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Guided Laminectomy With Augmented Duroplasty for Acute Traumatic Spinal Cord Injury
Sponsor: Xuanwu Hospital, Beijing
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: 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.
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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-09
Completion Date
2029-09
Last Updated
2026-09-03
Healthy Volunteers
No
Interventions
Expansile duraplasty
For 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.
Locations (13)
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Jiangong Hospital
Beijing, Beijing Municipality, China
Beijing Shuili Hospital
Beijing, Beijing Municipality, China
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China
Gaozhou Hospital of Traditional Chinese Medicine, Guangdong Province
Maoming, Guangdong, China
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Cangzhou, Hebei, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Xuanwu Hospital Inner Mongolia Hospital (Chifeng City Hospital)
Chifeng, Inner Mongolia, China
Shandong University Qilu Hospital (Dezhou Branch)
Dezhou, Shandong, China
Jinan Central Hospital, Affiliated to Shandong First Medical University
Jinan, Shandong, China
Liaocheng Brain Hospital
Liaocheng, Shandong, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China