Improving nutrition for patients undergoing joint replacement surgery
Oral Nutritional Optimization in Total Joint Arthroplasty
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT04210284 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: This approach is novel and has not been previously tested in randomized control studies for total joint arthroplasty patients.
Eligibility criteria
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 this trial is running
New York, New York and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.