NCT06375759

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Syringomyelia

Interventions

Type	Name	Description
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.
PROCEDURE	Intradural Adhesion Lysis	Intradural spinal cord Adhesion Lysis

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-04-01
• Completion: 2027-04-01
• First posted: 2024-04-19
• Last updated: 2024-04-19

Locations

1 site across 1 country: China