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GNRI and Rectus Femoris Muscle Thickness in Older Patients Undergoing Hip Fracture Surgery

6 de agosto de 2026 actualizado por: Oznur Demiroluk, Fatih Sultan Mehmet Training and Research Hospital

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

120

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

      • Istanbul, Turquía (Türkiye), 34000
        • University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Prolonged Postoperative Hospital Stay
Periodo de tiempo: 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.
From the date of surgery through discharge from the index hospitalization, assessed up to 30 days after surgery.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Surgical Site Infection
Periodo de tiempo: From the date of surgery through 90 days after surgery
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.
From the date of surgery through 90 days after surgery
Number of Participants With 30-Day All-Cause Mortality
Periodo de tiempo: within 30 days after surgery
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.
within 30 days after surgery
Number of Participants With 90-Day All-Cause Mortality
Periodo de tiempo: Within 90 days after surgery
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.
Within 90 days after surgery

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de agosto de 2026

Finalización primaria (Estimado)

1 de mayo de 2027

Finalización del estudio (Estimado)

1 de junio de 2027

Fechas de registro del estudio

Enviado por primera vez

3 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de agosto de 2026

Publicado por primera vez (Actual)

7 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

7 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • FSMTRH-GNRI
  • 2026/07-41 (Otro identificador: University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital Scientific Research Ethics Committee)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .