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

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Capital Medical University

Status

Not yet enrolling

Conditions

Recurrent Adult Tethered Cord Syndrome

Treatments

Procedure: Spinal Column Shortening Surgery
Procedure: Detethering Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT06197399
XW-NS-RCT-RTCS

Details and patient eligibility

About

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.

Full 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.

Enrollment

222 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

222 participants in 2 patient groups

Detethering Surgery
Experimental group
Description:
Participants in this arm will undergo detethering surgery, a traditional surgical intervention that involves releasing the spinal cord from its abnormal attachment. All surgeries will be performed by trained and experienced neurosurgeons following standardized protocols.
Treatment:
Procedure: Detethering Surgery
Spinal Column Shortening Surgery
Experimental group
Description:
Participants in this arm will undergo spinal column shortening surgery, a surgical technique aimed at reducing tension on the spinal cord by shortening the vertebral column. All surgeries will be conducted by trained and experienced neurosurgeons following standardized protocols. Postoperative care will be similar in both arms to minimize confounding variables.
Treatment:
Procedure: Spinal Column Shortening Surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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