Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07332052

Predicting of Frailty

This study aims to evaluate the frailty status of elderly patients undergoing surgery for hip fractures (femur trochanteric fractures). Since frailty is a critical factor in surgical outcomes and recovery, researchers want to find simple, fast, and objective ways to measure it. This study will investigate muscle thickness measured by ultrasound, handgrip strength measured by a dynamometer, and routine blood test values can accurately predict a patient's frailty level. If these objective methods are proven effective, it will help anesthesia and surgical teams manage the perioperative process more safely for high-risk elderly patients

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Muğla Sıtkı Koçman University Training and Research Hospital

Muğla, Menteşe, 48000, Turkey (Türkiye)

About this study

65 and over years old elderly patients admitted to the orthopedics department with a diagnosis of trochanteric femur fracture will be enrolled in this study.

Preoperative Assessment: A researcher anesthesiologist, who is not involved in the patient's perioperative clinical management, will conduct the assessments to ensure objectivity. One day prior to the scheduled surgery, the following procedures will be performed:

Frailty Evaluation: Clinical frailty status will be determined using the Clinical Frailty Scale. In conjunction with this, handgrip strength will be measured using a calibrated hand dynamometer.

Ultrasonographic Measurements: Ultrasound will be used to measure the thickness of the rectus femoris muscle and the distance from the femur to the skin. These measurements will serve as objective indicators of musculoskeletal status.

Data Collection: Demographic data (age, weight, height, comorbidities) and routine preoperative laboratory results will be recorded from the hospital's electronic medical records. Laboratory parameters to be analyzed include:

Hematological: Hemoglobin, MPV, MCV, Neutrophil, and Lymphocyte counts.

Biochemical: Albumin, Creatinine, CRP, and GFR.

The study focuses on evaluating the correlation between these objective measurements (ultrasound and dynamometry) and the established clinical frailty scores to determine their predictive value in the geriatric surgical population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 65 years and older.
  • Confirmed diagnosis of trochanteric femur fracture.
  • Planned for orthopedic surgery under general or regional anesthesia.
  • Ability to provide written informed consent (either by the patient or a legal representative).

Exclusion criteria

  • Patients with advanced dementia or severe cognitive impairment who cannot cooperate with the handgrip strength test or Fried criteria questionnaire.
  • Patients with terminal-stage diseases or those under palliative care.
  • History of neuromuscular diseases or severe muscle-wasting conditions that affect the lower limbs (e.g., advanced muscular dystrophy).
  • Patients with active infections or skin lesions at the site of ultrasound measurement (rectus femoris area).
  • Emergency cases requiring immediate surgery where preoperative assessment cannot be completed.

Treatment and study plan

Clinical and Functional Assessment

Other

Assessment of frailty status using the Clinical Frailty Scale and measurement of handgrip strength using a hand dynamometer (measured in kilograms). Ultrasonographic measurement of the rectus femoris muscle thickness (mm) and femur-skin distance (mm) conducted one day before surgery.

Other names: Clinical Frailty Scale, Hand Dynamometry, Rectus Femoris Ultrasound, Sarcopenia Screening via Ultrasound

Rectus femoris thickness measurement

Other

By using ultrasound linear prob the thickness of rectus femoris muscle will be measured

Primary outcomes

  1. Correlation between Rectus Femoris Muscle Thickness and Frailty Score

    Time frame: Preoperative (within 24 hours before surgery)

    Evaluation of the relationship between clinical frailty status (measured by the Clinical Frailty Scale) and objective muscle mass (measured as rectus femoris thickness in millimeters via ultrasonography). Over 5 point indicate frailty.

Secondary outcomes

  1. Predictive Value of Handgrip Strength for Frailty

    Time frame: Preoperative

    Assessment of handgrip strength using a hand dynamometer to evaluate its correlation with the Frailty Score.

  2. Correlation of Laboratory Biomarkers with Frailty Status

    Time frame: 1 day before operation

    Evaluation of the relationship between frailty and preoperative blood levels of Albumin, C-Reactive Protein (CRP), Glomerular Filtration Rate (GFR)

  3. Hematological Indicators of Frailty

    Time frame: 1 day before operation

    Analysis of Hemoglobin levels and Neutrophil-to-Lymphocyte Ratio (NLR) in relation to the patient's frailty score.

Study contacts

Contact information is provided by the study sponsor or research team.

Ali İhsan Uysal, Ass.Prof

CONTACT

[email protected]

+905067020960

Sponsors and collaborators

Lead sponsor

ali ihsan uysal

Other

Registry information

Official study title

Comparison of Parameters That Can be Used to Predict Frailty in Elderly Femur Fracture Patients.

Acronym: PRE-FRAIL

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.