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Nutritional Supplements for Joint Replacement Recovery
N/A
Waitlist Available
Led By Ran Schwarzkopf
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient are current candidates for elective primary total hip and total knee arthroplasty
Patient are current candidates for elective primary total hip and total knee arthroplasty
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 2 (2 wks pre) visit 3 (surgery day) visit 5 (4 weeks post)
Awards & highlights
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.
Who is the study for?
This trial is for people aged 55 to 95 who are about to have hip or knee replacement surgery and show signs of poor nutrition (low levels of certain proteins in their blood). It's not for those with revision surgeries, protein absorption issues, eating disorders, past septic arthritis, severe kidney/liver disease, allergies to oral supplements, or can't take them by mouth.Check my eligibility
What is being tested?
The study tests if a nutritional drink called Ensure can improve blood markers related to nutrition in patients who don't get enough nutrients and are having joint replacement surgery.See study design
What are the potential side effects?
Ensure is generally safe but may cause digestive upset like diarrhea or constipation. Some might experience lactose intolerance symptoms if sensitive. Allergic reactions are rare but possible.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a first-time hip or knee replacement surgery.
Select...
I am scheduled for a first-time hip or knee replacement surgery.
Select...
I am between 55 and 95 years old.
Select...
I am between 55 and 95 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 2 (2 wks pre) visit 3 (surgery day) visit 5 (4 weeks post)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 2 (2 wks pre) visit 3 (surgery day) visit 5 (4 weeks post)
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
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
1,358 Previous Clinical Trials
816,441 Total Patients Enrolled
17 Trials studying Osteoarthritis
3,753 Patients Enrolled for Osteoarthritis
Ran SchwarzkopfPrincipal InvestigatorNYU Langone
1 Previous Clinical Trials
160 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had septic arthritis in the past.You have an eating disorder.You cannot take medicine or supplements by mouth.My kidneys and liver are not in the final stages of failure.I am scheduled for a first-time hip or knee replacement surgery.You are allergic to taking pills or supplements by mouth.I have a condition that prevents my body from absorbing proteins properly.I am scheduled for a first-time hip or knee replacement surgery.I am between 55 and 95 years old.I am having or have had surgery to replace or fix a joint, but not a full knee replacement.I am between 55 and 95 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Nutritional supplementation
- Group 2: No Nutritional supplementation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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?
Rothman Orthopedic Institute
NYU Langone Health
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
Most responsive sites:
- Rothman Orthopedic Institute: < 24 hours
Typically responds via
Email
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