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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 222
- 试验地点
- 2
- 主要终点
- Incidence of cerebrospinal fluid leakage
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of cerebrospinal fluid leakage
时间窗: 7 days
Postoperative Incidence of cerebrospinal fluid leakage
次要结局
- 12-item Short Form Health Survey (SF-12)(3 months, 6 months)
- Visual Analogue Scale (VAS)(3 months, 6 months)
- Uroflow rate(6 months)
- Urodynamic test(6 months)
- Residual urine(6 months)
- Muscle strength(3 months, 6 months)