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Not yet recruiting NCT07332052

Predicting of Frailty

Observational Femur Fractures Frailty Sarcopenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clinical and Functional Assessment, Rectus femoris thickness measurement.
Who it may be relevant to
Registry conditions: Femur Fractures, Frailty, Sarcopenia. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Detailed description

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.

Interventions

  • Other Clinical and Functional Assessment
    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 Rectus femoris thickness measurement
    By using ultrasound linear prob the thickness of rectus femoris muscle will be measured

Primary outcome measures

  • Correlation between Rectus Femoris Muscle Thickness and Frailty Score [Time frame: Preoperative (within 24 hours before surgery)]
Secondary outcome measures (3)
  • Predictive Value of Handgrip Strength for Frailty [Time frame: Preoperative]
  • Correlation of Laboratory Biomarkers with Frailty Status [Time frame: 1 day before operation]
  • Hematological Indicators of Frailty [Time frame: 1 day before operation]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Muğla Sıtkı Koçman University Training and Research Hospital — Muğla

Publications

  • Mehmet H, Yang AWH, Robinson SR. Measurement of hand grip strength in the elderly: A scoping review with recommendations. J Bodyw Mov Ther. 2020 Jan;24(1):235-243. doi: 10.1016/j.jbmt.2019.05.029. Epub 2019 May 24. PMID 31987550
  • Sabatino A, Regolisti G, Bozzoli L, Fani F, Antoniotti R, Maggiore U, Fiaccadori E. Reliability of bedside ultrasound for measurement of quadriceps muscle thickness in critically ill patients with acute kidney injury. Clin Nutr. 2017 Dec;36(6):1710-1715. doi: 10.1016/j.clnu.2016.09.029. Epub 2016 Oct 1. PMID 27743614
  • Saglam Oz M, Toprak B, Bora R, Demir I. The Role of Hematological Parameters in Critically Ill Patients: Mortality Prediction in Elderly Intensive Care Unit Patients. Cureus. 2025 Apr 13;17(4):e82183. doi: 10.7759/cureus.82183. eCollection 2025 Apr. PMID 40364870

Identifiers

NCT: NCT07332052 · 250066

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗