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| Name | Class |
|---|---|
| Chinese PLA General Hospital | OTHER |
| Seventh Medical Center of PLA Army General Hospital | OTHER |
| Chifeng Municipal Hospital | OTHER |
| The First Hospital of Hebei Medical University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Detethering Surgery | Experimental | 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. |
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| Spinal Column Shortening Surgery | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of cerebrospinal fluid leakage | Postoperative Incidence of cerebrospinal fluid leakage | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) | Postoperative lumbar and lower extremities VAS | 3 months, 6 months |
| 12-item Short Form Health Survey (SF-12) | Postoperative SF-12 evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Beijing | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32032960 | Background | Zhang C, Chang CC, Mummaneni PV, Yuan C, Dhall S, Jian F, Gupta N, Chou D. Spinal column shortening versus revision detethering for recurrent adult tethered cord syndrome: a preliminary comparison of perioperative and clinical outcomes. J Neurosurg Spine. 2020 Feb 7;32(6):958-964. doi: 10.3171/2019.12.SPINE19659. Print 2020 Jun 1. | |
| 28362188 |
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| ID | Term |
|---|---|
| D009436 | Neural Tube Defects |
| ID | Term |
|---|---|
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| OTHER |
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| 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. |
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| 3 months, 6 months |
| Muscle strength | muscle strength of the lower extremities | 3 months, 6 months |
| Uroflow rate | Urodynamic test | 6 months |
| Urodynamic test | Cystometry | 6 months |
| Residual urine | Urodynamic test | 6 months |
| Aldave G, Hansen D, Hwang SW, Moreno A, Briceno V, Jea A. Spinal column shortening for tethered cord syndrome associated with myelomeningocele, lumbosacral lipoma, and lipomyelomeningocele in children and young adults. J Neurosurg Pediatr. 2017 Jun;19(6):703-710. doi: 10.3171/2017.1.PEDS16533. Epub 2017 Mar 31. |
| 20594004 | Background | Hsieh PC, Stapleton CJ, Moldavskiy P, Koski TR, Ondra SL, Gokaslan ZL, Kuntz C. Posterior vertebral column subtraction osteotomy for the treatment of tethered cord syndrome: review of the literature and clinical outcomes of all cases reported to date. Neurosurg Focus. 2010 Jul;29(1):E6. doi: 10.3171/2010.4.FOCUS1070. |
| 35245903 | Background | McVeigh LG, Anokwute MC, Chen S, Jea A. Spinal column shortening for tethered cord syndrome: a systematic review and individual patient data meta-analysis. J Neurosurg Pediatr. 2022 Mar 4;29(6):624-633. doi: 10.3171/2022.1.PEDS21503. Print 2022 Jun 1. |
| 32001403 | Background | O'Connor KP, Smitherman AD, Milton CK, Palejwala AH, Lu VM, Johnston SE, Homburg H, Zhao D, Martin MD. Surgical Treatment of Tethered Cord Syndrome in Adults: A Systematic Review and Meta-Analysis. World Neurosurg. 2020 May;137:e221-e241. doi: 10.1016/j.wneu.2020.01.131. Epub 2020 Jan 28. |