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Spinal Cord InjuryGLADNCT07733401

Guided Laminectomy With Augmented Duroplasty for Acute Traumatic Spinal Cord Injury

A study testing Expansile duraplasty in people with Spinal Cord Injury and Acute Spinal Cord Injury (SCI), run by Xuanwu Hospital, Beijing at 13 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Expansile duraplasty
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
13 sitesChina
Study dates
Sep 2026to Sep 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

13 sites in 1 country

China13 sites

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100053

    Wanru Duan, MD, duanwanru@xwhosp.org

    Xuanbo Shao, Drshao514@163.com

  • Beijing Jiangong Hospital

    Beijing, Beijing Municipality

    Sichen Wang

  • Beijing Shuili Hospital

    Beijing, Beijing Municipality

    Yaohui Wang, MD

  • Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

    Cangzhou, Hebei

    Nan Zhang

  • Xuanwu Hospital Inner Mongolia Hospital (Chifeng City Hospital)

    Chifeng, Inner Mongolia

    Yanze Gong

  • Shandong University Qilu Hospital (Dezhou Branch)

    Dezhou, Shandong, 253001

    Shugang Xu, MD

  • The Third Affiliated Hospital of Southern Medical University

    Guangzhou, Guangdong

    Liang Wang, MD

  • Jinan Central Hospital, Affiliated to Shandong First Medical University

    Jinan, Shandong

    Bin Ning, MD

  • Liaocheng Brain Hospital

    Liaocheng, Shandong

    Xueyuan Li

  • Gaozhou Hospital of Traditional Chinese Medicine, Guangdong Province

    Maoming, Guangdong

    Tianliang Chen

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Honglei Liu, MD

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi

    Guijun Jia

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality

    Hongtao Rong, MD

Other trials in China

About this study

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

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?
Read more

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.
Read the 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.

Being tested
Expansile duraplasty
Keywords
Acute Spinal Cord Injury
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Expansile duraplastyProcedure or surgery

    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.

Study groups in NCT07733401
Study groupRoleWhat they receive
Expansile duraplastyExperimentalParticipants in this arm receive expansile duraplasty during their standard surgery for spinal cord injury.
Receives: Procedure: Expansile duraplasty
No expansile duraplastyNo interventionParticipants in this arm do not receive expansile duraplasty during their standard surgery for spinal cord injury.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in AIS motor score

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

    Measured: 6 months versus baseline

Secondary outcomes (6)

  1. Change in AIS motor score

    Change in American Spinal Injury Association Impairment Scale total limb motor score at 12 months

    Measured: 12 months versus baseline

  2. Change in AIS grade

    Change in American Spinal Injury Association grade

    Measured: 6,12 months versus baseline

  3. WISCI II

    Walking Index for Spinal Cord Injury version ii

    Measured: 6,12 months

  4. SCIM III

    Spinal Cord Independence Measure version III

    Measured: 6,12 months

  5. SF-36

    Short Form survey 36

    Measured: 6,12 months

  6. Maximum Spinal Cord Compression (MSCC) metric

    The index value will be measured via MRI scan within 1 to 14 days after surgery or at hospital discharge (whichever occurs earlier) to evaluate the degree of spinal cord decompression achieved by the operation.MSCC = 2 × (Postoperative spinal cord diameter at the injured segment - Preoperative spinal cord diameter at the injured segment) / (Spinal cord diameter above the injured segment + Spinal cord diameter below the injured segment) × 100%

    Measured: within 1 to 14 days after surgery or at hospital discharge (whichever occurs earlier)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionSep 2029 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07733401
Sponsor's protocol ID
2026015001
Acronym
GLAD
Status last verified
Aug 2026
First submitted
24 Jul 2026
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 24231762

Questions about this trial

What is this clinical trial studying?

A study testing Expansile duraplasty in people with Spinal Cord Injury and Acute Spinal Cord Injury (SCI), run by Xuanwu Hospital, Beijing at 13 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in AIS motor score (time frame: 6 months versus baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07733401, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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