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