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Dural Graft Equivalent Comparison Trial (DECOMPRESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01667770
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : June 15, 2021
Sponsor:
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix

Tracking Information
First Submitted Date  ICMJE August 14, 2012
First Posted Date  ICMJE August 17, 2012
Last Update Posted Date June 15, 2021
Actual Study Start Date  ICMJE January 18, 2012
Actual Primary Completion Date December 21, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dural Graft Equivalent Comparison Trial
Official Title  ICMJE Dural Graft Equivalent Comparison Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Chiari Malformation
Intervention  ICMJE 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).
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2021)
41
Original Estimated Enrollment  ICMJE
 (submitted: August 15, 2012)
200
Actual Study Completion Date  ICMJE March 12, 2018
Actual Primary Completion Date December 21, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01667770
Other Study ID Numbers  ICMJE 11BN113
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party St. Joseph's Hospital and Medical Center, Phoenix
Original Responsible Party Same as current
Current Study Sponsor  ICMJE St. Joseph's Hospital and Medical Center, Phoenix
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert F Spetzler, M.D. Barrow Neurosurgical Associates
PRS Account St. Joseph's Hospital and Medical Center, Phoenix
Verification Date June 2021

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