NCT05579795

Brief Summary

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

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
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

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

October 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

November 2, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2024

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

2 years

First QC Date

October 3, 2022

Last Update Submit

November 1, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 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

    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

    Outcome of Detethering of the Tethered spinal cord according to is there urinary incontinence or stool incontinence and if improved or not

    Two years

Interventions

Release of the tethered spinal cord

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Males and Females below 16 years old with Tethered cord syndome

You may qualify if:

  • 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

You may not qualify if:

  • Asymptomatic Patients with Tethered cord discovered accidentally

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neural Tube Defects

Condition Hierarchy (Ancestors)

Nervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Amr Gamal Hussein, GP

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 3, 2022

First Posted

October 14, 2022

Study Start

November 2, 2022

Primary Completion

November 2, 2024

Study Completion

December 2, 2024

Last Updated

November 3, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

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

Shared Documents
CSR
Time Frame
two years