NCT04983316

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2023

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2024

Completed
Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

2.7 years

First QC Date

July 16, 2021

Last Update Submit

July 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Clinical factors

    1 year

  • Radiological factors

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of UZ Leuven

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Tibial Plateau Fractures

Condition Hierarchy (Ancestors)

Knee FracturesFractures, BoneWounds and InjuriesTibial FracturesKnee InjuriesLeg Injuries

Study Officials

  • Harm Hoekstra, Prof. MD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr. Harm Hoekstra

Study Record Dates

First Submitted

July 16, 2021

First Posted

July 30, 2021

Study Start

October 5, 2020

Primary Completion

June 27, 2023

Study Completion

December 6, 2024

Last Updated

July 29, 2025

Record last verified: 2025-07

Locations