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Ensure for Osteoarthritis

NYU Langone Health, New York, NY
EnsureN/ARecruitingLed by Ran SchwarzkopfResearch Sponsored by NYU Langone Health

Study Summary

This trial looks at whether giving extra nutrients to patients who are deficient in them can help improve recovery following joint replacement surgery.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 2 (2 wks pre) visit 3 (surgery day) visit 5 (4 weeks post)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 2 (2 wks pre) visit 3 (surgery day) visit 5 (4 weeks post) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in the patients' albumin, pre-albumin, and/or transferrin levels

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Nutritional supplementationExperimental Treatment1 Intervention
Given Ensure Max Protein Nutrition shake 2 weeks before surgery and continued 2 weeks after surgery.
Group II: No Nutritional supplementationActive Control1 Intervention
Treatment as usual
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ensure
2020
Completed Phase 2
~260

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,335 Previous Clinical Trials
794,744 Total Patients Enrolled
17 Trials studying Osteoarthritis
3,757 Patients Enrolled for Osteoarthritis
Ran SchwarzkopfPrincipal InvestigatorNYU Langone
1 Previous Clinical Trials
160 Total Patients Enrolled

Media Library

Ensure Clinical Trial Eligibility Overview. Trial Name: NCT04210284 — N/A
Osteoarthritis Research Study Groups: Nutritional supplementation, No Nutritional supplementation
Osteoarthritis Clinical Trial 2023: Ensure Highlights & Side Effects. Trial Name: NCT04210284 — N/A
Ensure 2023 Treatment Timeline for Medical Study. Trial Name: NCT04210284 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have registered to take part in this research effort?

"Affirmative. The clinical trial, which was initially posted on July 6th 2021, is currently in need of participants according to the information hosted on clinicaltrials.gov. 125 patients are required between two medical facilities."

Answered by AI

Are there any vacancies for individuals in this research program?

"Affirmative, the information available on clinicaltrials.gov confirms that this trial is still in need of participants, which it began to search for since July 6th 2021. The most recent update was made on October 11th 2022 and 125 people are required from 2 sites."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Pennsylvania
New York
How old are they?
18 - 65
What site did they apply to?
NYU Langone Health
Rothman Orthopedic Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Email
Most responsive sites:
  1. Rothman Orthopedic Institute: < 24 hours
Recent research and studies
clinicaltrials.govStudy
Oral Nutritional Optimization in Total Joint Arthroplasty
2021. "Oral Nutritional Optimization in Total Joint Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04210284.
All > Osteoarthritis
~0 spots leftby Dec 2023
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