Meniscus TearPhase 2/3NCT05505747
Enhancing Recovery Through a Combined Mechanobiologic Intervention Following Meniscus Repair
A Phase 2/3 study testing Fisetin in people with Meniscus Tear and Meniscus; Derangement, run by Austin V Stone at 1 site in United States.
Trial summary
Arthroscopic meniscal procedures are the most commonly performed orthopaedic procedure in the U.S. affecting 15% of Americans ages 10-65 years. Meniscus injury is also known to increase the risk of posttraumatic osteoarthritis (PTOA). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Meniscus Tear, Meniscus; Derangement, Meniscus Lesion
- What is being tested?
- Fisetin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2025to Feb 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects will be included if all the following criteria are met:
- Are male or female, ages 18-45;
- Are willing to comply with all study related procedures and assessments;
- Are ambulatory as defined by ability to complete functional performance testing;
- Medial, lateral or combined meniscus tear treated with surgical repair.
- Stable dose of screening/baseline medications for at least 2 months prior to the anticipated date of study drug dosing.
Who cannot join
- Subjects will be excluded if any of the following criteria are met:
- Females who are nursing, pregnant or planning to become pregnant during the duration of study drug dosing;
- Males who do not wish to abstain from sex or use contraceptive protection during study drug dosing and for 2 weeks after the last dose;
- Subjects who do not have the capacity to consent themselves;
- Subjects who are unable to tolerate oral medication;
- Subjects having previously undergone any of the following treatments in the stated time window.
Show all 29Show fewer
- Surgery on the Study Knee in the past 6 months;
- Partial or complete joint replacement in the study knee. Partial or complete joint replacement in the contralateral knee is acceptable as long as the surgery was performed at least 6 months prior to enrollment and the operative knee is asymptomatic;
- Patients who have undergone arthroscopic surgery (including microfracture and meniscectomy) on the Study Knee in the last 2 years prior to the Screening visit.
- Patients will be excluded from the study if an Outerbridge grade III or IV chondral lesion is identified during arthroscopy.
- Radiographic osteoarthritis (Kellgren-Lawrence Grade 2-4), full thickness chondral defect on MRI, BMI > 35 kg/m2, concomitant ligament injury, or prior ipsilateral knee ligament or meniscus surgery within prior 12 months of enrollment.
- The following intraarticular injections:
- Glucocorticoid within the last 2 months,
- Extended-release corticosteroid, hyaluronic acid, or other biologic injection (platelet-rich plasma, bone marrow, adipose tissue/cells) into the Study Knee in the past 6 months within the past 6 months
- Subjects with any of the following drug/medication statuses:
- Currently taking Losartan;
- Currently taking Warfarin or related anticoagulants;
- Opioid analgesics taken in the past 8 weeks;
- Senolytic agents taken within the past 6 months and are not willing to discontinue these medications through the duration of the study, including: Fisetin, Quercetin, Luteolin, Dasatinib, Piperlongumine, or Navitoclax;
- Drugs that induce significant cellular stress and are not willing to discontinue these medications through the duration of the study, including alkylating agents, anthracyclines, platins, other chemotherapy drugs;
- Medications that are sensitive substrates or substrates with a narrow therapeutic range for CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4, OATP1B1 or strong inhibitors or inducers of CYP3A4 (e.g. cyclosporine, tacrolimus or sirolimus);
- Subjects taking the following other drugs if they cannot be held (per the Principal Investigator) for at least 2 days before and during administration of Fisetin: cyclosporine, tacrolimus, repaglinide, and bosentan.
- Subjects with any of the following disease statuses:
- Significant liver disease (i.e. greater than or equal to 2x the upper limit of normal bilirubin levels) or as in the opinion of the Principal Investigator;
- Significant renal disease (eGFR of <60 ml/min/1.73m2) or as in the opinion of the Principal Investigator;
- History of other formally diagnosed joint diseases including osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos Syndrome, Gaucher's disease, Cushing's syndrome, Stickler's syndrome, joint infection, hemophilia, hemochromatosis, or neuropathic arthropathy of any cause;
- Any active systemic autoimmune disease with musculoskeletal involvement or any history of system inflammatory arthritis;
- Patients with type 1 or 2 diabetes (HbA1c>6.5%) and/or taking medications that affect insulin levels, including: Metformin (within the last week), Glucocorticoids (within the last month), Acarbose (within the last week);
- 9. Those with moderate to severe depression (PHQ-9 score > 10) will also be excluded since knee OA patients with depression have previously demonstrated worse pain trajectories; 10. Subjects that have any medical condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that in the opinion of the Investigator constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation or prevent the patient from fully participating in all aspects of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
UK Healthcare at Turfland
Lexington, Kentucky, 40504
About this study
Arthroscopic meniscal procedures are the most commonly performed orthopaedic procedure in the U.S. affecting 15% of Americans ages 10-65 years. Meniscus injury is also known to increase the risk of posttraumatic osteoarthritis (PTOA). The current randomized clinical trial will test a novel intervention after meniscal repair that combines an oral senolytic fisetin and real-time biofeedback program to restore joint loading and subsequent return to activity.
Read the detailed description
Arthroscopic meniscal procedures are the most commonly performed orthopaedic procedure in the U.S. affecting 15% of Americans ages 10-65 years. Meniscus injury is also known to increase the risk of posttraumatic osteoarthritis (PTOA). The current randomized clinical trial will test a novel mechanobiologic intervention after meniscal repair that combines an oral senolytic fisetin and real-time biofeedback program to restore joint loading and subsequent return to activity. The premise for this program is derived from growing evidence that under-loading early after an orthopedic surgery is a major contributing factor to future PTOA development. Despite the need to assess how much force the patient can produce in various exercises to better inform progression and progress, clinicians still have few tools. By providing the realtime feedback during all exercises, the program will promote the recovery of muscle function as well which is critical for normal joint loading.
The study will 1) evaluate the feasibility and acceptability of the mechanobiologic intervention following arthroscopic repair of meniscus tears, 2) determine if the mechanobiologic intervention improves physical function, patient reported outcomes, loading and muscle strength, and biomechanical symmetry in comparison to standard of care physical therapy and oral placebo, and 3) compare cartilage composition at 1 year after meniscus surgery between the mechnobiologic intervention and a control group treated standard of care physical therapy and oral placebo.
- Being tested
- Fisetin, Placebo oral capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FisetinDrug
Also called Novusetin, 7,3',4'-flavon-3-ol, 3,3',4',7-tetrahydroxyflavone
Fisetin is a plant flavanol senolytic found in strawberries, persimmons, and cucumbers. This naturally derived senolytic has few side effects and previous animal models of both osteoarthritis and rheumatoid arthritis have demonstrated that the senolytic supplement fisetin reduces inflammation and slows cartilage breakdown.
Placebo oral capsuleDrug
The oral placebo will consist of corn starch and gelatin capsules
| Study group | Role | What they receive |
|---|---|---|
| Fisetin | Experimental | Subjects assigned to the experimental group will take approximately 20 mg/kg/day of fisetin for 2 consecutive days, followed by a 28-day senescence washout period, and then another 2-day administration. Fisetin treatment begins at 8 weeks after surgery. Receives: Drug: Fisetin |
| Placebo | Placebo comparator | Subjects assigned to the experimental group will take approximately 20 mg/kg/day of placebo (corn starch) for 2 consecutive days, followed by a 28-day washout period, and then another 2-day administration. Placebo treatment begins at 8 weeks after surgery. Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Knee Documentation Committee (IKDC) Score between baseline and 1 year
The IKDC Score was designed to assess patients with a variety of knee disorders including meniscal injuries. The IKDC consists of 18 items, and scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Measured: Baseline, 1 year
Secondary outcomes (1)
Change in MRI T1rho between baseline and 1 year
Increased T1rho relaxation times have been associated with loss of proteoglycan content. This then corresponds with MRI changes associated with the loss of proteoglycan content.
Measured: Baseline, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study startJul 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Why it stopped: Funding not awarded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus TearStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austin V Stone
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Austin V Stone, University of Kentucky
- Investigators
- Austin Stone, MD, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505747
- Sponsor's protocol ID
- 80414
- Status last verified
- May 2025
- First submitted
- 16 Aug 2022
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Recovery Through a Combined Mechanobiologic Intervention Following Meniscus Repair
- ClinicalTrials.gov ID
- NCT05505747
- Acronym / sponsor ID
- 80414
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding not awarded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Austin V StoneUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 18 Aug 2022 (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.
Arthroscopic meniscal procedures are the most commonly performed orthopaedic procedure in the U.S. affecting 15% of Americans ages 10-65 years. Meniscus injury is also known to increase the risk of posttraumatic osteoarthritis (PTOA). The current randomized clinical trial will test a novel intervention after meniscal repair that combines an oral senolytic fisetin and real-time biofeedback program to restore joint loading and subsequent return to activity.
Detailed description
Arthroscopic meniscal procedures are the most commonly performed orthopaedic procedure in the U.S. affecting 15% of Americans ages 10-65 years. Meniscus injury is also known to increase the risk of posttraumatic osteoarthritis (PTOA). The current randomized clinical trial will test a novel mechanobiologic intervention after meniscal repair that combines an oral senolytic fisetin and real-time biofeedback program to restore joint loading and subsequent return to activity. The premise for this program is derived from growing evidence that under-loading early after an orthopedic surgery is a major contributing factor to future PTOA development. Despite the need to assess how much force the patient can produce in various exercises to better inform progression and progress, clinicians still have few tools. By providing the realtime feedback during all exercises, the program will promote the recovery of muscle function as well which is critical for normal joint loading.
The study will 1) evaluate the feasibility and acceptability of the mechanobiologic intervention following arthroscopic repair of meniscus tears, 2) determine if the mechanobiologic intervention improves physical function, patient reported outcomes, loading and muscle strength, and biomechanical symmetry in comparison to standard of care physical therapy and oral placebo, and 3) compare cartilage composition at 1 year after meniscus surgery between the mechnobiologic intervention and a control group treated standard of care physical therapy and oral placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fisetin | Experimental | Drug: FisetinSubjects assigned to the experimental group will take approximately 20 mg/kg/day of fisetin for 2 consecutive days, followed by a 28-day senescence washout period, and then another 2-day administration. Fisetin treatment begins at 8 weeks after surgery. |
| Placebo | Placebo comparator | Drug: Placebo oral capsuleSubjects assigned to the experimental group will take approximately 20 mg/kg/day of placebo (corn starch) for 2 consecutive days, followed by a 28-day washout period, and then another 2-day administration. Placebo treatment begins at 8 weeks after surgery. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Are male or female, ages 18-45;
- Are willing to comply with all study related procedures and assessments;
- Are ambulatory as defined by ability to complete functional performance testing;
- Medial, lateral or combined meniscus tear treated with surgical repair.
- Stable dose of screening/baseline medications for at least 2 months prior to the anticipated date of study drug dosing.
Key exclusion criteria (29 listed)
- Females who are nursing, pregnant or planning to become pregnant during the duration of study drug dosing;
- Males who do not wish to abstain from sex or use contraceptive protection during study drug dosing and for 2 weeks after the last dose;
- Subjects who do not have the capacity to consent themselves;
- Subjects who are unable to tolerate oral medication;
- Subjects having previously undergone any of the following treatments in the stated time window.
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 |
|---|---|---|
| FisetinAlso: Novusetin, 7,3',4'-flavon-3-ol, 3,3',4',7-tetrahydroxyflavoneFisetin is a plant flavanol senolytic found in strawberries, persimmons, and cucumbers. This naturally derived senolytic has few side effects and previous animal models of both osteoarthritis and rheumatoid arthritis have demonstrated that the senolytic supplement fisetin reduces inflammation and slows cartilage breakdown. | Drug | Fisetin |
| Placebo oral capsuleThe oral placebo will consist of corn starch and gelatin capsules | Drug | Placebo |
Primary outcome
Change in International Knee Documentation Committee (IKDC) Score between baseline and 1 year
Time frame: Baseline, 1 year
The IKDC Score was designed to assess patients with a variety of knee disorders including meniscal injuries. The IKDC consists of 18 items, and scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
1 secondary outcome
Change in MRI T1rho between baseline and 1 year
Time frame: Baseline, 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- 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. This study is not recruiting at the moment.
Austin Stone, MD, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fisetin in people with Meniscus Tear and Meniscus; Derangement, run by Austin V Stone 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 6 inclusion and 29 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: withdrawn, as of the sponsor's last update on 8 May 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Knee Documentation Committee (IKDC) Score between baseline and 1 year (time frame: Baseline, 1 year). 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 8 May 2025.