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
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…
Eligibility
- Age range
- 2–80 years
- Sex
- All
- Healthy volunteers
- No
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:…
Interventions
- ProcedureRelease of filum terminale
Surgery will be offered to section the filum terminale
Location
- Weill Cornell MedicineNew York, New York