Xuanwu Hospital, Capital Medical University
Beijing, 100000, China
NCT Number: NCT06197399
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.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Not applicable
Beijing, 100000, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
Time frame: 7 days
Postoperative Incidence of cerebrospinal fluid leakage
Time frame: 3 months, 6 months
Postoperative lumbar and lower extremities VAS
Time frame: 3 months, 6 months
Postoperative SF-12 evaluation
Time frame: 3 months, 6 months
muscle strength of the lower extremities
Time frame: 6 months
Urodynamic test
Time frame: 6 months
Cystometry
Time frame: 6 months
Urodynamic test
Xuanwu Hospital, Beijing
Other
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
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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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