Duraplasty for Acute Traumatic Spinal Cord Injury

Enrolling by invitation · Not applicable

Conditions studied: Spinal Cord Injury, Acute, Spinal Cord Injury (SCI), Initial Encounter, Spinal Cord Injury Cervical

In brief

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 facts

Study ID

NCT07280351

Run by

University of California, San Francisco

People needed

66

Starts

2026-05-04

Expected to finish

2029-06-01

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 approach to decompression and/or stabilization (e.g. anterior cervical discectomy and fusion) is the best treatment plan based on the patient's injury pattern
• Recent history (less than 1 year) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation, in the opinion of the investigator
• Active malignancy or history of invasive malignancy within the last five years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitely treated. Patients with carcinoma in situ of the uterine cervix treated definitely more than 1 year prior to enrollment may enter the study.
• Thrombocytopenia, defined as less than 100,000 platelets per microliter of blood, that is not correctible by transfusion
• Coagulopathy, defined as INR > 1.4, that is not correctible by transfusion
• Allergy to the study material, which may include fetal bovine tissue and collagen.
• Contraindications for study treatment or procedures
• Unable to give informed consent prior to their standard of care surgery

Where it is running

• Zuckerberg San Francisco General Hospital — San Francisco, California, United States

Full record on ClinicalTrials.gov

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