Femur FracturesPRE-FRAILNCT07332052
Predicting of Frailty
An observational study of Femur Fractures and Frailty, run by ali ihsan uysal at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Femur Fractures, Frailty, Sarcopenia
- What is being tested?
- Clinical and Functional Assessment and Rectus femoris thickness measurement
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2026to 15 Aug 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Muğla Sıtkı Koçman University Training and Research Hospital
Muğla, Menteşe, 48000
About this study
Official title: Comparison of Parameters That Can be Used to Predict Frailty in Elderly Femur Fracture Patients.
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
Read the 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.
- Conditions
- Femur Fractures, Frailty, Sarcopenia
- Being tested
- Clinical and Functional Assessment, Rectus femoris thickness measurement
- Keywords
- Geriatric Anesthesia, Frailty, Hip Fracture, Sarcopenia, Rectus Femoris
- Medical subject headings
- Femoral Fractures, Frailty, Sarcopenia, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and Functional AssessmentOther
Also called Clinical Frailty Scale, Hand Dynamometry, Rectus Femoris Ultrasound, Sarcopenia Screening via Ultrasound
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.
Rectus femoris thickness measurementOther
By using ultrasound linear prob the thickness of rectus femoris muscle will be measured
| Study group | Role | What they receive |
|---|---|---|
| Elderly Hip Fracture Patients | Patients aged 65 and older who have been diagnosed with a trochanteric femur fracture and are scheduled for orthopedic surgery. Receives: Other: Clinical and Functional Assessment; Other: Rectus femoris thickness measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative (within 24 hours before surgery)
Secondary outcomes (3)
Predictive Value of Handgrip Strength for Frailty
Assessment of handgrip strength using a hand dynamometer to evaluate its correlation with the Frailty Score.
Measured: Preoperative
Correlation of Laboratory Biomarkers with Frailty Status
Evaluation of the relationship between frailty and preoperative blood levels of Albumin, C-Reactive Protein (CRP), Glomerular Filtration Rate (GFR)
Measured: 1 day before operation
Hematological Indicators of Frailty
Analysis of Hemoglobin levels and Neutrophil-to-Lymphocyte Ratio (NLR) in relation to the patient's frailty score.
Measured: 1 day before operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start20 Jan 2026 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Femur FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- ali ihsan uysal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ali ihsan uysal, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332052
- Sponsor's protocol ID
- 250066
- Acronym
- PRE-FRAIL
- Status last verified
- Dec 2025
- First submitted
- 30 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 31987550Sabatino 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.
PubMed 27743614Saglam 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.
PubMed 40364870
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Parameters That Can be Used to Predict Frailty in Elderly Femur Fracture Patients.
- ClinicalTrials.gov ID
- NCT07332052
- Acronym / sponsor ID
- PRE-FRAIL / 250066
- Conditions
- Femur Fractures, Frailty, Sarcopenia
- Keywords
- Geriatric Anesthesia, Frailty, Hip Fracture, Sarcopenia, Rectus Femoris
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ali ihsan uysalUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly Hip Fracture Patients | – | Other: Clinical and Functional Assessment, Other: Rectus femoris thickness measurementPatients aged 65 and older who have been diagnosed with a trochanteric femur fracture and are scheduled for orthopedic surgery. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and Functional AssessmentAlso: Clinical Frailty Scale, Hand Dynamometry, Rectus Femoris Ultrasound, Sarcopenia Screening via UltrasoundAssessment 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 | Elderly Hip Fracture Patients |
| Rectus femoris thickness measurementBy using ultrasound linear prob the thickness of rectus femoris muscle will be measured | Other | Elderly Hip Fracture Patients |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Results publication: PubMed 31987550Mehmet 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.
- Results publication: PubMed 27743614Sabatino 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.
- Results publication: PubMed 40364870Saglam 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femur Fractures and Frailty, run by ali ihsan uysal at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali İhsan Uysal, Ass.Prof (+905067020960, alihsanuysal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Rectus Femoris Muscle Thickness and Frailty Score (time frame: Preoperative (within 24 hours before surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07332052, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.