跳至主要内容
临床试验/NCT04983316
NCT04983316终止不适用

Operative or Nonoperative Management of Tibial Plateau Fractures? Application of Machine Learning Algorithms to Assist in Treatment Decision

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年10月5日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
70
试验地点
1
主要终点
Machine learning algorithm

研究概览

简要总结

To adopt a machine learning technique to decide whether operative or non-operative treatment will result in the best patient-outcome.

详细描述

The overall goal is to adopt a machine learning technique to decide whether operative or non-operative treatment will result in the best patient-outcome.

The primary objectives are to identify the most suitable machine learning algorithm to predict the best treatment for future patients. Whether conservative or operative treatment will lead to the best patient outcome, will be decided on the predicted KOOS score. Several input factors, such as treatment (conservative or operative), number of fracture fragments, location of the fracture, soft tissue involvement,...for each patient will be used as training data for the algorithm. Some of these input data will be derived from CT-scans. Therefore, the CT scans will be segmented in Mimics, for which UZ Leuven recently purchased licenses. The output variable of the training data will be the KOOS score of each patient. Based on the input and output variable, the algorithm will determine a relation between these. For future patients of which the input variable are known, the output variable (=KOOS score) will be predicted both in case of operative and conservative treatment. We hypothesize that the prediction will be improved by adding more input data over time.

To secondary objective is to identify clinical and radiological factors that help predicting the best treatment for future patients.

As an outlook, the machine learning technique could be implemented in the future in clinical practice and utilized as a patient-specific planning tool for tibial plateau fracture management by aiding the surgeon to select the best treatment for a given case. The collected data in this registry will be used to validate the machine learning model. Patients will not yet be treated based on the results of the developed model, the trauma surgeon is responsible to decide which treatment option is best for the patient.

研究设计

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

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

  • Age > 18 years
  • Proximal tibia plateau fracture
  • Patient is able to attend follow-up visits

排除标准

  • Age < 18 years
  • Bilateral fractures
  • Neurologic disorders (ie paraplegia, CVA, dementia etc.)
  • Not understanding Dutch or English

结局指标

主要结局

Machine learning algorithm

时间窗: 1 year

To identify the most suitable machine learning algorithm that predicts the best treatment for future patients. The prediction will be improved over time by additional input.

次要结局

  • Clinical factors(1 year)
  • Radiological factors(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Harm Hoekstra, prof. dr.

Prof. dr. Harm Hoekstra

Universitaire Ziekenhuizen KU Leuven

研究点 (1)

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