NCT07350785

Brief Summary

Hip fracture is a common injury in older adults and is often associated with serious complications, longer hospital stays, and increased risk of death. One of the most important causes of poor outcomes after hip fracture surgery is infection, including severe infections such as sepsis. Early identification of patients at higher risk for complications could help improve treatment and survival. This study aims to examine whether a blood test parameter called Monocyte Distribution Width (MDW), along with other commonly used inflammatory markers, can help predict complications and survival in elderly patients with hip fracture. MDW is measured as part of a routine complete blood count and has shown promise in the early detection of infection and systemic inflammation. Approximately 100 patients aged 65 years or older who are admitted to the hospital with a low-energy hip fracture will be included in this study. Blood tests will be performed at hospital admission, after surgery, and at other time points as part of standard clinical care. These tests include routine blood counts and inflammatory markers such as C-reactive protein (CRP), procalcitonin (PCT), antithrombin III, and MDW. No additional invasive procedures are required beyond standard medical care. Researchers will collect information about each patient's medical history, overall health status, and daily activity level before the fracture. Patients will be followed after surgery to assess complications, length of hospital stay, and survival at 1 month, 3 months, and 1 year. The results of this study may help determine whether MDW can be used as a simple and reliable marker to identify patients at higher risk of complications or death after hip fracture. This could support earlier intervention, closer monitoring, and improved care for elderly patients with hip fractures in the future.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

December 21, 2025

Last Update Submit

January 10, 2026

Conditions

Keywords

Monocyte Distribution Width (MDW)Geriatric PatientsInflammatory BiomarkersPostoperative MortalityPostoperative MorbidityC-reactive ProteinProcalcitoninAntithrombin IIIHip Fracture

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    Assessment of all-cause mortality in geriatric patients with low-energy hip fracture and its association with Monocyte Distribution Width (MDW) values measured at admission and during hospitalization.

    Up to 12 months postoperatively.

Secondary Outcomes (4)

  • Postoperative morbidity

    From postoperative day 1 through study completion, an average of 1 year.

  • Incidence of sepsis

    From postoperative day 1 through study completion, an average of 1 year.

  • Change in Monocyte Distribution Width (MDW) over time

    From hospital admission through hospital discharge, up to 14 days postoperatively.

  • Length of hospital stay

    From the date of hospital admission until hospital discharge, assessed up to 30 days.

Study Arms (1)

Geriatric Patients With Hip Fracture

This cohort consists of patients aged 65 years or older who are admitted with a low-energy hip fracture and undergo surgical treatment. All participants receive standard-of-care clinical management according to institutional protocols. No experimental interventions are assigned as part of this study. Clinical data, medical history, and pre-fracture functional status are recorded at baseline. Blood samples are collected as part of routine care at hospital admission, postoperatively, and at discharge to measure complete blood count parameters, including Monocyte Distribution Width (MDW), and other inflammatory markers such as C-reactive protein, procalcitonin, and antithrombin III. Participants are followed postoperatively to assess clinical outcomes, including complications, morbidity, mortality, and health-related quality of life. Comparisons will be performed between subgroups defined by clinical outcomes or biomarker levels.

Eligibility Criteria

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

The study population includes approximately 100 geriatric patients aged 65 years and older admitted with low-energy hip fractures and treated surgically at the 2nd Orthopaedic Department of the General Hospital of Attica KAT. Participants undergo routine perioperative evaluation, including demographic and clinical data collection and laboratory assessment of inflammatory biomarkers such as monocyte distribution width (MDW), C-reactive protein, procalcitonin, and antithrombin III. Patients are followed prospectively to evaluate postoperative morbidity and all-cause mortality at 1 month, 3 months, and 12 months following surgery.

You may qualify if:

  • Patients aged ≥65 years
  • Admission with low-energy hip fracture (femoral neck, intertrochanteric, or subtrochanteric fracture)
  • Admission to General Hospital of Attica KAT
  • Availability of baseline laboratory measurements, including complete blood count with monocyte distribution width (MDW) and inflammatory biomarkers

You may not qualify if:

  • Age \<65 years
  • High-energy trauma-related hip fractures
  • Pathological fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory for Research of the Musculoskeletal System

Kifissia, Attica, 14561, Greece

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral venous blood samples

MeSH Terms

Conditions

SepsisHip Fractures

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Efstathios Chronopoulos

    KAT General Hospital, Athens Greece

    STUDY DIRECTOR

Central Study Contacts

Efstathios Chronopoulos

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Orthopeadics at National and Kapodistrian University of Athens, Laboratory for Reasearch of the Musculoskeletal System Director

Study Record Dates

First Submitted

December 21, 2025

First Posted

January 20, 2026

Study Start

December 1, 2024

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will be made available to qualified researchers upon reasonable request. Data sharing will comply with the General Data Protection Regulation (EU GDPR) and applicable ethical and institutional requirements. Requests must include a brief description of the intended research use. Approved requests will be granted access to fully anonymized data sets, ensuring that study participants cannot be identified.

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