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NCT04210284 | RECRUITING | Osteoarthritis

Oral Nutritional Optimization in Total Joint Arthroplasty
Sponsor:

NYU Langone Health

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.

Condition or disease

Osteoarthritis

Intervention/treatment

Ensure

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 372 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Oral Nutritional Optimization in Total Joint Arthroplasty
Actual Study Start Date : 2021-07-06
Estimated Primary Completion Date : 2025-07-01
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 55 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Oral Nutritional Optimization in Total Joint Arthroplasty

Location Details

NCT04210284

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

NYU Langone Health

New York, New York, United States, 10016

RECRUITING

United States, Pennsylvania

Rothman Orthopedic Institute

Philadelphia, Pennsylvania, United States, 19107