Fiber smoothie before knee revision to see if it lowers inflammation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial randomizes patients scheduled for elective revision total knee arthroplasty to either receive a daily whole-food plant-based smoothie for two weeks before surgery or continue their usual diet. Primary aims are to assess feasibility, including compliance and user experience, and to see if the smoothie changes inflammatory markers (IL-6 and CRP) around the surgery and recovery period. Secondary aims include examining changes in gut microbiome composition from fecal samples. Outcomes are measured at baseline, across the immediate postoperative days, and at six weeks post-op.

Why it matters

Who can join: the full rules

Inclusion:

* 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 85
* Diagnosed with osteoarthritis
* Diagnosed with 2+ modifiable chronic lifestyle diseases: Type 2 DM, CVD (such as CAD, heart disease, stroke, HTN), stress, anxiety, depression, ADHD, metabolic syndrome, certain types of cancer (such as breast, colorectal, lung, prostate), Alzheimer's disease, vascular cognitive impairment, CKD, RA, asthma, chronic pain conditions (such as chronic back pain and osteoarthritis), fibromyalgia, migraines, COPD (Steiber 2011, Grant 2014)
* 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) or 3 (patient with severe systemic disease that results in functional limitations)
* Ability to understand written and spoken English
* Willing to complete entire pre-operative and post-operative work up in NYC, main campus site and/or HSS Ambulatory Care Center
* Willing to follow a 2-week smoothie supplement, including willingness to purchase ingredients and have access to a blender for preparation

Exclusion:

* Age \>85 years or \<40 years
* Revision due to infection or trauma
* ASA class 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)
* Active infection, flare-up of seasonal allergies, or physical trauma (all can alter CRP)
* Medication changes the month leading up to surgery
* Specifically medications altering inflammation: Statins (Ridker 2008), steroids (Boumpas et al., Ann Intern Med 1993; glucocorticoid cytokine modulation research.), DMARDS/biologics/immunosuppressants (Clinical rheumatology guidelines, biologic RCTs (e.g., TNF inhibitors, IL-6 inhibitors), Colchicine (Tardif et al., N Engl J Med 2019; colchicine cardiovascular inflammation studies.), hormone replacement therapies (Ridker et al., JAMA 1999; OCs and CRP meta-analyses.), new psychiatric medications (Miller \& Raison, Nat Rev Immunol 2016; psychotropic-inflammation associations.)
* BMI \>40 kg/m2
* Food intolerance/allergy/sensitivity to ingredients suggested for smoothies
* History of IBD (and IBD medication)
* History of bariatric surgery
* History of cancer
* History of thyroid disease
* History of or current drug abuse
* Pregnancy
* Current smoker
* Any patient with an electronic cardiac implant

Where it's running

• HSS Main Hospital
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Erica Tafuro, MD — Hospital for Special Surgery, New York
• Study coordinator: Mia Zonies, BS
• Email: zoniesm@hss.edu
• Phone: 646-714-6849

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.