Duraplasty for Acute Traumatic Spinal Cord Injury

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07280351
Status
Enrolling By Invitation

Conditions

  • Spinal Cord Injury (SCI), Initial Encounter
  • Spinal Cord Injury Cervical
  • Spinal Cord Injury, Acute

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Expansile duraplasty — PROCEDURE
    During their standard of care surgery, in participants undergoing expansile duraplasty, the dura of the spinal cord will be opened linearly at midline to a target length of 3.5cm during surgery and a 1.5 wide x 3.5cm long suturable dural patch will be sutured in place with 6-0 polypropylene running suture to expand the intrathecal space and create room for post-injury spinal cord swelling. Duraplasty is performed during the index surgery for traumatic spinal cord injury, not as a separate, nor delayed surgery. The pia and the spinal cord will not be opened.

Study Details

The goal of this clinical trial is to learn if a procedure called "expansile duraplasty" can improve recovery in adults who have experienced an acute traumatic spinal cord injury (SCI). The main questions it aims to answer are: * Does expansile duraplasty work to improve recovery in people with acute traumatic SCI? * How safe is the use of expansile duraplasty in people with acute traumatic SCI? Researchers will compare the strength, movement, and overall recovery of participants who receive expansile duraplasty to that of participants who do not receive expansile duraplasty to see if the use of expansile duraplasty leads to better recovery for people with acute traumatic SCI. Participants will be randomly placed in one of two groups: an Experimental group and a Control group. Participants in the Experimental group will receive expansile duraplasty during their standard SCI surgery. Participants in the Control group will not receive expansile duraplasty during their standard SCI surgery. All participants will: * Provide samples of blood and cerebrospinal fluid * Undergo magnetic resonance imaging (MRI) scans * Undergo an assessment of the ability to move arms/legs and feel touch or pin prick * Answer questionnaires about medical history, pain, health, and independence with activities of daily living

Key Dates

Start date
May 31, 2026
Status verified
May 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    Participants in this arm receive expansile duraplasty during their standard surgery for spinal cord injury.
  • No Intervention: Control
    Participants in this arm do not receive expansile duraplasty during their standard surgery for spinal cord injury.

Primary Outcome Measure

Change in AIS grade from baseline [ Time Frame: From admission to 6 months post-injury ]

Locations (1)

FacilityCityStateZIPSite coordinators
Zuckerberg San Francisco General HospitalSan FranciscoCalifornia94110-

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Zuckerberg San Francisco General Hospital· San Francisco, CA

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