Duraplasty for Acute Traumatic Spinal Cord Injury

This study is looking into whether a surgical procedure called "expansile duraplasty" can help adults recover better after a recent traumatic spinal cord injury (SCI). During this procedure, the dura (the protective covering of the spinal cord) is opened during standard surgery. Researchers want to see if this leads to better recovery compared to those who don't have this specific procedure. You might be able to join if you are 18-80 years old, had a traumatic SCI within the last 24 hours, and meet other specific medical criteria, including having imaging that shows cord compression. The main goal is to see if expansile duraplasty improves your ability to move and feel, measured by changes in your AIS grade, over six months after your injury. The current status of this study is unclear.

Study design: This is a randomized, single-blinded study involving 66 participants. You would be randomly assigned to one of two groups: an experimental group receiving expansile duraplasty or a control group.
What's involved: During your standard surgery, if you are in the experimental group, the dura of your spinal cord will be opened. Your recovery will be monitored from admission up to 6 months post-injury.
Compensation: Not stated in the trial record.
Follow-up: Your recovery will be followed for six months after your injury to assess changes in your AIS grade.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Duraplasty for Acute Traumatic Spinal Cord Injury

Enrolling by Invitation

NAAges 18–80InterventionalTreatment

University of California, San Francisco

~66 participants

Updated 2026-07-21 on ClinicalTrials.gov

What's tested:Expansile duraplasty

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in AIS grade from baseline

Measured over From admission to 6 months post-injury

Conditions

Spinal Cord Injury, Acute

Spinal Cord Injury (SCI), Initial Encounter

Spinal Cord Injury Cervical

Where it's being run

1 sites across 1 states

California1

Study leadership

Rajiv Saigal, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

Change in AIS grade from baselineFrom admission to 6 months post-injury
The American Spinal Injury Association (ASIA) established the ASIA Injury Scale (AIS). The AIS grade is derived from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam, ASIA's standard assessment for documentation of the level and severity of a spinal cord injury. The ISNCSCI yields a grade from A to E, wherein A indicates greater severity.

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