Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07780006

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

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

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Femoral Neck Fractures Femoral Fractures Fractures, Bone Geriatric Hip Fracture Hip Fracture, Post Surgery Recovery, Muscle Resilience Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thammasat University

Pathum Thani, 12120, Thailand

Location contact

Department of Orthopaedics, Thammasat University

CONTACT

[email protected]

+669269775

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.)

Other names: Ensure Advanced Plus

Primary outcomes

  1. Hand grip strength

    Time frame: 12 weeks postoperatively

    Hand grip strength, assess using hand dynamometer

Secondary outcomes

  1. Hand grip strength

    Time frame: 2, 6 weeks postoperatively

    Hand grip strength, assess using hand dynamometer

  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

  5. Time up and go (TUG)

    Time frame: 2, 6, 12 weeks postoperatively

    Performance-based outcome

  6. Oxford hip score (OHS)

    Time frame: 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.

  7. Barthel index

    Time frame: 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.

  8. Mini Nutritional Assessment (MNA)

    Time frame: 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.

  9. Geriatric Nutritional Risk Index (GNRI)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Natthasit Wongwarawanith, MD

CONTACT

[email protected]

+66868855682

Supakit Kanitnate, MD

CONTACT

[email protected]

+66899853635

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Official study title

Efficacy of Oral Nutritional Supplement in Femoral Neck Fracture Patients Undergoing Hip Arthroplasty: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.