Active, not recruitingNCT06375759ClinicalTrials.gov record

Mis S-S Bypass Versus Adhesion Lysis in PTS

Syringomyelia · Spinal Cord Injury

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THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Not applicable
Age range: 18 years - 80 years
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 80 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

To determine whether A novel minimally invasive Subarachnoid-Subarachnoid (S-S) Bypass results in better patient outcomes with improved quality of life and fewer complications compared to intradural adhesion lysis in individuals with posttraumatic Syringomyelia.

Read the full description

Recently, our team was the first to report in the Journal of Neurosurgery: Spine (JNSSPINE) a minimally invasive subarachnoid-subarachnoid cerebrospinal fluid bypass technique for the treatment of post-traumatic syringomyelia. This novel approach has attracted considerable international attention and achieved favorable clinical outcomes for the treatment of post-traumatic syringomyelia. To establish high-level evidence, participants with posttraumatic Syringomyelia will be randomized to either have A novel minimally invasive 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, 12±2months. 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, 12±2months after the surgery.

The multicenter design, target sample size, assessor masking, eligibility criteria, and outcome hierarchy described in this record were specified in the ethics-approved protocol before enrollment of the first participant. The initial public registry entry did not fully reflect the finalized protocol. The registry record was corrected on 2026-11, before database lock and before any unblinded between-group analysis, to align it with the prospectively approved protocol.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

History of traumatic spinal cord injury
Evidence of progressive neurological deficit and/or pain syndrome
MRI showing a syringomyelia due to spinal cord injury
Both myelography and MRI show extensive arachnopathy exceeding 2 spinal segments in length

Exclusion Criteria:

Chiari malformation
Myelomalacia
Subarachnoid cyst
Syringomyelia due to other spinal diseases (such as degenerative spinal disease)
Marked spinal kyphosis

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Treatment, groups and participation

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Assignment: Random assignment
Masking: Single masked

A novel minimally invasive Subarachnoid-Subarachnoid (S-S) Bypass

After dissections of the normal arachnoid mater at the cephalic and caudal sites, 2 tubes made of medical grade silicone (internal diameter 1.1 mm, external diameter 2.5 mm; Sophysa Systems Corp.) were inserted into the cephalic and caudal ends of the normal subarachnoid space.

The tubes were only inserted into the normal subarachnoid space, with the remaining portions running subcutaneously.

Procedure: A novel minimally invasive Subarachnoid-Subarachnoid (S-S) Bypass

Intradural Adhesion Lysis

The dura is opened sharply, exposing the spinal cord. After microsurgical dissection adhesion, the dura is sewn closed with a dural graft.

Procedure: Intradural Adhesion Lysis

A novel minimally invasive Subarachnoid-Subarachnoid (S-S) Bypass PROCEDURE

After dissections of the normal dura mater at the cranial and caudal sites, a tunneling device (a passer) was used to create a subcutaneous tunnel. Two tubes made of medical grade silicone (internal diameter 1.1 mm, external diameter 2.5 mm; Sophysa Systems Corp.) were inserted into the cranial and caudal ends of the normal subarachnoid space.

Under the surgical microscope, the normal dura was incised bilaterally approximately 3 mm on either side of the midline at the cranial end. The arachnoid was opened, with the proximal ends of the drainage tubes inserted approximately 5 cm into the normal subarachnoid space, with the remaining portions running subcutaneously. No loosening operations were performed at the site of injury. The incisions were sutured layer by layer

Intradural Adhesion Lysis PROCEDURE

Intradural spinal cord Adhesion Lysis

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