Clinical trial NCT06079125: PFDD Versus PFDRT in Chiari Decompression Surgery
Official title: Type of Surgical Intervention for Chiari Malformation-syringomyelia: a Multicenter Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chiari Malformation Type I
Tonsillectomy
Keywords: posterior fossa decompression with duraplasty
tonsillectomy
FMDD
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 352
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Participants with Chiari Malformation type I and syringomyelia will be randomized to either have a posterior fossa decompression and duraplasty with or without tonsil manipulation. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: improvement or resolution of the syrinx,
timeFrame: 3-6, 12 and 24 months
Secondary outcomes:
measure: complication rates
timeFrame: 12 months
measure: Chicago Chiari Outcome Scale (CCOS) scale
timeFrame: 12 months
measure: visual analog scale (VAS)
timeFrame: 12 months
measure: Japanese Orthopaedic Association (JOA) scale
timeFrame: 12 months
measure: blood loss
timeFrame: 12 months
measure: hospital stay
timeFrame: 12 months
measure: cost for the hospitalisation.
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fengzeng Jian
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: fengzeng jian
role: STUDY_CHAIR
References:
citation: 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.
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citation: 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.
citation: 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.
citation: 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.