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临床试验/NCT03243409
NCT03243409Unknown不适用

Perioperative Complications in Proximal Humeral Fractures Treated With Reversed Shoulder Arthroplasties

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2017年7月25日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
105
试验地点
1
主要终点
Number of patients affected by minor complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.

研究概览

简要总结

Retrospective observational study of reversed shoulder arthroplasties by proximal humeral fracture. Analysis of preoperative risk factors as well as minor and major complications at the first week, 90 days and 1 year.

详细描述

The study is a multicenter retrospective observational study (3 centers). Data are collected from 105 patients over 65 years-old undergoing reversed shoulder arthroplasties by proximal humerus fractures, in 3 or 4 parts.

Patient information is obtained from the clinical records in their usual preoperative assessment, and follow-up on the usual routine checks, at the first week, 90 days and 1 year.

Minor and major complications rates are evaluated according to preoperative risk (ASA), underlying diseases and according to anticoagulant / antiaggregant treatments.

Likewise, transfusion rates related to ASA, as well as length of hospital stay related to it.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • Complex( 3- or 4-part) humerus fractures undergoing reversed shoulder arthroplasties.

排除标准

  • No exclusion criteria

结局指标

主要结局

Number of patients affected by minor complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.

时间窗: 1 year after surgery

Minor complications are medical complications, which usually don't affect to the functional outcome of arthroplasties

Number of patients affected by major complications according to preoperative risk (ASA) in reversed shoulder arthroplasties due to complex proximal humeral fractures.

时间窗: 1 year after surgery

Major complications are surgical complications( dislocation, periprosthetic fracture, infection) which usually affect to the functional outcome and can lead to a revision surgery

次要结局

  • Number of patients affected by minor complications after surgery, according to underlying disease(First week after surgery)
  • Number of patients with cardiovascular diseases affected by minor complications after surgery(1 year after surgery)
  • Number of patients with cardiovascular diseases affected by major complications after surgery(1 year after surgery)
  • Number of patients undergoing anticoagulant treatment with minor complications(90 days after surgery)
  • Number of patients undergoing anticoagulant treatment with major complications(90 days after surgery)
  • Number of patients undergoing antiplatelet treatment with minor complications(90 days after surgery)
  • Number of patients undergoing antiplatelet treatment with major complications(90 days after surgery)
  • Transfusion rates according to the preoperative ASA group(1 week after surgery)
  • Length of hospital stay according to the preoperative ASA group(1 week after surgery)

研究者

发起方
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
申办方类型
Other
责任方
Sponsor

研究点 (1)

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