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

NCT05163899 | Recruiting Phase 2 DMC

• 1 other identifier: 20-06022262
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Tethered Cord; Tethered Cord Syndrome; Occult Spina Bifida; Spina Bifida Occulta

Keywords

tethered cord; occult; filum terminale; tight filum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in urologic incontinence score

  Baseline, 1 year

• Change in fecal incontinence score

  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

  1 year

• Number of intra-operative findings that are discordant with MRI interpretations

  Intraoperative

Study Arms (2)

Surgery

ACTIVE COMPARATOR

Filum release

Procedure: Release of filum terminale

Observation

NO INTERVENTION

Medical Management only

Interventions

Release of filum terminale PROCEDURE

Surgery will be offered to section the filum terminale

Also known as: Laminectomy for tethered cord release

Surgery

Eligibility Criteria

• Age: 2 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 34268593 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Neural Tube Defects; Spina Bifida Occulta

Interventions

Laminectomy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spinal Dysraphism

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Decompression, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Jeffrey Greenfield, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Macie Tendrich, RN

CONTACT

(212) 746-2363; mat9275@med.cornell.edu

Jeffrey Greenfield, MD, PhD

CONTACT

(212) 746-2363; jpgreenf@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: For a surgical vs non-surgical trial, the investigator can not be masked thus only the evaluators will be unaware of the arm.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: December 20, 2021
• Study Start: May 19, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)