Oral Nutritional Optimization in Total Joint Arthroplasty

The purpose of this study is to determine the effect on hematological markers of nutritional intervention on nutritionally deficient patients following total joint replacement surgery.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health, New York, United States

About this study

Numerous pre-operative modifiable variables have been extensively investigated for their effect on outcomes in TJA. These include metabolic diseases such as diabetes mellitus, obesity, and smoking status. However, nutritional status has not been as thoroughly investigated; to date, no prospective randomized control study has assessed the effect of oral nutritional supplementation for malnourished patients. This study will be a novel investigation into the role for routine serum screening for malnutrition as well as oral nutritional supplementation in TJA patients. This study could serve as a stepping stone towards creating a new pathway to highlight at-risk patients and pre-operatively optimizing their outcomes after TJA.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patient are current candidates for elective primary total hip and total knee arthroplasty
Patients ≥55 years of age but ≤ 95
Patients who meet at least one of the following three laboratory criteria for malnutrition:

TSerum Albumin: ≤3.5 mg/dl Pre-Albumin: <15 mg/dl Transferrin: <200 mg/dl

Exclusion criteria

Previous history of septic arthritis
Allergy to oral supplementation
Inability to consume oral supplementation
Protein malabsorption syndromes
Eating disorders
End stage renal and hepatic disease
Revision surgery, non-elective surgery, hemiarthroplasty, and unicompartmental knee arthroplasty

Treatment and study plan

Ensure

Dietary Supplement

Ensure Max Protein Shake is an over the counter available drinkable nutritional supplement. Per serving, it contains:

160 Calories, 20 from fat
2g Total fat
0.5g Saturated fat
20mg Cholesterol
135mg Sodium
170mg Potassium
19g Total carbohydrate
<1g Fiber
4g Sugar
16g Protein

Participants will receive Ensure High Protein for 2 weeks pre- and 4 weeks post-operatively. These patients will be instructed to consume 1 serving (16fl oz) of Ensure High Protein daily. They will be provided with this product at a pre-operative clinical visit or have it mailed to their home. Hematologic nutritional values will be measured as specified previously.

Descriptive statistics will be used to report baseline characteristics and primary study objectives. Hematologic outcomes will be compared between the control ("NO ENSURE") and oral supplementation ("ENSURE") arms for the aforementioned baseline and perioperative variables

Primary outcomes

Changes in the patients' albumin, pre-albumin, and/or transferrin levels

Time frame: Visit 2 (2 wks pre) Visit 3 (surgery day) Visit 5 (4 weeks post)

Biological specimen collection and laboratory evaluations- all included patients' hematologic markers of malnutrition (albumin, pre-albumin, and transferrin) will be recorded at 2 weeks prior to surgery, the day of surgery, and 6 weeks. These blood tests can all be performed from one sample of blood at each visit. The results will then be accessed via the EMR

Study contacts

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

Daniel Waren

CONTACT

[email protected]

212-598-6245

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2026
Study completion: 2027
First posted: Dec 24, 2019
Registry last updated: Sep 11, 2025

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.

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