Recurrent Adult Tethered Cord Syndrome
Conditions
Keywords
Tethered cord syndrome, Detethering, Spinal Column Shortening
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.
Interventions
PROCEDUREDetethering 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.
PROCEDURESpinal 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; and the impact on spinal mobility is minimal after internal fixation at this region. This technique is designed to alleviate TCS symptoms while minimizing the risk of postoperative cerebrospinal fluid (CSF) leakage, which is a common complication in direct untethering procedures for recurrent cases. All procedures will be conducted by trained and experienced neurosurgeons following standardized protocols.
Sponsors
Chinese PLA General Hospital
Seventh Medical Center of PLA Army General Hospital
Chifeng Municipal Hospital
The First Hospital of Hebei Medical University
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of cerebrospinal fluid leakage | 7 days | Postoperative Incidence of cerebrospinal fluid leakage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uroflow rate | 6 months | Urodynamic test |
| Urodynamic test | 6 months | Cystometry |
| Muscle strength | 3 months, 6 months | muscle strength of the lower extremities |
| Visual Analogue Scale (VAS) | 3 months, 6 months | Postoperative lumbar and lower extremities VAS |
| 12-item Short Form Health Survey (SF-12) | 3 months, 6 months | Postoperative SF-12 evaluation |
| Residual urine | 6 months | Urodynamic test |
Countries
China
Outcome results
None listed