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Activo, sin reclutamientoNCT06375759Registro de ClinicalTrials.gov

Mis S-S Bypass Versus Adhesion Lysis in PTS

Syringomyelia · Spinal Cord Injury

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio
De intervención
Fase
No aplica
Rango de edad
18 años - 80 años
Sexo admitido
Todos los sexos
Voluntarios sanos
No aceptados
Participantes
80 Real

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

Leer la descripción completa

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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
Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
Asignación al azar
Enmascaramiento
Enmascaramiento simple
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

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

The Number of Patients With Clinical Improvement

Plazo: 3-6, 12±2 months

Number of patients who experienced improvement in clinical or neurological symptoms-such as; sensory dysfunction (numbness, paresthesia, or sensory loss), neuropathic pain, motor weakness, gait impairment, bowel and bladder dysfunction, and spasticity.

Medidas secundarias

change of the volume of syrinx,

Plazo: 3-6, 12±2 months

defined as change in length, maximal cross-sectional diameter, or both.

Klekamp and Sammi syringomyelia scale

Plazo: 3-6, 12±2 months

for evaluating the spinal cord function, Each item is scored on a scale from 0 to 5, with 5 representing the best possible functional status.

modified Japanese Orthopaedic Association Scores (mJOA)

Plazo: 3-6, 12±2 months

Motor function, sensory, bladder function;for evaluating the spinal cord function;0-17, higher scores mean a better outcome

xuanwu syringomyelia scale

Plazo: 3-6, 12±2 months

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

complication

Plazo: 3-6, 12±2 months

various complication, such as fever, csf fistula

ASIA score

Plazo: 3-6, 12±2 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

VAS score

Plazo: 3-6, 12±2 months

VAS Score for evaluating the degree of the pain, VAS 0-10, higher scores mean a worse outcome

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

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Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

Fengzeng JianBeijing, Beijing Municipality, ChinaEstado desconocido

Equipo y fechas

Patrocinador principal
Xuanwu Hospital, Beijing
Inicio del estudio
25 jun 2025 Real
Finalización primaria
25 jun 2027 Estimado
Finalización del estudio
25 jun 2027 Estimado
Primera publicación
19 abr 2024 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.

Título oficial del estudio

A Novel Minimally Invasive Subarachnoid-Subarachnoid (S-S) Bypass Versus Adhesion Lysis in Post-traumatic Syringomyelia

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026