NCT04210284 Oral Nutritional Optimization in Total Joint Arthroplasty
| NCT ID | NCT04210284 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2021-07-06 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2021-07-06 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Ran Schwarzkopf
PRINCIPAL INVESTIGATOR
NYU Langone
Frequently Asked Questions
Who can join the NCT04210284 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04210284 currently recruiting?
Yes, NCT04210284 is actively recruiting participants. Contact the research team at Daniel.waren@nyulangone.org for enrollment information.
Where is the NCT04210284 trial being conducted?
This trial is being conducted at New York, United States, Philadelphia, United States.
Who is sponsoring the NCT04210284 clinical trial?
NCT04210284 is sponsored by NYU Langone Health. The principal investigator is Ran Schwarzkopf at NYU Langone. The trial plans to enroll 72 participants.