Fisetin for Femoracetabular Impingement

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Steadman Clinic, Vail, CO
Femoracetabular Impingement+1 More
Fisetin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a senolytic agent might improve the benefit of Platelet-Rich Plasma and losartan for treatment of femoroacetabular impingement and labral tear.

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Eligible Conditions

  • Femoracetabular Impingement
  • Femoro-acetabular Impingement (FAI)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Femoracetabular Impingement

Study Objectives

This trial is evaluating whether Fisetin will improve 1 primary outcome and 9 secondary outcomes in patients with Femoracetabular Impingement. Measurement will happen over the course of From day of initial surgery until the end of the study, an average of 12 months.

Month 12
Patient Reported Outcomes Questionnaire- Hip Outcome Score: activities of daily living and sports subscales (HOS-ADL, HOS-SSS)
Patient Reported Outcomes Questionnaire-Modified Harris Hip Score (mHHS)
Patient Reported Outcomes Questionnaire-Numeric Rating Scale for Hip Pain
Patient Reported Outcomes Questionnaire-Optum Short Form physical and mental component scores (SF-12 PCS and SF-12 MCS)
Patient Reported Outcomes Questionnaire-Patient satisfaction with surgical outcome
Patient Reported Outcomes Questionnaire-Tegner Activity Scale
Patient Reported Outcomes Questionnaire-Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Week 12
Multi and singleplex immunoassays and flow cytometry senescence and SASP marker assessment of peripheral blood
Month 12
Incidence of Treatment-Emergent Adverse Events
Month 12
Incidence of revision arthroscopy or other hip surgery required post initial arthroscopy

Trial Safety

Safety Progress

1 of 3

Other trials for Femoracetabular Impingement

Trial Design

2 Treatment Groups

Fisetin group (investigational group)
1 of 2
Placebo group (control group)
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. Fisetin is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Fisetin group (investigational group)
Drug
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)
Placebo group (control group)
Drug
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)

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op for reporting.

Closest Location

The Steadman Clinic - Vail, CO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Between 18 and 80 years of age
Have been diagnosed with femoroacetabular impingement (FAI) and/or a hip labral tear
Capacity to personally give informed consent (consent via legally authorized representative will not be accepted) and who are willing to comply with all study-related procedures and assessments
You are scheduled to undergo hip arthroscopy to treat FAI and /or a hip labral tear

Patient Q&A Section

How many people get femoracetabular impingement a year in the United States?

"The current literature indicates an incidence rate of FAI as high as 60.0 to 90.5% in symptomatic cases and as low as 6.7% in asymptomatic cases. Given the prevalence of clinical FAI, it seems reasonable to evaluate every male to determine the presence of clinically verified FAI unless clinical signs and symptoms are present. On the basis of these results, it seems reasonable to have a radiographic evaluation of asymptomatic males from as young as 12 years of age." - Anonymous Online Contributor

Unverified Answer

What are common treatments for femoracetabular impingement?

"Because the underlying causes and the pain associated with hip dysplasia are often difficult to treat, physical therapy should be a key component of a comprehensive management plan. Treatment, if necessary, depends on the severity and is determined by an individual surgeon and patient. Patients typically require a combination of many treatments, with the treatment typically tailored to the specific biomechanical abnormality and patient needs with respect to activity level, weight-bearing, and pain." - Anonymous Online Contributor

Unverified Answer

Can femoracetabular impingement be cured?

"Although no firm evidence can prove the inability to cure the disorder, the lack of progress and limited benefit in many cases is considered insufficient evidence of its cure." - Anonymous Online Contributor

Unverified Answer

What causes femoracetabular impingement?

"It is proposed that hip loading in an upright position results in the repetitive, low energy-low frequency shear loading of the femoral neck by the acetabulum. Over time and with subsequent repetitive and continuous loading, this leads to bone resorption forming a cam-like deformity which leads to FAI. This hypothesis is consistent with the notion that FAI leads to further degenerative changes, as it may also lead to joint damage in the long term." - Anonymous Online Contributor

Unverified Answer

What is femoracetabular impingement?

"FAI affects about 10% of the population, but is unrecognized in a third of symptomatic hips. Patients with symptomatic FAI tend to be younger than patients without FAI. Radiographic hip abnormalities, including the presence or absence of alpha impingement, seem to be the best clinical predictor of symptomatic FAI and can therefore be used to guide further evaluation. Our patients with symptomatic FAI were more likely to have a history of shoulder arthritis, and the majority had a past history of pain in the groin area (a finding that the authors have termed groin pain syndrome-related FAI; GPFAI)." - Anonymous Online Contributor

Unverified Answer

What are the signs of femoracetabular impingement?

"The key to diagnosing impingement of the femoral head and neck of the hip is to ask the patient for symptoms, a thorough medical history, and a thorough physical examination. These will help physicians make the diagnosis. In the case of unilateral symptoms, the diagnosis may be straightforward. It is also possible to diagnose femoracetabular impingement without a thorough physical examination. However, one in five symptomatic patients can be misdiagnosed before they have surgery for femoral head osteoarthritis. With the help of some plain radiographs and a CT scan, a physician can make the diagnosis of bony impingement." - Anonymous Online Contributor

Unverified Answer

What is fisetin?

"In general, fisetin consumption over a 20-week period increased the mean urinary excretion of TMA and TFABP urinary levels. At the end of the trial, there were no statistically significant changes between placebo and treatment groups in urinary levels of TFABP or TMA. Moreover, baseline levels of urinary TFABP, but not TMA, were associated with improved PFM quality of life scores." - Anonymous Online Contributor

Unverified Answer

Does fisetin improve quality of life for those with femoracetabular impingement?

"Recent findings demonstrate that fisetin treatment increased the scores of all five WOMAC scores, and the improvement in ODI and KOOS scores, with the decrease of the hip score. We suggest that fisetin may be considered as a potential treatment for FAI." - Anonymous Online Contributor

Unverified Answer

Does femoracetabular impingement run in families?

"Based on the familial pattern and frequency of arthroscopy in our series, we conclude that femoracetabular impingement is not usually transmitted as a unit, but appears to be caused by a heterogeneous and complex assortment of causative factors which are transmitted with many different combinations of genetic predispositions. Thus family history, even incomplete, is a prerequisite criterion for diagnosis of FAI." - Anonymous Online Contributor

Unverified Answer

How does fisetin work?

"This investigation showed that fisetin has antiinflammatory, antioxidant, and anti-inflammatory properties through which it could help treat various pathologies involving tissue damage, such as inflammation or inflammation-related problems." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in fisetin for therapeutic use?

"Fisetin-derived compounds may have a future in the treatment of a wide range of human disease including cardiovascular, neuropsychiatric and inflammatory diseases. Given the many mechanisms of fisetin action, we can be assured that further studies will provide improved fisetin-based pharmacotherapies." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for femoracetabular impingement?

"Clinical trials of surgical hip replacement are an important part of evidence-based practice, and evidence on which to base patient decisions does not exist. Patients who are medically unfit or have contraindications for surgery, who have failed conservative therapy and would consider surgery notwithstanding, or those with symptoms for more than 2 months that cannot be improved or relieved with conservative therapy may be candidates for clinical trials." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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