Oral Nutritional Optimization in Total Joint Arthroplasty

NYU Langone Health

Status: Enrolling

Conditions: Osteoarthritis

Treatments: Dietary Supplement: Ensure

Study type: Interventional

Funder types: Other

Identifiers

NCT04210284

18-01976

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Nutritional supplementation

Experimental group

Description:

Given Ensure Max Protein Nutrition shake 2 weeks before surgery and continued 2 weeks after surgery.

Treatment:

Dietary Supplement: Ensure

No Nutritional supplementation

No Intervention group

Description:

Treatment as usual