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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in symptoms related to tethered cord, as measured by the OCCULT Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
For a surgical vs non-surgical trial, the investigator can not be masked thus only the evaluators will be unaware of the arm.
入排标准
- 年龄范围
- 2 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Surgery
Filum release
干预措施: Release of filum terminale (Procedure)
Observation
Medical Management only
结局指标
主要结局
Change in symptoms related to tethered cord, as measured by the OCCULT Scale
时间窗: 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.
次要结局
- Change in urologic incontinence score(Baseline, 1 year)
- Number of patients who cross over(1 year)
- Change in fecal incontinence score(Baseline, 1 year)
- Number of intra-operative findings that are discordant with MRI interpretations(Intraoperative)
- Percent of patients with a decrease in anticholinergic medications at 1 year post-surgery(1 year)