Efficacy of Oral Nutritional Supplement in Femoral Neck Fracture Patients Undergoing Hip Arthroplasty

N/ANot Yet RecruitingNCT07780006

Thammasat University60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Femoral Neck Fractures Geriatric Hip Fracture

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Hand grip strength

Hand grip strength, assess using hand dynamometer

Time frame: 12 weeks postoperatively

Secondary Outcomes

Hand grip strength

Hand grip strength, assess using hand dynamometer

Time frame: 2, 6 weeks postoperatively

Body weight