NCT06961253

Brief Summary

This study aims to externally validate ten existing prediction models with a low risk of bias for 30-day mortality following hip fracture. Data will be collected from the Dutch Hip Fracture Audit (DHFA) and supplemented with structured and unstructured data extracted through text mining using CTcue. Approximately 35 clinical variables will be used, including factors consistently associated with short-term mortality. The primary outcome is all-cause mortality within 30 days after hip fracture. Predictive performance will be assessed through discrimination (AUC), explained variance (R²), and calibration analysis. Clinical usefulness will be evaluated using Net Benefit and Decision Curve Analysis. This study seeks to identify models with strong predictive performance and practical applicability to support shared decision-making between clinicians and patients.

Trial Health

55
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

June 1, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 7, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

November 17, 2025

Status Verified

April 1, 2025

Enrollment Period

1.6 years

First QC Date

April 29, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

hip fracturehip surgerymortalityprediction models

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality

    Occurrence of death from any cause within 30 days following hip fracture diagnosis or hospital admission. Mortality status (yes/no) will be determined based on hospital records and confirmed via the Dutch national population registry (Basisregistratie Personen, BRP).

    30 days post-fracture

Secondary Outcomes (1)

  • Discriminative Ability (AUC)

    30 days post-fracture

Other Outcomes (4)

  • Explained Variance (R²)

    30 days post-fracture

  • Calibration

    30 days post-fracture

  • Comparison of Model Discrimination (DeLong Test)

    30 days post-fracture

  • +1 more other outcomes

Eligibility Criteria

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

The study population consists of patients who underwent surgery for a hip fracture at OLVG between January 1, 2016, and June 6, 2024, including procedures with hemiarthroplasty or internal fixation. The average age of the study population is approximately 80 years. The cohort is inclusive due to the broad inclusion and minimal exclusion criteria, and data collection is based on an anonymous search strategy. This real-world population includes individuals who might not typically participate in randomized clinical trials, enhancing the generalizability of the results. In addition, the study identifies patients admitted with a hip fracture who did not undergo surgery during the same period, allowing for a comparison of demographic and clinical characteristics between operated and non-operated patients.

You may qualify if:

  • Patients admitted to OLVG between January 1, 2016, and March 1, 2024, with a diagnosis of hip fracture; and/or.
  • Patients who underwent surgery at OLVG between January 1, 2016, and March 1, 2024, with an indication of hip fracture; and.
  • Availability of independent predictor variables for at least one of the selected prediction models in the medical record.

You may not qualify if:

  • Patients with unknown 30-day follow-up mortality status.
  • Patients with periprosthetic fractures (fractures around an existing hip prosthesis) at the time of presentation.
  • Patients aged under 18 years at the time of hip fracture.
  • Patients who declined the use of their medical data for research purposes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OLVG

Amsterdam, 1091AC, Netherlands

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Diederik H.R. Kempen, Dr.

    OLVG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2025

First Posted

May 7, 2025

Study Start

June 1, 2024

Primary Completion

December 31, 2025

Study Completion

June 1, 2026

Last Updated

November 17, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Retrospective study using patient records without explicit consent for IPD sharing.

Locations