What is the Outcome Study?
- It is a prospective study looking at surgical outcomes for Chiari I-associated syringomyelia
- It is the first Chiari/Syringomyelia multi-center trial in the U.S., with a total of 12 facilities participating
- This is a pilot study that will attempt to compare three main surgical techniques:
- Bone decompression
- Bone decompression with duraplasty
- Bone decompression with duraplasty and tonsillar shrinkage
- Study will collect data on clinical characteristics (symptoms and signs) and radiographical characteristics (extent of tonsillar descent, size of syrinx) for patients who undergo surgical intervention
- It is endorsed by the American Society of Pediatric Neurosurgeons
Goals of the study:
- Provide data to help determine if one surgical procedure is more effective at resolving syrinxes
- Identify characteristics that might predict favorable surgical outcome
- Since this is a pilot study, the goal is not to give a definite answer about which procedure is best, but to show the feasibility of such studies and facilitate the funding and implementation of future larger studies. The ultimate goal is thus to gather preliminary data that will allow researchers to seek federal funding for a larger, multicenter trial for Chiari I and syringomyelia.
Why is this study so unique?
Most studies published to date are single institution and retrospective. This makes them less than adequate at determining the effectiveness of surgery with objectivity and reasonable accuracy. This is the first attempt at having multiple centers collaborate to answer a question in Chiari and syringomyelia using objective methodology.
