Investigation of Surgical Sectioning of the Filum Terminale in Treating Occult Tethered Cord Syndrome Patients
Recruiting now · Not applicable
Conditions studied: Tethered Cord, Tethered Cord Syndrome, Occult Spina Bifida, Spina Bifida Occulta
In brief
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.
Key facts
- Study ID
- NCT05163899
- Run by
- Weill Medical College of Cornell University
- People needed
- 20
- Starts
- 2022-05-19
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-05-14
Who can join
Age: 2 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Weill Cornell Medicine — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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