Tethered Cord SyndromeNCT05579795
Surgical Management and Outcome of Tethered Cord Syndrome
An observational study of Tethered Cord Syndrome, run by Assiut University.
Trial summary
The aim of this study is to assess surgical management and outcome of Tethered cord syndrome Read more about this study
- Who is it for?
- Ages 1 year to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Tethered Cord Syndrome
- What is being tested?
- Detethering of the spinal cord
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2022to 2 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Males and Females below 16 years old with Tethered cord syndome
Who may be able to join
- 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
Who cannot join
- Asymptomatic Patients with Tethered cord discovered accidentally
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Tethered Cord Syndrome: Surgical Management and Outcome
The aim of this study is to assess surgical management and outcome of Tethered cord syndrome
Read the 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.
- Conditions
- Tethered Cord Syndrome
- Being tested
- Detethering of the spinal cord
- Medical subject headings
- Neural Tube Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detethering of the spinal cordProcedure or surgery
Release of the tethered spinal cord
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start2 Nov 2022 (estimated)
- Primary completion2 Nov 2024 (estimated)
- Study completion2 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tethered Cord SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Gamal Hussein Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579795
- Sponsor's protocol ID
- Tethered Cord Syndrome
- Status last verified
- Nov 2022
- First submitted
- 3 Oct 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The aim of this study is to assess surgical management and outcome of Tethered cord syndrome.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tethered Cord Syndrome: Surgical Management and Outcome
- ClinicalTrials.gov ID
- NCT05579795
- Acronym / sponsor ID
- Tethered Cord Syndrome
- Conditions
- Tethered Cord Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 2 Nov 2022 (estimated)
- Primary completion
- 2 Nov 2024 (estimated)
- Study completion
- 2 Dec 2024 (estimated)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess surgical management and outcome of Tethered cord syndrome
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Males and Females below 16 years old with Tethered cord syndome
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Asymptomatic Patients with Tethered cord discovered accidentally
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detethering of the spinal cordRelease of the tethered spinal cord | Procedure or surgery | – |
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: Yes. The aim of this study is to assess surgical management and outcome of Tethered cord syndrome.
Related trials for Tethered Cord Syndrome
Recruiting
Investigation of Surgical Sectioning of the Filum Terminale in Treating Occult Tethered Cord Syndrome Patients
Tethered Cord, Tethered Cord Syndrome
Not yet recruiting
Effectiveness of Electrical Pudendal Nerve Stimulation for Neurogenic Lower Urinary Tract Dysfunction in Pediatric Tethered Cord Syndrome Post-Surgery
Postoperative Neurogenic Lower Urinary Tract Dysfunction Secondary to Tethered Cord Syndrome
Not yet recruiting
A Randomized Controlled Trial for Surgical Treatment of Recurrent Adult Tethered Cord Syndrome
Recurrent Adult Tethered Cord Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Tethered Cord Syndrome, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr Gamal Hussein, GP (01067651618 ext. +2, amrgamalz@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor power (time frame: Two years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.