TPF Machine Learning Algorithms

Tibial Plateau Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04983316
• Other study ID #: S64352
• Status: Recruiting
• Start date: October 5, 2020
• Est. completion date: August 2026

Study information

• Verified date: August 2022
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Harm Hoekstra, Prof. MD
• Phone: 016341327
• Email: harm.hoekstra[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2026
• Est. primary completion date: August 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Tibial Plateau Fracture

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Machine learning algorithm	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.	1 year
Secondary	Clinical factors	To identify clinical factors that help predicting the best treatment for future patients	1 year
Secondary	Radiological factors	To identify radiological factors that help predicting the best treatment for future patients	1 year