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PFDD Versus PFDRT in Chiari Decompression Surgery

Sponsor
Xuanwu Hospital, Beijing (Other)
Overall Status
Recruiting
CT.gov ID
NCT06079125
Collaborator
(none)
352
Enrollment
1
Location
2
Arms
50
Anticipated Duration (Months)
7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Posterior fossa decompression with duraplasty
  • Procedure: PFDD with tonsillar resection/reduction
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
352 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Type of Surgical Intervention for Chiari Malformation-syringomyelia: a Multicenter Randomized Controlled Study
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2027
Anticipated Study Completion Date :
Dec 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Posterior fossa decompression with duraplasty

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.

Procedure: Posterior fossa decompression with duraplasty
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.
Experimental: PFDD with tonsillar resection/reduction

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.

Procedure: PFDD with tonsillar resection/reduction
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.

Outcome Measures

Primary Outcome Measures

  1. improvement or resolution of the syrinx, [3-6, 12 and 24 months]

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

Secondary Outcome Measures

  1. complication rates [12 months]

    Reoperation,Wound infection,Aseptic meningitis,CSF fistula,Subcutaneous hydrops,Other complications

  2. Chicago Chiari Outcome Scale (CCOS) scale [12 months]

  3. visual analog scale (VAS) [12 months]

    degree of the pain

  4. Japanese Orthopaedic Association (JOA) scale [12 months]

    Japanese Orthopaedic Association Scores

  5. blood loss [12 months]

    blood loss

  6. hospital stay [12 months]

    hospital stay

  7. cost for the hospitalisation. [12 months]

    cost for the hospitalisation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fengzeng Jian Beijing Beijing China 100053

Sponsors and Collaborators

  • Xuanwu Hospital, Beijing

Investigators

  • Study Chair: fengzeng jian, Xuanwu Hospital, Beijing

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier:
NCT06079125
Other Study ID Numbers:
  • DDCS
First Posted:
Oct 12, 2023
Last Update Posted:
Oct 12, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xuanwu Hospital, Beijing
posterior fossa decompression with duraplasty
tonsillectomy
FMDD
Additional relevant MeSH terms:
Arnold-Chiari Malformation
Congenital Abnormalities

Study Results

No Results Posted as of Oct 12, 2023