Health TrialsbyHealthPanel

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

ConditionsFemoral Neck FracturesGeriatric Hip FractureHip Fracture, Post Surgery Recovery, Muscle Resilience
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorThammasat University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oral nutritional supplementation

    Dietary supplement

    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.)

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ONS groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Hand grip strength

Hand grip strength, assess using hand dynamometer

Time frame
12 weeks postoperatively

Secondary outcomes

1

Hand grip strength

Hand grip strength, assess using hand dynamometer

Time frame
2, 6 weeks postoperatively
2

Body weight

Time frame
2, 6, 12 weeks postoperatively
3

Body mass index (BMI)

Time frame
2, 6, 12 weeks postoperatively
4

Serum albumin

Time frame
2, 6, 12 weeks postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thammasat University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: