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NCT07780006
Efficacy of Oral Nutritional Supplement in Femoral Neck Fracture Patients Undergoing Hip Arthroplasty
Conditions: Femoral Neck Fractures, Geriatric Hip Fracture, Hip Fracture, Post Surgery Recovery, Muscle Resilience
Sex: All
Ages: 65 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Thammasat University
Location: Thammasat University Pathum Thani
Summary
This study aim to compare the efficacy of oral nutritional supplementation (ONS) in femoral neck fracture patients undergoing hip arthroplasty compared with placebo. The hypothesis is "Oral nutritional supplement with Beta-hydroxy-beta-methylbutyrate (HMB) can improve muscle strength in femoral neck fracture patients undergoing hip arthroplasty".
Femoral neck fracture patients aged more than 65 years will be enrolled and allocated into 2 groups
* ONS group: Oral nutritional supplement (Ensure® Plus Advance) 2 serves / day x 30 days + Standard oral intake
* Control group: Standard oral intake
Primary outcome is Grip strength, assessed using hand dynamometer on admission and 2, 6, 12 weeks postoperatively.
Secondary outcomes are
* Serum albumin assessed on admission and 2, 6, 12 weeks postoperatively
* Barthel index assessed at 2, 6, 12 weeks postoperatively
* Mini Nutritional Assessment (MNA), Geriatric Nutritional Risk Index (GNRI) assessed at 2, 6, 12 weeks postoperatively
* Length of stay (day)
* Time up and go (TUG), assessed at 2, 6, 12 weeks postoperatively
* Oxford hip score (OHS), assessed at 2, 6, 12 weeks postoperatively
* Complications, rate of readmission, mortality rate assessed until 3 months
Eligibility Criteria
Inclusion Criteria:
* Femoral neck fracture patients undergoing hip arthroplasty (Total hip arthroplasty or bipolar hemiarthroplasty)
* Age ≥ 65 years
* American Society of Anesthesiologists (ASA) class I-III
* Participants understand and consent to the protocol of the trial
Exclusion Criteria:
* Pathologic fracture or high impact fracture
* Morbid obesity (Body mass index \> 40)
* Chronic kidney disease (Chronic kidney disease stage \> 3b or estimated glomerular filtration rate (eGFR) \< 30)
* Thyroid disease or endrocrinopathy
* Gastrointestinal intolerance preventing oral supplementation or Malabsorption syndromes
* Malignancy with radiotherapy or chemotherapy
* Cognitive disorder
* Decompensated Liver Disease or Cirrhosis Child-Pugh Class B-C
* Known allergy/intolerance to milk or other supplement ingredients
Source: ClinicalTrials.gov (NCT07780006). StuddyBuddy aggregates publicly available trial information.