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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Expansile duraplasty
Procedure/SurgeryFor participants receiving expansile duraplasty during standard spinal surgery, the dura mater is longitudinally incised along the midline, followed by watertight augmented repair with autologous fascial graft to expand the intrathecal space and accommodate edematous spinal cord after trauma. The length of the dural incision matches the extent of spinal cord edema shown on preoperative MRI. This duraplasty procedure is performed concurrently with the index surgery for traumatic spinal cord injury, rather than as a staged or delayed secondary operation. The pia mater and spinal cord parenchyma remain intact and are not incised intraoperatively.
Treatment groups
Trial outcomes
Primary outcomes
Change in AIS motor score
Change in American Spinal Injury Association Impairment Scale total limb motor score at 6 months
Secondary outcomes
Change in AIS motor score
Change in American Spinal Injury Association Impairment Scale total limb motor score at 12 months
Change in AIS grade
Change in American Spinal Injury Association grade
WISCI II
Walking Index for Spinal Cord Injury version ii
SCIM III
Spinal Cord Independence Measure version III
Other outcomes
Incidence of adverse events
Number of observed events following the time of intervention during a participant's standard surgery.
Mortality
Mortality
Length of hospital stay
Length of hospital stay
Spinal re-operations
Number of reoperations on spine
Sponsors and contacts
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