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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 13
- 主要终点
- Change in AIS motor score
研究概览
简要总结
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.
详细描述
Study Objective To evaluate whether bony decompression combined with expansile duraplasty yields superior motor functional outcomes compared with bony decompression alone in patients with traumatic spinal cord injury (TSCI).
Research Rationale Traumatic spinal cord injury is a severely disabling neurological disorder that can result in permanent motor and sensory deficits, lifelong functional dependence, and a heavy socioeconomic burden, making it a prominent global public health concern.
The standard surgical management for acute traumatic spinal cord injury consists of laminectomy for bony decompression combined with spinal fixation. While this procedure effectively relieves extradural mechanical compression, it fails to reliably alleviate intrathecal hypertension. Clinical and imaging evidence confirms that even when adequate bony decompression is achieved radiographically, the edematous spinal cord frequently remains apposed to the inner wall of the dura mater, leaving residual risk of spinal cord ischemia.
This therapeutic gap stands in stark contrast to the management of severe traumatic brain injury, where dural opening is routinely performed during decompressive craniectomy to control intracranial hypertension. In spinal trauma, however, dural decompression is not incorporated into standard treatment protocols.
Preclinical studies and small observational clinical trials have demonstrated that duraplasty reduces intrathecal pressure, elevates spinal cord perfusion pressure, and correlates with improved neurological recovery. Nevertheless, high-quality evidence from randomized controlled trials remains absent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
No expansile duraplasty
Participants in this arm do not receive expansile duraplasty during their standard surgery for spinal cord injury.
Expansile duraplasty
Participants in this arm receive expansile duraplasty during their standard surgery for spinal cord injury.
干预措施: Expansile duraplasty (Procedure)
结局指标
主要结局
Change in AIS motor score
时间窗: 6 months versus baseline
Change in American Spinal Injury Association Impairment Scale total limb motor score at 6 months
次要结局
- Change in AIS motor score(3,12 months versus baseline)
- Change in AIS grade(3,6,12 months versus baseline)
- WISCI II(3,6,12 months)
- SCIM III(3,6,12 months)
- SF-36(3,6,12 months)
- Maximum Spinal Cord Compression (MSCC) metric(within 1 to 14 days after surgery or at hospital discharge (whichever occurs earlier))
- Change in AIS motor score(12 months versus baseline)
- Change in AIS grade(6,12 months versus baseline)
- WISCI II(6,12 months)
- SCIM III(6,12 months)
- SF-36(6,12 months)