Guided Laminectomy With Augmented Duroplasty for Acute Traumatic Spinal Cord Injury
Key facts
- Where
- Beijing, Cangzhou, Chifeng, Dezhou, Guangzhou, Jinan, Liaocheng, Maoming, Shijiazhuang, Taiyuan, and Tianjin, ChinaSee the 13 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07733401, who can take part
Where in China
- Beijing Jiangong HospitalBeijing, ChinaContact: Sichen WangNo longer taking part
- Beijing Shuili HospitalBeijing, ChinaContact: Yaohui Wang, MDNo longer taking part
- Xuanwu Hospital, Capital Medical UniversityBeijing, ChinaContact: Wanru Duan, MDNo longer taking part
- Cangzhou Hospital of Integrated Traditional Chinese and Western MedicineCangzhou, ChinaContact: Nan ZhangNo longer taking part
- Xuanwu Hospital Inner Mongolia Hospital (Chifeng City Hospital)Chifeng, ChinaContact: Yanze GongNo longer taking part
- Shandong University Qilu Hospital (Dezhou Branch)Dezhou, ChinaContact: Shugang Xu, MDNo longer taking part
- The Third Affiliated Hospital of Southern Medical UniversityGuangzhou, ChinaContact: Liang Wang, MDNo longer taking part
- Jinan Central Hospital Affiliated to Shandong First Medical UniversityJinan, ChinaContact: Bin Ning, MDNo longer taking part
- Liaocheng Brain HospitalLiaocheng, ChinaContact: Xueyuan LiNo longer taking part
- Gaozhou Hospital of Traditional Chinese Medicine, Guangdong ProvinceMaoming, ChinaContact: Tianliang ChenNo longer taking part
- The First Hospital of Hebei Medical UniversityShijiazhuang, ChinaContact: Honglei Liu, MDNo longer taking part
- Shanxi Provincial People's HospitalTaiyuan, ChinaContact: Guijun JiaNo longer taking part
- Tianjin Medical University General HospitalTianjin, ChinaContact: Hongtao Rong, MDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Xuanwu Hospital, Beijing
- Trial code
- NCT07733401
- Record updated
- 3 September 2026
- Original description
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:Read full original descriptionShow less
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
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.
Inclusion: 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: 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); 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.