TPF Machine Learning Algorithms

NCT ID: NCT04983316

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-05
• Study Completion Date: 2024-12-06

Brief 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

Tibial Plateau Fracture

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Harm Hoekstra, prof. dr.

Prof. dr. Harm Hoekstra

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harm Hoekstra, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Countries

Belgium

Other Identifiers

S64352

Identifier Type: -

Identifier Source: org_study_id