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Spine InjuryNCT06552507

The Outcome of Injured Cervical Spinal Cord With Uncontrolled Swelling Under Duraplasty

A study testing Duroplasty in people with Spine Injury and Cord Injury, Spinal, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

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Sites and contacts
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Trial summary

Overall Objective: To assess whether incorporating duraplasty alongside bony decompression enhances motor function outcomes in individuals following Traumatic Spinal Cord Injury (TSCI). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Duroplasty
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
1 siteTaiwan
Study dates
1 May 2024to 1 Dec 2027
Phase
Interventional

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years
  • Severe cervical (C2 - T1) traumatic spinal cord injury (AIS grade A-C)
  • Deemed to require and be suitable for surgery that includes laminectomy or diskectomy by local surgeon
  • Surgery within 72 hours of traumatic spinal cord injury
  • Able to provide informed consent or consultee declaration or proxy consent

Who cannot join

  • Life-limiting or rehabilitation-restricting co-morbidities
  • Thoracic or lumbar traumatic spinal cord injury
  • Probable dural tear due to injury
  • Other central nervous system disease

Trial locations and contacts

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

Li Ying Ching Ying-Ching Li, Dr. contact

886953723572

johnhunter0823@gmail.com

Taiwan1 site, 1 recruiting
  • Ying-Ching Li

    Taoyuan, Taiwan, 333

    Recruiting

Other trials in Taiwan

About this study

Overall Objective: To assess whether incorporating duraplasty alongside bony decompression enhances motor function outcomes in individuals following Traumatic Spinal Cord Injury (TSCI).

Rationale for Research:

Read more

In a systematic review, individuals suffering from cervical Traumatic Spinal Cord Injuries (TSCIs) identified specific priorities for improvement in their quality of life. These priorities encompassed enhanced arm and hand function, improved bladder and bowel control, sexual function, and the nurturing of personal relationships with their families and friends.

In this context, the investigators posit that augmenting standard treatment with expansion duraplasty has the potential to address several critical aspects of TSCI. Our hypothesis centers on the idea that the incorporation of duraplasty into the treatment regimen can lead to a reduction in spinal cord compression, an enhancement in Spinal Cord Perfusion Pressure (SCPP), an amelioration in spinal cord metabolism, and a mitigation of inflammation at the injury site. The investigatorsanticipate that these physiological and metabolic enhancements will contribute to increased neuronal survival, ultimately resulting in improved motor outcomes. These improved motor outcomes, in turn, are expected to translate into enhanced limb function, superior bladder and bowel control, and an overall improvement in the quality of life for the patients.

Our investigative focus encompasses a comprehensive examination of the impact of duraplasty on various facets of spinal cord physiology, metabolism, inflammation, motor and sensory performance, and Health-Related Quality of Life (HRQoL) measures. These HRQoL measures encompass aspects such as hand function, ambulation, bladder and bowel function, as well as the mental, emotional, and social well-being of the patients.

In the north area of R.O.C, individuals with TSCI are initially admitted to Linkou Chang Guan Memorial Hospital, where they typically undergo surgery involving spinal instrumentation (e.g., screws and rods) to address deformities and instability. Bony decompression, typically carried out through laminectomy, is a common surgical intervention aimed at addressing the adverse effects of bony compression on the spinal cord. It is worth noting that a significant majority of surgeons (ranging from 85% to 96%) advocate for bony decompression as a primary treatment for TSCI, as recommended by the National Institute for Health and Care Excellence (NICE) guidelines in 2016. However, the effectiveness of bony decompression in improving outcomes following TSCI remains a topic of debate and uncertainty, largely due to the absence of robust evidence from randomized controlled trials (RCTs).

Our proposal suggests that bony decompression in isolation may offer only partial relief to the swollen and injured spinal cord, which continues to experience compression against the dura. This may explain the persisting uncertainty surrounding the benefits of bony decompression in TSCI treatment. Achieving adequate cord decompression through surgical intervention assumes particular importance in this context, given the lack of pharmaceutical treatments proven to enhance outcomes in individuals with acute and severe TSCI. While the administration of methylprednisolone initially showed promise, subsequent trials, observational studies, and meta-analyses have cast doubt on its efficacy and raised concerns about potential harm.

The management of TSCI in the R.O.C is characterized by considerable variation among major trauma centers, encompassing diverse practices related to factors such as target blood pressure, choice of anesthetic agents, extent of monitoring (including the use of arterial and central lines), and timing of surgery. To circumvent these controversies and differences in practice, the "The outcome of Injured cervical Spinal Cord with Uncontrolled Swelling under Duraplasty" trial has been meticulously designed in a single major trauma center to allow participating surgeon can follow the same protocol about time to surgery and medically management.

The "The outcome of Injured cervical Spinal Cord with Uncontrolled Swelling under Duraplasty" trial was conceived with the aim of addressing these critical questions surrounding TSCI management, ultimately seeking to improve the outcomes and quality of life for individuals grappling with this challenging condition.

Being tested
Duroplasty
Keywords
Duroplasty; spinal cord injury; Dura augmentation
Medical subject headings
Spinal Injuries, Spinal Cord Injuries

What participants receive

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

  • DuroplastyProcedure or surgery

    The investigators open the dura from midline and repaired with fish mouth for dura augmentation

Study groups in NCT06552507
Study groupRoleWhat they receive
Laminectomy with DuroplastyExperimentalDuroplasty
Receives: Procedure: Duroplasty
Laminectomy onlyNo interventionlaminectomy without duroplasty

What is being measured

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

  1. Delta-AMS

    The change in American Spinal Injury Association Impairment Scale (AIS) motor score. We also call it Delta-AMS, and the maximum is 100 and the minimum is 0. If the Delta-AMS is higher then it mean the patient has better recovery of the muscle power regained and vice versa.

    Measured: 6 months post-randomisation minus pre-operative baseline

Secondary outcomes (4)
  1. CUE-Q

    Capabilities of Upper Extremity Test (CUE-Q) [Maximum= 128, Minimum: 0, Higher the better]

    Measured: 3, 6 and 12 month

  2. WISCI-II

    Walking Index for Spinal Cord Injury (WISCI-II) [Level 0--20, the higher level the better outcome]

    Measured: 3, 6 and 12 month

  3. SCIM-II

    Spinal Cord Independence Measure (SCIM-II) [Maximum: 100, Minimum:0, the higher score the better outcome] [weight in kilograms, height in meters]

    Measured: 3, 6 and 12 month

  4. SF-36

    life quality the evaluation scale is not the simple meaning of score, there are eight category of the scale, and each has it's specific score sum of the scale .

    for example the [Physical functioning, PF] is the sum of the question 3, and the maximum and minimum are 30 and 10 respectively.

    Measured: 3, 6 and 12 months.

Timeline

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

  1. First posted14 Aug 2024
  2. Study start1 May 2024
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2027 (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
None (open label)
Enrolment
104 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06552507
Sponsor's protocol ID
2312250059
Status last verified
Sep 2026
First submitted
16 Jul 2024
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Simpson LA, Eng JJ, Hsieh JT, Wolfe DL; Spinal Cord Injury Rehabilitation Evidence Scire Research Team. The health and life priorities of individuals with spinal cord injury: a systematic review. J Neurotrauma. 2012 May 20;29(8):1548-55. doi: 10.1089/neu.2011.2226. Epub 2012 Apr 18.

    PubMed 22320160
  • Farmer C, Fenu E, O'Flynn N, Guthrie B. Clinical assessment and management of multimorbidity: summary of NICE guidance. BMJ. 2016 Sep 21;354:i4843. doi: 10.1136/bmj.i4843. No abstract available.

    PubMed 27655884
  • Liu J, Liu P, Ma Z, Mou J, Wang Z, Sun D, Cheng J, Zhang D, Xiao J. The effects of aging on the profile of the cervical spine. Medicine (Baltimore). 2019 Feb;98(7):e14425. doi: 10.1097/MD.0000000000014425.

    PubMed 30762749
  • 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

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