Syringomyelia
Conditions
Keywords
syringomyelia
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.
Interventions
PROCEDURESubarachnoid-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.
PROCEDUREIntradural Adhesion Lysis
Intradural spinal cord Adhesion Lysis
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complication | 12 months | Reoperation,Wound infection,Aseptic meningitis,CSF fistula,Subcutaneous hydrops,Other complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| improvement or resolution of the syrinx, | 3-6, 12 and 24 months | defined as \> 50% improvement in length, maximal cross-sectional diameter, or both. |
| 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 |
| 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 |
Countries
China
Contacts
Primary Contactfengzeng jian
Backup Contactyuan chenghua
Outcome results
None listed