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

Not Applicable

Not yet recruiting

• Conditions: Recurrent Adult Tethered Cord Syndrome
• Interventions: Procedure: Detethering Surgery; Procedure: Spinal Column Shortening Surgery

• Registration Number: NCT06197399
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Study Timeline

• Study First Submitted: 2023-07-30
• Status Verified: 2023-12
• Study First Submitted QC: 2024-01-08
• Last Update Submitted: 2024-01-08
• Study First Posted: 2024-01-09
• Last Update Posted: 2024-01-09
• Study Start: 2024-02-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 222

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Detethering Surgery	Detethering Surgery	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.
Spinal Column Shortening Surgery	Spinal Column Shortening Surgery	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.

Primary Outcome Measures

Name	Time	Method
Incidence of cerebrospinal fluid leakage	7 days	Postoperative Incidence of cerebrospinal fluid leakage

Secondary Outcome Measures

Name	Time	Method
Residual urine	6 months	Urodynamic test
12-item Short Form Health Survey (SF-12)	3 months, 6 months	Postoperative SF-12 evaluation
Visual Analogue Scale (VAS)	3 months, 6 months	Postoperative lumbar and lower extremities VAS
Uroflow rate	6 months	Urodynamic test
Urodynamic test	6 months	Cystometry
Muscle strength	3 months, 6 months	muscle strength of the lower extremities

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, China