Femoral Neck Fractures, Geriatric Hip Fracture, Hip Fracture, Post Surgery Recovery, Muscle Resilience
Conditions
Keywords
Femoral neck fractures, Oral nutritional supplementation, HMB
Brief 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
Interventions
DIETARY_SUPPLEMENTOral nutritional supplementation
Oral nutritional supplement that consists of 20 grams of protein, 1.5 grams of calcium β-hydroxy-β-methylbutyrate (CaHMB), 0.5 gram of calcium, 500 international units (IU) of vitamin D and calories of 330 kcal per one bottle of 220 ml (Ensure® Advance Plus, Abbott Laboratorios S.A.)
Sponsors
Thammasat University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hand grip strength | 12 weeks postoperatively | Hand grip strength, assess using hand dynamometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hand grip strength | 2, 6 weeks postoperatively | Hand grip strength, assess using hand dynamometer |
| Body weight | 2, 6, 12 weeks postoperatively | — |
| Body mass index (BMI) | 2, 6, 12 weeks postoperatively | — |
| Serum albumin | 2, 6, 12 weeks postoperatively | — |
| Time up and go (TUG) | 2, 6, 12 weeks postoperatively | Performance-based outcome |
| Oxford hip score (OHS) | 2, 6, 12 weeks postoperatively | Patient-reported outcomes measurement of the hip function. Scores range from 0 to 48. Higher scores mean greater hip function and less pain. |
| Barthel index | 2, 6, 12 weeks postoperatively | Index for Activities of Daily Living. Scores range from 0 to 100, with higher scores mean the person is more independent. |
| Mini Nutritional Assessment (MNA) | 2, 6, 12 weeks postoperatively | Validated tool for assessment of elderly nutritional status. Scores range from 0 to 30. The higher scores mean normal nutritional status of the participants. |
| Geriatric Nutritional Risk Index (GNRI) | 2, 6, 12 weeks postoperatively | A tool used to evaluate nutritional risk, morbidity, and mortality in older adults. Scores are calculated from serum albumin and body weight of the participants (No range). Higher scores means low risk of malnutrition. |
Countries
Thailand
Contacts
CONTACTNatthasit Wongwarawanith, MD
CONTACTSupakit Kanitnate, MD
Outcome results
None listed