Investigation of Surgical Sectioning of the Filum Terminale in Treating Occult Tethered Cord Syndrome Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-19

Study Completion Date

2028-05-31

Brief Summary

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The investigators hypothesize that surgical release of the filum terminale (strand of fibrous tissue at the end of the spinal cord) is a more efficacious treatment option for symptomatic relief than medical management in subjects with Occult Tethered Cord Syndrome (OTCS) and that the risks do not outweigh the benefit profile.

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Detailed Description

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This is a phase II pilot randomized-controlled, single-site trial to determine if surgical untethering of the filum terminale is more effective, preliminarily, than medical management as a treatment option for OTCS. Subjects will be randomized to one of two arms: surgical untethering or medical management only. Symptom improvement and adverse events will be assessed and recorded for 1 year from initiation of treatment. After a minimum of 1 year, subjects who were randomized to the medical management arm may cross over to the surgical arm if the PI deems it is in the subject's best interest to do so. The exploratory hypothesis is that surgery for OTCS is both safe and more effective than medical management at relieving the symptoms of OTCS.

Conditions

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Tethered Cord Tethered Cord Syndrome Occult Spina Bifida Spina Bifida Occulta

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Subjects will be randomized to one of two arms: surgical untethering or medical management only. Symptom improvement and adverse events will be assessed and recorded for 1 year from initiation of treatment. After a minimum of 1 year, subjects who were randomized to the medical management arm may cross over to the surgical arm if the PI deems it is in the subject's best interest to do so.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

For a surgical vs non-surgical trial, the investigator can not be masked thus only the evaluators will be unaware of the arm.

Study Groups

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Surgery

Filum release

Group Type ACTIVE_COMPARATOR

Release of filum terminale

Intervention Type PROCEDURE

Surgery will be offered to section the filum terminale

Observation

Medical Management only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Release of filum terminale

Surgery will be offered to section the filum terminale

Intervention Type PROCEDURE

Other Intervention Names

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Laminectomy for tethered cord release

Eligibility Criteria

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Inclusion Criteria

* Male or female ≥ 2 and \< 80 years of age.
* Refractory to medical management of symptoms for at least 1 year.
* Documentation of OTCS, as defined by a total score of at least 30 on the following scale:

OCCULT Grading Scale (Score 0-100) Orthopedic Abnormality: 0-15; Central Nervous System Dysfunction: 0-25; Cutaneous Stigmata: 0-10; Urological or Bowel Dysfunction: 0-25; Lumbosacral Anatomy: 0-15; Tissue Integrity Disorder: 0-10.

Exclusion Criteria

* Subjects \< 2 or \> 80 years of age.
* Radiographically identified tethered cord, as defined by any of the following:

* A low-lying conus (at or below the L2-3 disc space)
* A thickened filum (\>2 mm)
* Fat in the filum or lipoma
* Distinct adhesion or tethering.
* A history of Meningocele manqué or Myelomeningocele.
* Cutaneous markings of dermal sinus tract.
* History of prior surgery on the lumbar spine.
* History of prior surgery for spinal dysraphism.
* History of prior infection or autoimmune condition of the central nervous system.

Minimum Eligible Age

2 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No