Decompression with or without Duraplasty for Chiari I and Syringomyelia
BACKGROUND: In children with Chiari type I malformation and syringomyelia, neurosurgical posterior fossa decompression (PFD) provides clinical improvement, but whether duraplasty (incising the dura and placing a dural graft) improves outcomes is unclear. METHODS: We conducted a multicenter, cluster-randomized, controlled trial of PFD with duraplasty (PFD-D) as compared with PFD alone. Persons 21 years of age or younger with cerebellar tonsillar ectopia of at least 5 mm and a maximum syrinx diameter of 3.0 to 9.9 mm were enrolled at 38 centers. Centers were cluster-randomized: all the participants within each center underwent the same intervention. The primary outcome was surgical complications within 6 months. Secondary outcomes were clinical improvement, syrinx reduction, and repeat decompression at 10 to 24 months and the change in overall health-related quality of life at 6 to 24 months. RESULTS: A total of 162 participants were included in the trial, of whom 78 were assigned to undergo PFD-D and 84 to undergo PFD alone. The percentage of participants with complications within 6 months was 14% with PFD-D and 6% with PFD (adjusted odds ratio, 2.59; 95% confidence interval [CI], 0.86 to 7.84; P = 0.11). At 24 months, the percentage of participants with clinical improvement was 58% with PFD-D and 46% with PFD; the mean (±SD) syrinx reduction was 3.08±2.33 mm and 1.22±1.79 mm, respectively; and the percentage of participants with repeat decompression was 3% and 14%. Changes in health-related quality of life were similar in the two groups. CONCLUSIONS: The percentage of participants with surgical complications did not differ significantly between those who underwent PFD-D and and those who underwent PFD alone. Larger trials are needed to determine the relative benefits and risks of these two procedures. (Funded by the Patient-Centered Outcomes Research Institute and others; ClinicalTrials.gov number, NCT02669836.).
Authors
- Thanda Meehan
- Gregory Heuer
- Rick Labuda
- Francesco T. Mangano (ORCID: https://orcid.org/0000-0003-2723-3771)
- Sean D. McEvoy
- Jacob K. Greenberg (ORCID: https://orcid.org/0000-0003-2675-5658)
- Jeffrey P. Greenfield (ORCID: https://orcid.org/0000-0003-1904-1040)
- Laurie L. Ackerman (ORCID: https://orcid.org/0000-0001-5085-6913)
- Toba N. Niazi
- Cormac O. Maher (ORCID: https://orcid.org/0000-0001-6221-6040)
- George I. Jallo (ORCID: https://orcid.org/0000-0001-9607-6867)
- Tammy Bethel-Anderson
- Gerald F. Tuite (ORCID: https://orcid.org/0000-0001-7508-2651)
- Scellig S. D. Stone (ORCID: https://orcid.org/0000-0002-4546-6790)
- Joshua J. Chern (ORCID: https://orcid.org/0000-0001-6936-2876)
- Patrick Graupman (ORCID: https://orcid.org/0000-0003-3379-4532)
- Mark D. Krieger
- Naina L. Gross (ORCID: https://orcid.org/0000-0002-9107-6590)
- Scott D. Wait (ORCID: https://orcid.org/0000-0002-2598-7580)
- Robert C. McKinstry (ORCID: https://orcid.org/0000-0003-3578-4899)
- Haley Vance
- Joshua S. Shimony (ORCID: https://orcid.org/0000-0002-6228-776X)
- James M. Johnston (ORCID: https://orcid.org/0000-0001-8564-1808)
- Ralph G. Dacey (ORCID: https://orcid.org/0000-0002-9181-6413)
- Arnold H. Menezes (ORCID: https://orcid.org/0000-0002-0819-209X)
- Douglas L. Brockmeyer (ORCID: https://orcid.org/0000-0001-8602-0931)
- Richard C. E. Anderson (ORCID: https://orcid.org/0000-0001-6808-0201)
- Jerry Oakes
- Elizabeth C. Tyler‐Kabara (ORCID: https://orcid.org/0000-0003-3286-1094)
- Bermans J. Iskandar (ORCID: https://orcid.org/0000-0002-3856-1597)
- Tord D. Alden (ORCID: https://orcid.org/0000-0003-3486-634X)
- Brian J. Dlouhy (ORCID: https://orcid.org/0000-0001-6724-688X)
- Raheel Ahmed (ORCID: https://orcid.org/0000-0003-2814-7314)
- M Tamber
- John C. Wellons (ORCID: https://orcid.org/0000-0002-5418-4672)
- Philipp R. Aldana (ORCID: https://orcid.org/0000-0001-5923-4838)
- Greg Olavarria
- Marisa Kallem
- Sandy Spears
- Gina Tramelli
- Samuel Reeves (ORCID: https://orcid.org/0000-0001-8805-967X)
- Brent R. O’Neill
- WE Whitehead
- Robert C. Dauser
- Stephen R. Gannon
- Susan Durham
- P. David Adelson
- Ramin Eskandari
- Daniel Couture
- T. Hankinson
- Jeffrey R. Leonard
- David Bauer
- Chevis N. Shannon
- Alexander T. Yahanda
- Abhaya V. Kulkarni
- Daniel J. (Daniel James) Guillaume
- David J. Daniels
- Michael P. Kelly
- J. Gordon McComb
- Yan Yan
- Lissa C. Baird
- James C. Torner
- John Ragheb
- Mark Iantosca
- Gregory Albert
- David D. Limbrick (ORCID: https://orcid.org/0000-0001-6557-373X)
- Eric M. Jackson
- Richard G. Ellenbogen
- Jennifer M. Strahle
- Emine O. Bayman
- Stephanie Greene
- Nathan R. Selden
- Robert F. Keating
- Matthew D. Smyth
- Elaine Kennedy
- Tae Sung Park
- Lisa Reynolds
- Gerald A. Grant
- Karin Bierbrauer
- Dorothy Poppe
- Manish N. Shah
Institutions
- University of Arkansas at Little Rock (US)
- West Virginia University (US)
- University of Iowa (US)
- Atrium Health Wake Forest Baptist (US)
- Cincinnati Children's Hospital Medical Center (US)
- Primary Children's Hospital (US)
- Children's Hospital of Philadelphia (US)
- Children's National (US)
- Children's Hospital of Los Angeles (US)
- NewYork–Presbyterian Hospital (US)
- University of Wisconsin–Madison (US)
- Harvard University (US)
- Johns Hopkins University (US)
- Medical University of South Carolina (US)
- Oregon Health & Science University (US)
- Duke University (US)
- Baylor College of Medicine (US)
- Virginia Commonwealth University (US)
- University of Washington (US)
- Washington University in St. Louis (US)
- Cornell University (US)
- Johns Hopkins Medicine (US)
- Arnold Palmer Hospital for Children (US)
- New York Hospital Queens (US)
- Hospital for Sick Children (CA)
- University of Iowa Hospitals and Clinics (US)
- University of Alabama at Birmingham (US)
- Jacksonville University (US)
- Rady Children's Hospital-San Diego (US)
- Carolina Neurosurgery and Spine Associates (US)
- Children's Hospital Colorado (US)
- Johns Hopkins All Children's Hospital (US)
- Gillette Children's Specialty Healthcare (US)
- Mallinckrodt (United States) (US)
- Hope Center for Neurological Disorders (US)
- Mayo Clinic in Arizona (US)
- Lurie Children's Hospital (US)
- University of Minnesota Medical Center (US)
- Stanford Medicine (US)
- Saint Francis Health System (US)
- Chiari & Syringomyelia Foundation (US)
- Miami Children's Hospital (US)
- Children's Healthcare of Atlanta (US)
- BC Children's Hospital (CA)
- Instituto de Fomento Pesquero (CL)
- Neurological Surgery (US)
- The University of Texas Health Science Center (US)
- Virginia Mason Bainbridge Island Medical Center (US)
- The Ohio State University (US)
- Indiana University – Purdue University Indianapolis (US)
- New York University (US)
- Penn State Milton S. Hershey Medical Center (US)
- The University of Texas at Austin (US)
- Vanderbilt University Medical Center (US)
- University of Colorado Denver (US)
- Florida College (US)
Publication Details
- Journal
- New England Journal of Medicine
- Published
- 2026-05-27
- DOI
- https://doi.org/10.1056/nejmoa2402821
- Primary Topic
- Spinal Dysraphism and Malformations
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Patient-Centered Outcomes Research Institute