Dural Graft Equivalent Comparison Trial (DECOMPRESS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by St. Joseph's Hospital and Medical Center, Phoenix
Sponsor:
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier:
NCT01667770
First received: August 14, 2012
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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 Intervention
Chiari Malformation
Procedure: decompression of Chiari malformation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Dural Graft Equivalent Comparison Trial

Resource links provided by NLM:


Further study details as provided by St. Joseph's Hospital and Medical Center, Phoenix:

Primary Outcome Measures:
  • Complications encountered during the subject's post-operative care [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667770

Contacts
Contact: Justin Clark, M.D. 602-746-1468 justin.clark@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
  More Information

No publications provided

Responsible Party: St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT01667770     History of Changes
Other Study ID Numbers: 11BN113
Study First Received: August 14, 2012
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 21, 2014