Clinical Trial: Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia
Brief 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.
Detailed Summary: 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.
Sponsor: Washington University School of Medicine
Current Primary Outcome:
- The number of participants with complications such as cerebrospinal fluid (CSF) leaks, pseudomeningoceles, infections, aseptic meningitis, hydrocephalus, and revisions. [ Time Frame: 6 months from decompression ]
- The number of participants with complications such as cerebrospinal fluid (CSF) leaks, pseudomeningoceles, infections, aseptic meningitis, hydrocephalus, and revisions. [ Time Frame: 12 months from decompression ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Compare the change in size of syrinx before and after decompression. [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: Washington University School of Medicine
Dates:
Date Received: January 13, 2016
Date Started: April 2016
Date Completion: April 2019
Last Updated: February 7, 2017
Last Verified: February 2017