- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06614478
Frailty, Hip Fractures and Inflammatory Biomarkers
May 3, 2026 updated by: Elena Arnaoutoglou, University of Thessaly
Frailty in Hip Fracture Patients Treated With Surgery; the Role of Simple Inflammatory Biomarkers. An Observational Study
We ought to investigate if hip fracture patients suffering from frailty have higher inflammatory burden according to simple inflammatory biomarkers.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Frailty (F) is a prevalent syndrome among elderly patient with hip fractures (HF) and has been linked to poor prognosis.
Inflammatory biomarkers have been used as prognostic indexes in patients with HF.
We ought to investigate if hip fracture patients suffering from frailty have higher inflammatory burden according to simple inflammatory biomarkers.
Study Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eleni Arnaoutoglou, Professor
- Phone Number: +302413502952
- Email: earnaout@gmail.com
Study Contact Backup
- Name: Maria Ntalouka, MD, PhD, MSc
Study Locations
-
-
Thessaly
-
Larissa, Thessaly, Greece, 41110
- Recruiting
- Larissa University Hospital
-
Contact:
- Eleni Arnaoutoglou, Professor
- Phone Number: 030241302952
- Email: earnaout@gmail.com
-
Larissa, Thessaly, Greece, 41110
- Recruiting
- UHL
-
Contact:
- Eleni Arnaoutoglou, Professor
- Phone Number: +30241302952
- Email: earnaout@gmail.com
-
Contact:
- Maria Ntalouka, MD, PhD, Mac
- Email: maria.ntalouka@icloud.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
hip fracture patients treated with surgery
Description
Inclusion Criteria:
- age >65 years, ASA PS I-III, non- institutionalized, able to communicate patients
Exclusion Criteria:
- Patients with severe cognitive dysfunction, those treated conservatively, those with pathological fractures and patients who refused to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
hip fracture patients treated with surgery
Hip fracture patients treated with surgery.
Frailty will be categorized based on the validated Groningen Frailty Indicator (GFI)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frailty status
Time Frame: preoperatively
|
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
Time Frame: preoperatively
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Eleni Arnaoutoglou, Professor, University of Thessaly
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2023
Primary Completion (Estimated)
February 25, 2027
Study Completion (Estimated)
April 12, 2027
Study Registration Dates
First Submitted
September 23, 2024
First Submitted That Met QC Criteria
September 23, 2024
First Posted (Actual)
September 26, 2024
Study Record Updates
Last Update Posted (Actual)
May 5, 2026
Last Update Submitted That Met QC Criteria
May 3, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Frailty and hip fractures
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.