- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07350785
Prediction of Mortality and Morbidity After Hip Fracture Using Monocyte Distribution Width (MDW) (MDW)
The Role of Monocyte Distribution Width (MDW) and Other Inflammatory Biomarkers in the Prediction of Mortality and Morbidity in Patients With Hip Fracture
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Efstathios Chronopoulos
- Phone Number: 00306944837793
- Email: stathi24@yahoo.gr
Study Contact Backup
- Name: Lamprini Agapitou
- Phone Number: 00306943550207
- Email: labrini.agapitou@gmail.com
Study Locations
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Attica
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Kifissia, Attica, Greece, 14561
- Recruiting
- Laboratory for Research of the Musculoskeletal System
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Contact:
- Efstathios Chronopoulos, Prof.
- Phone Number: 00306944837793
- Email: stathi24@yahoo.gr
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Sub-Investigator:
- Kalliopi Lampropoulou-Adamidou
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Contact:
- Lamprini Agapitou
- Phone Number: 00306943550207
- Email: labrini.agapitou@gmail.com
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Principal Investigator:
- Efstathios Chronopoulos
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Sub-Investigator:
- Lamprini Agapitou
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Age <65 years
- High-energy trauma-related hip fractures
- Pathological fractures
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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All-cause mortality
Time Frame: Up to 12 months postoperatively.
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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.
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Up to 12 months postoperatively.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative morbidity
Time Frame: From postoperative day 1 through study completion, an average of 1 year.
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Assessment of postoperative morbidity, including infectious and non-infectious complications, and its association with Monocyte Distribution Width (MDW) and other inflammatory markers (C-reactive protein, procalcitonin, antithrombin III).
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From postoperative day 1 through study completion, an average of 1 year.
|
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Incidence of sepsis
Time Frame: From postoperative day 1 through study completion, an average of 1 year.
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Occurrence of sepsis during hospitalization or postoperative follow-up, evaluated in relation to MDW values and other inflammatory biomarkers.
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From postoperative day 1 through study completion, an average of 1 year.
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Change in Monocyte Distribution Width (MDW) over time
Time Frame: From hospital admission through hospital discharge, up to 14 days postoperatively.
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Evaluation of changes in MDW values from admission through the postoperative period and at discharge, and their association with clinical outcomes.
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From hospital admission through hospital discharge, up to 14 days postoperatively.
|
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Length of hospital stay
Time Frame: From the date of hospital admission until hospital discharge, assessed up to 30 days.
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Duration of hospitalization measured in days and its association with MDW and inflammatory marker levels.
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From the date of hospital admission until hospital discharge, assessed up to 30 days.
|
Collaborators and Investigators
Investigators
- Study Director: Efstathios Chronopoulos, KAT General Hospital, Athens Greece
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5570/04-03-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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