Preoperative Oral Nutrition And Outcomes In Frail Elderly Patients With Femur Fractures

NCT07463352 | Recruiting

• 1 other identifier: drozlemersoy8
• Study Type: observational
• Target: 228
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Femoral Fractures; Frailty; Malnutrition

Keywords

Hip Fractures; Geriatric Patients; Frailty; Malnutrition; Hemodynamic Stability

Outcome Measures

Primary Outcomes (1)

• 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.

  perioperatively/periprocedurally

Secondary Outcomes (7)

• Postoperative Morbidity Rate

  During hospital stay, and at postoperative 30 and 90 days

• All-Cause Mortality

  During hospital stay, and at postoperative 30 and 90 days

• ICU Length of Stay

  From ICU admission to ICU discharge during the index hospitalization, assessed up to 90 days postoperatively.

• Total Hospital Length of Stay

  From hospital admission to hospital discharge during the index hospitalization, assessed up to 90 days postoperatively.

• Anthropometric Measurements (Arm and Waist Circumference Change)

  Baseline (Day 1 of hospitalization) and at hospital discharge during the index hospitalization, assessed up to 90 days.

Study Arms (2)

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.

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.

Interventions

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.

Group 1: Patients receiving preoperative oral nutritional support in the orthopedic ward.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Duzce University Health Research Center

Düzce, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Femoral Fractures; Frailty; Malnutrition; Hip Fractures

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Hip Injuries

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Özlem Ersoy Karka, Ass. Prof.

  Duzce University Faculty of Medicine

  STUDY CHAIR

Central Study Contacts

Özlem Ersoy Karka, Ass. Prof.

CONTACT

+90 533 729 3978; drozlemersoy@gmail.com

Gizem Merve Önemli, MD

CONTACT

+90 506 892 1804; gizemtez78@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 11, 2026
• Study Start: March 12, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)