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临床试验/NCT03952026
NCT03952026已完成不适用

Impact of Associated Abdominal Injuries on Clinical and Operative Outcome in Pelvic Fractures - a Multicenter Study From the German Pelvic Registry

BG Trauma Center Tuebingen1 个研究点 分布在 1 个国家目标入组 16,359 人开始时间: 2018年12月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16,359
试验地点
1
主要终点
"Matta" Grading

研究概览

简要总结

Pelvic fractures are severe injuries which require advanced orthopedic surgical skills to treat. On the other hand, abdominal injuries are severe injuries, which might require quick general surgical treatment. The combination of both injuries is a challenge for orthopedic surgeons, as the abdominal injury might lead to a delayed surgical treatment of the pelvic fracture. Whether an associated abdominal injury influences the quality of care of pelvic fractures, is aim of this registry study.

详细描述

The German Pelvic Registry of the German Trauma Society is a multicenter prospective registry which collects data of patients with pelvic injuries since 2003. Beside demographic data (including concomitant injuries) allowing for epidemiological evaluations of the development of surgical care in these patients, namely the operative care is focus of this registry. Beside the chosen procedure or surgical approach, this includes both intraoperative data like time until operation, duration of the procedure or intraoperative blood loss and reduction parameters (pre- and postoperative fracture steps). The clinical course is recorded also including overall morbidity, overall mortality and osteosynthesis-related complications.

The influence of a concomitant abdominal trauma on the quality of care regarding operative parameters like reduction quality or the clinical course in pelvic injuries has not been investigated yet.

The investigators therefore retrospectively analyze the prospective consecutive data of patients from the multicenter German Pelvic Registry of the German Trauma Society in the years 2003 - 2017. Demographic, clinical and operative parameter were recorded and compared in two groups (isolated pelvic fracture vs. combined abdominal/pelvic trauma).

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Pelvic fracture

排除标准

  • no agreement to participate in the registry

结局指标

主要结局

"Matta" Grading

时间窗: through study completion, at least 1 year after inclusion

Quality of the reduction of the pelvic fracture measured in mm residual step at the fracture's site. A residual step of 0-2mm is graded as an "anatomical reduction" (=Matta 1), a residual step of 2-3mm is graded as an "Imperfect reduction" (=Matta 2) and a residual step \>3mm is graded as a "poor reduction" (=Matta 3).

Overall morbidity

时间窗: through study completion, at least 1 year after inclusion

Rate of overall complications

次要结局

  • length of hospital stay(through study completion, at least 1 year after inclusion)
  • Time until definitive pelvic surgery(through study completion, at least 1 year after inclusion)
  • osteosynthesis-associated complications(through study completion, at least 1 year after inclusion)

研究者

发起方
BG Trauma Center Tuebingen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Markus Küper

Principal Investigator

BG Trauma Center Tuebingen

研究点 (1)

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