AzTrials
AzTrials

SyringomyeliaNCT06375759

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

A study testing Subarachnoid-Subarachnoid (S-S) Bypass and Intradural Adhesion Lysis in people with Syringomyelia, run by Xuanwu Hospital, Beijing at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Syringomyelia
What is being tested?
Subarachnoid-Subarachnoid (S-S) Bypass and Intradural Adhesion Lysis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
Apr 2024to Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Chiari-malformation, myelomalacia, subarachnoid cyst, syringomyelia due to other spinal diseases (such as degenerative spinal disease)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

fengzeng jian contact

01083198899

jianfengzeng@xwh.ccmu.edu.cn

yuan chenghua contact

01083198899

yuanchenghua@ccmu.edu.cn

China1 site, 1 recruiting

  • Fengzeng Jian

    Beijing, Beijing Municipality, 100053

    Yuan Chenghua, yuanchenghua@ccmu.edu.cn

    Jian Fengzeng, jianfengzeng@xwh.ccmu.edu.cn

    Recruiting

Other trials in China

About this study

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.

Read the 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.

Conditions
Syringomyelia
Being tested
Subarachnoid-Subarachnoid (S-S) Bypass, Intradural Adhesion Lysis
Keywords
syringomyelia
Medical subject headings
Syringomyelia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subarachnoid-Subarachnoid (S-S) BypassProcedure or 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 LysisProcedure or surgery

    Intradural spinal cord Adhesion Lysis

Study groups in NCT06375759
Study groupRoleWhat they receive
Subarachnoid-Subarachnoid (S-S) BypassExperimentalAfter 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. The total length of the tube was equal to the distance between the cephalic and caudal ends of the normal dissected arachnoid mater, along with approximately 4 cm of extra tubing.
Receives: Procedure: Subarachnoid-Subarachnoid (S-S) Bypass
Intradural Adhesion LysisActive comparatorThe dura is opened sharply, exposing the spinal cord. After microsurgical dissection adhesion, the dura is sewn closed with a dural graft.
Receives: Procedure: Intradural Adhesion Lysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. complication

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

    Measured: 12 months

Secondary outcomes (5)

  1. improvement or resolution of the syrinx,

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

    Measured: 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

    Measured: 3-6, 12 and 24 months

  3. Klekamp and Sammi syringomyelia scale

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

    Measured: 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

    Measured: 3-6, 12 and 24 months

  5. xuanwu syringomyelia scale

    for evaluating the spinal cord function, for evaluating the spinal cord function；0-18， higher scores mean a worse outcome

    Measured: 3-6, 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2024
  2. Study startApr 2024 (estimated)
  3. Primary completionApr 2025 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06375759
Sponsor's protocol ID
XWSSB
Status last verified
Apr 2024
First submitted
16 Apr 2024
Last updated
19 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hayashi T, Ueta T, Kubo M, Maeda T, Shiba K. Subarachnoid-subarachnoid bypass: a new surgical technique for posttraumatic syringomyelia. J Neurosurg Spine. 2013 Apr;18(4):382-7. doi: 10.3171/2013.1.SPINE12828. Epub 2013 Feb 22.

    PubMed 23432327

  • Heiss JD. Cerebrospinal Fluid Hydrodynamics in Chiari I Malformation and Syringomyelia: Modeling Pathophysiology. Neurosurg Clin N Am. 2023 Jan;34(1):81-90. doi: 10.1016/j.nec.2022.08.007. Epub 2022 Nov 3.

    PubMed 36424067

  • Hemley SJ, Bilston LE, Cheng S, Stoodley MA. Aquaporin-4 expression and blood-spinal cord barrier permeability in canalicular syringomyelia. J Neurosurg Spine. 2012 Dec;17(6):602-12. doi: 10.3171/2012.9.SPINE1265. Epub 2012 Oct 19.

    PubMed 23082850

  • Guan J, Yuan C, Yao Q, Du Y, Fang Z, Zhang L, Jia S, Zhang C, Liu Z, Wang K, Duan W, Wang Z, Wang X, Wu H, Chen Z, Jian F. A novel scoring system for assessing adult syringomyelia associated with CM I treatment outcomes. Acta Neurol Belg. 2023 Jun;123(3):807-814. doi: 10.1007/s13760-023-02264-4. Epub 2023 Apr 12.

    PubMed 37046133

  • Guan J, Yuan C, Zhang C, Ma L, Yao Q, Cheng L, Liu Z, Wang K, Duan W, Wang X, Wu H, Chen Z, Jian F. Intradural Pathology Causing Cerebrospinal Fluid Obstruction in Syringomyelia and Effectiveness of Foramen Magnum and Foramen of Magendie Dredging Treatment. World Neurosurg. 2020 Dec;144:e178-e188. doi: 10.1016/j.wneu.2020.08.068. Epub 2020 Aug 15.

    PubMed 32805463

  • Yuan C, Xia P, Duan W, Wang J, Guan J, Du Y, Zhang C, Liu Z, Wang K, Wang Z, Wang X, Wu H, Chen Z, Jian F. Long-Term Impairment of the Blood-Spinal Cord Barrier in Patients With Post-Traumatic Syringomyelia and its Effect on Prognosis. Spine (Phila Pa 1976). 2024 Mar 15;49(6):E62-E71. doi: 10.1097/BRS.0000000000004884. Epub 2023 Nov 28.

    PubMed 38014747

Questions about this trial

What is this clinical trial studying?

A study testing Subarachnoid-Subarachnoid (S-S) Bypass and Intradural Adhesion Lysis in people with Syringomyelia, run by Xuanwu Hospital, Beijing at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact fengzeng jian (01083198899, jianfengzeng@xwh.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

complication (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06375759, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in