A Randomized Controlled Trial for Surgical Treatment of Recurrent Adult Tethered Cord Syndrome

Официальное название

A Multicenter, Prospective, Randomized Controlled Trial Comparing the Efficacy of Detethering Surgery and Spinal Column Shortening Surgery in Adult Patients With Recurrent Tethered Cord Syndrome

Обзор

This trial compares detethering surgery and spinal column shortening surgery, two treatments for adults with recurrent tethered cord syndrome (TCS), a neurological disorder where the spinal cord becomes abnormally attached to tissue. Detethering surgery carries a higher risk of postoperative complications such as cerebrospinal fluid (CSF) leakage, while spinal column shortening surgery's comparative efficacy is unclear. This study aims to clarify the optimal surgical management for recurrent TCS in adults, assessing postoperative complication rate and improvement of symptoms.

Подробное описание

This study is a multicenter, prospective, randomized controlled trial designed to compare the effectiveness and safety of detethering surgery and spinal column shortening surgery in adults diagnosed with recurrent tethered cord syndrome. TCS is a condition that causes neurological symptoms due to an abnormal attachment of the spinal cord to the surrounding tissue. The recurrent form in adults presents unique clinical challenges and limited treatment options.

Detethering surgery, a conventional treatment method, involves releasing the spinal cord from its abnormal attachment. While this technique directly addresses the cause of the condition, it also carries a high risk of cerebrospinal fluid (CSF) leakage, a severe postoperative complication.

Spinal column shortening surgery is a relatively new technique that aims to reduce tension on the spinal cord by shortening the vertebral column. It has been reported to offer a lower risk of CSF leakage, but its comparative efficacy to detethering surgery remains unclear due to limited evidence.

The proposed multicenter, prospective, randomized controlled trial aims to fill this knowledge gap by comparing the efficacy and safety of detethering surgery versus spinal column shortening surgery in adults with recurrent TCS. The results of this study will provide valuable insights into the optimal surgical management of adult patients with recurrent TCS, potentially improving patient outcomes, enhancing clinical practice, and guiding future research in this field.

Вмешательства

• Процедура Detethering Surgery
  Detethering surgery, or cord untethering, is a conventional surgical approach for treating tethered cord syndrome (TCS). It involves releasing the spinal cord from its abnormal attachment. During the surgical procedure, once the tethered area is identified, careful microsurgical techniques are used to separate the spinal cord from the surrounding abnormal tissue. This operation aims to alleviate the symptoms of TCS by removing the cause of tension on the spinal cord.
• Процедура Spinal Column Shortening Surgery
  Spinal column shortening surgery is an innovative surgical approach that involves reducing the tension on the spinal cord by shortening the spinal column, effectively "untethering" the spinal cord indirectly. The procedure primarily involves the thoracolumbar region.The choice of this region for intervention offers several advantages: it is a safe distance from the previous detethering surgery area; it is closer to the conus medullaris of the spinal cord, ensuring better treatment effectiveness;

Первичные конечные точки

• Incidence of cerebrospinal fluid leakage [Срок оценки: 7 days]

Вторичные конечные точки (6)

• Visual Analogue Scale (VAS) [Срок оценки: 3 months, 6 months]
• 12-item Short Form Health Survey (SF-12) [Срок оценки: 3 months, 6 months]
• Muscle strength [Срок оценки: 3 months, 6 months]
• Uroflow rate [Срок оценки: 6 months]
• Urodynamic test [Срок оценки: 6 months]
• Residual urine [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Patients who have previously detethering surgery for primary tethered cord syndrome, including filum terminale untethering, dermoid or lipoma resection, with a recurrence of spinal cord tethering postoperatively.
• The presence of related clinical symptoms, including bowel and bladder dysfunction, sensory impairment, numbness, pain in the lower limbs, perineal or buttock area, motor dysfunction of the lower limbs, muscle weakness, and sexual dysfunction.
• Primary diagnosis of a thickened filum terminale, low-lying conus medullaris, meningocele, lipoma, dermoid, or spina bifida.

Критерии исключения

• Patients with severe scoliosis at the thoracolumbar junction.
• Patients with severe osteoporosis or other conditions that contraindicate internal fixation.
• Patients with severe pressure ulcers or skin breakdown in the lumbar or thoracic region.
• Patients with severe systemic diseases that cannot tolerate surgery.
• Other cases deemed unsuitable for inclusion following evaluation by professional neurosurgeons.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xuanwu Hospital, Capital Medical University — Пекин

Публикации

• Zhang C, Chang CC, Mummaneni PV, Yuan C, Dhall S, Jian F, Gupta N, Chou D. Spinal column shortening versus revision detethering for recurrent adult tethered cord syndrome: a preliminary comparison of perioperative and clinical outcomes. J Neurosurg Spine. 2020 Feb 7;32(6):958-964. doi: 10.3171/2019.12.SPINE19659. Print 2020 Jun 1. PMID 32032960
• Aldave G, Hansen D, Hwang SW, Moreno A, Briceno V, Jea A. Spinal column shortening for tethered cord syndrome associated with myelomeningocele, lumbosacral lipoma, and lipomyelomeningocele in children and young adults. J Neurosurg Pediatr. 2017 Jun;19(6):703-710. doi: 10.3171/2017.1.PEDS16533. Epub 2017 Mar 31. PMID 28362188
• Hsieh PC, Stapleton CJ, Moldavskiy P, Koski TR, Ondra SL, Gokaslan ZL, Kuntz C. Posterior vertebral column subtraction osteotomy for the treatment of tethered cord syndrome: review of the literature and clinical outcomes of all cases reported to date. Neurosurg Focus. 2010 Jul;29(1):E6. doi: 10.3171/2010.4.FOCUS1070. PMID 20594004
• McVeigh LG, Anokwute MC, Chen S, Jea A. Spinal column shortening for tethered cord syndrome: a systematic review and individual patient data meta-analysis. J Neurosurg Pediatr. 2022 Mar 4;29(6):624-633. doi: 10.3171/2022.1.PEDS21503. Print 2022 Jun 1. PMID 35245903
• O'Connor KP, Smitherman AD, Milton CK, Palejwala AH, Lu VM, Johnston SE, Homburg H, Zhao D, Martin MD. Surgical Treatment of Tethered Cord Syndrome in Adults: A Systematic Review and Meta-Analysis. World Neurosurg. 2020 May;137:e221-e241. doi: 10.1016/j.wneu.2020.01.131. Epub 2020 Jan 28. PMID 32001403

Идентификаторы

NCT: NCT06197399 · XW-NS-RCT-RTCS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗