Investigation of Surgical Sectioning of the Filum Terminale in Treating Occult Tethered Cord Syndrome Patients (OCCULT)
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- STATUS
- Recruiting
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- End date
- May 24, 2025
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- participants needed
- 20
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- sponsor
- Weill Medical College of Cornell University
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.
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.
Details
| Condition | Tethered Cord, Tethered Cord Syndrome, Occult Spina Bifida, Spina Bifida Occulta |
|---|---|
| Treatment | Release of filum terminale |
| Clinical Study Identifier | NCT05163899 |
| Sponsor | Weill Medical College of Cornell University |
| Last Modified on | 4 October 2022 |
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