TPF Machine Learning Algorithms

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Recruiting
CT.gov ID
NCT04983316
Collaborator
(none)
300
1
69.8
4.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Operative or Nonoperative Management of Tibial Plateau Fractures? Application of Machine Learning Algorithms to Assist in Treatment Decision
    Actual Study Start Date :
    Oct 5, 2020
    Anticipated Primary Completion Date :
    Aug 1, 2025
    Anticipated Study Completion Date :
    Aug 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Machine learning algorithm [1 year]

      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.

    Secondary Outcome Measures

    1. Clinical factors [1 year]

      To identify clinical factors that help predicting the best treatment for future patients

    2. Radiological factors [1 year]

      To identify radiological factors that help predicting the best treatment for future patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UZ Leuven Leuven Vlaams-Brabant Belgium 3000

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen Leuven

    Investigators

    • Principal Investigator: Harm Hoekstra, Prof. MD, UZ Leuven

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Harm Hoekstra, prof. dr., Prof. dr. Harm Hoekstra, Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT04983316
    Other Study ID Numbers:
    • S64352
    First Posted:
    Jul 30, 2021
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 9, 2022