Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540339
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-20
Brief Title:
A Snapshot Audit of Traumatic Pelvic Ring Injuries
Sponsor:
None
Organization:
None
Study Overview
Official Title:
SnapPelvis International Prospective Observational Cohort Study of Traumatic Pelvic Ring Injuries
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
Multicenter snapshot cohort studies or audits have the ability to gather large patient numbers in short time periods from many healthcare systems with different resources or practices of care concerning one specific surgical condition This type of studies allows exploration of differences in patient populations and management across the sampled cohort to identify areas of practice variability that may result in apparent differences in outcome As such whilst not providing true evidence of efficacy or the impact of a single variable on overall outcome these studies can be hypothesis-generating and identify areas warranting further study in future randomized controlled trials 1 Snapshots also shed light on the real world practice rather than the presumed or guideline suggested patient care 2
Traumatic Pelvic Ring Injuries TPRI represent a broad spectrum of trauma-associated pathologies with a distinct bimodal age distribution in patients admitted through the Emergency Departments of all acute care hospitals In younger patients this type of injury is often associated with high-energy trauma hemodynamic instability high mortality and morbidity rates 3-6 In the elderly population pelvic fractures result from low energy trauma mechanisms eg ground level fall and can affect the long-term independency and life quality of geriatric patients 7
There is substantial variation in the management of pelvic ring injuries among pelvic trauma surgeons these variations include but are not limited to the timing of definitive fixation the indications and protocols of conservative treatment and the appropriate osteosynthesis of the anterior andor posterior pelvic fractures 8
This ESTES snapshot audit -a prospective observational cohort study- has a dual purpose Firstly as an epidemiological study it aims to report the burden of injury in specific hospitals distributed widely throughout Europe Secondly this study aims to demonstrate current strategies for both younger after high-energy trauma and geriatric patients after low-energy trauma employed to assess and treat these patients These twin aims will serve to provide a snapshot of current medical practice but will also be hypothesis-generating while providing a rich source of patient-level data to allow further analysis of particular clinical questions The acquired study data can be subsequently evaluated and compared to patient data of established pelvic trauma registries across Europe
Traumatic Pelvic Ring Injuries TPRI represent a broad spectrum of trauma-associated pathologies with a distinct bimodal age distribution in patients admitted through the Emergency Departments of all acute care hospitals In younger patients this type of injury is often associated with high-energy trauma hemodynamic instability high mortality and morbidity rates 3-6 In the elderly population pelvic fractures result from low energy trauma mechanisms eg ground level fall and can affect the long-term independency and life quality of geriatric patients 7
There is substantial variation in the management of pelvic ring injuries among pelvic trauma surgeons these variations include but are not limited to the timing of definitive fixation the indications and protocols of conservative treatment and the appropriate osteosynthesis of the anterior andor posterior pelvic fractures 8
This ESTES snapshot audit -a prospective observational cohort study- has a dual purpose Firstly as an epidemiological study it aims to report the burden of injury in specific hospitals distributed widely throughout Europe Secondly this study aims to demonstrate current strategies for both younger after high-energy trauma and geriatric patients after low-energy trauma employed to assess and treat these patients These twin aims will serve to provide a snapshot of current medical practice but will also be hypothesis-generating while providing a rich source of patient-level data to allow further analysis of particular clinical questions The acquired study data can be subsequently evaluated and compared to patient data of established pelvic trauma registries across Europe
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