OsteoarthritisNCT04210284
Oral Nutritional Optimization in Total Joint Arthroplasty
A study testing Ensure in people with Osteoarthritis, run by NYU Langone Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Ensure
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jul 2021to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
Daniel Waren, 212-598-6245, daniel.waren@nyulangone.org
Ran Schwarzkopf, MD
- Recruiting
Rothman Orthopedic Institute
Philadelphia, Pennsylvania, 19107
Alicia Reyes, 267-339-3627, Alicia.Reyes@rothmanortho.com
About this study
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Ensure
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnsureDietary 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 group | Role | What they receive |
|---|---|---|
| Nutritional supplementation | Experimental | Given Ensure Max Protein Nutrition shake 2 weeks before surgery and continued 2 weeks after surgery. Receives: Dietary Supplement: Ensure |
| No Nutritional supplementation | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Visit 2 (2 wks pre) Visit 3 (surgery day) Visit 5 (4 weeks post)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start6 Jul 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ran Schwarzkopf, Principal investigator, NYU Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210284
- Sponsor's protocol ID
- 18-01976
- Status last verified
- Oct 2026
- First submitted
- 23 Dec 2019
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Nutritional Optimization in Total Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT04210284
- Acronym / sponsor ID
- 18-01976
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional supplementation | Experimental | Dietary Supplement: EnsureGiven Ensure Max Protein Nutrition shake 2 weeks before surgery and continued 2 weeks after surgery. |
| No Nutritional supplementation | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Previous history of septic arthritis
- Allergy to oral supplementation
- Inability to consume oral supplementation
- Protein malabsorption syndromes
- Eating disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnsureEnsure 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 | Dietary supplement | Nutritional supplementation |
Primary outcome
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)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ran Schwarzkopf principal investigator
NYU Langone
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ensure in people with Osteoarthritis, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Waren (212-598-6245, Daniel.waren@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.