Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Prospective, Single Arm Investigation to Assess Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05112926
• Other study ID #: 20210848
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: University of Miami
• Contact: Lia Quezada
• Phone: 305-243-2210
• Email: Lquezada[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to evaluate the effectiveness and safety of a permanent embolic (Embosphere Microspheres) for embolization of the geniculate artery for the treatment of moderate to severe knee osteoarthritis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subject has signed informed consent

• Subject is age 40-80

• Subject is able to have an MRI

• Minimum of prior 12 weeks of failed response to conservative therapy for knee osteoarthritis, which may include one or more of:

a) Oral or topical NSAIDS, opioid medications, intra-articular injection of glucocorticoids or hyaluronic acid, physical therapy.

• Localized tenderness in anterior knee area

• Kellgren-Lawrence grade 1, 2, or 3 as assessed by weight-bearing knee radiographs

• Synovitis present as assessed by WORMS

• VAS >50 mm

• WOMAC score >30

Exclusion Criteria:

• Rheumatoid arthritis

• Local infection of the target knee(s)

• Kellgren-Lawrence grade >3

• Osteonecrosis evident by MRI

• Prior knee arthroplasty

• Allergy to iodinated contrast agents that cannot be managed by prophylaxis

• Hypersensitivity to gelatin products

• Any known condition that limits catheter-based intervention or is a contraindication to embolization

• Active malignancy other than non-melanomatous skin cancer

• Subject is pregnant, breastfeeding, or pre-menopausal and intending to become pregnant

• Any other condition related to the subject's health and wellbeing deemed exclusionary in the opinion of the investigator

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Embosphere Microspheres
Embosphere Microspheres are 100-300µm small, compressible, hydrophilic, biocompatible spheres made of acrylic polymer and porcine-derived gelatin used for embolization of geniculate artery.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Shivank Bhatia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in knee pain as assessed by the WOMAC	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain index assesses participants' pain on a scale ranging from 0 (none) to 4 (extreme). The pain subscale consists of 5 items and total scores can range from 0-20, with larger scores indicating greater pain.	Baseline, 24 Weeks (Post Embolization Surgery)
Primary	Incidence of treatment related adverse events	Procedure-related and target knee osteoarthritis-related adverse events as assessed by treating physician	Up to 4 weeks (Post Embolization Surgery)
Secondary	Change in knee pain as assessed by VAS	Visual Analog Scale (VAS) has a total score ranging from 0-10 with the higher score indicating greater pain	Baseline, up to 52 weeks (Post Embolization Surgery)
Secondary	Change in knee pain	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain index assesses participants' pain on a scale ranging from 0 (none) to 4 (extreme). The pain subscale consists of 5 items and total scores can range from 0-20, with larger scores indicating greater pain.	Baseline, up to 52 weeks (Post Embolization Surgery)
Secondary	Incidence of adverse events	Procedure-related and target knee osteoarthritis-related adverse events as assessed by treating physician	Up to 52 weeks (Post Embolization Surgery)
Secondary	WORMS Score for Synovitis	Whole-Organ Magnetic Resonance Imaging Score (WORMS) has a score ranging from zero representing no knee problems and 332 representing knee problems	Baseline, up to 52 weeks (Post Embolization Surgery)
Secondary	Kellgren-Lawrence Grade	As assessed by X-Ray. Radiograph imaging graded on scale 1 (no arthritis) to 4 (severe arthritis)	Baseline, up to 52 weeks (Post Embolization Surgery)