FrailtyNCT06614478
Frailty, Hip Fractures and Inflammatory Biomarkers
An observational study of Frailty and Hip Fracture, run by University of Thessaly at 2 sites in Greece.
Trial summary
We ought to investigate if hip fracture patients suffering from frailty have higher inflammatory burden according to simple inflammatory biomarkers. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Hip Fracture, Inflammatory Biomarkers
- How many people
- 200 participants
- Where
- 2 sitesGreece
- Study dates
- 1 Apr 2023to 12 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: hip fracture patients treated with surgery
Who may be able to join
- age \>65 years, ASA PS I-III, non- institutionalized, able to communicate patients
Who cannot join
- Patients with severe cognitive dysfunction, those treated conservatively, those with pathological fractures and patients who refused to participate
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Maria Ntalouka, MD, PhD, MSc contact
Greece2 sites, 2 recruiting
- Recruiting
Larissa University Hospital
Larissa, Thessaly, 41110
Eleni Arnaoutoglou, Professor, 030241302952, earnaout@gmail.com
- Recruiting
UHL
Larissa, Thessaly, 41110
Eleni Arnaoutoglou, Professor, +30241302952, earnaout@gmail.com
Maria Ntalouka, MD, PhD, Mac, maria.ntalouka@icloud.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Frailty, Hip Fracture, Inflammatory Biomarkers
- Medical subject headings
- Frailty, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Apr 2023
- Primary completion25 Feb 2027 (estimated)
- Study completion12 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Arnaoutoglou, University of Thessaly
- Investigators
- Eleni Arnaoutoglou, Professor, Study chair, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614478
- Sponsor's protocol ID
- Frailty and hip fractures
- Status last verified
- May 2026
- First submitted
- 23 Sep 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty in Hip Fracture Patients Treated With Surgery; the Role of Simple Inflammatory Biomarkers. An Observational Study
- ClinicalTrials.gov ID
- NCT06614478
- Acronym / sponsor ID
- Frailty and hip fractures
- Conditions
- Frailty, Hip Fracture, Inflammatory Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 25 Feb 2027 (estimated)
- Study completion
- 12 Apr 2027 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We ought to investigate if hip fracture patients suffering from frailty have higher inflammatory burden according to simple inflammatory biomarkers.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hip fracture patients treated with surgery | – | –Hip fracture patients treated with surgery. Frailty will be categorized based on the validated Groningen Frailty Indicator (GFI) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- hip fracture patients treated with surgery
Key inclusion criteria (1 listed)
- age \>65 years, ASA PS I-III, non- institutionalized, able to communicate patients
Key exclusion criteria (1 listed)
- Patients with severe cognitive dysfunction, those treated conservatively, those with pathological fractures and patients who refused to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Ntalouka, MD, PhD, MSc contact
Eleni Arnaoutoglou, Professor study chair
University of Thessaly
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Hip Fracture, run by University of Thessaly at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eleni Arnaoutoglou, Professor (+302413502952, earnaout@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty status (time frame: preoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.