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

ConditionSyringomyelia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXuanwu Hospital, Beijing

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Subarachnoid-Subarachnoid (S-S) Bypass

    Procedure/Surgery

    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 Adhesion Lysis

    Procedure/Surgery

    Intradural spinal cord Adhesion Lysis

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Subarachnoid-Subarachnoid (S-S) BypassExperimental treatment 1 intervention
Group B: Intradural Adhesion LysisActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

complication

Reoperation,Wound infection,Aseptic meningitis,CSF fistula,Subcutaneous hydrops,Other complications

Time frame
12 months

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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