Chiari Type I Malformation Treatment Comparison

Protocol Description

The purpose of this research study is to compare the two most common surgical treatments for Chiari type I malformation with syringomyelia (CM+SM): posterior fossa decompression (PFD) or PDF with duraplasty (PFDD). The fundamental difference between the two approaches is that PFDD also surgically opens the dura, the thickest and strongest of the three linings of the central nervous system. Researchers will evaluate each approach in terms of effectiveness, quality of life, and surgical complications.

Eligibility Criteria

This study is enrolling male and females through age 21, diagnosed with CM+SM who will be undergoing surgical treatment for their condition.
Males and Females: Through age 21

Requirements

Through random selection participants will receive either the PFD or PFDD surgical treatment. Participants will be followed at specific intervals for up to 14 months after surgery, as is required for standard care for a procedure of this type. Information about patients’ health and response to treatment will be collected along with quality of life information that will assess cognitive, psychosocial, and physical symptoms.
Visits: None beyond normal clinical care
Duration: Up to 14 months

Status: Open to Enrollment

Source(s) of Support

Washington University School of Medicine
Patient-Centered Outcomes Research Institute

Additional Information

Study Description at National Institutes of Health
Neurosurgery Research

Primary Investigator

Stephanie Greene, MD, PHD

Contact Information

For more information about the study or enrollment, please contact:
Kimberly Diamond, BS, BA
412-692-9965