Total Knee Arthroplasty RevisionNCT06896240
Fiber Smoothie Supplement
A study testing Assigned Interventions in people with Total Knee Arthroplasty Revision and Inflammatory Markers, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
This study aims to assess the feasibility of a 2-week dietary whole-food smoothie intervention and compare outcomes between two groups: patients that integrated a daily whole food plant-based smoothie into their diet for two weeks prior to surgery, and a control group of revision TKA patients that made no nutritional… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty Revision, Inflammatory Markers, Gut Microbiota
- What is being tested?
- Assigned Interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2026to 1 Jan 2028
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
HSS Main Hospital
New York, New York, 10021
Mia Zonies, 646-714-6849, zoniesm@hss.edu
About this study
Official title: The Impact of a Daily Whole Food Plant-based Smoothie Utilization 2 Weeks Prior to Revision Total Knee Replacement Surgery on Inflammation and Post-operative Pain.
This study aims to assess the feasibility of a 2-week dietary whole-food smoothie intervention and compare outcomes between two groups: patients that integrated a daily whole food plant-based smoothie into their diet for two weeks prior to surgery, and a control group of revision TKA patients that made no nutritional changes to their diet prior to surgery. The main research questions are:
- Among patients planned for elective TKA revision surgery, what is the feasibility of a 2-week dietary intervention implemented 2 weeks prior to surgery? [Outcomes will be compliance, noted barriers and/or facilitators, satisfaction with diet]
- Determine if the implementation of a daily whole food plant- based smoothie dietary supplement 2 weeks prior to TKA revision surgery will reduce inflammation -measured in plasma levels of IL-6 and CRP- at POD0, POD1, POD2, POD3, and 6 Weeks Post-operative as compared to 1) baseline (prior to dietary intervention initiation) and 2) control patients who did not make changes in their diet prior to surgery.
- Determine if the implementation of a daily whole food plant-based smoothie dietary supplement 2 weeks prior to TKA revision surgery will result in quantifiable changes in the gut microbiome composition -measured via fecal samples- as compared to control patients who did not make changes in their diet prior to surgery.
- Determine if the implementation of a daily whole food plant- based smoothie dietary supplement 2 weeks prior to TKA revision surgery will result in improved immediate postoperative pain -measured through numeric rating scale (NRS) pain scores- and opioid use -measured in morphine milligram equivalents (MME)- as compared to control patients.
- Compare patient satisfaction and adoption of nutritional behavioral changes in patients implementing a whole food plant-based smoothie 2 weeks prior to TKA revision surgery to patients undergoing the same surgery but did not me pre-surgery dietary changes.
The researcher's primary outcome is measuring feasibility and patient compliance with smoothie consumption. Secondarily, the investigators are interested in measuring if the preoperative smoothie can alter the gut microbiome and decrease systemic inflammation, leading to lowered post-operative pain and opioid use.
Read the detailed description
This study aims to assess the feasibility of a 2-week dietary whole-food smoothie intervention and compare outcomes between two groups: patients that integrated a daily whole food plant-based smoothie into their diet for two weeks prior to surgery, and a control group of revision TKA patients that made no nutritional changes to their diet prior to surgery. The main research questions are:
- Among patients planned for elective TKA revision surgery, what is the feasibility of a 2-week dietary intervention implemented 2 weeks prior to surgery? [Outcomes will be compliance, noted barriers and/or facilitators, satisfaction with diet]
- Determine if the implementation of a daily whole food plant- based smoothie dietary supplement 2 weeks prior to TKA revision surgery will reduce inflammation -measured in plasma levels of IL-6 and CRP- at POD0, POD1, POD2, POD3, and 6 Weeks Post-operative as compared to 1) baseline (prior to dietary intervention initiation) and 2) control patients who did not make changes in their diet prior to surgery.
- Determine if the implementation of a daily whole food plant-based smoothie dietary supplement 2 weeks prior to TKA revision surgery will result in quantifiable changes in the gut microbiome composition -measured via fecal samples- as compared to control patients who did not make changes in their diet prior to surgery.
- Determine if the implementation of a daily whole food plant- based smoothie dietary supplement 2 weeks prior to TKA revision surgery will result in improved immediate postoperative pain -measured through numeric rating scale (NRS) pain scores- and opioid use -measured in morphine milligram equivalents (MME)- as compared to control patients.
- Compare patient satisfaction and adoption of nutritional behavioral changes in patients implementing a whole food plant-based smoothie 2 weeks prior to TKA revision surgery to patients undergoing the same surgery but did not me pre-surgery dietary changes.
Participants will be randomly assigned to consume the whole food plant-based smoothie intervention daily for the two weeks leading up to surgery, or to have no preoperative diet intervention (control group).
The researcher's primary outcome is measuring feasibility and patient compliance with smoothie consumption. Secondarily, the investigators are interested in measuring if the preoperative smoothie can alter the gut microbiome and decrease systemic inflammation, leading to lowered post-operative pain and opioid use.
- Being tested
- Assigned Interventions
- Keywords
- TKA Revision, Inflammation, Diet, Gut Microbiome
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigned InterventionsDietary supplement
The "Green Smoothie Guide" from the American College of Lifestyle Medicine contains guidelines for a 6-step smoothie to include whole and high fiber foods.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 No Smoothie | No intervention | This group will make no changes to their pre-operative diet and will not consume the smoothie leading up to their TKA revision surgery. |
| Group 2 Smoothie | Experimental | This group will receive the "Green Smoothie Guide" from the American College of Lifestyle Medicine which they will use to prepare a daily smoothie for the 14 days leading up to their total knee arthroplasty revision surgery. No other changes will be made to their pre-operative diet. Receives: Dietary Supplement: Assigned Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Measured in Terms of Compliance
Compliance is measured as number of days in the two-week intervention timeframe that patients reported having consumed the smoothie. The investigators will conduct fourteen daily phone calls to assess yes/no smoothie intake and ingredients used. Informed by nutrition compliance in the literature, the investigators will apply an 80% threshold for compliance rate which translates to roughly 11/14 days. The compliance range is 0%-100% or 0-14 days with 100% or 14 days indicating higher smoothie compliance and a more favorable outcome.
Measured: Daily for 14 days pre-operative
Feasibility Measured in Terms of Noted Barriers/Facilitators
Noted barriers/facilitators are open-ended questions in unstructured free text format. A feedback form will be sent to participants, and feedback and suggestions will be recorded by the investigators.
Measured: Day 0
Feasibility Measured in Terms of Satisfaction with Diet
The quantification of satisfaction with diet using the verified Diet Satisfaction Scale with 28 questions. Individual questions are scored on a scale of 1-5 with a higher score indicating higher diet satisfaction and a more favorable outcome. Scores from each question will be compiled into a total score for the questionnaire.
Measured: Baseline and 6 weeks post-operative
Secondary outcomes (13)
Inflammation and Pain Control: C-Reactive Protein
Inflammation and pain control are quantified by biological markers of inflammation such as C-reactive protein found in the blood. C-reactive protein is produced in the liver, and its levels rise in response to inflammation. A normal range of C-reactive protein is less than 0.3mg/dL and is a more favorable outcome than an elevated level of C-reactive protein.
Measured: Baseline, Day 0, Day 1, Day 2, Day 3, 6 weeks post-op
Inflammation and Pain Control: Interleukin 6
Inflammation and pain control are quantified by biological markers of inflammation such as the pro-inflammatory cytokine, interleukin 6, found in the blood. An elevated amount of Interleukin 6, above 15pg/mL, is indicative of increased inflammatory response in the body and is less favorable outcome.
Measured: Baseline, Day 0, Day 1, Day 2, Day 3, 6 weeks post-op
Inflammation and Pain Control: Microbiome Composition
Inflammation and pain control are quantified firstly by biological markers of inflammation such as microbiome composition. Participants will complete three self-administered stool sample collections and ship their samples to Mount Sinai Laboratory. Mount Sinai will conduct raw 16S rRNA sequencing to show alpha and beta bacteria diversity. Higher diversity 4 days pre-op and 2 days pre-op relative to baseline is indicative of a more successful intervention and a more favorable outcome.
Measured: Baseline, 4 Days Pre-op, 2 Days Pre-op
Inflammation and Pain Control- Numerical Rating Scales
Inflammation and pain control are quantified firstly by markers of acute pain/analgesia which are measured by Numerical Rating Scales (NRS) of pain. Participants will be asked questions about their knee pain on a scale of 0-10 where higher scores are indicative of increased pain and a less favorable outcome.
Measured: Baseline, Day 0, Day 1, Day 2, Day 3, 6 weeks post-op
Inflammation and Pain Control: Opioid Intake
Inflammation and pain control are quantified by markers of acute pain/analgesia such as opioid intake. Opioid intake will be recorded from participants' medical charts while they are under care at HSS Main Hospital. Opioid intake will be measured in morphine milligram equivalents (MME) with a lower opioid intake being more favorable.
Measured: Postoperatively; 0-24 hours, 24-48 hours, and 48-72 hours
Diet Quantification
Diet will be quantified using Diet ID Inc.'s online software, a validated tool, which measures diet quality, caloric intake, and nutrient intake. After participants go through the Diet ID survey, the Diet ID platform will calculate a "Nutrition Score" which will be the recorded value of nutrition. The scores will be reported on a scale of 1-10 with higher scores indicating "better" nutrition and a more favorable outcome.
Measured: Baseline, Day 0, and 6 weeks post-op.
BIA Measurements: Phase Angle
Bioelectrical Impedance Analysis (BIA) produces a measurement of phase angle (PhA) which measures the water distribution among intracellular and extracellular space. Phase angle is measured in degrees with 6.5-7.5 degrees being described as a healthy range and lower degrees being less favorable.
Measured: Baseline, Day 0, and 6 weeks post-op.
BIA Measurements: Fat-Free Mass (Index)
Bioelectrical Impedance Analysis (BIA) produces a measurement of fat-free mass (FFM) which is a measurement of the total body weight excluding fat. BIA testing produces a fat-free mass weight in kg which is divided by the total kg of the participant to produce a percentage of fat-free mass. For men, a healthy range for a fat-free mass percentage is ~78%-87%, and for women, a healthy range is ~67%-75%. The fat-free mass index measurement can also be calculated using the measurement of fat-free mass relative to height.
Measured: Baseline, Day 0, and 6 weeks post-op.
BIA Measurements: Extracellular Water
Bioelectrical Impedance Analysis (BIA) can produce measurements of extracellular water (ECW) which is the water outside of the cells.
Measured: Baseline, Day 0, and 6 weeks post-op.
BIA Measurements: Extracellular Water, Total Body Water, and Ratio ECW/TBW
Bioelectrical Impedance Analysis (BIA) can produce measurements of Extracellular Water (ECW)--the fluid outside of the cells--and Total Body Water (TBW). Then, a ratio of extracellular water to total body water (ECW/TBW) can be calculated with a normal range for this ratio being 0.360-0.390. A higher value for this ratio is indicative of a less favorable outcome.
Measured: Baseline, Day 0, and 6 weeks post-op.
PROMIS-Global 10
The PROMIS-Global 10 is a validated 10-item questionnaire to evaluate health in relation to quality of life. Questions are rated on a scale of 1-5 with a higher score being indicative of higher health and a more favorable outcome. Scores for all questions will be added up to calculate a total score.
Measured: Baseline, Day 0, 6 weeks post-op, and 6 months post-op.
Range of Motion
Angle of knee movement in degrees as recorded during all standard of care visits. Measurement points include: the internist physician during pre-surgical screening, the surgeon on Day 0, physical therapy on Days 1-3, the surgeon during the 6-week post-operative follow-up visit.
Measured: Baseline, Day 0, Day 1, Day 2, Day 3, 6 weeks post-op
Frailty
The 5-Item frailty index is a standardized, comorbidity-based risk stratification tool used to predict adverse events.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start28 Apr 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Arthroplasty RevisionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized control trial of two groups, intervention vs. control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erica Tafuro, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896240
- Sponsor's protocol ID
- 2024-2396
- Status last verified
- Jul 2026
- First submitted
- 13 Mar 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Daily Whole Food Plant-based Smoothie Utilization 2 Weeks Prior to Revision Total Knee Replacement Surgery on Inflammation and Post-operative Pain.
- ClinicalTrials.gov ID
- NCT06896240
- Acronym / sponsor ID
- 2024-2396
- Keywords
- TKA Revision, Inflammation, Diet, Gut Microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 26 Mar 2025 (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.
This study aims to assess the feasibility of a 2-week dietary whole-food smoothie intervention and compare outcomes between two groups: patients that integrated a daily whole food plant-based smoothie into their diet for two weeks prior to surgery, and a control group of revision TKA patients that made no nutritional changes to their diet prior to surgery. The main research questions are:
- Among patients planned for elective TKA revision surgery, what is the feasibility of a 2-week dietary intervention implemented 2 weeks prior to surgery? [Outcomes will be compliance, noted barriers and/or facilitators, satisfaction with diet]
- Determine if the implementation of a daily whole food plant- based smoothie dietary supplement 2 weeks prior to TKA revision surgery will reduce inflammation -measured in plasma levels of IL-6 and CRP- at POD0, POD1, POD2, POD3, and 6 Weeks Post-operative as compared to 1) baseline (prior to dietary intervention initiation) and 2) control patients who did not make changes in their diet prior to surgery.
- Determine if the implementation of a daily whole food plant-based smoothie dietary supplement 2 weeks prior to TKA revision surgery will result in quantifiable changes in the gut microbiome composition -measured via fecal samples- as compared to control patients who did not make changes in their diet prior to surgery.
- Determine if the implementation of a daily whole food plant- based smoothie dietary supplement 2 weeks prior to TKA revision surgery will result in improved immediate postoperative pain -measured through numeric rating scale (NRS) pain scores- and opioid use -measured in morphine milligram equivalents (MME)- as compared to control patients.
- Compare patient satisfaction and adoption of nutritional behavioral changes in patients implementing a whole food plant-based smoothie 2 weeks prior to TKA revision surgery to patients undergoing the same surgery but did not me pre-surgery dietary changes.
The researcher's primary outcome is measuring feasibility and patient compliance with smoothie consumption. Secondarily, the investigators are interested in measuring if the preoperative smoothie can alter the gut microbiome and decrease systemic inflammation, leading to lowered post-operative pain and opioid use.
Detailed description
This study aims to assess the feasibility of a 2-week dietary whole-food smoothie intervention and compare outcomes between two groups: patients that integrated a daily whole food plant-based smoothie into their diet for two weeks prior to surgery, and a control group of revision TKA patients that made no nutritional changes to their diet prior to surgery. The main research questions are:
- Among patients planned for elective TKA revision surgery, what is the feasibility of a 2-week dietary intervention implemented 2 weeks prior to surgery? [Outcomes will be compliance, noted barriers and/or facilitators, satisfaction with diet]
- Determine if the implementation of a daily whole food plant- based smoothie dietary supplement 2 weeks prior to TKA revision surgery will reduce inflammation -measured in plasma levels of IL-6 and CRP- at POD0, POD1, POD2, POD3, and 6 Weeks Post-operative as compared to 1) baseline (prior to dietary intervention initiation) and 2) control patients who did not make changes in their diet prior to surgery.
- Determine if the implementation of a daily whole food plant-based smoothie dietary supplement 2 weeks prior to TKA revision surgery will result in quantifiable changes in the gut microbiome composition -measured via fecal samples- as compared to control patients who did not make changes in their diet prior to surgery.
- Determine if the implementation of a daily whole food plant- based smoothie dietary supplement 2 weeks prior to TKA revision surgery will result in improved immediate postoperative pain -measured through numeric rating scale (NRS) pain scores- and opioid use -measured in morphine milligram equivalents (MME)- as compared to control patients.
- Compare patient satisfaction and adoption of nutritional behavioral changes in patients implementing a whole food plant-based smoothie 2 weeks prior to TKA revision surgery to patients undergoing the same surgery but did not me pre-surgery dietary changes.
Participants will be randomly assigned to consume the whole food plant-based smoothie intervention daily for the two weeks leading up to surgery, or to have no preoperative diet intervention (control group).
The researcher's primary outcome is measuring feasibility and patient compliance with smoothie consumption. Secondarily, the investigators are interested in measuring if the preoperative smoothie can alter the gut microbiome and decrease systemic inflammation, leading to lowered post-operative pain and opioid use.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized control trial of two groups, intervention vs. control.
| Arm | Type | Receives |
|---|---|---|
| Group 1 No Smoothie | No intervention | –This group will make no changes to their pre-operative diet and will not consume the smoothie leading up to their TKA revision surgery. |
| Group 2 Smoothie | Experimental | Dietary Supplement: Assigned InterventionsThis group will receive the "Green Smoothie Guide" from the American College of Lifestyle Medicine which they will use to prepare a daily smoothie for the 14 days leading up to their total knee arthroplasty revision surgery. No other changes will be made to their pre-operative diet. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (18 listed)
- 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)
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 |
|---|---|---|
| Assigned InterventionsThe "Green Smoothie Guide" from the American College of Lifestyle Medicine contains guidelines for a 6-step smoothie to include whole and high fiber foods. | Dietary supplement | Group 2 Smoothie |
Primary outcome
Feasibility Measured in Terms of Compliance
Time frame: Daily for 14 days pre-operative
Compliance is measured as number of days in the two-week intervention timeframe that patients reported having consumed the smoothie. The investigators will conduct fourteen daily phone calls to assess yes/no smoothie intake and ingredients used. Informed by nutrition compliance in the literature, the investigators will apply an 80% threshold for compliance rate which translates to roughly 11/14 days. The compliance range is 0%-100% or 0-14 days with 100% or 14 days indicating higher smoothie compliance and a more favorable outcome.
Feasibility Measured in Terms of Noted Barriers/Facilitators
Time frame: Day 0
Noted barriers/facilitators are open-ended questions in unstructured free text format. A feedback form will be sent to participants, and feedback and suggestions will be recorded by the investigators.
Feasibility Measured in Terms of Satisfaction with Diet
Time frame: Baseline and 6 weeks post-operative
The quantification of satisfaction with diet using the verified Diet Satisfaction Scale with 28 questions. Individual questions are scored on a scale of 1-5 with a higher score indicating higher diet satisfaction and a more favorable outcome. Scores from each question will be compiled into a total score for the questionnaire.
13 secondary outcomes
Inflammation and Pain Control: C-Reactive Protein
Time frame: Baseline, Day 0, Day 1, Day 2, Day 3, 6 weeks post-op
Inflammation and Pain Control: Interleukin 6
Time frame: Baseline, Day 0, Day 1, Day 2, Day 3, 6 weeks post-op
Inflammation and Pain Control: Microbiome Composition
Time frame: Baseline, 4 Days Pre-op, 2 Days Pre-op
Inflammation and Pain Control- Numerical Rating Scales
Time frame: Baseline, Day 0, Day 1, Day 2, Day 3, 6 weeks post-op
Inflammation and Pain Control: Opioid Intake
Time frame: Postoperatively; 0-24 hours, 24-48 hours, and 48-72 hours
Diet Quantification
Time frame: Baseline, Day 0, and 6 weeks post-op.
BIA Measurements: Phase Angle
Time frame: Baseline, Day 0, and 6 weeks post-op.
BIA Measurements: Fat-Free Mass (Index)
Time frame: Baseline, Day 0, and 6 weeks post-op.
BIA Measurements: Extracellular Water
Time frame: Baseline, Day 0, and 6 weeks post-op.
BIA Measurements: Extracellular Water, Total Body Water, and Ratio ECW/TBW
Time frame: Baseline, Day 0, and 6 weeks post-op.
PROMIS-Global 10
Time frame: Baseline, Day 0, 6 weeks post-op, and 6 months post-op.
Range of Motion
Time frame: Baseline, Day 0, Day 1, Day 2, Day 3, 6 weeks post-op
Frailty
Time frame: Baseline
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 28 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Erica Tafuro, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assigned Interventions in people with Total Knee Arthroplasty Revision and Inflammatory Markers, run by Hospital for Special Surgery, New York at 1 site 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 8 inclusion and 18 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 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Mia Zonies, BS (646-714-6849, zoniesm@hss.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Measured in Terms of Compliance (time frame: Daily for 14 days pre-operative). The study lists 3 primary outcomes in all. 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 28 Sep 2026.