1000 Participants Needed

Artery Embolization for Osteoarthritis

Recruiting at 1 trial location
AI
MT
Overseen ByMeaghan Thomas, CCRP
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vascular Solutions of North Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of artery embolization as a treatment for chronic pain caused by osteoarthritis or other conditions that lead to localized pain. Researchers aim to determine if this procedure can reduce pain levels and improve the quality of life for participants. The trial will compare pain and quality of life before and after the treatment. Individuals who have undergone artery embolization for chronic pain from osteoarthritis or similar issues may be suitable candidates for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to understanding its impact.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to ask the trial coordinators for more details.

What prior data suggests that artery embolization is safe for treating chronic pain in osteoarthritis patients?

Studies have shown that artery embolization, a procedure that blocks blood flow to specific areas, is generally well-tolerated. Research indicates that issues related to this procedure occur in about 0 to 2.6% of cases, and these are usually minor. Common minor issues include pain at the procedure site and sometimes minor bleeding or infection. Reports of major problems during the procedure do not exist.

Some people may experience temporary skin color changes or a tingling sensation afterward. These effects are usually not serious and tend to resolve on their own. Overall, based on previous studies, artery embolization appears to be a safe option for managing chronic pain in conditions like osteoarthritis.12345

Why are researchers excited about this trial?

Researchers are excited about artery embolization in treating certain conditions because it offers a minimally invasive approach to block blood flow to problematic areas, potentially reducing symptoms and improving quality of life. Unlike traditional surgical options, artery embolization can target specific blood vessels, which may lead to quicker recovery times and less pain for patients post-procedure. Additionally, this method might reduce the need for medication after the procedure, as it aims to directly address the source of pain and symptoms. This innovative approach could signify a significant advancement in patient care, offering a more tailored and efficient treatment option.

What evidence suggests that artery embolization is effective for chronic pain in osteoarthritis?

Research has shown that artery embolization, a treatment that stops blood flow to certain areas, may help reduce pain for people with osteoarthritis. One study found that pain levels dropped significantly, as measured by a pain rating tool, from 66 out of 100 at the start to 40 after six months. Another study reported that patients who underwent this procedure experienced better movement and quality of life. This trial will evaluate the efficacy and overall improvement of patients post-artery embolization by comparing preoperative and postoperative pain, medication use, and quality of life. These findings suggest that artery embolization can relieve pain and improve daily life for those with knee osteoarthritis.678910

Who Is on the Research Team?

SR

Siddhartha Rao, MD

Principal Investigator

Vascular Solutions of North Carolina

AI

Amer Iqbal

Principal Investigator

Vascular Solutions of North Carolina

MT

Meaghan Thomas, CCRP

Principal Investigator

Vascular Solutions of North Carolina

Are You a Good Fit for This Trial?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo artery embolization as an outpatient procedure to reduce blood flow to the target area, aiming to decrease inflammation and pain.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, with assessments at 1, 3, 6, and 12 months post-procedure.

12 months
4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Artery Embolization

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vascular Solutions of North Carolina

Lead Sponsor

Trials
1
Recruited
1,000+

Citations

Transarterial Embolization of Geniculate Arteries Reduces ...

The primary endpoint, VAS at 6 months, showed a significant improvement from baseline (median 66 mm [IQR 61–73] at baseline, median 40 mm [IQR ...

Genicular artery embolization for knee osteoarthritis

Functional outcomes were mixed; one trial reported significant improvement in WOMAC function, and another found enhanced quality of life in patients undergoing ...

Mid- and Long-Term Quality-of-Life Assessment in Patients ...

Postinterventional pain was the most common side effect after uterine fibroid embolization (83%), followed by postembolization syndrome (41.5%) in our cohort.

Short- and long-term evaluation of disease-specific symptoms ...

The purpose of this study is to evaluate uterine artery embolization (UAE) for the management of symptomatic uterine leiomyomas regarding ...

Effectiveness of a nurse-led pain management model ...

These results support the potential effectiveness of a nurse-led pain management model in improving postoperative outcomes following TACE, ...

Safety Profile of Ambulatory Prostatic Artery Embolization after ...

Embolization-related adverse events varied between 0 and 2.6%, access-site adverse events between 0 and 18%, and were all minor. There was no major event.

Prostate Artery Embolization (PAE) Side Effects

Infection: There is a risk of infection following PAE. · Bleeding: During the PAE procedure, there is a risk of bleeding. · Pain: Pain in the lower abdominal or ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28795212/

A Review of Adverse Events Related to Prostatic Artery ...

Low adverse events rates have been reported following prostate artery embolization and may include dysuria, urinary infection, hematuria, hematospermia, acute ...

Clinical outcomes of primary arterial embolization in severe ...

The arterial embolization success rate ranged from 80% to 97%. The most commonly reported complication was bile leak, with an incidence of 5.7%. Nineteen ...

SAFETY OF GENICULAR ARTERY EMBOLIZATION FOR ...

These results indicate that the most common AE attributable to GAE is transient skin discoloration. Persisting AEs reported were paresthesia.