Guided Laminectomy With Augmented Duroplasty for Acute Traumatic Spinal Cord Injury

NCT07733401 | Not Yet Recruiting DMC

• 1 other identifier: 2026015001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 13

Brief 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. 1.Does expansile duraplasty lead to superior motor function recovery in patients with acute severe traumatic spinal cord injury?
2. 2.How safe is the use of expansile duraplasty in people with acute traumatic SCI?
3. 3.Receive standardized spinal surgery ;
4. 4.Provide blood and cerebrospinal fluid samples during hospitalization;
5. 5.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;
6. 6.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);
7. 7.Fill out questionnaires at each follow-up visit, including the 36-Item Short Form Health Survey (SF-36);
8. 8.Be continuously monitored for all adverse events and surgical complications throughout the 12-month follow-up period.

Conditions

Spinal Cord Injury; Acute Spinal Cord Injury (SCI)

Keywords

Acute Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• Change in AIS motor score

  Change in American Spinal Injury Association Impairment Scale total limb motor score at 6 months

  6 months versus baseline

Secondary Outcomes (6)

• 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

Other Outcomes (4)

• Incidence of adverse events

  From enrollment to 12 months post-injury

• Mortality

  From enrollment to 12 months post-injury

• Length of hospital stay

  12 months post-injury

Study Arms (2)

Expansile duraplasty

EXPERIMENTAL

Participants in this arm receive expansile duraplasty during their standard surgery for spinal cord injury.

Procedure: Expansile duraplasty

No expansile duraplasty

NO INTERVENTION

Participants in this arm do not receive expansile duraplasty during their standard surgery for spinal cord injury.

Interventions

Expansile duraplasty PROCEDURE

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.

Expansile duraplasty

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (13)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Beijing Jiangong Hospital

Beijing, Beijing Municipality, China

Location

Beijing Shuili Hospital

Beijing, Beijing Municipality, China

Location

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

Gaozhou Hospital of Traditional Chinese Medicine, Guangdong Province

Maoming, Guangdong, China

Location

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Cangzhou, Hebei, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Xuanwu Hospital Inner Mongolia Hospital (Chifeng City Hospital)

Chifeng, Inner Mongolia, China

Location

Shandong University Qilu Hospital (Dezhou Branch)

Dezhou, Shandong, 253001, China

Location

Jinan Central Hospital, Affiliated to Shandong First Medical University

Jinan, Shandong, China

Location

Liaocheng Brain Hospital

Liaocheng, Shandong, China

Location

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Location

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Wanru Duan, MD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)