NCT07607886

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
233

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Jan 2021

Longer than P75 for all trials

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 Progress99%
Jan 2021Jun 2026

Study Start

First participant enrolled

January 1, 2021

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

5.5 years

First QC Date

May 12, 2026

Last Update Submit

May 25, 2026

Conditions

Keywords

Proximal Femoral NailingInflammatory IndicesRDW-to-Albumin RatioEarly MortalityIntensive Care UnitGeriatric PatientsHip Fracture SurgeryRARPFN

Outcome Measures

Primary Outcomes (1)

  • 30-Day Mortality

    Evaluation of all-cause mortality occurring within the first 30 postoperative days in geriatric patients undergoing proximal femoral nailing surgery.

    Within 30 days after surgery

Secondary Outcomes (1)

  • Intensive Care Unit Length of Stay

    30 days

Study Arms (1)

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Gazi Yaşargil Training and Research Hospital

Diyarbakır, Diyarbakır, Turkey (Türkiye)

Location

Study Officials

  • selen topalel, MD

    Department of Anesthesiology and Reanimation, Gazi Yaşargil Training and Research Hospital, University of Health Sciences, Diyarbakır, Türkiye

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

May 12, 2026

First Posted

May 26, 2026

Study Start

January 1, 2021

Primary Completion

June 15, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

May 28, 2026

Record last verified: 2026-05

Locations