PFDD Versus PFDRT in Chiari Decompression Surgery

NCT06079125 | Completed DMC

• 1 other identifier: DDCS
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

posterior fossa decompression with duraplasty; tonsillectomy; foramen magnum and foramen of Magendie dredging; chiari malformation; syringomyelia

Outcome Measures

Primary Outcomes (1)

• improvement or resolution of the syrinx,

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

  3-6, 12 and 24 months

Secondary Outcomes (7)

• complication rates

  12 months

• Chicago Chiari Outcome Scale (CCOS) scale

  12 months

• visual analog scale (VAS)

  12 months

• Japanese Orthopaedic Association (JOA) scale

  12 months

• blood loss

  12 months

Study Arms (2)

Posterior fossa decompression with duraplasty

EXPERIMENTAL

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: Posterior fossa decompression with duraplasty

PFDD with tonsillar resection/reduction

EXPERIMENTAL

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.

Procedure: PFDD with tonsillar resection/reduction

Interventions

Posterior fossa decompression with duraplasty PROCEDURE

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.

Posterior fossa decompression with duraplasty

PFDD with tonsillar resection/reduction PROCEDURE

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.

PFDD with tonsillar resection/reduction

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥14 years old
• Chiari malformation type I ≥5 mm tonsillar ectopia
• a syrinx with a width \> 50% of the cross-sectional diameter of the spinal cord , and a length of at least 2 cervical and/or thoracic vertebral segments.
• MRI of the brain and cervical and thoracic spine are required prior to surgery and must be available to be shared with the Data Coordinating Center

You may not qualify if:

• included one or more of the following preexisting conditions: hydrocephalus; tumor; brain trauma; stroke; meningitis; abscess;
• other congenital anomalies of the brain or skull base; vertebral anomalies (i.e., Klippel-Feil, atlas assimilation, etc.);
• degenerative or demyelinating disease;
• CM-I without syringomyelia;
• syringomyelia with cerebellar tonsils in a normal position;
• fibromyalgia;
• chronic fatigue syndrome;
• prior posterior fossa surgery.
• Unable to share pre-decompression MRI of the brain and spine Patients who do not wish to participate

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• The First Hospital of Hebei Medical University: collaborator
• Beijing Jiangong Hospital: collaborator

Study Sites (1)

Fengzeng Jian

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (6)

• Hale AT, Adelson PD, Albert GW, Aldana PR, Alden TD, Anderson RCE, Bauer DF, Bonfield CM, Brockmeyer DL, Chern JJ, Couture DE, Daniels DJ, Durham SR, Ellenbogen RG, Eskandari R, George TM, Grant GA, Graupman PC, Greene S, Greenfield JP, Gross NL, Guillaume DJ, Heuer GG, Iantosca M, Iskandar BJ, Jackson EM, Johnston JM, Keating RF, Leonard JR, Maher CO, Mangano FT, McComb JG, Meehan T, Menezes AH, O'Neill B, Olavarria G, Park TS, Ragheb J, Selden NR, Shah MN, Smyth MD, Stone SSD, Strahle JM, Wait SD, Wellons JC, Whitehead WE, Shannon CN, Limbrick DD; Park-Reeves Syringomyelia Research Consortium Investigators. Factors associated with syrinx size in pediatric patients treated for Chiari malformation type I and syringomyelia: a study from the Park-Reeves Syringomyelia Research Consortium. J Neurosurg Pediatr. 2020 Mar 6;25(6):629-639. doi: 10.3171/2020.1.PEDS19493. Print 2020 Jun 1.

  PMID: 32114543 BACKGROUND

• Yuan C, Wei M, Li W, Wang X, Jian F. Comparison of Foramen Magnum Decompression with and without Duraplasty in the Treatment of Adult Chiari Malformation Type I: A Meta-Analysis and Systematic Review. Turk Neurosurg. 2022;32(6):893-902. doi: 10.5137/1019-5149.JTN.35727-21.5.

  PMID: 35652180 BACKGROUND

• 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.

  PMID: 32805463 BACKGROUND

• Yuan C, Guan J, Du Y, Zhang C, Ma L, Yao Q, Cheng L, Liu Z, Wang K, Duan W, Wang X, Wu H, Chen Z, Jian F. Repeat Craniocervical Decompression in Patients with a Persistent or Worsening Syrinx: A Preliminary Report and Early Results. World Neurosurg. 2020 Jun;138:e95-e105. doi: 10.1016/j.wneu.2020.02.015. Epub 2020 Feb 12.

  PMID: 32059967 BACKGROUND

• Heiss JD, Jarvis K, Smith RK, Eskioglu E, Gierthmuehlen M, Patronas NJ, Butman JA, Argersinger DP, Lonser RR, Oldfield EH. Origin of Syrinx Fluid in Syringomyelia: A Physiological Study. Neurosurgery. 2019 Feb 1;84(2):457-468. doi: 10.1093/neuros/nyy072.

  PMID: 29618081 BACKGROUND

• Koueik J, Sandoval-Garcia C, Kestle JRW, Rocque BG, Frim DM, Grant GA, Keating RF, Muh CR, Oakes WJ, Pollack IF, Selden NR, Tubbs RS, Tuite GF, Warf B, Rajamanickam V, Broman AT, Haughton V, Rebsamen S, George TM, Iskandar BJ. Outcomes in children undergoing posterior fossa decompression and duraplasty with and without tonsillar reduction for Chiari malformation type I and syringomyelia: a pilot prospective multicenter cohort study. J Neurosurg Pediatr. 2019 Oct 18;25(1):21-29. doi: 10.3171/2019.8.PEDS19154. Print 2020 Jan 1.

  PMID: 31628281 BACKGROUND

MeSH Terms

Conditions

Arnold-Chiari Malformation; Syringomyelia

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spinal Cord Diseases; Central Nervous System Diseases

Study Officials

• fengzeng jian

  Xuanwu Hospital, Beijing

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2023
• First Posted: October 12, 2023
• Study Start: January 31, 2024
• Primary Completion: February 12, 2026
• Study Completion: February 12, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)