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
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Pregnancy
* In custody
* Under psychiatric hold
* Presence of traumatic durotomy severe enough to preclude study treatment or procedures, in the opinion of the treating surgeon
* Extensive polytrauma as determined by ISS score of \>25
* History of prior spinal cord injury
* Concomitant non-traumatic spinal cord injury (e.g. infection or tumor)
* Significant concomitant head injury as defined by a Glasgow Coma Scale (GCS) \<14 or a clinically significant abnormality on a head CT (head CT required only for patients suspected to have a brain injury at the discretion of the investigator)
* GCS Motor score \< 6
* Pre-existing neurologic or mental disorder which would preclude accurate evaluation and follow-up (i.e. Alzheimer's disease, Parkinson's disease, unstable psychiatric disorder with hallucinations and/or delusions or schizophrenia)
* The treating surgeon deems that an anterior-only a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.