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临床试验/NCT05684042
NCT05684042招募中不适用

Fracture Database of the University Hospital Basel: A REDCap Assisted Reliability and Validity Study of Fracture Classifications of the Distal Radius

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2022年6月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
216
试验地点
1
主要终点
Number of discrepancies between the classifications of the expert group and the fracture database

研究概览

简要总结

The primary goal of this research project is to measure the accuracy of the classifications of the distal radius fracture in the fracture database. The evaluation of the extracted data analyzes the validity of the fracture classifications that the medical staff carry out in everyday clinical practice.

Endpoint of this project is the reclassification of the selected fractures by an in-house group of experts in order to be able to carry out a subsequent statistical evaluation. It is analyzed whether there are significant deviations between the classifications of the expert group and the fracture database.

详细描述

Since 2017, a fracture database has been developed in the Department of Orthopedics and Traumatology at the University Hospital in Basel. Since November 2018, all patients who are treated surgically in the Clinic for Traumatology & Orthopedics due to fractures of the extremities or the pelvis have been included in the fracture database of the University Hospital Basel for quality assurance purposes.

This database was created with the research software REDCap and is used for internal quality measurement. It essentially consists of three instruments: the encoded patient data, the diagnosis and the therapy. In order to promote rapid digitized progress in the health care system, the quality of the recorded data must be checked regularly through suitable studies. This type of quality management is of essential scientific relevance for the fracture database of the University Hospital Basel. For this reason, the classifications of the recorded fractures in the database are to be examined on a random basis so that weak points in the system can be addressed and staff can be better trained. The primary goal of the project is to measure the accuracy of the classifications of the distal radius fracture in the fracture database. The evaluation of the extracted data analyzes the validity of the fracture classifications that the medical staff carry out in everyday clinical practice.

Endpoint of this project is the reclassification of the selected fractures by an in-house group of experts in order to be able to carry out a subsequent statistical evaluation. It is analyzed whether there are significant deviations between the classifications of the expert group and the fracture database.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients at least 16 years of age and regardless of gender
  • Surgical treatment of a primary fracture of the distal radius was performed
  • Pre-therapeutic radiographs of good quality and in two planes
  • General consent for quality assurance and research was not rejected

排除标准

  • Existence of a documented refusal
  • Patients under the age of 16, as they are treated in the children's hospital
  • Conservative treatment of the distal radius fracture
  • Re-fracture after conservative or surgical treatment
  • Incorrect planes and poor quality of X-rays
  • Exclusive performance of a computed tomography, e.g. after polytrauma
  • Duplicates within the database
  • X-rays with forearm cast

结局指标

主要结局

Number of discrepancies between the classifications of the expert group and the fracture database

时间窗: one time assessment at baseline

Number of discrepancies between the classifications of the expert group and the fracture database

次要结局

未报告次要终点

研究者

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

研究点 (1)

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