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

Capital Medical University

Status

Enrolling

Conditions

Syringomyelia

Treatments

Procedure: Intradural Adhesion Lysis

Procedure: Subarachnoid-Subarachnoid (S-S) Bypass

Study type

Interventional

Funder types

Other

Identifiers

NCT06375759

XWSSB

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Subarachnoid-Subarachnoid (S-S) Bypass

Experimental group

Description:

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.

Treatment:

Procedure: Subarachnoid-Subarachnoid (S-S) Bypass

Intradural Adhesion Lysis

Active Comparator group

Description:

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

Treatment:

Procedure: Intradural Adhesion Lysis