Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia

Syringomyelia Clinical Trial

Official title:

Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02669836
• Other study ID #: PCORI275- 201604044
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: July 31, 2020

Study information

• Verified date: August 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a posterior fossa decompression or a posterior fossa decompression with duraplasty results in better patient outcomes with fewer complications and improved quality of life in those who have Chiari malformation type I and syringomyelia.

Description:

Participants with Chiari Malformation type I and syringomyelia will be randomized to either have a posterior fossa decompression done with or without duraplasty. The participant will then return to the neurosurgeon's office at the following time points which are consistent with standard of care practice: < 6 weeks, 3-6 months, and 12 months. At these visits, the clinician will complete a physical exam and the participant will report on the prognosis of symptoms and complete two quality of life questionnaires. A brain and cervical spine MRI will be performed 12 months after the decompression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

Inclusion Criteria:

1. Age =21 years old

2. Chiari malformation type I =5 mm tonsillar ectopia

3. Syrinx between 3 mm and 6 mm

4. Chiari Severity Index (CSI) classification 1

5. 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:

1. CSI-2 or CSI-3 classification

2. Syrinx <3 mm and/or =6 mm

3. Neuro-imaging demonstrating basilar invagination

4. Clival canal angle <120° (signs of severe craniovertebral junction disease)

5. Chiari Malformation I + syringomyelia secondary to other pathology (e.g. a tumor)

6. Unable to share pre-decompression MRI of the brain and cervical and thoracic spine

7. Patients who do not wish to participate

Related Conditions & MeSH terms

• Arnold-Chiari Malformation
• Arnold-Chiari Malformation, Type 1
• Chiari Malformation Type I
• Congenital Abnormalities
• Syringomyelia
• Type I Arnold-Chiari Malformation

Intervention

Procedure:
• Posterior fossa decompression
Planned areas of bone removal from the suboccipital region of the skull and cervical l1 lamina. Then, the constricting epidural band at the level of the foramen magnum is resected.
• Dural Augmentation
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.

Locations

Country	Name	City	State
United States	St. Louis Children's Hospital	Saint Louis	Missouri

Sponsors (43)

Lead Sponsor

Collaborator

Washington University School of Medicine

Ann & Robert H Lurie Children's Hospital of Chicago, Arkansas Children's Hospital Research Institute, Baylor College of Medicine, Birmingham Children’s Hospital, Boston Children’s Hospital, Children's Healthcare of Atlanta, Children's Hospital and Health System Foundation, Wisconsin, Children's Hospital Colorado, Children's Hospital Los Angeles, Children's Hospital Medical Center, Cincinnati, Children's Hospital of Philadelphia, Children's National Research Institute, Children’s Hospital of New York-Presbyterian, Children’s Hospital of Phoenix, Columbia University, Dartmouth-Hitchcock Medical Center, Gillette Children's Specialty Healthcare, Johns Hopkins All Children's Hospital, Levine Children's Hospital, Mayo Clinic, MUSC Children’s Hospital, Nationwide Children's Hospital, Nicklaus Children's Hospital f/k/a Miami Children's Hospital, Oregon Health and Science University, Patient-Centered Outcomes Research Institute, Penn State University, Primary Children's Hospital, Seattle Children's Hospital, Stanford University, The Children’s Hospital at OU Medical Center, The University of Texas Health Science Center, Houston, University of California, University of Iowa, University of Michigan, University of Minnesota, University of Pittsburgh, University of Vermont Children’s Hospital, University of Wisconsin, Madison, UVA Children’s Hospital, Vanderbilt University, Wake Forest University, Yale University

Country where clinical trial is conducted

United States, 

References & Publications (43)

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* Note: There are 43 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of quality of life using Children Health Index Pediatrics (CHIP) questionnaire.		6 weeks from decompression
Other	Change of quality of life using Children Health Index Pediatrics (CHIP)questionnaire.		6 months from decompression
Other	Change of quality of life using Children Health Index Pediatrics (CHIP)questionnaire.		12 months from decompression
Other	Change of quality of life using Health Utilities 3 (HUI-3) questionnaire.		6 weeks from decompression
Other	Change of quality of life using Health Utilities 3 (HUI-3) questionnaire.		6 months from decompression
Other	Change of quality of life using Health Utilities 3 (HUI-3) questionnaire.		12 months from decompression
Primary	The number of participants with complications such as cerebrospinal fluid (CSF) leaks, pseudomeningoceles, infections, aseptic meningitis, hydrocephalus, and revisions.		6 months from decompression
Primary	The number of participants with complications such as cerebrospinal fluid (CSF) leaks, pseudomeningoceles, infections, aseptic meningitis, hydrocephalus, and revisions.		12 months from decompression
Secondary	Compare the change in size of syrinx before and after decompression.	Syrinx size will be measured with radiographic imaging pre-operatively and 12 months post-operatively.	12 months