Improving nutrition for patients undergoing joint replacement surgery
Official title: Oral Nutritional Optimization in Total Joint Arthroplasty
Run by NYU Langone Health · NCT04210284 · Data updated 2026-11-12
This study tests if giving extra nutrition to patients who are malnourished before joint replacement surgery can help them recover better and improve their overall health.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 55 Years and up |
| Sex | All |
| Enrollment | 72 (estimated) |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Status | Recruiting |
| Started | July 6, 2021 |
| Main results expected | December 31, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | October 30, 2026 |
| Trial ID | NCT04210284 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 55 to 95 who are scheduled for elective primary total hip or knee arthroplasty and meet specific laboratory criteria for malnutrition.
✕Probably not a fit
Patients with a history of septic arthritis, allergies to oral supplementation, or those unable to consume oral supplements will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the impact of nutritional interventions on patients with malnutrition who are scheduled for total joint arthroplasty. It aims to assess how oral nutritional supplementation can affect hematological markers and overall outcomes in these patients. By screening for malnutrition and providing targeted nutritional support, the study seeks to optimize pre-operative care and improve recovery after surgery. This is a novel approach, as no previous randomized control study has focused on this aspect in total joint arthroplasty patients.
Why it matters
Potential benefit: If successful, this study could enhance recovery and outcomes for malnourished patients undergoing joint replacement surgery.
How similar studies have gone: This approach is novel and has not been previously tested in randomized control studies for total joint arthroplasty patients.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient are current candidates for elective primary total hip and total knee arthroplasty 2. Patients ≥55 years of age but ≤ 95 3. 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: 1. Previous history of septic arthritis 2. Allergy to oral supplementation 3. Inability to consume oral supplementation 4. Protein malabsorption syndromes 5. Eating disorders 6. End stage renal and hepatic disease 7. Revision surgery, non-elective surgery, hemiarthroplasty, and unicompartmental knee arthroplasty
Where it's running
-
NYU Langone Health
New York, New York, United States Recruiting -
Rothman Orthopedic Institute
Philadelphia, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Ran Schwarzkopf — NYU Langone
- Study coordinator: Daniel Waren
- Email: Daniel.waren@nyulangone.org
- Phone: 212-598-6245
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.