Oral Nutritional Optimization in Total Joint Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ensure.
- Who it may be relevant to
- Registry conditions: Osteoarthritis. Basic parameters: from 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Changes in the patients' albumin, pre-albumin, and/or transferrin levels [Time frame: Visit 2 (2 wks pre) Visit 3 (surgery day) Visit 5 (4 weeks post)]
Eligibility criteria
Inclusion criteria
- Patient are current candidates for elective primary total hip and total knee arthroplasty
- Patients ≥55 years of age but ≤ 95
- 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
- Previous history of septic arthritis
- Allergy to oral supplementation
- Inability to consume oral supplementation
- Protein malabsorption syndromes
- Eating disorders
- End stage renal and hepatic disease
- Revision surgery, non-elective surgery, hemiarthroplasty, and unicompartmental knee arthroplasty
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- NYU Langone Health — New York
- Rothman Orthopedic Institute — Philadelphia
Identifiers
NCT: NCT04210284 · 18-01976