Back to Trials
NCT04210284NARecruiting

Oral Nutritional Optimization in Total Joint Arthroplasty

NYU Langone Health

Start Date

7/6/2021

Completion Date

6/30/2027

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.

Detailed 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 Criteria

Age Range: 55 years to No maximum

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

Interventions

DIETARY_SUPPLEMENT

Ensure

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Osteoarthritis

Locations

NYU Langone Health

New York, New York 10016

United States

Rothman Orthopedic Institute

Philadelphia, Pennsylvania 19107

United States