University of California, San Francisco
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
This is a prospective, multi-center, randomized, single-blinded controlled trial aimed at evaluating safety and effectiveness of expansile duraplasty in people hospitalized for acute traumatic spinal cord injury (SCI). Traumatic SCI remains a challenging clinical problem for which treatment options remain limited, despite significant ongoing efforts by industry, non-profit organizations and academia to unveil the mechanisms behind it. There is currently no clearly beneficial pharmaceutical therapy for SCI, so in the absence of suitable pharmacotherapy, early surgical decompression and optimiz…
Inclusion Criteria: * In initial hospitalization for recent (less than 24 hours) acute, traumatic spinal cord injury at a participating site * Diagnosis of acute, traumatic spinal cord injury * AIS grade A - C * C3 - T10 neurological level of injury on ISNCSCI exam * Imaging showing cord compression * Surgical decompression initiated within 24 hours after injury * At sites where lumbar drain placement is standard of care: placement of lumbar drain * Able to cooperate in the completion of standardized neurological examinations Exclusion Criteria: * Injury arising from penetrating mechanism *…
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.