the first rib Clinical manifestations can include upper extremity pain paresthesias numbness weakness fatigability swelling discoloration and Raynaud phenomenon Vascular TOS can involve the subclavian artery or vein

Most patients who suffer TOSs have an anatomical predisposition and sport activities of upper limbs may contribute to TOS onset Disability and postintervention recovery related to TOS treatment and possible surgery can have a significant effect in the overall performance abilities of affected patients and little has been published specifically about the risk of TOS athletes Computational fluid dynamics CFD analysis is one of the key analysis methods used in bioengineering applications in studying the cardiovascular system In this context a typical fluid dynamics analysis involves evaluation of basic fluid properties like flow velocity and pressure in relation to time and space

This study aims to study CFD factors in thoracic outlet region cervicothoracobrachial region in order to evaluate the fluid - structure interactions between muscles bones and vessels in this region in sporty subjects that participate in the following sports baseball tennis swimming rowing volleyball rugby football weightlifting

A cohort of healthy sporty subjects will be recruited and will undergo to diagnostic tests in order to assess the thoracic outlet region For this reason a Magnetic Resonance scan of the cervicothoracobrachial region and a duplex ultrasound of the upper limbs will be performed

COMSOL Multiphysics cross-platform will be used for elements analysis in the simulation study The simulation will be implemented with FreeCAD 3d modeling in order to 3D geometry of studied elements

The primary endpoint of this study is to calculate the risk of TOS onset in sporty subjects in order to prevent a disabling disease in this kind of subjects

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None