MedTrace Logo

PFDD Versus PFDRT in Chiari Decompression Surgery

NCT06079125 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-02-17

No results posted yet for this study

Summary

The purpose of this study is to determine whether a posterior fossa decompression and duraplasty with or without tonsil manipulation results in better patient outcomes with fewer complications and improved quality of life in those who have Chiari malformation type I and syringomyelia.

Conditions

  • Chiari Malformation Type I
  • Tonsillectomy

Interventions

PROCEDURE

Posterior fossa decompression with duraplasty

In brief, a midline incision was made from the inion to the C2 level. A piece of autologous fascia was harvested from the muscular fascia layer. Paraspinal muscles were dissected to expose the occipital bone, posterior arch of the atlas and axis, spinous process, and lamina. The inferior portion of the occipital bone and approximately 2 cm of the posterior arch of C1 were removed, achieving bony decompression (approximately 2.5-3 × 2.5-3 cm). Once the dura was exposed, the atlanto-occipital membrane was coagulated and dissected off the dura. The dura was then incised in a Y-shaped fashion, with care taken to preserve the underlying arachnoid. Watertight duraplasty was performed using the autologous fascia. The wound was closed in anatomical layers.

PROCEDURE

PFDD with tonsillar resection/reduction

Briefly, a midline incision approximately 3-4 cm posterior to the foramen magnum is made. The incision is deepened layer by layer along the midline to reach the occipital bone, exposing the posterior margin of the foramen magnum and part of the occipital squama. The posterior edge of the foramen magnum is opened, and part of the occipital squama is removed up to the junction of the cerebellar vermis and cerebellar tonsils. The occipitoatlantal fascia is exposed and dissected. The dura mater and arachnoid mater are incised longitudinally and suspended bilaterally to provide a clear surgical field. The primary objectives of resection were: ensuring no significant obstruction of CSF circulation at the foramen magnum and the foramen of Magendie under natural conditions. Preventing occlusion of the foramen of Magendie caused by herniated cerebellar tonsils or any membranous structures under natural conditions. The dura is closed in situ.

Sponsors & Collaborators

  • The First Hospital of Hebei Medical University

    collaborator OTHER

  • Beijing Jiangong Hospital

    collaborator UNKNOWN

  • Xuanwu Hospital, Beijing

    lead OTHER

Principal Investigators

  • fengzeng jian · Xuanwu Hospital, Beijing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2026-02-12
Completion
2026-02-12

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06079125 on ClinicalTrials.gov