Subarachnoid-Subarachnoid (S-S) Bypass Versus Adhesion Lysis in Spinal Arachnoiditis and Syringomyelia

NCT06375759 | Recruiting

• 1 other identifier: XWSSB
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To determine whether Subarachnoid-Subarachnoid (S-S) Bypass results in better patient outcomes with fewer complications and improved quality of life compared to intradural adhesion lysis in individuals with Spinal Arachnoiditis and Syringomyelia.

Conditions

Syringomyelia

Keywords

syringomyelia

Outcome Measures

Primary Outcomes (1)

• complication

  Reoperation,Wound infection,Aseptic meningitis,CSF fistula,Subcutaneous hydrops,Other complications

  12 months

Secondary Outcomes (5)

• improvement or resolution of the syrinx,

  3-6, 12 and 24 months

• ASIA score

  3-6, 12 and 24 months

• Klekamp and Sammi syringomyelia scale

  3-6, 12 and 24 months

• modified Japanese Orthopaedic Association Scores (mJOA)

  3-6, 12 and 24 months

• xuanwu syringomyelia scale

  3-6, 12 and 24 months

Study Arms (2)

Subarachnoid-Subarachnoid (S-S) Bypass

EXPERIMENTAL

After dissections of the normal arachnoid mater at the cephalic and caudal sites, 1 or 2 tubes made of medical grade silicone (ventricular drainage tube; internal diameter 1.5-2.0 mm, external diameter 2.5-3.3 mm) were inserted into the cephalic and caudal ends of the normal subarachnoid space. The part of the tube inserted into the subarachnoid space was approximately 2 cm long. The total length of the tube was equal to the distance between the cephalic and caudal ends of the normal dissected arachnoid mater, along with approximately 4 cm of extra tubing.

Procedure: Subarachnoid-Subarachnoid (S-S) Bypass

Intradural Adhesion Lysis

ACTIVE COMPARATOR

The dura is opened sharply, exposing the spinal cord. After microsurgical dissection adhesion, the dura is sewn closed with a dural graft.

Procedure: Intradural Adhesion Lysis

Interventions

Subarachnoid-Subarachnoid (S-S) Bypass PROCEDURE

The dura was widely exposed beyond the level of trauma, and then a midline dural opening was made under an operative microscope. When dura and arachnoid were adhered because of an expansion of arachnoiditis, they had to be released with great care to place the bypass tubes. During this procedure, S-S bypass was not usually needed to performed arachnoid lysis. This exposure had to reach the normal arachnoid mater free from arachnoiditis and adhesion, with normal CSF circulation. After dissections of the normal arachnoid mater at the cephalic and caudal sites, 1 or 2 tubes made of medical grade silicone (ventricular drainage tube; internal diameter 1.5-2.0 mm, external diameter 2.5-3.3 mm) were inserted into the cephalic and caudal ends of the normal subarachnoid space. The part of the tube inserted into the subarachnoid space was approximately 2 cm long.

Subarachnoid-Subarachnoid (S-S) Bypass

Intradural Adhesion Lysis PROCEDURE

Intradural spinal cord Adhesion Lysis

Intradural Adhesion Lysis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) history of traumatic spinal cord injury or other infection; 2) evidence of progressive neurological deficit, and/or pain syndrome; 3) MRI showing a syringomyelia due to spinal trauma or other infection; and 4) minimum follow-up period of more than 1 year.

You may not qualify if:

• Chiari-malformation, myelomalacia, subarachnoid cyst, syringomyelia due to other spinal diseases (such as degenerative spinal disease)

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Fengzeng Jian

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (6)

• Hayashi T, Ueta T, Kubo M, Maeda T, Shiba K. Subarachnoid-subarachnoid bypass: a new surgical technique for posttraumatic syringomyelia. J Neurosurg Spine. 2013 Apr;18(4):382-7. doi: 10.3171/2013.1.SPINE12828. Epub 2013 Feb 22.

  PMID: 23432327 BACKGROUND

• Heiss JD. Cerebrospinal Fluid Hydrodynamics in Chiari I Malformation and Syringomyelia: Modeling Pathophysiology. Neurosurg Clin N Am. 2023 Jan;34(1):81-90. doi: 10.1016/j.nec.2022.08.007. Epub 2022 Nov 3.

  PMID: 36424067 BACKGROUND

• Hemley SJ, Bilston LE, Cheng S, Stoodley MA. Aquaporin-4 expression and blood-spinal cord barrier permeability in canalicular syringomyelia. J Neurosurg Spine. 2012 Dec;17(6):602-12. doi: 10.3171/2012.9.SPINE1265. Epub 2012 Oct 19.

  PMID: 23082850 BACKGROUND

• Guan J, Yuan C, Yao Q, Du Y, Fang Z, Zhang L, Jia S, Zhang C, Liu Z, Wang K, Duan W, Wang Z, Wang X, Wu H, Chen Z, Jian F. A novel scoring system for assessing adult syringomyelia associated with CM I treatment outcomes. Acta Neurol Belg. 2023 Jun;123(3):807-814. doi: 10.1007/s13760-023-02264-4. Epub 2023 Apr 12.

  PMID: 37046133 BACKGROUND

• Guan J, Yuan C, Zhang C, Ma L, Yao Q, Cheng L, Liu Z, Wang K, Duan W, Wang X, Wu H, Chen Z, Jian F. Intradural Pathology Causing Cerebrospinal Fluid Obstruction in Syringomyelia and Effectiveness of Foramen Magnum and Foramen of Magendie Dredging Treatment. World Neurosurg. 2020 Dec;144:e178-e188. doi: 10.1016/j.wneu.2020.08.068. Epub 2020 Aug 15.

  PMID: 32805463 BACKGROUND

• Yuan C, Xia P, Duan W, Wang J, Guan J, Du Y, Zhang C, Liu Z, Wang K, Wang Z, Wang X, Wu H, Chen Z, Jian F. Long-Term Impairment of the Blood-Spinal Cord Barrier in Patients With Post-Traumatic Syringomyelia and its Effect on Prognosis. Spine (Phila Pa 1976). 2024 Mar 15;49(6):E62-E71. doi: 10.1097/BRS.0000000000004884. Epub 2023 Nov 28.

  PMID: 38014747 RESULT

MeSH Terms

Conditions

Syringomyelia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

fengzeng jian

CONTACT

01083198899; jianfengzeng@xwh.ccmu.edu.cn

yuan chenghua

CONTACT

01083198899; yuanchenghua@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

CN (1)