Muğla Sıtkı Koçman University Training and Research Hospital
Muğla, Menteşe, 48000, Turkey (Türkiye)
NCT Number: NCT07332052
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
Trial opening soon.
Get Notified65 year and older
All sexes
Observational
Muğla, Menteşe, 48000, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
By using ultrasound linear prob the thickness of rectus femoris muscle will be measured
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.
Time frame: Preoperative
Assessment of handgrip strength using a hand dynamometer to evaluate its correlation with the Frailty Score.
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)
Time frame: 1 day before operation
Analysis of Hemoglobin levels and Neutrophil-to-Lymphocyte Ratio (NLR) in relation to the patient's frailty score.
Contact information is provided by the study sponsor or research team.
ali ihsan uysal
Other
Comparison of Parameters That Can be Used to Predict Frailty in Elderly Femur Fracture Patients.
Acronym: PRE-FRAIL
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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.
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