An interventional study of Duroplasty in Spine Injury, Cord Injury, Spinal and Cord Infarction Spinal, sponsored by Chang Gung Memorial Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment
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:
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.
57 studies on the registry are indexed under Spinal Injuries; 15 are open to participants now.
This study's planned enrollment of 104 is above the median of 52 across 31 interventional studies indexed under Spinal Injuries.
Browse Spinal Injuries studies →Chang Gung Memorial Hospital is the lead sponsor of 1,096 studies on the registry; 239 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Duroplasty
Procedure: Duroplasty
laminectomy without duroplasty
The investigators open the dura from midline and repaired with fish mouth for dura augmentation
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.
Time frame: 6 months post-randomisation minus pre-operative baseline
CUE-Q
Capabilities of Upper Extremity Test (CUE-Q) \[Maximum= 128, Minimum: 0, Higher the better\]
Time frame: 3, 6 and 12 month
WISCI-II
Walking Index for Spinal Cord Injury (WISCI-II) \[Level 0--20, the higher level the better outcome\]
Time frame: 3, 6 and 12 month
SCIM-II
Spinal Cord Independence Measure (SCIM-II) \[Maximum: 100, Minimum:0, the higher score the better outcome\] \[weight in kilograms, height in meters\]
Time frame: 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.
Time frame: 3, 6 and 12 months.
Started May 2024 (actual). Primary completion is estimated for Dec 2026, 31 months after the start.
Of 23 interventional studies with no phase under Spinal Injuries, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 75. This study's planned 31 months is above that.
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