NCT06614478

Brief Summary

We ought to investigate if hip fracture patients suffering from frailty have higher inflammatory burden according to simple inflammatory biomarkers.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Apr 2023

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
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 Progress77%
Apr 2023Apr 2027

Study Start

First participant enrolled

April 1, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2027

Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

3.9 years

First QC Date

September 23, 2024

Last Update Submit

May 3, 2026

Conditions

FrailtyHip FractureInflammatory Biomarkers

Outcome Measures

Primary Outcomes (2)

  • Frailty status

    Frailty will be categorized based on the validated Groningen Frailty Indicator (GFI) as non-frail (NF, score 0,1), pre-frail (PF, score 2, 3) and severe frail (SF, score \>4).

    preoperatively

  • Inflammatory biomarkers

    Upon admission and immediate before surgery upper limits of white blood cells (WBC) within normal range (WBC \>8 10\^3/μL), NLR (neutrophils/lymphocytes), PLR (platelets/lymphocytes), CRP (C-reactive protein) and CLR (CRP/lymphocytes), will be recorded.

    preoperatively

Study Arms (1)

hip fracture patients treated with surgery

Hip fracture patients treated with surgery. Frailty will be categorized based on the validated Groningen Frailty Indicator (GFI)

Eligibility Criteria

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

hip fracture patients treated with surgery

You may qualify if:

  • age \>65 years, ASA PS I-III, non- institutionalized, able to communicate patients

You may not qualify if:

  • Patients with severe cognitive dysfunction, those treated conservatively, those with pathological fractures and patients who refused to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Larissa University Hospital

Larissa, Thessaly, 41110, Greece

RECRUITING

UHL

Larissa, Thessaly, 41110, Greece

RECRUITING

MeSH Terms

Conditions

FrailtyHip Fractures

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Eleni Arnaoutoglou, Professor

    University of Thessaly

    STUDY CHAIR

Central Study Contacts

Eleni Arnaoutoglou, Professor

CONTACT

+302413502952earnaout@gmail.com

Maria Ntalouka, MD, PhD, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Professor of Anaesthesiology

Study Record Dates

First Submitted

September 23, 2024

First Posted

September 26, 2024

Study Start

April 1, 2023

Primary Completion (Estimated)

February 25, 2027

Study Completion (Estimated)

April 12, 2027

Last Updated

May 5, 2026

Record last verified: 2026-05

Locations

GR(2)