CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 162 enrolled
Drug / intervention
Posterior fossa decompression +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02669836
NCT02669836N/ACompleted
CompareCT.gov

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

Washington University School of Medicine·interventional·Posted Feb 1, 2016·Updated Oct 31, 2024

In Brief

A clinical study evaluating Posterior fossa decompression and Dural Augmentation for Arnold-Chiari Malformation, Type 1 and 3 related conditions. Completed, enrolled 162 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArnold-Chiari Malformation, Type 1, Chiari Malformation Type I, Type I Arnold-Chiari Malformation, Syringomyelia
CountriesUnited States
CollaboratorsPatient-Centered Outcomes Research Institute, Johns Hopkins All Children's Hospital, Arkansas Children's Hospital Research Institute, Boston Children's Hospital, Children's Healthcare of Atlanta, Dartmouth-Hitchcock Medical Center, Children's Hospital Colorado, Birmingham Children's Hospital, Morgan Stanley Children's Hospital, Phoenix Children's Hospital, Children's Hospital and Health System Foundation, Wisconsin, Children's National Research Institute, Children's Hospital of Philadelphia, Children's Hospital Medical Center, Cincinnati, Columbia University, Gillette Children's Specialty Healthcare, Levine Children's Hospital, Children's Hospital Los Angeles, Ann & Robert H Lurie Children's Hospital of Chicago, Mayo Clinic, Nicklaus Children's Hospital f/k/a Miami Children's Hospital, Medical University of South Carolina Shawn Jenkins Children's Hospital, Oregon Health and Science University, Penn State University, University of Pittsburgh, Primary Children's Hospital, Seattle Children's Hospital, Stanford University, Baylor College of Medicine, The Children's Hospital at OU Medical Center, Nationwide Children's Hospital, University of California, University of Iowa, University of Michigan, The University of Texas Health Science Center, Houston, University of Minnesota, University of Vermont, UVA Children's Hospital, University of Wisconsin, Madison, Vanderbilt University, Wake Forest University, Yale University

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 1, 2016
Enrollment StartApr 1, 2016
Primary CompletionJul 31, 2020
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 10.4 years ago

Interventions

Posterior fossa decompressionprocedure

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 Augmentationprocedure

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.