Clinical trial NCT05163899: Investigation of Surgical Sectioning of the Filum Terminale in Treating Occult Tethered Cord Syndrome Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Tethered Cord
Tethered Cord Syndrome
Occult Spina Bifida
Spina Bifida Occulta
Keywords: tethered cord
occult
filum terminale
tight filum
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in symptoms related to tethered cord, as measured by the OCCULT Scale
timeFrame: Baseline, 1 year
Secondary outcomes:
measure: Change in urologic incontinence score
timeFrame: Baseline, 1 year
measure: Change in fecal incontinence score
timeFrame: Baseline, 1 year
measure: Number of patients who cross over
timeFrame: 1 year
measure: Percent of patients with a decrease in anticholinergic medications at 1 year post-surgery
timeFrame: 1 year
measure: Number of intra-operative findings that are discordant with MRI interpretations
timeFrame: Intraoperative
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jeffrey Greenfield, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Michael MM, Garton ALA, Kuzan-Fischer CM, Uribe-Cardenas R, Greenfield JP. A critical analysis of surgery for occult tethered cord syndrome. Childs Nerv Syst. 2021 Oct;37(10):3003-3011. doi: 10.1007/s00381-021-05287-5. Epub 2021 Jul 15.