Occult Spina Bifida, Spina Bifida Occulta, Tethered Cord, Tethered Cord Syndrome
Conditions
Keywords
tethered cord, occult, filum terminale, tight filum
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.
Detailed 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.
Interventions
PROCEDURERelease of filum terminale
Surgery will be offered to section the filum terminale
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
For a surgical vs non-surgical trial, the investigator can not be masked thus only the evaluators will be unaware of the arm.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
2 Years to 80 Years
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: * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in symptoms related to tethered cord, as measured by the OCCULT Scale | Baseline, 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in urologic incontinence score | Baseline, 1 year | Score is measured by the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form. The minimum score is 0 and the maximum score is 21. The higher the score, the more severe the urinary incontinence symptoms and/or effect of symptoms on quality of life. |
| Change in fecal incontinence score | Baseline, 1 year | Score is measured by the Rapid Assessment Faecal Incontinence Score. The minimum score is 0 and the maximum score is 20. The higher the score, the more severe the fecal incontinence symptoms and/or effect of symptoms on quality of life. |
| Number of patients who cross over | 1 year | — |
| Percent of patients with a decrease in anticholinergic medications at 1 year post-surgery | 1 year | For patients who presented with urological symptoms |
| Number of intra-operative findings that are discordant with MRI interpretations | Intraoperative | To examine whether there is a limitation in MRI in identifying pathology that is identified at the time of surgery |
Countries
United States
Contacts
CONTACTCynthia Nguyen
CONTACTJeffrey Greenfield, MD, PhD
PRINCIPAL_INVESTIGATORJeffrey Greenfield, MD, PhD
Weill Medical College of Cornell University
Outcome results
None listed