PFD vs PFDD trial

This is a prospective, cluster randomization study that is designed to address the critical information gap in the management of Chiari type I malformation (CM) and syringomyelia (SM) by comparing the risk of harm, effectiveness, and impact on Quality of Life (QOL) of posterior fossa decompression with duraplasty (PFDD) and extradural posterior fossa decompression without dural opening or duraplasty (PFD). The study will help patients and families make informed healthcare decisions about how best to help their children while minimizing the risk of harm. The central hypothesis of this study is that, compared with PFDD, PFD will result in fewer surgical complications and thus less harm to patients within 12 months of surgery. With a more favorable risk profile, a non-inferior effect on clinical outcome and, syrinx size compared with PFDD, PFD will be associated with superior QOL.