Oral Nutritional Optimization in Total Joint Arthroplasty

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT04210284
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ensure — DIETARY_SUPPLEMENT
    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

Study Details

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.

Key Dates

Start date
Jul 6, 2021
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nutritional supplementation
    Given Ensure Max Protein Nutrition shake 2 weeks before surgery and continued 2 weeks after surgery.
  • No Intervention: No Nutritional supplementation
    Treatment as usual

Primary Outcome Measure

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) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016
Daniel Waren
[email protected]
212-598-6245
Ran Schwarzkopf, MD (PRINCIPAL_INVESTIGATOR)
Rothman Orthopedic InstitutePhiladelphiaPennsylvania19107
Alicia Reyes
[email protected]
267-339-3627

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By research site
NYU Langone Health· New York, NYRothman Orthopedic Institute· Philadelphia, PA

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