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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The purpose is to explore the possible benefit of administration of Fisetin, (a senolytic agent) to improve the benefit of Platelet-Rich Plasma and losartan for treatment of femoroacetabular impingement and labral tear.
We believe that giving Fisetin, a senolytic agent, will improve the benefit of PRP by eliminating senescent cells and senescence-associated secretory phenotype (SASP), known to exist in PRP. The main objectives of this study are to determine if pre- and post-operative administration of a senolytic agent will improve the beneficial effects of PRP when used in conjunction with surgical treatment of FAI and/or labral tear, to determine whether pre- and postoperative administration of Fisetin is associated with adverse events, and to determine if pre- and post-operative administration of Fisetin leads to a decrease in systemic senescence, serum SASP, and fibrotic markers.
Patients suffering from femoroacetabular impingement and labral tear, who are planning to undergo hip arthroscopy combined with standard of care intra-operative PRP injection and post-operative losartan administration will be recruited from the clinical practice of the Principal Clinical Investigator or his designee at The Steadman Clinic (TSC).
This is a pilot, prospective, randomized, double-blind, placebo control clinical trial is proposed to evaluate the safety and efficacy of a senolytic agent (Fisetin) to improve the benefits of standard of care platelet rich plasma (PRP) injection and antifibrotic medication (Losartan) in patients undergoing hip arthroscopy for treatment of femoroacetabular impingement (FAI) and/or labral tear (LT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fisetin group (investigational group) | Experimental | 20mg/kg of Fisetin per day for days 1 and 2 prior to surgery and days 33, 34, 63, 64, 93, and 94 post surgery. (The pills are 100mg each. For example, if a participant weighs 160 pounds (about 73 kg), the participant will need to take 15 pills per day) |
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| Placebo group (control group) | Placebo Comparator | 20mg/kg of Placebo per day for days 1 and 2 prior to surgery and days 33, 34, 63, 64, 93, and 94 post surgery. (The pills are 100mg each. For example, if a participant weighs 160 pounds (about 73 kg), the participant will need to take 15 pills per day) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fisetin | Drug | Oral Fisetin 20 mg/kg taken for 8 days total. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Occurrence of adverse events | From date of study drug dosing until the end of the study, an average of 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcomes Questionnaire-Modified Harris Hip Score (mHHS) | Consists of 8 questions covering domains of pain, gait, and functional activities. Scored on a 100-point scale, with each answer receiving a specific amount of points. Higher score represents greater hip health. | Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnny L Huard, PhD | Steadman Philippon Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Steadman Clinic | Vail | Colorado | 81657 | United States |
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| ID | Term |
|---|---|
| D057925 | Femoracetabular Impingement |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C017875 | fisetin |
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pilot, prospective, randomized, double-blind, placebo control clinical trial
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The Investigator or properly trained and delegated study team member (research PA) will write the prescription for the study medication. The subject's randomization block and within-block random number will be communicated directly to the Vail Health pharmacy. The Vail Health pharmacy will maintain an unblinded, de-identified randomization spreadsheet that documents group allocation for each subject. The Vail Health Pharmacy oversees and manages drug disbursement for research.
| Placebo | Drug | Fisetin appearance-matched microcrystalline cellulose placebo. 20 mg/kg taken for 8 days total. |
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| Patient Reported Outcomes Questionnaire- Hip Outcome Score: activities of daily living and sports subscales (HOS-ADL, HOS-SSS) | Includes two subscales to calculate the total score:19 items in the HOS-ADL subscale and 9 items in the HOS-sports subscale. | Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op |
| Patient Reported Outcomes Questionnaire-Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Scale from 0-96. Higher score represents worse hip health. | Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op |
| Patient Reported Outcomes Questionnaire-Optum Short Form physical and mental component scores (SF-12 PCS and SF-12 MCS) | Includes two subscales to calculate the total score. Higher score represents greater health. Scale standardized to a US Population mean of 50 and standard deviation of 10 points. | Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op |
| Patient Reported Outcomes Questionnaire-Tegner Activity Scale | Scale from 0-10. Higher score represents greater activity level. | Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op |
| Patient Reported Outcomes Questionnaire-Numeric Rating Scale for Hip Pain | Scale from 1-10. Higher score represents greater hip pain. | Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op |
| Patient Reported Outcomes Questionnaire-Patient satisfaction with surgical outcome | 1-10-point scale | Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op |
| Multi and singleplex immunoassays and flow cytometry senescence and SASP marker assessment of peripheral blood | Concentrations of secreted protein markers found in serum in pg/ml | Baseline, and 8-12 weeks post-op |
| Incidence of revision arthroscopy or other hip surgery required post initial arthroscopy | Incidence of revision surgery from day of initial surgery will be recorded | From day of initial surgery until the end of the study, an average of 12 months |