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临床试验/NCT05735561
NCT05735561已完成不适用

Association Between the Direction of Proximal Humerus Fracture Dislocation and Risk of Avascular Necrosis Following Open Reduction Internal Fixation - An Observational, Cohort Study

Fraser Orthopaedic Research Society1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年2月15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
25
试验地点
1
主要终点
Rates of Avascular Necrosis

研究概览

简要总结

The purpose of the study is to see if there is a connection between a proximal humerus fracture dislocation direction and the likelihood of developing avascular necrosis. Utilizing a retrospective cohort from the last ten years we hope to bring consenting patients back for a single visit to have x-rays and complete patient reported outcome measures to assess for evidence of avascular necrosis.

详细描述

The incidence of proximal humerus fractures continues to increase and is among one of the more common fractures seen in the adult population. Proximal humerus fracture dislocations, however, are less common. Despite the decreased prevalence, fracture dislocations have unique challenges with respect to obtaining an anatomical reduction and more frequently involve an open surgical reduction. In addition, depending on other fracture characteristics, there are various treatment options for the fracture itself. While fracture dislocations ultimately lead to increased AVN and revision surgery, further discussion surrounding the direction of dislocation and how it may influence overall outcomes has not been addressed in the previous literature. The study design utilizes a retrospective cohort from the last ten years, by asking patients who have had a previously surgically treated proximal humerus fracture dislocations to come back to the surgeon's private clinic to complete a single visit assessment. During this assessment the consenting participant will receive x-rays and complete patient reported outcome measures. In conjunction, these will be utilized to assess overall function and the existence of avascular necrosis.

研究设计

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

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

  • Patients 18 years of age or older
  • Patients who underwent operative fixation of proximal humerus fracture dislocation at Royal Columbian Hospital between January 2011 and July 2021
  • Willing and able to consent and complete patient reported outcome measures
  • Willing and able to follow the protocol and attend a follow-up visit
  • Able to read and understand English or have an interpreter available

排除标准

  • Skeletally immature patients
  • Patient with pathological fractures
  • Patients who have had previous operative fixation of proximal humerus
  • Patients treated non-operatively
  • patients presenting outside of the study duration window
  • Patients treated by a non-participating surgeon
  • Deceased patients
  • Patients unable to complete patient reported outcome measures
  • Patients declining to come back to the clinic for updated x-rays
  • Incarceration

结局指标

主要结局

Rates of Avascular Necrosis

时间窗: At least 2 years post fracture fixation

The presence and advancement of avascular necrosis (as classified by the Cruess Classification System) and as assessed on radiographs.

Direction of the Humeral Fracture Dislocation

时间窗: At least 2 years post fracture fixation

As characterized by the direction of the humeral head in relation to the glenoid, based on AP, Lateral, or Axillary x-ray views.

次要结局

  • Constant Score (functional outcome)(At least 2 years post fracture fixation)
  • DASH (functional outcome)(At least 2 years post fracture fixation)

研究者

发起方
Fraser Orthopaedic Research Society
申办方类型
Network
责任方
Sponsor

研究点 (1)

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