Oral Nutritional Optimization in Total Joint Arthroplasty

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	55 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04210284
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	NYU Langone Health
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ran Schwarzkopf
Principal Investigator Affiliation	NYU Langone
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis

Additional Details

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.

Arms & Interventions

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

Interventions

Dietary Supplement: - 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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

NYU Langone Health, New York, New York

Status

Recruiting

Address

NYU Langone Health

New York, New York, 10016

Site Contact

Daniel Waren

[email protected]

212-598-6245

Rothman Orthopedic Institute, Philadelphia, Pennsylvania

Status

Recruiting

Address

Rothman Orthopedic Institute

Philadelphia, Pennsylvania, 19107

Site Contact

Alicia Reyes

[email protected]

267-339-3627

Clinical Trial Finder