About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Chiari-malformation, myelomalacia, subarachnoid cyst, syringomyelia due to other spinal diseases (such as degenerative spinal disease)
Trial design
Parallel
Treatments tested in this trial
Subarachnoid-Subarachnoid (S-S) Bypass
Procedure/SurgeryThe 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 Adhesion Lysis
Procedure/SurgeryIntradural spinal cord Adhesion Lysis
Treatment groups
Trial outcomes
Primary outcomes
complication
Reoperation,Wound infection,Aseptic meningitis,CSF fistula,Subcutaneous hydrops,Other complications
Secondary outcomes
improvement or resolution of the syrinx,
defined as \> 50% improvement in length, maximal cross-sectional diameter, or both.
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
Klekamp and Sammi syringomyelia scale
for evaluating the spinal cord function, higher scores mean a better outcome
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
Sponsors and contacts
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