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Oral Nutritional Optimization in Total Joint Arthroplasty

Primary Purpose

Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ensure
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • NYU Langone HealthRecruiting
  • Rothman Orthopedic InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nutritional supplementation

No Nutritional supplementation

Arm Description

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

Treatment as usual

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 23, 2019
Last Updated
August 31, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT04210284
Brief Title
Oral Nutritional Optimization in Total Joint Arthroplasty
Official Title
Oral Nutritional Optimization in Total Joint Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
372 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nutritional supplementation
Arm Type
Experimental
Arm Description
Given Ensure Max Protein Nutrition shake 2 weeks before surgery and continued 2 weeks after surgery.
Arm Title
No Nutritional supplementation
Arm Type
No Intervention
Arm Description
Treatment as usual
Intervention Type
Dietary Supplement
Intervention Name(s)
Ensure
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in the patients' albumin, pre-albumin, and/or transferrin levels
Description
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
Time Frame
Visit 2 (2 wks pre) Visit 3 (surgery day) Visit 5 (4 weeks post)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Waren
Phone
212-598-6245
Email
Daniel.waren@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ran Schwarzkopf
Organizational Affiliation
NYU Langone
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Waren
Phone
212-598-6245
Email
daniel.waren@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Ran Schwarzkopf, MD
Facility Name
Rothman Orthopedic Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicia Reyes
Phone
267-339-3627
Email
Alicia.Reyes@rothmanortho.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data. Upon reasonable request Requests should be directed to Daniel.waren@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

Oral Nutritional Optimization in Total Joint Arthroplasty

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