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

Syringomyelia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06375759
• Other study ID #: XWSSB
• Status: Recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: April 2027

Study information

• Verified date: April 2024
• Source: Xuanwu Hospital, Beijing
• Contact: fengzeng jian
• Phone: 01083198899
• Email: jianfengzeng[@]xwh.ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Participants with Spinal Arachnoiditis and Syringomyelia will be randomized to either have a Subarachnoid-Subarachnoid (S-S) Bypass or intradural adhesion Lysis. The participant will then return to the neurosurgeon's office at the following time points which are consistent with standard of care practice: 3-6 months, 12 and 24 months. At these visits, the clinician will complete a physical exam and the participant will report on the prognosis of symptoms and complete questionnaires. A spine MRI will be performed 3-6 months, 12 and 24 months after the decompression.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2027
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 1) 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Arachnoiditis
• Syringomyelia

Intervention

Procedure:
• Subarachnoid-Subarachnoid (S-S) Bypass
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.
• Intradural Adhesion Lysis
Intradural spinal cord Adhesion Lysis

Locations

Country	Name	City	State
China	Fengzeng Jian	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 197 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complication	Reoperation,Wound infection,Aseptic meningitis,CSF fistula,Subcutaneous hydrops,Other complications	12 months
Secondary	improvement or resolution of the syrinx,	defined as > 50% improvement in length, maximal cross-sectional diameter, or both.	3-6, 12 and 24 months
Secondary	ASIA score	American Spinal Injury Association(ASIA) Score for evaluating the spinal cord function, degree of the spinal cord function, motor1-100, sensory 1-224, higher scores mean a better outcome	3-6, 12 and 24 months
Secondary	Klekamp and Sammi syringomyelia scale	for evaluating the spinal cord function, higher scores mean a better outcome	3-6, 12 and 24 months
Secondary	modified Japanese Orthopaedic Association Scores (mJOA)	Motor function, sensory, bladder function;for evaluating the spinal cord function;0-17, higher scores mean a better outcome	3-6, 12 and 24 months
Secondary	xuanwu syringomyelia scale	for evaluating the spinal cord function, for evaluating the spinal cord function;0-18, higher scores mean a worse outcome	3-6, 12 and 24 months