Duraplasty for Acute Traumatic Spinal Cord Injury

NCT07280351 | Enrolling By Invitation

• 2 other identifiers: 24-42716CDMRP-SC240090
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

spinal cord injury; SCI; expansile duraplasty; duraplasty; acute SCI; traumatic SCI; acute traumatic spinal cord injury

Outcome Measures

Primary Outcomes (1)

• Change in AIS grade from baseline

  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.

  From admission to 6 months post-injury

Secondary Outcomes (5)

• SCIM III scores

  At 6 months post-injury

• SF-36 scores

  At 6 months post-injury

• Pain assessment (modified from Neuropathic Pain 4; International Spinal Cord Injury Pain Basic Data Set version 2.0)

  At 6 months post-injury

• Proportion of time during first 5 days after injury that SCPP was greater than 65 mmHg

  From admission to 5 days post-injury

• Maximum Spinal Cord Compression (MSCC) metric

  At 3 days post-injury

Other Outcomes (1)

• Incidence of adverse events

  From enrollment to 6 months post-injury

Study Arms (2)

Experimental

EXPERIMENTAL

Participants in this arm receive expansile duraplasty during their standard surgery for spinal cord injury.

Procedure: Expansile duraplasty

Control

NO INTERVENTION

Participants in this arm do not receive expansile duraplasty during their standard surgery for spinal cord injury.

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• United States Department of Defense: collaborator
• University of California, San Francisco: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Rajiv Saigal, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)