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NCT Number: NCT06197399

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, 100000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Detethering Surgery

Procedure

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.

Spinal Column Shortening Surgery

Procedure

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.

Primary outcomes

  1. Incidence of cerebrospinal fluid leakage

    Time frame: 7 days

    Postoperative Incidence of cerebrospinal fluid leakage

Secondary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: 3 months, 6 months

    Postoperative lumbar and lower extremities VAS

  2. 12-item Short Form Health Survey (SF-12)

    Time frame: 3 months, 6 months

    Postoperative SF-12 evaluation

  3. Muscle strength

    Time frame: 3 months, 6 months

    muscle strength of the lower extremities

  4. Uroflow rate

    Time frame: 6 months

    Urodynamic test

  5. Urodynamic test

    Time frame: 6 months

    Cystometry

  6. Residual urine

    Time frame: 6 months

    Urodynamic test

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Collaborators

  • Chifeng Municipal Hospital
  • Chinese PLA General Hospital
  • Seventh Medical Center of PLA Army General Hospital
  • The First Hospital of Hebei Medical University

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 9, 2024
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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