Guided Laminectomy With Augmented Duroplasty for Acute Traumatic Spinal Cord Injury

Overview

The goal of this clinical trial is to learn whether expansile duraplasty can improve neurological recovery in adult patients with acute severe traumatic spinal cord injury, as well as evaluate the safety of this surgical strategy. The main questions the study aims to answer are: 1. Does expansile duraplasty lead to superior motor function recovery in patients with acute severe traumatic spinal cord injury? 2. How safe is the use of expansile duraplasty in people with acute traumatic SCI? Researchers will compare neurological function, quality of life and all safety indicators who receive expansile duraplasty to that of participants who do not receive expansile duraplasty, to determine whether the additional expansile duraplasty provides better recovery benefits for patients with traumatic spinal cord injury. Participants will be randomly assigned to one of two groups: the laminectomy combined with expansile duraplasty group and the laminectomy-only group. All participants will complete the following procedures: 1. Receive standardized spinal surgery ; 2. Provide blood and cerebrospinal fluid samples during hospitalization; 3. Undergo spinal computed tomography (CT) and magnetic resonance imaging (MRI) scans at baseline (pre-operation), discharge, 3 months, 6 months and 12 months after surgery; 4. Complete standardized neurological assessments at 3, 6 and 12 months postoperatively, including ASIA motor and sensory scores, Walking Index for Spinal Cord Injury II (WISCI II), and Spinal Cord Independence Measure III (SCIM III); 5. Fill out questionnaires at each follow-up visit, including the 36-Item Short Form Health Survey (SF-36); 6. Be continuously monitored for all adverse events and surgical complications throughout the 12-month follow-up period.

Study Objective To evaluate whether bony decompression combined with expansile duraplasty yields superior motor functional outcomes compared with bony decompression alone in patients with traumatic spinal cord injury (TSCI). Research Rationale Traumatic spinal cord injury is a severely disabling neurological disorder that can result in permanent motor and sensory deficits, lifelong functional dependence, and a heavy socioeconomic burden, making it a prominent global public health concern. The standard surgical management for acute traumatic spinal cord injury consists of laminectomy for bony decompression combined with spinal fixation. While this procedure effectively relieves extradural mechanical compression, it fails to reliably alleviate intrathecal hypertension. Clinical and imaging evidence confirms that even when adequate bony decompression is achieved radiographically, the edematous spinal cord frequently remains apposed to the inner wall of the dura mater, leaving residual risk of spinal cord ischemia. This therapeutic gap stands in stark contrast to the management of severe traumatic brain injury, where dural opening is routinely performed during decompressive craniectomy to control intracranial hypertension. In spinal trauma, however, dural decompression is not incorporated into standard treatment protocols. Preclinical studies and small observational clinical trials have demonstrated that duraplasty reduces intrathecal pressure, elevates spinal cord perfusion pressure, and correlates with improved neurological recovery. Nevertheless, high-quality evidence from randomized controlled trials remains absent. Accordingly, this trial aims to rigorously verify whether the addition of expansile duraplasty to standard bony decompression confers additional benefits in neurological function, functional prognosis, and safety for patients with acute severe traumatic spinal cord injury. Study Methods This is a prospective, multicenter randomized controlled trial (RCT). A total of 80 adult patients with acute severe traumatic spinal cord injury (TSCI) meeting the ASIA Impairment Scale (AIS) grade A, B or C will be enrolled and randomly assigned at a 1:1 ratio to receive either bony decompression alone or bony decompression combined with expansile duraplasty. Both participants and outcome assessors will be blinded to treatment allocation. Primary Outcome Measure: The change in ASIA Motor Score (AMS) from admission baseline to 6 months after surgery (Δ-AMS). Secondary Outcome Measures: Motor function, health-related quality of life, surgical complications and mortality will be assessed at randomization, 3 months, 6 months and 12 months postoperatively. Study Value If this randomized controlled trial verifies that combined duraplasty brings significant clinical benefits, this surgical technique is expected to provide high-level evidence for the surgical management of such patients.