Preoperative Whole Food Plant-Based Fiber Smoothie for Total Knee Arthroplasty Revision
Launched by HOSPITAL FOR SPECIAL SURGERY, NEW YORK · Mar 19, 2025
Trial Information
Current as of April 29, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of a daily whole food plant-based smoothie on patients who are scheduled for knee surgery called total knee arthroplasty revision. Specifically, the researchers want to see if drinking this smoothie for two weeks before surgery can help reduce inflammation, improve gut health, and lower pain after the surgery compared to patients who do not change their diet. Participants will be divided into two groups: one group will follow the smoothie diet, while the other will not make any dietary changes.
To be eligible for the study, participants must be between 40 and 80 years old, scheduled for knee replacement surgery not due to infection or trauma, and have a diagnosis of osteoarthritis. Participants should also be in good health overall and able to follow the smoothie regimen, which includes buying the ingredients and using a blender. Throughout the trial, participants will provide feedback on their experience with the smoothie and how they feel before and after surgery. This study aims to find out if this dietary change can make a positive difference in recovery for knee surgery patients.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Scheduled for revision TKA at HSS with participating surgeons; not as a result of infection or trauma and all components (tibial and femoral) needing replacement
- • Age between 40 and 80
- • Diagnosed with osteoarthritis
- • ASA Class 1 ('normal' healthy patient) or 2 (patient with mild systemic disease and no functional limitations; the diseases the patient has are well controlled)
- • Ability to understand written and spoken English
- • Willing to complete entire pre-operative and post-operative work up in NYC, main campus site
- • Willing to follow a 2-week smoothie supplement, which means willingness to purchase ingredients and currently own/have access to a blender
- Exclusion Criteria:
- • Age \>80 years or \<40 years
- • Revision due to infection or trauma
- • ASA class 3 (patient with severe systemic disease that results in functional limitations) or 4 (patient with severe systemic disease that is a constant threat to life)
- • Not interested or unable to provide informed consent
- • Unstable weight (\>5kg weight change in the past 3 months, documented in Epic) or currently on weight loss drugs such as GLP-1 agonists
- • Already participating in a specific diet such as (i.e. low carbohydrate high-fat, Paleo, Mediterranean) and unwilling to supplement their diet with a daily smoothie during this time; (for LIFE study they excluded vegetarian, vegan, paleo, or keto diet specifically) Weight Watchers.
- • Active infection, flare-up of seasonal allergies, or physical trauma (all can alter CRP)
- • Could not start or stop a medication during the 2-week study period because some medications, such as statins, can alter CRP concentrations (Ridker 2008) BMI \>40 kg/m2
- • Food intolerance/allergy/sensitivity to ingredients suggested for smoothies
- • History of IBD
- • History of bariatric surgery
- • History of cancer
- • History of thyroid disease
- • History of or current drug abuse
- • Pregnancy
- • Current smoker
- • Cardiac implant or pacemaker
About Hospital For Special Surgery, New York
The Hospital for Special Surgery (HSS) in New York is a world-renowned institution specializing in orthopedic surgery, rheumatology, and rehabilitation. Recognized for its commitment to advancing medical research and improving patient outcomes, HSS serves as a leading clinical trial sponsor, facilitating innovative studies that explore cutting-edge treatments and therapies. With a team of expert clinicians and researchers, HSS aims to enhance clinical practices through rigorous scientific inquiry, ultimately contributing to the advancement of musculoskeletal health and patient care on a global scale.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
New York City, New York, United States
Patients applied
Trial Officials
Erica Tafuro, MD
Principal Investigator
Hospital for Special Surgery, New York
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported