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Dural Graft Equivalent Comparison Trial (DECOMPRESS)

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ClinicalTrials.gov Identifier: NCT01667770
Recruitment Status : Recruiting
First Posted : August 17, 2012
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix

Brief Summary:
This research study is to find out which types of dural grafts used during surgery for Chiari Malformations are superior. We believe that autologous dural grafts are superior to non-autologous grafts.

Condition or disease Intervention/treatment Phase
Chiari Malformation Procedure: decompression of Chiari malformation Not Applicable

Detailed Description:
The study compares autologous grafts vs. non-autologous grafts. Non-autologous grafts include synthetics and grafts from animals. Autologous grafts have a better side-effect profile than non-autologous grafts. We believe this improved side-effect profile will result in a decreased incidence of reoperation for post-operative infections and post-operative fluid collections (pseudomeningoceles and seromas). Study is open to all non-pregnant minor and adult subjects. Subjects must have symptomatic Chiari Malformation described as > or equal to 6mm descent of the cerebellar tonsils below the foramen magnum with accompanying headaches and/or neurologic findings (arm pain/weakness, myelopathy, etc.). After the 12-month follow-up is completed on the first 100 subjects there will be an interim analysis of the results in order to determine whether one of the treatments has a statistically superior outcome. If a statistically superior outcome is noted, the trial will stop after being reviewed by a data monitoring committee. If no statistically significant difference is seen at one year, the study will continue until the 12-month follow-up is completed on the 200th patient.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Dural Graft Equivalent Comparison Trial
Study Start Date : January 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: surgery - autologous graft
surgical intervention: decompression of Chiari malformation by suboccipital craniectomy using autologous graft
Procedure: decompression of Chiari malformation
Removal of a small section of bone at the back of the skull (posterior foramen magnum decompression) or upper cervical spine. During surgery, the covering of the brain (dura) is enlarged with a graft (autologous or non-autologous).

Active Comparator: surgery - non-autologous graft
surgical intervention: decompression of Chiari malformation by suboccipital craniectomy using using non-autologous graft
Procedure: decompression of Chiari malformation
Removal of a small section of bone at the back of the skull (posterior foramen magnum decompression) or upper cervical spine. During surgery, the covering of the brain (dura) is enlarged with a graft (autologous or non-autologous).




Primary Outcome Measures :
  1. Complications encountered during the subject's post-operative care [ Time Frame: 2 years ]
    After the 12-month follow-up is completed on the first 100 subjects there will be an interim analysis of the results in order to determine whether one of the treatments has a statistically superior outcome. If a statistically superior outcome is noted, the trial will stop after being reviewed by a data monitoring committee. If no statistically significant difference is seen at one year, the study will continue until the 12-month follow-up is completed on the 200th patient.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Minor or adult males and females
  • Symptomatic Chiari Malformation
  • Greater or equal to 6mm descent of the cerebellar tonsils below the foramen magnum
  • Headaches and/or neurologic findings (e.g., arm pain/weakness, myelopathy, etc.)

Exclusion Criteria:

  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667770


Contacts
Contact: Michael Bohl, M.D. 602-406-3181 michael.bohl@bnaneuro.net
Contact: Madelon Petersen, RN 602-406-3246 madelon.petersen@dignityhealth.org

Locations
United States, Arizona
St. Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Principal Investigator: Robert F Spetzler, M.D.         
Sponsors and Collaborators
St. Joseph's Hospital and Medical Center, Phoenix
Investigators
Principal Investigator: Robert F Spetzler, M.D. Barrow Neurosurgical Associates

Responsible Party: St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT01667770     History of Changes
Other Study ID Numbers: 11BN113
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Congenital Abnormalities
Arnold-Chiari Malformation
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases