Clinical Trials Directory

Trials / Terminated

TerminatedNCT04983316

TPF Machine Learning Algorithms

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

Status
Terminated
Phase
Study type
Observational
Enrollment
70 (actual)
Sponsor
Universitaire Ziekenhuizen KU Leuven · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

Summary

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

Detailed description

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.

Conditions

Timeline

Start date
2020-10-05
Primary completion
2023-06-27
Completion
2024-12-06
First posted
2021-07-30
Last updated
2025-07-29

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT04983316. Inclusion in this directory is not an endorsement.