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

Description

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Tethered Cord
Intervention / Treatment

-

Contacts and Locations

New York

Weill Cornell Medicine, New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • * 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

2 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Weill Medical College of Cornell University,

Jeffrey Greenfield, MD, PhD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

2026-05