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临床试验/NCT06540339
NCT06540339尚未招募不适用

SnapPelvis: International Prospective Observational Cohort Study of Traumatic Pelvic Ring Injuries

University Hospital, Aachen0 个研究点目标入组 500 人开始时间: 2025年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
500
主要终点
Mortality after traumatic pelvic ring injuries

研究概览

简要总结

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 (e.g. 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 and/or 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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (≥18 years of age) admitted for traumatic pelvic ring injuries (AO/FFP-Classification).

排除标准

  • Concomitant acetabular fractures

结局指标

主要结局

Mortality after traumatic pelvic ring injuries

时间窗: 6 months

次要结局

  • Rate of systemic complications after traumatic pelvic ring injuries(6 months)
  • Re-admission rate for fracture-related implant failure, infections and re-operations within 6 months after traumatic pelvic ring injuries(6 months)
  • Rate of social reintegration after traumatic pelvic ring injuries(6 months)
  • Pelvic Outcome Score after traumatic pelvic ring injuries(6 months)

研究者

发起方
University Hospital, Aachen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. med. Eftychios Bolierakis

Dr. med. Eftychios Bolierakis

University Hospital, Aachen

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