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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05579795
Other study ID # Tethered Cord Syndrome
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 2, 2022
Est. completion date December 2, 2024

Study information

Verified date November 2022
Source Assiut University
Contact Amr Gamal Hussein, GP
Phone 01067651618
Email amrgamalz@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to assess surgical management and outcome of Tethered cord syndrome


Description:

Tethered cord syndrome (TCS) is a developmental abnormality of the neuroaxis which is usually diagnosed in childhood. The actual tethering has been attributed to a variety of pathologic entities, including a thickened tight filum terminale , intradural lipomas with or without a connecting extradural component, intradural fibrous adhesions, diastematomyelia, and adherence of the neural placode following previous closure of a myelomeningocele. However, sufficient differences in the mode of onset, clinical manifestations, and outcome exist between pediatric and adolescent patients with tethered cord to warrant a more detailed analysis of the adult syndrome. The most problematic technical consideration in surgery for the release of the tethered cord is how to preserve functioning neural elements and rebuild the dural sac to avoid CSF leak. The purpose of this study is to review causes of Tethered cord, clinical presentation, diagnostic tools, treatment options and outcome in school-aged children, adolescents, and young adults with Tethered cord.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 35
Est. completion date December 2, 2024
Est. primary completion date November 2, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 16 Years
Eligibility Inclusion Criteria: - Patients with Tethered cord syndrome presenting at our institute - Patients with spinal dysraphism - Lipomyelomeningocele with Tethered cord - patients presented with neurological deficit after lipomyelomeningocele repair due to Tethered cord - patients presented with neurological deficit after myelomeningocele repair due to Tethered cord - Diastematomyelia with Tethered cord - Tethered cord due to filum terminale. - Tethered cord due to fibrous adhesions Exclusion Criteria: - Asymptomatic Patients with Tethered cord discovered accidentally

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Detethering of the spinal cord
Release of the tethered spinal cord

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Motor power Outcome of Detethering of the Tethered spinal cord according to Motor power of the lower limbs 5 grades 0: No visible muscle contraction
Visible muscle contraction with no or trace movement
Limb movement, but not against gravity
Movement against gravity but not resistance
Movement against at least some resistance supplied by the examiner
Full strength
Two years
Primary Sensations Outcome of Detethering of the Tethered spinal cord according to the sensations of lower limbs , is there decreased sensations of lower limbs and if improved or not Two years
Primary Sphincter's function Outcome of Detethering of the Tethered spinal cord according to is there urinary incontinence or stool incontinence and if improved or not Two years
See also
  Status Clinical Trial Phase
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Recruiting NCT05163899 - Investigation of Surgical Sectioning of the Filum Terminale in Treating Occult Tethered Cord Syndrome Patients Phase 2
Recruiting NCT04738539 - Efficacy of Contrast Enhanced Voiding Urosonography for Urodynamic Studies
Recruiting NCT03262844 - Efficacy and Safety of Nerve Root Axial Decompression Surgery in The Treatment of Tethered Cord Syndrome N/A