Guided Laminectomy With Augmented Duroplasty for Acute Traumatic Spinal Cord Injury

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

Overview

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.

Detailed description

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.

Accordingly, this trial aims to rigorously verify whether the addition of expansile duraplasty to standard bony decompression confers additional benefits in neurological function, functional prognosis, and safety for patients with acute severe traumatic spinal cord injury.

Study Methods This is a prospective, multicenter randomized controlled trial (RCT). A total of 80 adult patients with acute severe traumatic spinal cord injury (TSCI) meeting the ASIA Impairment Scale (AIS) grade A, B or C will be enrolled and randomly assigned at a 1:1 ratio to receive either bony decompression alone or bony decompression combined with expansile duraplasty. Both participants and outcome assessors will be blinded to treatment allocation.

Primary Outcome Measure: The change in ASIA Motor Score (AMS) from admission baseline to 6 months after surgery (Δ-AMS).

Secondary Outcome Measures: Motor function, health-related quality of life, surgical complications and mortality will be assessed at randomization, 3 months, 6 months and 12 months postoperatively.

Study Value If this randomized controlled trial verifies that combined duraplasty brings significant clinical benefits, this surgical technique is expected to provide high-level evidence for the surgical management of such patients.

Interventions

• Procedure 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 injur

Primary outcome measures

• Change in AIS motor score [Time frame: 6 months versus baseline]

Secondary outcome measures (6)

• Change in AIS motor score [Time frame: 3,12 months versus baseline]
• Change in AIS grade [Time frame: 3,6,12 months versus baseline]
• WISCI II [Time frame: 3,6,12 months]
• SCIM III [Time frame: 3,6,12 months]
• SF-36 [Time frame: 3,6,12 months]
• Maximum Spinal Cord Compression (MSCC) metric [Time frame: within 1 to 14 days after surgery or at hospital discharge (whichever occurs earlier)]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 13 centers

• Xuanwu Hospital, Capital Medical University — Beijing
• Beijing Jiangong Hospital — Beijing
• Beijing Shuili Hospital — Beijing
• The Third Affiliated Hospital of Southern Medical University — Guangzhou
• Gaozhou Hospital of Traditional Chinese Medicine, Guangdong Province — Maoming
• Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine — Cangzhou
• The First Hospital of Hebei Medical University — Shijiazhuang
• Xuanwu Hospital Inner Mongolia Hospital (Chifeng City Hospital) — Chifeng
• … and 5 more centers

Publications

• Li YC, Chen KH, Li CY, Lu YJ. The outcome of injured cervical spinal cord with uncontrolled swelling under duraplasty: protocol of the ISCUD randomized controlled trial. Trials. 2025 Dec 2;26(1):559. doi: 10.1186/s13063-025-09288-6. PMID 41331929
• Saadoun S, Grassner L, Belci M, Cook J, Knight R, Davies L, Asif H, Visagan R, Gallagher MJ, Thome C, Hutchinson PJ, Zoumprouli A, Wade J, Farrar N, Papadopoulos MC. Duroplasty for injured cervical spinal cord with uncontrolled swelling: protocol of the DISCUS randomized controlled trial. Trials. 2023 Aug 7;24(1):497. doi: 10.1186/s13063-023-07454-2. PMID 37550727
• Greil ME, Hunt ER, Torres Espin A, Saigal R. Retrospective Analysis of Expansile Duraplasty as Surgical Adjunct After Acute Traumatic Spinal Cord Injury. Global Spine J. 2026 Mar;16(2):1212-1220. doi: 10.1177/21925682251376321. Epub 2025 Sep 4. PMID 40906933
• Zhu F, Yao S, Ren Z, Telemacque D, Qu Y, Chen K, Yang F, Zeng L, Guo X. Early durotomy with duroplasty for severe adult spinal cord injury without radiographic abnormality: a novel concept and method of surgical decompression. Eur Spine J. 2019 Oct;28(10):2275-2282. doi: 10.1007/s00586-019-06091-1. Epub 2019 Aug 22. PMID 31440894
• Saadoun S, Werndle MC, Lopez de Heredia L, Papadopoulos MC. The dura causes spinal cord compression after spinal cord injury. Br J Neurosurg. 2016 Oct;30(5):582-4. doi: 10.3109/02688697.2016.1173191. Epub 2016 Apr 15. PMID 27080553
• Werndle MC, Saadoun S, Phang I, Czosnyka M, Varsos GV, Czosnyka ZH, Smielewski P, Jamous A, Bell BA, Zoumprouli A, Papadopoulos MC. Monitoring of spinal cord perfusion pressure in acute spinal cord injury: initial findings of the injured spinal cord pressure evaluation study*. Crit Care Med. 2014 Mar;42(3):646-55. doi: 10.1097/CCM.0000000000000028. PMID 24231762

Identifiers

NCT: NCT07733401 · 2026015001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗