Surgical Management and Outcome of Tethered Cord Syndrome

November 1, 2022 updated by: Amr Gamal Hussein Mohamed, Assiut University

Tethered Cord Syndrome: Surgical Management and Outcome

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

35

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

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

1 year to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Males and Females below 16 years old with Tethered cord syndome

Description

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 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Two years
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
Two years
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
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

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 (Anticipated)

November 2, 2022

Primary Completion (Anticipated)

November 2, 2024

Study Completion (Anticipated)

December 2, 2024

Study Registration Dates

First Submitted

October 3, 2022

First Submitted That Met QC Criteria

October 11, 2022

First Posted (Actual)

October 14, 2022

Study Record Updates

Last Update Posted (Actual)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tethered Cord Syndrome

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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

IPD Sharing Time Frame

two years

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

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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