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NCT Number: NCT06375759

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

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.

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Key information

Conditions

Syringomyelia Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fengzeng Jian

Beijing, Beijing Municipality, 100053, China

Location status: Recruiting

Location contact

Jian Fengzeng

CONTACT

[email protected]

Yuan Chenghua

CONTACT

[email protected]

jian guan, dr

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Subarachnoid-Subarachnoid (S-S) Bypass

Procedure

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

Intradural spinal cord Adhesion Lysis

Primary outcomes

  1. complication

    Time frame: 12 months

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

Secondary outcomes

  1. improvement or resolution of the syrinx,

    Time frame: 3-6, 12 and 24 months

    defined as > 50% improvement in length, maximal cross-sectional diameter, or both.

  2. ASIA score

    Time frame: 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

  3. Klekamp and Sammi syringomyelia scale

    Time frame: 3-6, 12 and 24 months

    for evaluating the spinal cord function, higher scores mean a better outcome

  4. modified Japanese Orthopaedic Association Scores (mJOA)

    Time frame: 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

  5. xuanwu syringomyelia scale

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

fengzeng jian

CONTACT

[email protected]

01083198899

yuan chenghua

CONTACT

[email protected]

01083198899

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Apr 19, 2024
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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