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Oral Nutritional Optimization in Total Joint Arthroplasty

Recruiting
55 years of age
Both
Phase N/A

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Overview

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.

Description

Numerous pre-operative modifiable variables have been extensively investigated for their effect on outcomes in TJA. These include metabolic diseases such as diabetes mellitus, obesity, and smoking status. However, nutritional status has not been as thoroughly investigated; to date, no prospective randomized control study has assessed the effect of oral nutritional supplementation for malnourished patients. This study will be a novel investigation into the role for routine serum screening for malnutrition as well as oral nutritional supplementation in TJA patients. This study could serve as a stepping stone towards creating a new pathway to highlight at-risk patients and pre-operatively optimizing their outcomes after TJA.

Eligibility

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

Study details

Osteoarthritis

NCT04210284

NYU Langone Health

14 October 2025

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