Duraplasty for Acute Traumatic Spinal Cord Injury

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

Interventions

PROCEDURE

Expansile duraplasty

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.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• Congressionally Directed Medical Research Programs

  collaborator FED

• University of California, San Francisco

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-31

Primary Completion

2029-06-30

Completion

2029-06-30

Countries

• United States

Study Locations