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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Release of filum terminale
  Surgery will be offered to section the filum terminale

Первичные конечные точки

• Change in symptoms related to tethered cord, as measured by the OCCULT Scale [Срок оценки: Baseline, 1 year]

Вторичные конечные точки (5)

• Change in urologic incontinence score [Срок оценки: Baseline, 1 year]
• Change in fecal incontinence score [Срок оценки: Baseline, 1 year]
• Number of patients who cross over [Срок оценки: 1 year]
• Percent of patients with a decrease in anticholinergic medications at 1 year post-surgery [Срок оценки: 1 year]
• Number of intra-operative findings that are discordant with MRI interpretations [Срок оценки: Intraoperative]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Weill Cornell Medicine — New York

Публикации

• Michael MM, Garton ALA, Kuzan-Fischer CM, Uribe-Cardenas R, Greenfield JP. A critical analysis of surgery for occult tethered cord syndrome. Childs Nerv Syst. 2021 Oct;37(10):3003-3011. doi: 10.1007/s00381-021-05287-5. Epub 2021 Jul 15. PMID 34268593

Идентификаторы

NCT: NCT05163899 · 20-06022262

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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