Hip FracturePROTECTNCT06961253
External Validation of Ten Prediction Models for 30-day Mortality Following Hip Fracture
An observational study of Hip Fracture and Hip Fracture Surgeries, run by JointResearch at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Fracture, Hip Fracture Surgeries
- How many people
- 3,500 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2024to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Validation of Ten Prediction Models With Low Risk of Bias for 30-day Mortality Following Hip Fracture: A Focus on Predictive Performance and Clinical Applicability
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.
Read the detailed description
Hip fractures are a major health concern, especially among older adults, and are associated with substantial morbidity, mortality, and healthcare costs. While surgical intervention is standard practice for most patients, a growing number of cases require careful consideration of operative versus non-operative management based on individual risk profiles and patient preferences.
Several prediction models have been developed to estimate the risk of short-term mortality after hip fracture, but many have shown only moderate predictive performance or lacked clinical applicability. In 2024, a systematic review identified ten models with a low risk of bias, based on methodological criteria such as adequate sample size, proper handling of missing data, internal validation, and assessment of calibration.
This study aims to externally validate these ten prediction models using data from the Dutch Hip Fracture Audit (DHFA) combined with additional structured and unstructured clinical information extracted through CTcue, a text-mining software tool. Approximately 35 variables, including key preoperative factors such as age, sex, ASA score, institutionalization, and metastatic cancer, will be analyzed. Missing data will be addressed through multiple imputation.
The primary outcome is 30-day all-cause mortality following a hip fracture. Validation of the models will involve evaluation of predictive performance through discrimination (area under the curve [AUC]), explained variance (R²), and calibration curves. The DeLong test will be used to statistically compare model AUCs. Clinical usefulness will be assessed by calculating Net Benefit and conducting Decision Curve Analysis.
By rigorously validating these models in a large, real-world cohort, the study aims to identify which models offer both strong predictive accuracy and practical feasibility for supporting shared decision-making between clinicians and patients.
- Conditions
- Hip Fracture, Hip Fracture Surgeries
- Keywords
- hip fracture, hip surgery, mortality, prediction models
- Medical subject headings
- Hip Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days post-fracture
Secondary outcomes (1)
Discriminative Ability (AUC)
Area Under the Receiver Operating Characteristic Curve (AUC) for each prediction model, measuring the ability to distinguish between patients who die and those who survive within 30 days post-fracture.
Measured: 30 days post-fracture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start1 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JointResearch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diederik H.R. Kempen, Dr., Principal investigator, OLVG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961253
- Sponsor's protocol ID
- WO 24.013
- Acronym
- PROTECT
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Retrospective study using patient records without explicit consent for IPD sharing.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Validation of Ten Prediction Models With Low Risk of Bias for 30-day Mortality Following Hip Fracture: A Focus on Predictive Performance and Clinical Applicability
- ClinicalTrials.gov ID
- NCT06961253
- Acronym / sponsor ID
- PROTECT / WO 24.013
- Conditions
- Hip Fracture, Hip Fracture Surgeries
- Keywords
- hip fracture, hip surgery, mortality, prediction models
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- JointResearchUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hip fractures are a major health concern, especially among older adults, and are associated with substantial morbidity, mortality, and healthcare costs. While surgical intervention is standard practice for most patients, a growing number of cases require careful consideration of operative versus non-operative management based on individual risk profiles and patient preferences.
Several prediction models have been developed to estimate the risk of short-term mortality after hip fracture, but many have shown only moderate predictive performance or lacked clinical applicability. In 2024, a systematic review identified ten models with a low risk of bias, based on methodological criteria such as adequate sample size, proper handling of missing data, internal validation, and assessment of calibration.
This study aims to externally validate these ten prediction models using data from the Dutch Hip Fracture Audit (DHFA) combined with additional structured and unstructured clinical information extracted through CTcue, a text-mining software tool. Approximately 35 variables, including key preoperative factors such as age, sex, ASA score, institutionalization, and metastatic cancer, will be analyzed. Missing data will be addressed through multiple imputation.
The primary outcome is 30-day all-cause mortality following a hip fracture. Validation of the models will involve evaluation of predictive performance through discrimination (area under the curve [AUC]), explained variance (R²), and calibration curves. The DeLong test will be used to statistically compare model AUCs. Clinical usefulness will be assessed by calculating Net Benefit and conducting Decision Curve Analysis.
By rigorously validating these models in a large, real-world cohort, the study aims to identify which models offer both strong predictive accuracy and practical feasibility for supporting shared decision-making between clinicians and patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
30-day mortality
Time frame: 30 days post-fracture
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).
1 secondary outcome
Discriminative Ability (AUC)
Time frame: 30 days post-fracture
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No. Retrospective study using patient records without explicit consent for IPD sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diederik H.R. Kempen, Dr. principal investigator
OLVG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fracture and Hip Fracture Surgeries, run by JointResearch at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality (time frame: 30 days post-fracture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.