Clinical trial Recruiting at 2 sites Interventional Ages 55 and up

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 typeInterventional
Ages55 Years and up
SexAll
Enrollment72 (estimated)
SponsorNYU Langone Health
Academic / other
Locations2 sites (New York, New York and 1 other locations)
StatusRecruiting
StartedJuly 6, 2021
Main results expectedDecember 31, 2026
Study endsJune 30, 2027
Registry record updatedOctober 30, 2026
Trial IDNCT04210284 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.