Hip FractureNCT07751692
GNRI and Rectus Femoris Muscle Thickness in Older Patients Undergoing Hip Fracture Surgery
An observational study of Hip Fracture and Malnutrition, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study will evaluate whether nutritional risk and reduced muscle mass are associated with postoperative outcomes in adults aged 65 years or older undergoing surgery for hip fracture. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fracture, Malnutrition, Sarcopenia
- What is being tested?
- Geriatric Nutritional Risk Index Assessment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2026to Jun 2027
- 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 will consist of consecutive patients aged 65 years or older who are admitted to Fatih Sultan Mehmet Training and Research Hospital with a hip fracture and are scheduled to undergo surgical treatment. Eligible participants of both sexes will be enrolled after informed consent is obtained. Participants will receive routine perioperative clinical care without any treatment allocation by the study.
Who may be able to join
- Age 65 years or older
- Scheduled to undergo surgical treatment for hip fracture
- Provision of informed consent by the participant or, when applicable, a legally authorized representative
Who cannot join
- Pathological fracture or fracture related to malignancy
- Advanced neuromuscular disease
- Active infection
- Planned revision surgery
- Lower limb amputation or severe deformity preventing rectus femoris muscle thickness measurement
- Inability to obtain informed consent from the participant or a legally authorized representative
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
University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital
Istanbul, 34000
cansu ofluoğlu, md, +905358640564, cansuakin.iu@gmail.com
About this study
Official title: Prognostic Value of the Geriatric Nutritional Risk Index and Ultrasonographic Rectus Femoris Muscle Thickness in Older Patients Undergoing Hip Fracture Surgery: A Prospective Observational Study
This prospective observational study will evaluate whether nutritional risk and reduced muscle mass are associated with postoperative outcomes in adults aged 65 years or older undergoing surgery for hip fracture.
Nutritional risk will be assessed using the Geriatric Nutritional Risk Index (GNRI), which is calculated from routine preoperative serum albumin, body weight, and ideal body weight. Rectus femoris muscle thickness will be measured before surgery using a brief, noninvasive ultrasound examination of the non-fractured thigh.
Participants will receive routine clinical care, and no treatment or anesthesia method will be assigned by the study. Clinical information will be collected from hospital records, including postoperative length of hospital stay, surgical site infection, and mortality. Survival status will be evaluated at 30 and 90 days after surgery using hospital records and/or telephone follow-up.
Read the detailed description
This is a single-center, prospective observational cohort study involving consecutive patients aged 65 years or older who are scheduled to undergo surgical treatment for hip fracture at Fatih Sultan Mehmet Training and Research Hospital. The study will investigate the prognostic value of the Geriatric Nutritional Risk Index (GNRI) and ultrasonographic rectus femoris muscle thickness (RF-MT) for postoperative clinical outcomes.
After informed consent is obtained, demographic and preoperative clinical data will be recorded, including age, sex, height, weight, body mass index, comorbidities, American Society of Anesthesiologists physical status, fracture type, serum albumin, hemoglobin, C-reactive protein, and creatinine.
The GNRI will be calculated using the following formula:
GNRI = [1.489 × serum albumin (g/L)] + [41.7 × current body weight/ideal body weight].
When the ratio of current body weight to ideal body weight is greater than 1, the ratio will be set to 1. Participants will be classified according to the original GNRI categories: no nutritional risk (GNRI greater than 98), low nutritional risk (GNRI 92 to 98), and moderate or severe nutritional risk (GNRI less than 92).
Rectus femoris muscle thickness will be measured preoperatively on the non-fractured side using a high-frequency linear ultrasound probe. The measurement will be performed with the participant in the supine position at the midpoint between the anterior superior iliac spine and the upper border of the patella. Minimal probe pressure will be applied to avoid muscle compression. After the rectus femoris muscle is visualized in the transverse plane, muscle thickness will be measured as the greatest vertical distance between the superficial and deep fascia. Three measurements will be obtained, and their mean value will be used for analysis. All measurements will be performed by the same investigator experienced in ultrasonography.
Perioperative and postoperative data will include surgical procedure, anesthesia technique, duration of surgery, estimated blood loss, blood transfusion, intensive care unit admission, postoperative hospital length of stay, surgical site infection, and all-cause mortality at 30 and 90 days.
Postoperative hospital length of stay will be calculated as the number of days between surgery and hospital discharge. Prolonged postoperative hospital stay will be defined as a stay exceeding the 75th percentile of postoperative length of stay in the completed study cohort. Surgical site infections will be evaluated according to the Centers for Disease Control and Prevention criteria. Mortality status will be determined from hospital records and/or telephone follow-up.
No study-specific medication, anesthesia technique, surgical treatment, or additional blood sampling will be administered. The only study-specific procedure will be the noninvasive preoperative ultrasound measurement. Associations between GNRI, RF-MT, and postoperative outcomes will be evaluated using multivariable regression and receiver operating characteristic curve analyses.
- Conditions
- Hip Fracture, Malnutrition, Sarcopenia, Postoperative Complications
- Being tested
- Geriatric Nutritional Risk Index Assessment
- Keywords
- Geriatric Nutritional Risk Index, Rectus Femoris Muscle Thickness, Muscle Ultrasound, Geriatric Hip Fracture, Nutritional Risk, Postoperative Length of Stay, Surgical Site Infection, Prognostic Factors, 30-Day Mortality, 90-Day Mortality
- Medical subject headings
- Hip Fractures, Malnutrition, Sarcopenia, Postoperative Complications, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric Nutritional Risk Index AssessmentOther
Preoperative nutritional risk will be assessed using the Geriatric Nutritional Risk Index (GNRI), calculated from routine serum albumin, current body weight, and ideal body weight. Participants will be categorized as having no nutritional risk (GNRI greater than 98), low nutritional risk (GNRI 92 to 98), or moderate/severe nutritional risk (GNRI less than 92). The assessment will not alter routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric Hip Fracture Cohort | Patients aged 65 years or older undergoing surgical treatment for hip fracture. Preoperative nutritional risk will be assessed using the Geriatric Nutritional Risk Index, and rectus femoris muscle thickness will be measured by ultrasound on the non-fractured side. Participants will receive routine clinical care, and no treatment, anesthesia technique, or surgical intervention will be assigned by the study. Receives: Other: Geriatric Nutritional Risk Index Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Prolonged Postoperative Hospital Stay
Postoperative hospital length of stay will be calculated as the number of days from the date of surgery to the date of discharge. Prolonged postoperative hospital stay will be defined as a length of stay exceeding the 75th percentile of the postoperative length-of-stay distribution in the completed study cohort. The outcome will be reported as the number and percentage of participants meeting this criterion.
Measured: From the date of surgery through discharge from the index hospitalization, assessed up to 30 days after surgery.
Secondary outcomes (3)
Number of Participants With Surgical Site Infection
Surgical site infection will be assessed according to the Centers for Disease Control and Prevention criteria. Superficial and deep incisional infections will be identified using clinical findings, microbiological culture results, radiological findings, and/or a clinical diagnosis made by an infectious diseases or orthopedic specialist. The outcome will be reported as the number and percentage of participants with a surgical site infection.
Measured: From the date of surgery through 90 days after surgery
Number of Participants With 30-Day All-Cause Mortality
Vital status will be determined using hospital records and/or telephone follow-up. The outcome will be reported as the number and percentage of participants who die from any cause within 30 days after surgery.
Measured: within 30 days after surgery
Number of Participants With 90-Day All-Cause Mortality
Vital status will be determined using hospital records and/or telephone follow-up. The outcome will be reported as the number and percentage of participants who die from any cause within 90 days after surgery.
Measured: Within 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oznur Demiroluk, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751692
- Sponsor's protocol ID
- FSMTRH-GNRI
- Other IDs
- 2026/07-41
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of the Geriatric Nutritional Risk Index and Ultrasonographic Rectus Femoris Muscle Thickness in Older Patients Undergoing Hip Fracture Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07751692
- Acronym / sponsor ID
- FSMTRH-GNRI
- Conditions
- Hip Fracture, Malnutrition, Sarcopenia, Postoperative Complications
- Keywords
- Geriatric Nutritional Risk Index, Rectus Femoris Muscle Thickness, Muscle Ultrasound, Geriatric Hip Fracture, Nutritional Risk, Postoperative Length of Stay, Surgical Site Infection, Prognostic Factors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 7 Aug 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 prospective observational study will evaluate whether nutritional risk and reduced muscle mass are associated with postoperative outcomes in adults aged 65 years or older undergoing surgery for hip fracture.
Nutritional risk will be assessed using the Geriatric Nutritional Risk Index (GNRI), which is calculated from routine preoperative serum albumin, body weight, and ideal body weight. Rectus femoris muscle thickness will be measured before surgery using a brief, noninvasive ultrasound examination of the non-fractured thigh.
Participants will receive routine clinical care, and no treatment or anesthesia method will be assigned by the study. Clinical information will be collected from hospital records, including postoperative length of hospital stay, surgical site infection, and mortality. Survival status will be evaluated at 30 and 90 days after surgery using hospital records and/or telephone follow-up.
Detailed description
This is a single-center, prospective observational cohort study involving consecutive patients aged 65 years or older who are scheduled to undergo surgical treatment for hip fracture at Fatih Sultan Mehmet Training and Research Hospital. The study will investigate the prognostic value of the Geriatric Nutritional Risk Index (GNRI) and ultrasonographic rectus femoris muscle thickness (RF-MT) for postoperative clinical outcomes.
After informed consent is obtained, demographic and preoperative clinical data will be recorded, including age, sex, height, weight, body mass index, comorbidities, American Society of Anesthesiologists physical status, fracture type, serum albumin, hemoglobin, C-reactive protein, and creatinine.
The GNRI will be calculated using the following formula:
GNRI = [1.489 × serum albumin (g/L)] + [41.7 × current body weight/ideal body weight].
When the ratio of current body weight to ideal body weight is greater than 1, the ratio will be set to 1. Participants will be classified according to the original GNRI categories: no nutritional risk (GNRI greater than 98), low nutritional risk (GNRI 92 to 98), and moderate or severe nutritional risk (GNRI less than 92).
Rectus femoris muscle thickness will be measured preoperatively on the non-fractured side using a high-frequency linear ultrasound probe. The measurement will be performed with the participant in the supine position at the midpoint between the anterior superior iliac spine and the upper border of the patella. Minimal probe pressure will be applied to avoid muscle compression. After the rectus femoris muscle is visualized in the transverse plane, muscle thickness will be measured as the greatest vertical distance between the superficial and deep fascia. Three measurements will be obtained, and their mean value will be used for analysis. All measurements will be performed by the same investigator experienced in ultrasonography.
Perioperative and postoperative data will include surgical procedure, anesthesia technique, duration of surgery, estimated blood loss, blood transfusion, intensive care unit admission, postoperative hospital length of stay, surgical site infection, and all-cause mortality at 30 and 90 days.
Postoperative hospital length of stay will be calculated as the number of days between surgery and hospital discharge. Prolonged postoperative hospital stay will be defined as a stay exceeding the 75th percentile of postoperative length of stay in the completed study cohort. Surgical site infections will be evaluated according to the Centers for Disease Control and Prevention criteria. Mortality status will be determined from hospital records and/or telephone follow-up.
No study-specific medication, anesthesia technique, surgical treatment, or additional blood sampling will be administered. The only study-specific procedure will be the noninvasive preoperative ultrasound measurement. Associations between GNRI, RF-MT, and postoperative outcomes will be evaluated using multivariable regression and receiver operating characteristic curve analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric Hip Fracture Cohort | – | Other: Geriatric Nutritional Risk Index AssessmentPatients aged 65 years or older undergoing surgical treatment for hip fracture. Preoperative nutritional risk will be assessed using the Geriatric Nutritional Risk Index, and rectus femoris muscle thickness will be measured by ultrasound on the non-fractured side. Participants will receive routine clinical care, and no treatment, anesthesia technique, or surgical intervention will be assigned by the study. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population will consist of consecutive patients aged 65 years or older who are admitted to Fatih Sultan Mehmet Training and Research Hospital with a hip fracture and are scheduled to undergo surgical treatment. Eligible participants of both sexes will be enrolled after informed consent is obtained. Participants will receive routine perioperative clinical care without any treatment allocation by the study.
Key inclusion criteria (3 listed)
- Age 65 years or older
- Scheduled to undergo surgical treatment for hip fracture
- Provision of informed consent by the participant or, when applicable, a legally authorized representative
Key exclusion criteria (6 listed)
- Pathological fracture or fracture related to malignancy
- Advanced neuromuscular disease
- Active infection
- Planned revision surgery
- Lower limb amputation or severe deformity preventing rectus femoris muscle thickness measurement
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 |
|---|---|---|
| Geriatric Nutritional Risk Index AssessmentPreoperative nutritional risk will be assessed using the Geriatric Nutritional Risk Index (GNRI), calculated from routine serum albumin, current body weight, and ideal body weight. Participants will be categorized as having no nutritional risk (GNRI greater than 98), low nutritional risk (GNRI 92 to 98), or moderate/severe nutritional risk (GNRI less than 92). The assessment will not alter routine clinical care. | Other | Geriatric Hip Fracture Cohort |
Primary outcome
Number of Participants With Prolonged Postoperative Hospital Stay
Time frame: From the date of surgery through discharge from the index hospitalization, assessed up to 30 days after surgery.
Postoperative hospital length of stay will be calculated as the number of days from the date of surgery to the date of discharge. Prolonged postoperative hospital stay will be defined as a length of stay exceeding the 75th percentile of the postoperative length-of-stay distribution in the completed study cohort. The outcome will be reported as the number and percentage of participants meeting this criterion.
3 secondary outcomes
Number of Participants With Surgical Site Infection
Time frame: From the date of surgery through 90 days after surgery
Number of Participants With 30-Day All-Cause Mortality
Time frame: within 30 days after surgery
Number of Participants With 90-Day All-Cause Mortality
Time frame: Within 90 days after surgery
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 7 Aug 2026.
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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 Hip Fracture and Malnutrition, run by Fatih Sultan Mehmet Training and Research Hospital 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 3 inclusion and 6 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 7 Aug 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 Öznur Demiroluk, MD (+905335229508, onrdemiroluk@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Prolonged Postoperative Hospital Stay (time frame: From the date of surgery through discharge from the index hospitalization, assessed up to 30 days after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2026.