Recurrent Adult Tethered Cord SyndromeNCT06197399

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

A study testing Detethering Surgery and Spinal Column Shortening Surgery in people with Recurrent Adult Tethered Cord Syndrome, run by Xuanwu Hospital, Beijing at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Recurrent Adult Tethered Cord Syndrome
What is being tested?: Detethering Surgery and Spinal Column Shortening Surgery
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 222 participants
Where: 1 siteChina
Study dates: 1 Feb 2024to 31 May 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

Xuanwu Hospital, Capital Medical University
Beijing, 100000

Other trials in China

About this study

Official 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

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.

Read the 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.

Conditions: Recurrent Adult Tethered Cord Syndrome
Being tested: Detethering Surgery, Spinal Column Shortening Surgery
Keywords: Tethered cord syndrome, Detethering, Spinal Column Shortening
Medical subject headings: Neural Tube Defects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Detethering SurgeryProcedure or surgery
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 SurgeryProcedure or surgery
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.

Study groups in NCT06197399
Study group	Role	What they receive
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. Receives: Procedure: Detethering Surgery
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. Receives: Procedure: Spinal Column Shortening Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of cerebrospinal fluid leakage
Postoperative Incidence of cerebrospinal fluid leakage
Measured: 7 days

Secondary outcomes (6)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202431 May 2027

First posted9 Jan 2024
Study start1 Feb 2024 (estimated)
Primary completion31 Dec 2026 (estimated)
Study completion31 May 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Recurrent Adult Tethered Cord SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 222 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06197399
Sponsor's protocol ID: XW-NS-RCT-RTCS
Status last verified: Dec 2023
First submitted: 30 Jul 2023
Last updated: 9 Jan 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 32032960
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.
PubMed 28362188
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.
PubMed 20594004
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.
PubMed 35245903
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.
PubMed 32001403