CLINICAL TRIAL

Embozene Microspheres for Knee Pain Chronic

Waitlist Available · 18+ · All Sexes · Boston, MA

Genicular Artery Embolization (GAE) for the Treatment of Chronic Post Knee Arthroplasty Pain

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About the trial for Knee Pain Chronic

Eligible Conditions
Knee Pain Chronic · Arterial Occlusion · Knee Swelling Pain

Treatment Groups

This trial involves 2 different treatments. Embozene Microspheres is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Embozene Microspheres
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Embozene Microspheres
2014
N/A
~300

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Ambulatory
You have had a total knee arthroplasty or revision arthroplasty in the symptomatic knee. show original
Moderate to severe knee pain: pain VAS ≥50 mm
You are not pregnant at the time of screening. show original
Provision of signed and dated informed consent form
You are willing, able, and mentally competent to provide informed consent and to tolerate angiography, US, and MRI. show original
You have knee pain resistant to at least 3 months of conservative therapy including pharmacologic therapy or intra-articular injection. show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Embozene Microspheres will improve 1 primary outcome and 5 secondary outcomes in patients with Knee Pain Chronic. Measurement will happen over the course of 6 months.

MHI-5
6 MONTHS
Assess for associations between mental health and post TKA pain as assessed by the MHI-5 by comparing scores at 1 week, 1, 3, and 6 months to the pre-procedure score.
6 MONTHS
KOOS - Pain subscale KOOS Scale - Pain
6 MONTHS
Estimate the effect of genicular artery embolization on the change in knee pain, as assessed by the KOOS, at 6 months post vs. pre-intervention, in patients with chronic knee pain following TKA
6 MONTHS
VAS Scale
6 MONTHS
Estimate the effect of genicular artery embolization on the change in knee pain, as assessed by the VAS scale, at 1 week, 1, 3, and 6 months, in patients in patients with chronic knee pain following TKA.
6 MONTHS
CRP & IL-6
6 MONTHS
Estimate the effect of genicular artery embolization on CRP and IL-6, by comparing baseline laboratory values to 6-month post procedure values.
6 MONTHS
Analgesic Utilization
6 MONTHS
Estimate the effect of genicular artery embolization on analgesic utilization as measured by morphine equivalents and non-steroidal anti-inflammatories utilization
6 MONTHS
KOOS - Non-Pain Components
6 MONTHS
Estimate effect in non-pain components of the KOOS score (KOOS Symptoms, KOOS ADL, KOOS Sport ADL, and KOOS QOL) by comparing these scores at 1 week, 1,3, and 6 months to the pre-procedure score.
6 MONTHS

Who is running the study

Principal Investigator
Y. E. M.
Yan Epelboym M.D.,M.P.H., Principal Investigator
Brigham and Women's Hospital

Patient Q & A Section

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

What are common treatments for knee pain chronic?

Common treatments for [knee pain](https://www.withpower.com/clinical-trials/knee-pain) include pain medications, physical therapy, analgesic knee sleeves, and knee braces. There are no studies demonstrating that patients benefit from any of these treatments for knee pain.

Anonymous Patient Answer

What is knee pain chronic?

The study provides the first evidence of moderate intensity pain at the knee and the impact of this symptom among patients experiencing knee pain. Knee pain of at least moderate intensity has an important causal role in the daily lives of patients. It is particularly relevant in the management and outcomes of knee osteoarthritis.

Anonymous Patient Answer

What are the signs of knee pain chronic?

Pain along with stiffness and limitation of knee movements are the most common symptoms of [knee pain](https://www.withpower.com/clinical-trials/knee-pain) chronic. Chronic knee pain often arises from other joint and soft tissue disorders such as osteoarthritis, ACL injury, peripheral bursitis, pirifomitis, periarticular bony abnormalities, ligamentous laxity and tendinitis. Knee pain may be treated with pain killers and physical therapy but may occasionally necessitate surgical intervention. Knee pain chronic is especially common as we age, and may result in severe distress for those with chronic pain condition.

Anonymous Patient Answer

Can knee pain chronic be cured?

A combination of rehabilitation exercises and proprioceptive exercise therapy was effective in correcting knee pain chronic. A knee joint should be surgically solved when knee pain chronic is not cured after proper rehabilitation.

Anonymous Patient Answer

What causes knee pain chronic?

The cause of chronic [knee pain](https://www.withpower.com/clinical-trials/knee-pain) is still unknown. Pain can be associated with injury of the bones and surrounding soft tissues which can occur after trauma or repetitive activities. The pain can occur as a secondary complication to a more serious pathology such as a fracture.

Anonymous Patient Answer

How many people get knee pain chronic a year in the United States?

Approximately 19.9 million U.S. adults report having knee pain for at least two months in a given year. It is important to understand the impact of knee pain on individuals' daily lives and what treatment may be most appropriate.

Anonymous Patient Answer

How serious can knee pain chronic be?

Recent findings of studies on the diagnosis and treatment of [knee pain](https://www.withpower.com/clinical-trials/knee-pain) provide a basis for considering knee pain chronic as being of low or moderate severity. In the past, however, there has been emphasis on the use of radiographic techniques of assessing and diagnosing patellofemoral pain and its sequelae as potentially disabling and disabling. However, the results of recent studies have suggested that patellofemoral pain, while not necessarily a debilitating condition, does have significant negative impacts of daily living and is highly likely to increase the risk of future joint pain and other health problems. The implication is that knee pain chronic is a serious disabling condition that significantly impacts quality of life and is likely to have substantial negative impacts on the individual.

Anonymous Patient Answer

Does embozene microspheres improve quality of life for those with knee pain chronic?

The embozene microspheres were found to have a significant effect over the placebo on patient-reported functional pain and QoL. In a recent study, findings could be useful when planning randomized trials of embozene in patients.

Anonymous Patient Answer

Does knee pain chronic run in families?

Chronic knee pain is seen a higher frequency in families with a positive history of CKP, suggesting that familial factors may play a role in the etiology of CKP.

Anonymous Patient Answer

What is embozene microspheres?

For knee pain chronic of the knee, embozene microsphere is a new treatment for adjuvant to current treatments with a good improvement but no statistical significance which may prove to be the effect in long time.

Anonymous Patient Answer

What does embozene microspheres usually treat?

The majority of patients with refractory chronic Knee pain treated with the addition of a single EMB microsphere (40 mg) to their ongoing medical treatment will obtain pain relief, improved function, and improved quality of life.

Anonymous Patient Answer

Has embozene microspheres proven to be more effective than a placebo?

Microspheres showed some advantage compared to a placebo in eliminating pain, reducing knee stiffness and improving function in patients with [knee osteoarthritis](https://www.withpower.com/clinical-trials/knee-osteoarthritis). Although further long-term studies are warranted, the use of microspheres may become a novel approach to treat osteoarthritis pain.

Anonymous Patient Answer
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