Guided Laminectomy With Augmented Duroplasty for Acute Traumatic Spinal Cord Injury

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXuanwu Hospital, Beijing

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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);

Trial design

Treatments tested in this trial

  • Expansile duraplasty

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators