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Surgical Management and Outcome of Tethered Cord Syndrome

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ClinicalTrials.gov Identifier: NCT05579795
Recruitment Status : Not yet recruiting
First Posted : October 14, 2022
Last Update Posted : November 3, 2022
Sponsor:
Information provided by (Responsible Party):
Amr Gamal Hussein Mohamed, Assiut University

Study Description
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Brief Summary:
The aim of this study is to assess surgical management and outcome of Tethered cord syndrome

Condition or disease Intervention/treatment
Tethered Cord Syndrome Procedure: Detethering of the spinal cord

Detailed 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.
Study Design
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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tethered Cord Syndrome: Surgical Management and Outcome
Estimated Study Start Date : November 2, 2022
Estimated Primary Completion Date : November 2, 2024
Estimated Study Completion Date : December 2, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Procedure: Detethering of the spinal cord
    Release of the tethered spinal cord

Outcome Measures
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Primary Outcome Measures :
  1. Motor power [ Time Frame: Two years ]

    Outcome of Detethering of the Tethered spinal cord according to Motor power of the lower limbs 5 grades 0: No visible muscle contraction

    1. Visible muscle contraction with no or trace movement
    2. Limb movement, but not against gravity
    3. Movement against gravity but not resistance
    4. Movement against at least some resistance supplied by the examiner
    5. Full strength

  2. Sensations [ Time Frame: Two years ]
    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

  3. Sphincter's function [ Time Frame: Two years ]
    Outcome of Detethering of the Tethered spinal cord according to is there urinary incontinence or stool incontinence and if improved or not


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Males and Females below 16 years old with Tethered cord syndome
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05579795


Contacts
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Contact: Amr Gamal Hussein, GP 01067651618 ext +2 amrgamalz@yahoo.com

Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: Amr Gamal Hussein Mohamed, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT05579795    
Other Study ID Numbers: Tethered Cord Syndrome
First Posted: October 14, 2022    Key Record Dates
Last Update Posted: November 3, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The aim of this study is to assess surgical management and outcome of Tethered cord syndrome.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: two years

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neural Tube Defects
Syndrome
Disease
Pathologic Processes
 Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities