Oral Nutritional Optimization in Total Joint Arthroplasty

NCT04210284 | Recruiting DMC

• 1 other identifier: 18-01976
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

  Visit 2 (2 wks pre) Visit 3 (surgery day) Visit 5 (4 weeks post)

Study Arms (2)

Nutritional supplementation

EXPERIMENTAL

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

Dietary Supplement: Ensure

No Nutritional supplementation

NO INTERVENTION

Treatment as usual

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

Nutritional supplementation

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (2)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Rothman Orthopedic Institute

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ran Schwarzkopf

  NYU Langone

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Waren

CONTACT

212-598-6245; Daniel.waren@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: December 24, 2019
• Study Start: July 6, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (2)