Back to resultsPFDD Versus PFDRT in Chiari Decompression Surgery
Primary Purpose
Chiari Malformation Type I, Tonsillectomy
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Posterior fossa decompression with duraplasty
PFDD with tonsillar resection/reduction
Sponsored by
About this trial
This is an interventional treatment trial for Chiari Malformation Type I focused on measuring posterior fossa decompression with duraplasty, tonsillectomy, FMDD
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
Sites / Locations
- Fengzeng JianRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Posterior fossa decompression with duraplasty
PFDD with tonsillar resection/reduction
Arm Description
The bone is removed from the suboccipital region of the skull and Cervical 1 lamina so the constricting epidural band can be resected. Then, the dura is opened. Microsurgical dissection is performed and the dura is sewn closed.
The bone is removed from the suboccipital region of the skull and Cervical 1 lamina so the constricting epidural band can be resected. Then, the dura is opened and herniated tonsil will be manipulated. Microsurgical dissection is performed and the dura is sewn closed.
Outcomes
Primary Outcome Measures
improvement or resolution of the syrinx,
defined as > 50% improvement in length, maximal cross-sectional diameter, or both.
Secondary Outcome Measures
complication rates
Reoperation,Wound infection,Aseptic meningitis,CSF fistula,Subcutaneous hydrops,Other complications
Chicago Chiari Outcome Scale (CCOS) scale
visual analog scale (VAS)
degree of the pain
Japanese Orthopaedic Association (JOA) scale
Japanese Orthopaedic Association Scores
blood loss
blood loss
hospital stay
hospital stay
cost for the hospitalisation.
cost for the hospitalisation.
Full Information
NCT ID
NCT06079125
First Posted
August 20, 2023
Last Updated
October 9, 2023
Sponsor
Xuanwu Hospital, Beijing
1. Study Identification
Unique Protocol Identification Number
NCT06079125
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanwu Hospital, Beijing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chiari Malformation Type I, Tonsillectomy
Keywords
posterior fossa decompression with duraplasty, tonsillectomy, FMDD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
352 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Posterior fossa decompression with duraplasty
Arm Type
Experimental
Arm Description
The bone is removed from the suboccipital region of the skull and Cervical 1 lamina so the constricting epidural band can be resected. Then, the dura is opened. Microsurgical dissection is performed and the dura is sewn closed.
Arm Title
PFDD with tonsillar resection/reduction
Arm Type
Experimental
Arm Description
The bone is removed from the suboccipital region of the skull and Cervical 1 lamina so the constricting epidural band can be resected. Then, the dura is opened and herniated tonsil will be manipulated. Microsurgical dissection is performed and the dura is sewn closed.
Intervention Type
Procedure
Intervention Name(s)
Posterior fossa decompression with duraplasty
Intervention Description
The dura is opened sharply, exposing the cerebellar tonsils, brainstem, and upper spinal cord. After microsurgical dissection, the dura is sewn closed with a dural graft.
Intervention Type
Procedure
Intervention Name(s)
PFDD with tonsillar resection/reduction
Intervention Description
The dura is opened sharply, exposing the cerebellar tonsils, brainstem, and upper spinal cord. Then herniated tonsil will be manipulated and adhesion was released. After microsurgical manipulated, the dura is sewn closed with a dural graft.
Primary Outcome Measure Information:
Title
improvement or resolution of the syrinx,
Description
defined as > 50% improvement in length, maximal cross-sectional diameter, or both.
Time Frame
3-6, 12 and 24 months
Secondary Outcome Measure Information:
Title
complication rates
Description
Reoperation,Wound infection,Aseptic meningitis,CSF fistula,Subcutaneous hydrops,Other complications
Time Frame
12 months
Title
Chicago Chiari Outcome Scale (CCOS) scale
Time Frame
12 months
Title
visual analog scale (VAS)
Description
degree of the pain
Time Frame
12 months
Title
Japanese Orthopaedic Association (JOA) scale
Description
Japanese Orthopaedic Association Scores
Time Frame
12 months
Title
blood loss
Description
blood loss
Time Frame
12 months
Title
hospital stay
Description
hospital stay
Time Frame
12 months
Title
cost for the hospitalisation.
Description
cost for the hospitalisation.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
fengzeng jian, M.D.
Phone
+861083198899
Email
jianfengzeng@xwh.ccmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fengzeng jian
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Study Chair
Facility Information:
Facility Name
Fengzeng Jian
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan Chenghua
Email
yuanchenghua@ccmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Jian Fengzeng
Email
jianfengzeng@xwh.ccmu.edu.cn
First Name & Middle Initial & Last Name & Degree
jian guan, dr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32114543
Citation
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Results Reference
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PubMed Identifier
35652180
Citation
Chenghua Y, Min W, Wei L, Xinyu W, Fengzeng J. 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 Jan 10. doi: 10.5137/1019-5149.JTN.35727-21.5. Online ahead of print.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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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.
Results Reference
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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.
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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 18:1-9. doi: 10.3171/2019.8.PEDS19154. Online ahead of print.
Results Reference
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PFDD Versus PFDRT in Chiari Decompression Surgery
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