Oral Nutritional Optimization in Total Joint Arthroplasty

Not Applicable

Recruiting

• Conditions: Osteoarthritis
• Interventions: Dietary Supplement: Ensure

• Registration Number: NCT04210284
• Lead 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-23
• Study First Submitted QC: 2019-12-23
• Study First Posted: 2019-12-24
• Study Start: 2021-07-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-31
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 372

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutritional supplementation	Ensure	Given Ensure Max Protein Nutrition shake 2 weeks before surgery and continued 2 weeks after surgery.

Primary Outcome Measures

Name	Time	Method
Changes in the patients' albumin, pre-albumin, and/or transferrin levels	Visit 2 (2 wks pre) Visit 3 (surgery day) Visit 5 (4 weeks post)	Biological specimen collection and laboratory evaluations- all included patients' hematologic markers of malnutrition (albumin, pre-albumin, and transferrin) will be recorded at 2 weeks prior to surgery, the day of surgery, and 6 weeks. These blood tests can all be performed from one sample of blood at each visit. The results will then be accessed via the EMR

Trial Locations

Locations (2)

NYU Langone Health; 🇺🇸 New York, New York, United States

Rothman Orthopedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States