- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07607886
Inflammatory Indices, Early Mortality, and ICU Stay in Geriatric PFN Patients (PFN-RAR)
Association of Preoperative and Postoperative Inflammatory Indices With 30-Day Mortality and Intensive Care Unit Length of Stay in Geriatric Patients Undergoing Proximal Femoral Nailing: A Retrospective Observational Cohort Study
Study Overview
Status
Detailed Description
Hip fractures are associated with substantial morbidity and mortality in the geriatric population. Intertrochanteric femur fractures, in particular, frequently require surgical stabilization with proximal femoral nailing (PFN). Despite advances in perioperative care, early postoperative mortality rates and intensive care utilization remain high in elderly patients undergoing PFN surgery. Identifying reliable biomarkers that reflect the acute systemic inflammatory response to surgical trauma may improve perioperative risk stratification and postoperative management.
In recent years, several hematologic inflammatory indices derived from routine laboratory parameters have emerged as potential prognostic markers in different clinical settings. These include neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), monocyte-to-lymphocyte ratio (MLR), systemic immune-inflammation index (SII), systemic inflammation response index (SIRI), aggregate index of systemic inflammation (AIS), immune-inflammatory prognostic index (IPI), and red cell distribution width-to-albumin ratio (RAR). However, data regarding the prognostic significance of these inflammatory indices in geriatric orthopedic trauma patients remain limited.
This retrospective observational cohort study evaluates the association between preoperative and postoperative inflammatory indices and early postoperative outcomes in geriatric patients undergoing PFN surgery for intertrochanteric femur fractures. Electronic medical records of eligible patients aged 65 years and older will be reviewed retrospectively. Demographic characteristics, comorbidities, perioperative laboratory findings, inflammatory indices, 30-day mortality, and intensive care unit (ICU) length of stay will be analyzed.
The primary outcome of the study is 30-day mortality. The secondary outcome is ICU length of stay. The study aims to determine whether inflammatory indices, particularly RDW-to-albumin ratio (RAR), are independently associated with early mortality and prolonged ICU stay in the acute postoperative period. The findings may contribute to the identification of simple and cost-effective biomarkers for early risk assessment in geriatric hip fracture patients.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Diyarbakır
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Diyarbakır, Diyarbakır, Turkey (Türkiye)
- University of Health Sciences Gazi Yaşargil Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 65 years and older
- Diagnosis of intertrochanteric femur fracture
- Undergoing proximal femoral nailing (PFN) surgery
- Availability of preoperative laboratory data
- Availability of early postoperative laboratory measurements
- Availability of 30-day mortality data
- Availability of intensive care unit admission and ICU length of stay data
- Complete electronic medical records
Exclusion Criteria:
- Patients with missing clinical or laboratory data
- Pathological fractures
- Multiple trauma patients
- Revision surgeries
- Presence of active infection or sepsis before surgery
- Hematologic diseases that could affect inflammatory indices
- Unavailable 30-day mortality or ICU data
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Geriatric PFN Cohort
Geriatric patients aged 65 years and older who underwent proximal femoral nailing (PFN) surgery for intertrochanteric femur fractures and were retrospectively evaluated for inflammatory indices, 30-day mortality, and intensive care unit length of stay.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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30-Day Mortality
Time Frame: Within 30 days after surgery
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Evaluation of all-cause mortality occurring within the first 30 postoperative days in geriatric patients undergoing proximal femoral nailing surgery.
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Within 30 days after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Intensive Care Unit Length of Stay
Time Frame: 30 days
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ICU stay duration in days
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30 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: selen topalel, MD, Department of Anesthesiology and Reanimation, Gazi Yaşargil Training and Research Hospital, University of Health Sciences, Diyarbakır, Türkiye
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GYEAH-PFN-RAR-2026-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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