Guided Laminectomy With Augmented Duroplasty for Acute Traumatic Spinal Cord Injury | NCT07733401

NCT07733401

Overview

NCT ID: NCT07733401
Lead Sponsor: Xuanwu Hospital, BeijingOTHER
Official Title: Efficacy and Safety of Bony Decompression Combined With Dural Decompression Versus Isolated Bony Decompression for Acute Severe Traumatic Spinal Cord Injury: A Prospective, Multicenter, Randomized Controlled Trial
Brief Summary: 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:

Does expansile duraplasty lead to superior motor function recovery in patients with acute severe traumatic spinal cord injury?

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:

Receive standardized spinal surgery ;

Provide blood and cerebrospinal fluid samples during hospitalization;

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;

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);

Fill out questionnaires at each follow-up visit, including the 36-Item Short Form Health Survey (SF-36);

Be continuously monitored for all adverse events and surgical complications throughout the 12-month follow-up period.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Sep 2026Estimated
Primary Completion Date: Sep 2029Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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).

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 80Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: No data available
Locations: Xuanwu Hospital, Capital Medical University

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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