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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorFatih Sultan Mehmet Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pathological fracture or fracture related to malignancy

Advanced neuromuscular disease

Active infection

Planned revision surgery

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Geriatric Nutritional Risk Index Assessment

    Other intervention

    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.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Geriatric Hip Fracture Cohort1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From the date of surgery through discharge from the index hospitalization, assessed up to 30 days after surgery.

Secondary outcomes

1

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.

Time frame
From the date of surgery through 90 days after surgery
2

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.

Time frame
within 30 days after surgery
3

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.

Time frame
Within 90 days after surgery

Other outcomes

Sponsors and contacts

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