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.
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
- Conditions the study is for
- Spine Injury, Cord Injury, Spinal, Cord Infarction Spinal
- 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.
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.
- Conditions
- Spine Injury, Cord Injury, Spinal, Cord Infarction Spinal, Incomplete Spinal Cord Injury, Complete Spinal Cord Injury
- 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 group | Role | What they receive |
|---|---|---|
| Laminectomy with Duroplasty | Experimental | Duroplasty Receives: Procedure: Duroplasty |
| Laminectomy only | No intervention | laminectomy without duroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
CUE-Q
Capabilities of Upper Extremity Test (CUE-Q) [Maximum= 128, Minimum: 0, Higher the better]
Measured: 3, 6 and 12 month
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
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
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.
- First posted14 Aug 2024
- Study start1 May 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spine InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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 22320160Farmer 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 27655884Liu 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 30762749Li 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