Subarachnoid-Subarachnoid (S-S) Bypass Versus Adhesion Lysis in Spinal Arachnoiditis and Syringomyelia
- Conditions
- Syringomyelia
- Interventions
- Procedure: Subarachnoid-Subarachnoid (S-S) BypassProcedure: Intradural Adhesion Lysis
- Registration Number
- NCT06375759
- Lead Sponsor
- Xuanwu Hospital, Beijing
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
-
- 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.
- Chiari-malformation, myelomalacia, subarachnoid cyst, syringomyelia due to other spinal diseases (such as degenerative spinal disease)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Subarachnoid-Subarachnoid (S-S) Bypass Subarachnoid-Subarachnoid (S-S) Bypass 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. Intradural Adhesion Lysis Intradural Adhesion Lysis The dura is opened sharply, exposing the spinal cord. After microsurgical dissection adhesion, the dura is sewn closed with a dural graft.
- Primary Outcome Measures
Name Time Method complication 12 months Reoperation,Wound infection,Aseptic meningitis,CSF fistula,Subcutaneous hydrops,Other complications
- Secondary Outcome Measures
Name Time Method improvement or resolution of the syrinx, 3-6, 12 and 24 months defined as \> 50% improvement in length, maximal cross-sectional diameter, or both.
modified Japanese Orthopaedic Association Scores (mJOA) 3-6, 12 and 24 months Motor function， sensory， bladder function；for evaluating the spinal cord function；0-17， higher scores mean a better outcome
xuanwu syringomyelia scale 3-6, 12 and 24 months for evaluating the spinal cord function, for evaluating the spinal cord function；0-18， higher scores mean a worse outcome
ASIA score 3-6, 12 and 24 months 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
Klekamp and Sammi syringomyelia scale 3-6, 12 and 24 months for evaluating the spinal cord function, higher scores mean a better outcome
Trial Locations
- Locations (1)
Fengzeng Jian
🇨🇳Beijing, Beijing, China