Oral Nutritional Optimization in Total Joint Arthroplasty
Recruiting · NCT04210284 · Interventional (participants receive a specific treatment) · Lead sponsor: NYU Langone Health
View the official record on ClinicalTrials.gov →Interventions studied
Ensure
What this trial is about
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.
Who can take part
Age range
55 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed across 2 US states.
- NYU Langone Health - New York, New York, United States
- Rothman Orthopedic Institute - Philadelphia, Pennsylvania, United States