Clinical trial NCT06197399: A Randomized Controlled Trial for Surgical Treatment of Recurrent Adult Tethered Cord Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Recurrent Adult Tethered Cord Syndrome
Keywords: Tethered cord syndrome
Detethering
Spinal Column Shortening
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
name: Seventh Medical Center of PLA Army General Hospital
name: Chifeng Municipal Hospital
name: The First Hospital of Hebei Medical University
First posted: 2024-01-09
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of cerebrospinal fluid leakage
timeFrame: 7 days
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 3 months, 6 months
measure: 12-item Short Form Health Survey (SF-12)
timeFrame: 3 months, 6 months
measure: Muscle strength
timeFrame: 3 months, 6 months
measure: Uroflow rate
timeFrame: 6 months
measure: Urodynamic test
timeFrame: 6 months
measure: Residual urine
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.