Femoral FracturesNCT07463352
Preoperative Oral Nutrition And Outcomes In Frail Elderly Patients With Femur Fractures
An observational study of Femoral Fractures and Frailty, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn whether preoperative oral nutrition support improves clinical outcomes in elderly patients with femur fractures who have a high frailty index. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Femoral Fractures, Frailty, Malnutrition
- What is being tested?
- Oral Nutritional Supplement (ONS)
- Type of treatment
- Pill or oral medicine
- How many people
- 228 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Mar 2026to 1 Jan 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: The study population consists of elderly patients aged 65 years or older with femur fractures and a high frailty index (Clinical Frailty Scale ≥5) who are admitted for surgery at Düzce University Faculty of Medicine Hospital and are expected to require postoperative intensive care. Patients receiving preoperative oral nutritional support as part of routine clinical practice and those continuing their usual diet will be observed and followed perioperatively and postoperatively.
Who may be able to join
- Patients aged 65 years or older hospitalized with a diagnosis of femur fracture
- High frailty index (Clinical Frailty Scale ≥ 5)
- Patients expected to require postoperative intensive care
Who cannot join
- Patients requiring preoperative intensive care
- Patients unable to tolerate enteral nutrition
- Patients with advanced liver or kidney failure
- Patients unable to cooperate
- Patients with neuromuscular disease
- Patients with severe malnutrition according to NRS-2002 guidelines
- Patients who refuse to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Duzce University Health Research Center
Düzce
Ozlem Ersoy Karka, Ass.Prof., +90 533 729 3978, ozlemersoykarka@duzce.edu.tr
Gizem Önemli, Dr.
About this study
Official title: Evaluation of the Effects of Preoperative Oral Nutritional Support on Hemodynamic Stability, Morbidity, Mortality, and Anthropometric Measurements in Patients With Femur Fractures and High Frailty Index: A Prospective Observational Study
The goal of this observational study is to learn whether preoperative oral nutrition support improves clinical outcomes in elderly patients with femur fractures who have a high frailty index. The main questions it aims to answer are:
- Does preoperative nutrition support improve hemodynamic stability during and after surgery?
- Does it reduce postoperative complications, mortality, and length of hospital stay?
Read more
Researchers will compare patients who receive preoperative oral nutrition support with those who follow routine nutrition.
Participants will:
- Receive routine medical care with or without nutrition support
- Have their hemodynamic values, complications, and outcomes recorded during hospitalization
- Be followed at 30 and 90 days after surgery for complications and mortality.
Read the detailed description
Femur fractures in elderly patients with a high frailty index are associated with increased perioperative morbidity and mortality. Malnutrition is common in this population and may worsen hemodynamic instability, delay recovery, and increase postoperative complications. Although nutritional support has been studied in geriatric patients, data specific to frail patients with femur fractures are limited.
This prospective observational study will be conducted at the Düzce University Faculty of Medicine, Department of Anesthesiology and Reanimation, between January 2026 and December 2027. Patients aged 65 years or older with femur fractures and a Clinical Frailty Scale score ≥5 who are scheduled for surgery and expected to require postoperative intensive care will be included. Nutritional status will be assessed using NRS-2002 and Food Quality Score Index questionnaires.
Participants will be observed in two groups according to routine clinical practice: patients receiving preoperative oral nutritional support recommended by the nutrition clinic, and patients continuing their usual diet without additional support. No intervention will be assigned by the investigators.
Hemodynamic parameters will be recorded intraoperatively and during postoperative intensive care and ward follow-up. Anthropometric measurements (arm and waist circumference), laboratory values, morbidity, mortality, ICU length of stay, and total hospital stay will be documented. Patients will also be evaluated at postoperative 30 and 90 days for complications and survival.
The study aims to determine whether preoperative nutritional support is associated with improved hemodynamic stability and reduced morbidity and mortality in frail elderly patients with femur fractures. The results may guide perioperative nutritional strategies in high-risk geriatric surgical populations.
- Conditions
- Femoral Fractures, Frailty, Malnutrition
- Being tested
- Oral Nutritional Supplement (ONS)
- Keywords
- Hip Fractures, Geriatric Patients, Frailty, Malnutrition, Hemodynamic Stability
- Medical subject headings
- Femoral Fractures, Frailty, Malnutrition, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Nutritional Supplement (ONS)Dietary supplement
Standard preoperative oral nutritional supplements recommended by the hospital nutrition clinic are provided to frail elderly patients with femur fractures during their orthopedic ward stay before surgery. Supplements are given according to routine clinical practice and are not assigned by the investigators.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Patients receiving preoperative oral nutritional support in the orthopedic ward. | Elderly patients with femur fractures and high frailty who receive preoperative oral nutritional supplements in the orthopedic ward according to routine nutrition clinic recommendations. Patients are followed perioperatively and postoperatively for hemodynamic stability, complications, and mortality. Receives: Dietary Supplement: Oral Nutritional Supplement (ONS) | |
| Group 2: Patients followed with routine dietary intake without additional nutritional support. | Elderly patients with femur fractures and high frailty who continue their usual diet without additional nutritional support before surgery. Patients are followed with the same perioperative and postoperative outcome measurements for comparison. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pleth Variability Index (ΔPVI)
PVI values recorded with finger-probe noninvasive hemodynamic monitoring; ΔPVI will be calculated across predefined perioperative time points as an indicator of hemodynamic stability.
Measured: perioperatively/periprocedurally
Secondary outcomes (7)
Postoperative Morbidity Rate
Incidence of postoperative complications recorded during ICU and ward follow-up.
Measured: During hospital stay, and at postoperative 30 and 90 days
All-Cause Mortality
Mortality recorded during hospitalization and follow-up visits
Measured: During hospital stay, and at postoperative 30 and 90 days
ICU Length of Stay
Duration of ICU stay in days.
Measured: From ICU admission to ICU discharge during the index hospitalization, assessed up to 90 days postoperatively.
Total Hospital Length of Stay
Total days from admission to discharge.
Measured: From hospital admission to hospital discharge during the index hospitalization, assessed up to 90 days postoperatively.
Anthropometric Measurements (Arm and Waist Circumference Change)
Change in arm and waist circumference as indicators of nutritional status.
Measured: Baseline (Day 1 of hospitalization) and at hospital discharge during the index hospitalization, assessed up to 90 days.
Serum Albumin Level Change
Albumin values obtained from routine laboratory tests.
Measured: Baseline (Day 1 of hospitalization) and preoperative period (within 24 hours before surgery), assessed up to 90 days.
Intraoperative Hemodynamic Events
Incidence of hypotension, bradycardia, and inotrope requirement.
Measured: perioperatively/periprocedurally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start12 Mar 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral FracturesStudies of the same condition, open and under way.
- 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
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Ersoy Karka, Duzce University
- Investigators
- Özlem Ersoy Karka, Ass. Prof., Study chair, Duzce University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463352
- Sponsor's protocol ID
- drozlemersoy8
- Status last verified
- Jun 2026
- First submitted
- 24 Feb 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Preoperative Oral Nutritional Support on Hemodynamic Stability, Morbidity, Mortality, and Anthropometric Measurements in Patients With Femur Fractures and High Frailty Index: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07463352
- Acronym / sponsor ID
- drozlemersoy8
- Conditions
- Femoral Fractures, Frailty, Malnutrition
- Keywords
- Hip Fractures, Geriatric Patients, Frailty, Malnutrition, Hemodynamic Stability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 11 Mar 2026 (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.
The goal of this observational study is to learn whether preoperative oral nutrition support improves clinical outcomes in elderly patients with femur fractures who have a high frailty index. The main questions it aims to answer are:
- Does preoperative nutrition support improve hemodynamic stability during and after surgery?
- Does it reduce postoperative complications, mortality, and length of hospital stay?
Researchers will compare patients who receive preoperative oral nutrition support with those who follow routine nutrition.
Participants will:
- Receive routine medical care with or without nutrition support
- Have their hemodynamic values, complications, and outcomes recorded during hospitalization
- Be followed at 30 and 90 days after surgery for complications and mortality.
Detailed description
Femur fractures in elderly patients with a high frailty index are associated with increased perioperative morbidity and mortality. Malnutrition is common in this population and may worsen hemodynamic instability, delay recovery, and increase postoperative complications. Although nutritional support has been studied in geriatric patients, data specific to frail patients with femur fractures are limited.
This prospective observational study will be conducted at the Düzce University Faculty of Medicine, Department of Anesthesiology and Reanimation, between January 2026 and December 2027. Patients aged 65 years or older with femur fractures and a Clinical Frailty Scale score ≥5 who are scheduled for surgery and expected to require postoperative intensive care will be included. Nutritional status will be assessed using NRS-2002 and Food Quality Score Index questionnaires.
Participants will be observed in two groups according to routine clinical practice: patients receiving preoperative oral nutritional support recommended by the nutrition clinic, and patients continuing their usual diet without additional support. No intervention will be assigned by the investigators.
Hemodynamic parameters will be recorded intraoperatively and during postoperative intensive care and ward follow-up. Anthropometric measurements (arm and waist circumference), laboratory values, morbidity, mortality, ICU length of stay, and total hospital stay will be documented. Patients will also be evaluated at postoperative 30 and 90 days for complications and survival.
The study aims to determine whether preoperative nutritional support is associated with improved hemodynamic stability and reduced morbidity and mortality in frail elderly patients with femur fractures. The results may guide perioperative nutritional strategies in high-risk geriatric surgical populations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Patients receiving preoperative oral nutritional support in the orthopedic ward. | – | Dietary Supplement: Oral Nutritional Supplement (ONS)Elderly patients with femur fractures and high frailty who receive preoperative oral nutritional supplements in the orthopedic ward according to routine nutrition clinic recommendations. Patients are followed perioperatively and postoperatively for hemodynamic stability, complications, and mortality. |
| Group 2: Patients followed with routine dietary intake without additional nutritional support. | – | –Elderly patients with femur fractures and high frailty who continue their usual diet without additional nutritional support before surgery. Patients are followed with the same perioperative and postoperative outcome measurements for comparison. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population consists of elderly patients aged 65 years or older with femur fractures and a high frailty index (Clinical Frailty Scale ≥5) who are admitted for surgery at Düzce University Faculty of Medicine Hospital and are expected to require postoperative intensive care. Patients receiving preoperative oral nutritional support as part of routine clinical practice and those continuing their usual diet will be observed and followed perioperatively and postoperatively.
Key inclusion criteria (3 listed)
- Patients aged 65 years or older hospitalized with a diagnosis of femur fracture
- High frailty index (Clinical Frailty Scale ≥ 5)
- Patients expected to require postoperative intensive care
Key exclusion criteria (7 listed)
- Patients requiring preoperative intensive care
- Patients unable to tolerate enteral nutrition
- Patients with advanced liver or kidney failure
- Patients unable to cooperate
- Patients with neuromuscular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Nutritional Supplement (ONS)Standard preoperative oral nutritional supplements recommended by the hospital nutrition clinic are provided to frail elderly patients with femur fractures during their orthopedic ward stay before surgery. Supplements are given according to routine clinical practice and are not assigned by the investigators. | Dietary supplement | Group 1: Patients receiving preoperative oral nutritional support in the orthopedic ward. |
Primary outcome
Change in Pleth Variability Index (ΔPVI)
Time frame: perioperatively/periprocedurally
PVI values recorded with finger-probe noninvasive hemodynamic monitoring; ΔPVI will be calculated across predefined perioperative time points as an indicator of hemodynamic stability.
7 secondary outcomes
Postoperative Morbidity Rate
Time frame: During hospital stay, and at postoperative 30 and 90 days
All-Cause Mortality
Time frame: During hospital stay, and at postoperative 30 and 90 days
ICU Length of Stay
Time frame: From ICU admission to ICU discharge during the index hospitalization, assessed up to 90 days postoperatively.
Total Hospital Length of Stay
Time frame: From hospital admission to hospital discharge during the index hospitalization, assessed up to 90 days postoperatively.
Anthropometric Measurements (Arm and Waist Circumference Change)
Time frame: Baseline (Day 1 of hospitalization) and at hospital discharge during the index hospitalization, assessed up to 90 days.
Serum Albumin Level Change
Time frame: Baseline (Day 1 of hospitalization) and preoperative period (within 24 hours before surgery), assessed up to 90 days.
Intraoperative Hemodynamic Events
Time frame: perioperatively/periprocedurally
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 16 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Femoral Fractures
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
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.
Özlem Ersoy Karka, Ass. Prof. study chair
Duzce University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Fractures and Frailty, run by Duzce University at 1 site in Turkey (Türkiye).
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 3 inclusion and 7 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 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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 Özlem Ersoy Karka, Ass. Prof. (+90 533 729 3978, drozlemersoy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pleth Variability Index (ΔPVI) (time frame: perioperatively/periprocedurally). 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 16 Jun 2026.