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NCT Number: NCT07607886

Inflammatory Indices, Early Mortality, and ICU Stay in Geriatric PFN Patients

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Health Sciences Gazi Yaşargil Training and Research Hospital

Diyarbakır, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Intensive Care Unit Length of Stay

    Time frame: 30 days

    ICU stay duration in days

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study 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

Acronym: PFN-RAR

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
May 26, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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