NCT07751692

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Aug 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

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Study Timeline

Key milestones and dates

Study Progress21%
Aug 2026Jun 2027

Study Start

First participant enrolled

August 1, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

August 7, 2026

Status Verified

August 1, 2026

Enrollment Period

9 months

First QC Date

August 3, 2026

Last Update Submit

August 6, 2026

Conditions

Keywords

Geriatric Nutritional Risk IndexRectus Femoris Muscle ThicknessMuscle UltrasoundGeriatric Hip FractureNutritional RiskPostoperative Length of StaySurgical Site InfectionPrognostic Factors30-Day Mortality90-Day Mortality

Outcome Measures

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.

    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

    From the date of surgery through 90 days after surgery

  • Number of Participants With 30-Day All-Cause Mortality

    within 30 days after surgery

  • Number of Participants With 90-Day All-Cause Mortality

    Within 90 days after surgery

Study Arms (1)

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.

Other: Geriatric Nutritional Risk Index Assessment

Interventions

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.

Geriatric Hip Fracture Cohort

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hip FracturesMalnutritionSarcopeniaPostoperative ComplicationsSurgical Wound Infection

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesNutrition DisordersNutritional and Metabolic DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPathologic ProcessesWound InfectionInfections

Central Study Contacts

Öznur Demiroluk, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology and Reanimation

Study Record Dates

First Submitted

August 3, 2026

First Posted

August 7, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

August 7, 2026

Record last verified: 2026-08

Locations