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临床试验/NCT06338228
NCT06338228已完成不适用

A New Decisional Tree for the Management of Acetabular Fractures : Monocentric Observational Study

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年3月1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
250
试验地点
1
主要终点
The main objective of the study is to evaluate and compare the results of a decision tree for the management of acetabulum fractures (also called acetabulum) in a large cohort of patients from the trauma center at Grenoble University Hospital

研究概览

简要总结

Acetabular fractures are challenging fractures to treat. Many fracture patterns occur, in a deep anatomical area surrounded by numerous vascular and nervous elements, generally in a polytraumatic context . A reduction with less than 2 mm of incongruence is generally considered acceptable, limiting post-operative osteoarthritis that could rapidly require total hip arthroplasty. Due to the long learning curve, this surgery is limited to large reference centers

. In the last twenty years, the main series published in the literature are small series due to the rarity of the fractures and their trauma context (loss of follow-up, polytrauma patients…). The large variety of fracture patterns according to the Letournel classification creates a spread in patient distribution and decreases the power of statistical analysis. That is the reason why big series are rare and only a few of them allow significant conclusions . The other studies are meta-analyses with their limitations

The lack of consensus makes it difficult to interpret the results between series, so the investigators developed a decision tree to address this knowledge gap.

The aim of this study is to assess and compare the results of a decisional tree for acetabular fracture in a large cohort of patients from a well-known experimental trauma center.

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patient at the time of injury
  • Acetabular fracture
  • Pre-operative standard X-ray image
  • Pre-operative CT image
  • Post-operative X-ray standard image (AP-alar and obturator views)
  • Post-operative CT scan.
  • Willingness and ability to participate in the study

排除标准

  • Ipsilateral fracture femoral and/or associated pelvic ring fracture (Floating Hip C or B)
  • Pregnant, lactating women
  • Subject under administrative or judicial supervision

研究组 & 干预措施

patients managed for Acetabular fracture

collect the data for all the patients managed and operated on between 01/01/2020 AND 31/01/2022 for Acetabular fracture

结局指标

主要结局

The main objective of the study is to evaluate and compare the results of a decision tree for the management of acetabulum fractures (also called acetabulum) in a large cohort of patients from the trauma center at Grenoble University Hospital

时间窗: 1 year

Clinical results according to the Postel-Merle d'Aubigné score (PMA)

次要结局

  • Propose a new assessment of the traumatic hip joint based on PROMs (Patient Reported Outcomes Measures) via a dedicated digital application (Orthense by Digikare)(1 year)
  • Evaluation of Outcomes and Complications of Early Weight Bearing in Older Adults(1 year)
  • Define the prognostic factors associated with poor clinical outcomes and total hip replacement surgery(1 year)
  • Compare clinical and radiological findings with the literature(1 year)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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