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
About this trial
This is an interventional treatment trial for Osteoarthritis
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
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
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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