Oral Nutritional Optimization in Total Joint Arthroplasty
NCT ID: NCT04210284
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
72 participants
INTERVENTIONAL
2021-07-06
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nutritional supplementation
Given Ensure Max Protein Nutrition shake 2 weeks before surgery and continued 2 weeks after surgery.
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
No Nutritional supplementation
Treatment as usual
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
55 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Ran Schwarzkopf
Role: PRINCIPAL_INVESTIGATOR
NYU Langone
Locations
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NYU Langone Health
New York, New York, United States
Rothman Orthopedic Institute
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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18-01976
Identifier Type: -
Identifier Source: org_study_id
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