Oral Nutritional Optimization in Total Joint Arthroplasty

Osteoarthritis Clinical Trial

Official title:

Oral Nutritional Optimization in Total Joint Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04210284
• Other study ID #: 18-01976
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 6, 2021
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 372
• Est. completion date: July 2024
• Est. primary completion date: August 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Dietary Supplement:
• Ensure
Ensure Max Protein Shake is an over the counter available drinkable nutritional supplement. Per serving, it contains: 160 Calories, 20 from fat 2g Total fat 0.5g Saturated fat 20mg Cholesterol 135mg Sodium 170mg Potassium 19g Total carbohydrate <1g Fiber 4g Sugar 16g Protein Participants will receive Ensure High Protein for 2 weeks pre- and 4 weeks post-operatively. These patients will be instructed to consume 1 serving (16fl oz) of Ensure High Protein daily. They will be provided with this product at a pre-operative clinical visit or have it mailed to their home. Hematologic nutritional values will be measured as specified previously. Descriptive statistics will be used to report baseline characteristics and primary study objectives. Hematologic outcomes will be compared between the control ("NO ENSURE") and oral supplementation ("ENSURE") arms for the aforementioned baseline and perioperative variables

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York
United States	Rothman Orthopedic Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the patients' albumin, pre-albumin, and/or transferrin levels	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	Visit 2 (2 wks pre) Visit 3 (surgery day) Visit 5 (4 weeks post)