跳至主要内容
临床试验/NCT06724094
NCT06724094尚未招募不适用

Using Machine Learning to Detect and Predict Loosening NexGen Total Knee Replacement

University Hospital Southampton NHS Foundation Trust0 个研究点目标入组 2,105 人开始时间: 2025年8月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
2,105
主要终点
Predictive accuracy of machine learning model

研究概览

简要总结

The goal of this trial is to investigate whether Machine Learning (ML) can be used to detect small degrees of loosening, lucent zones, or any other changes on radiographs that might predict early failure following NexGen total knee replacement.

Researchers will identify plain AP and lateral plain film radiographs from two groups of patients. Those who has NexGen total knee replacements (TKRs) that went on to failure, and those who has well performing TKRs. Radiographs from these two groups will be labelled as 'failure' and 'well performing' and will be processed through a machine learning algorithm.

The algorithm will be successful if it is able to detect a NexGen TKR that went on to failure or went on to perform well. This will be determined by using a test set.

The population will be adults who had the recalled a NexGen Total Knee Replacement with a standard tibial tray. It will include adults only, who has the TKR at University Hospitals Southampton between 2003 and 2022.

Failure will be defined as revision of tibial or femoral components which is likely due to aspectic loosening. It will exclude washouts, exchange of poly, peri-prosthetic fractures, microbiologically confirmed infection.

Well performing TKRs will be defined as patients who have had their TKR in situ for 10 years and have reported no significant symptoms.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Had a NexGen TKR between 2003 and 2022.

排除标准

  • Below 18 yrs old.
  • Revision surgery for any reason other than aseptic loosening
  • patients who have not had a revision but who do not have a well functioning TKR.

结局指标

主要结局

Predictive accuracy of machine learning model

时间窗: Up to 21 years. Data starts from 2003.

The predictive accuracy of a machine learning algorithm. Using common ML measured, AUROC etc.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

相似试验