PFDD Versus PFDRT in Chiari Decompression Surgery

October 9, 2023 updated by: Xuanwu Hospital, Beijing

Type of Surgical Intervention for Chiari Malformation-syringomyelia: a Multicenter Randomized Controlled Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

352

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improvement or resolution of the syrinx,
Time Frame: 3-6, 12 and 24 months
defined as > 50% improvement in length, maximal cross-sectional diameter, or both.
3-6, 12 and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complication rates
Time Frame: 12 months
Reoperation,Wound infection,Aseptic meningitis,CSF fistula,Subcutaneous hydrops,Other complications
12 months
Chicago Chiari Outcome Scale (CCOS) scale
Time Frame: 12 months
12 months
visual analog scale (VAS)
Time Frame: 12 months
degree of the pain
12 months
Japanese Orthopaedic Association (JOA) scale
Time Frame: 12 months
Japanese Orthopaedic Association Scores
12 months
blood loss
Time Frame: 12 months
blood loss
12 months
hospital stay
Time Frame: 12 months
hospital stay
12 months
cost for the hospitalisation.
Time Frame: 12 months
cost for the hospitalisation.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Investigators

  • Study Chair: fengzeng jian, Xuanwu Hospital, Beijing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

August 20, 2023

First Submitted That Met QC Criteria

October 9, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DDCS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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