Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552507
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
The Outcome of Injured Cervical Spinal Cord With Uncontrolled Swelling Under Duraplasty
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Outcome of Injured Cervical Spinal Cord With Uncontrolled Swelling Under Duraplasty
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 ROC individuals with TSCI are initially admitted to Linkou Chang Guan Memorial Hospital where they typically undergo surgery involving spinal instrumentation eg 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 ROC 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
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 ROC individuals with TSCI are initially admitted to Linkou Chang Guan Memorial Hospital where they typically undergo surgery involving spinal instrumentation eg 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 ROC 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None