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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Phase II Pilot Randomized-Controlled Trial for the Investigation of the Preliminary Efficacy of Surgical Sectioning of the Filum Terminale in Treating Occult Tethered Cord Syndrome Patients

Conditions
-----------------
Tethered Cord, Tethered Cord Syndrome, Occult Spina Bifida, Spina Bifida Occulta

Intervention / Treatment
-----------------
* Procedure: Release of filum terminale


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgery<br>Filum release | Procedure: Release of filum terminale<br>* Surgery will be offered to section the filum terminale<br>* Other names: Laminectomy for tethered cord release;|
| No Intervention: Observation<br>Medical Management only | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in symptoms related to tethered cord, as measured by the OCCULT Scale | Combination of neurologic, urologic, orthopedic, and cutaneous assessments. The OCCULT Scale is from 0-100, with 0 being none of the listed signs/symptoms present and 100 being all listed signs/symptoms present with maximum severity. | Baseline, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urologic incontinence score | Score is measured by the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form. The minimum score is 0 and the maximum score is 21. The higher the score, the more severe the urinary incontinence symptoms and/or effect of symptoms on quality of life. | Baseline, 1 year | 
| Change in fecal incontinence score | Score is measured by the Rapid Assessment Faecal Incontinence Score. The minimum score is 0 and the maximum score is 20. The higher the score, the more severe the fecal incontinence symptoms and/or effect of symptoms on quality of life. | Baseline, 1 year | 
| Number of patients who cross over |  | 1 year | 
| Percent of patients with a decrease in anticholinergic medications at 1 year post-surgery | For patients who presented with urological symptoms | 1 year | 
| Number of intra-operative findings that are discordant with MRI interpretations | To examine whether there is a limitation in MRI in identifying pathology that is identified at the time of surgery | Intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tethered cord, occult, filum terminale, tight filum