NCT07332052

Brief Summary

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 Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Jan 2026Aug 2026

First Submitted

Initial submission to the registry

December 30, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

January 20, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Last Updated

January 12, 2026

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

December 30, 2025

Last Update Submit

December 30, 2025

Conditions

Keywords

Geriatric AnesthesiaFrailtyHip FractureSarcopeniaRectus Femoris

Outcome Measures

Primary Outcomes (1)

  • Correlation between Rectus Femoris Muscle Thickness and Frailty Score

    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.

    Preoperative (within 24 hours before surgery)

Secondary Outcomes (3)

  • Predictive Value of Handgrip Strength for Frailty

    Preoperative

  • Correlation of Laboratory Biomarkers with Frailty Status

    1 day before operation

  • Hematological Indicators of Frailty

    1 day before operation

Study Arms (1)

Elderly Hip Fracture Patients

Patients aged 65 and older who have been diagnosed with a trochanteric femur fracture and are scheduled for orthopedic surgery.

Other: Clinical and Functional AssessmentOther: Rectus femoris thickness measurement

Interventions

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.

Also known as: Clinical Frailty Scale, Hand Dynamometry, Rectus Femoris Ultrasound, Sarcopenia Screening via Ultrasound
Elderly Hip Fracture Patients

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

Elderly Hip Fracture Patients

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of geriatric patients aged 65 years and older who have been hospitalized at the Orthopedics and Traumatology department of Mugla Sitki Kocman University Training and Research Hospital with a diagnosis of trochanteric femur fracture. This population includes patients scheduled for elective or semi-urgent orthopedic surgery who are capable of undergoing preoperative clinical and ultrasonographic assessments.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muğla Sıtkı Koçman University Training and Research Hospital

Muğla, Menteşe, 48000, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Femoral FracturesFrailtySarcopeniaHip Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg InjuriesPathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and SymptomsHip Injuries

Central Study Contacts

Ali İhsan Uysal, Ass.Prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass.Prof.

Study Record Dates

First Submitted

December 30, 2025

First Posted

January 12, 2026

Study Start

January 20, 2026

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

January 12, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared to protect the privacy of the participants and to maintain confidentiality in accordance with the institutional review board's (Mugla Sitki Kocman University Ethics Committee) regulations and local data protection laws.

Locations