Dural Graft Equivalent Comparison Trial
DECOMPRESS
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 18, 2012
CompletedFirst Submitted
Initial submission to the registry
August 14, 2012
CompletedFirst Posted
Study publicly available on registry
August 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2018
CompletedJune 15, 2021
June 1, 2021
4.9 years
August 14, 2012
June 11, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Complications encountered during the subject's post-operative care
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.
2 years
Study Arms (2)
surgery - autologous graft
ACTIVE COMPARATORsurgical intervention: decompression of Chiari malformation by suboccipital craniectomy using autologous graft
surgery - non-autologous graft
ACTIVE COMPARATORsurgical intervention: decompression of Chiari malformation by suboccipital craniectomy using using non-autologous graft
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.)
You may not qualify if:
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert F Spetzler, M.D.
Barrow Neurosurgical Associates
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2012
First Posted
August 17, 2012
Study Start
January 18, 2012
Primary Completion
December 21, 2016
Study Completion
March 12, 2018
Last Updated
June 15, 2021
Record last verified: 2021-06