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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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 spinal cord Adhesion Lysis
Fengzeng Jian
Beijing, Beijing Municipality, China
RECRUITINGcomplication
Reoperation,Wound infection,Aseptic meningitis,CSF fistula,Subcutaneous hydrops,Other complications
Time frame: 12 months
improvement or resolution of the syrinx,
defined as \> 50% improvement in length, maximal cross-sectional diameter, or both.
Time frame: 3-6, 12 and 24 months
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
Time frame: 3-6, 12 and 24 months
Klekamp and Sammi syringomyelia scale
for evaluating the spinal cord function, higher scores mean a better outcome
Time frame: 3-6, 12 and 24 months
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
Time frame: 3-6, 12 and 24 months
xuanwu syringomyelia scale
for evaluating the spinal cord function, for evaluating the spinal cord function;0-18, higher scores mean a worse outcome
Time frame: 3-6, 12 and 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.