Guided Laminectomy With Augmented Duroplasty for Acute Traumatic Spinal Cord Injury

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.

Inclusion criteria

• Aged between 18 and 80 years old, with no restrictions on gender;
• Patients diagnosed with traumatic cervical or thoracic spinal cord injury (C2-T12) via clinical evaluation including medical history collection, physical examination and auxiliary imaging tests;
• Classified as Grade A, B or C according to the ASIA Impairment Scale (AIS) based on the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI);
• Scheduled to receive surgical intervention within 72 hours after traumatic spinal cord injury;
• Preoperative T2-weighted MRI shows no cerebrospinal fluid signal between the spinal cord and dura mater at a minimum of one vertebral segment;
• Good general physical condition with an expected survival time of no less than 12 months;
• Voluntarily participate in this trial, sign the written informed consent form, exhibit good compliance and cooperate with all follow-up visits;
• Judged by attending surgeons to meet the surgical indications for posterior laminectomy and spinal internal fixation, with surgical decision-making based on surgeons' clinical experience.

Exclusion criteria

• Transverse spinal cord injury;
• Gunshot or penetrating sharp spinal cord injury;
• Pre-existing dural laceration caused by traumatic spinal cord injury;
• Spinal cord injury without radiographic abnormality (SCIWORA, spinal injury without fracture or dislocation);
• Acute exacerbation of pre-existing chronic spinal cord injury;
• Traumatic spinal cord injury complicated with epidural or subdural hematoma;
• Severe concomitant traumatic brain injury defined as a Glasgow Coma Scale (GCS) score < 14; patients unable to follow simple verbal commands due to altered mental status; or patients with clinically significant abnormalities on cranial CT (only patients with suspected brain injury identified by investigators require cranial CT scanning);
• Presence of underlying comorbidities that contraindicate surgery or interfere with accurate medical and neurological assessments (judged by the principal investigator).