Intertrochanteric Femur FracturePFN-RARNCT07607886
Inflammatory Indices, Early Mortality, and ICU Stay in Geriatric PFN Patients
An observational study of Intertrochanteric Femur Fracture and Hip Fracture Surgeries, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This retrospective observational cohort study aims to evaluate the association between preoperative and postoperative inflammatory indices and early postoperative outcomes in geriatric patients undergoing proximal femoral nailing (PFN) for intertrochanteric femur fractures. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Intertrochanteric Femur Fracture, Hip Fracture Surgeries, Geriatric Anesthesia
- How many people
- 233 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Geriatric patients aged 65 years and older who underwent proximal femoral nailing (PFN) surgery for intertrochanteric femur fractures at a tertiary referral center were retrospectively evaluated. The study population consisted of patients with available perioperative laboratory data, 30-day mortality information, and intensive care unit follow-up records.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Gazi Yaşargil Training and Research Hospital
Diyarbakır, Diyarbakır
About this study
Official title: 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
This retrospective observational cohort study aims to evaluate the association between preoperative and postoperative inflammatory indices and early postoperative outcomes in geriatric patients undergoing proximal femoral nailing (PFN) for intertrochanteric femur fractures. The primary outcome of the study is 30-day mortality, while the secondary outcome is intensive care unit (ICU) length of stay. Various inflammatory biomarkers derived from routine laboratory parameters, including 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), immune-inflammatory prognostic index (IPI), aggregate index of systemic inflammation (AIS), and RDW-to-albumin ratio (RAR), will be analyzed to investigate their prognostic value in the acute postoperative period. The study seeks to identify simple and readily accessible biomarkers that may contribute to early risk stratification and perioperative management in elderly hip fracture patients.
Read the 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.
- Keywords
- Proximal Femoral Nailing, Inflammatory Indices, RDW-to-Albumin Ratio, Early Mortality, Intensive Care Unit, Geriatric Patients, Hip Fracture Surgery, RAR, PFN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-Day Mortality
Evaluation of all-cause mortality occurring within the first 30 postoperative days in geriatric patients undergoing proximal femoral nailing surgery.
Measured: Within 30 days after surgery
Secondary outcomes (1)
Intensive Care Unit Length of Stay
ICU stay duration in days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Jan 2021
- Primary completion1 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intertrochanteric Femur FractureStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selen Topalel, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Investigators
- selen topalel, MD, Principal investigator, Department of Anesthesiology and Reanimation, Gazi Yaşargil Training and Research Hospital, University of Health Sciences, Diyarbakır, Türkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607886
- Sponsor's protocol ID
- GYEAH-PFN-RAR-2026-05
- Acronym
- PFN-RAR
- Status last verified
- Oct 2026
- First submitted
- 12 May 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07607886
- Acronym / sponsor ID
- PFN-RAR / GYEAH-PFN-RAR-2026-05
- Keywords
- Proximal Femoral Nailing, Inflammatory Indices, RDW-to-Albumin Ratio, Early Mortality, Intensive Care Unit, Geriatric Patients, Hip Fracture Surgery, RAR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 26 May 2026 (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 retrospective observational cohort study aims to evaluate the association between preoperative and postoperative inflammatory indices and early postoperative outcomes in geriatric patients undergoing proximal femoral nailing (PFN) for intertrochanteric femur fractures. The primary outcome of the study is 30-day mortality, while the secondary outcome is intensive care unit (ICU) length of stay. Various inflammatory biomarkers derived from routine laboratory parameters, including 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), immune-inflammatory prognostic index (IPI), aggregate index of systemic inflammation (AIS), and RDW-to-albumin ratio (RAR), will be analyzed to investigate their prognostic value in the acute postoperative period. The study seeks to identify simple and readily accessible biomarkers that may contribute to early risk stratification and perioperative management in elderly hip fracture patients.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Geriatric patients aged 65 years and older who underwent proximal femoral nailing (PFN) surgery for intertrochanteric femur fractures at a tertiary referral center were retrospectively evaluated. The study population consisted of patients with available perioperative laboratory data, 30-day mortality information, and intensive care unit follow-up records.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- Patients with missing clinical or laboratory data
- Pathological fractures
- Multiple trauma patients
- Revision surgeries
- Presence of active infection or sepsis before surgery
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: Within 30 days after surgery
Evaluation of all-cause mortality occurring within the first 30 postoperative days in geriatric patients undergoing proximal femoral nailing surgery.
1 secondary outcome
Intensive Care Unit Length of Stay
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
selen topalel, MD principal investigator
Department of Anesthesiology and Reanimation, Gazi Yaşargil Training and Research Hospital, University of Health Sciences, Diyarbakır, Türkiye
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 Intertrochanteric Femur Fracture and Hip Fracture Surgeries, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 8 inclusion and 7 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: finished, as of the sponsor's last update on 15 Oct 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Within 30 days after surgery). 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 15 Oct 2026.