Dural Graft Equivalent Comparison Trial (DECOMPRESS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 22, 2014
Last verified: October 2014

August 14, 2012
October 22, 2014
January 2012
December 2018   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01667770 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Dural Graft Equivalent Comparison Trial
Dural Graft Equivalent Comparison Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Chiari Malformation
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 - autologous graft
    surgical intervention: decompression of Chiari malformation by suboccipital craniectomy using autologous graft
    Intervention: Procedure: decompression of Chiari malformation
  • Active Comparator: surgery - non-autologous graft
    surgical intervention: decompression of Chiari malformation by suboccipital craniectomy using using non-autologous graft
    Intervention: Procedure: decompression of Chiari malformation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2018
December 2018   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Michael Bohl, M.D. 602-406-3181 michael.bohl@bnaneuro.net
Contact: Madelon Petersen, RN 602-406-3246 madelon.petersen@dignityhealth.org
United States
 
NCT01667770
11BN113
No
St. Joseph's Hospital and Medical Center, Phoenix
St. Joseph's Hospital and Medical Center, Phoenix
Not Provided
Principal Investigator: Robert F Spetzler, M.D. Barrow Neurosurgical Associates
St. Joseph's Hospital and Medical Center, Phoenix
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP