Clinical trial NCT05112926: Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in knee pain as assessed by the WOMAC
timeFrame: Baseline, 24 Weeks (Post Embolization Surgery)
measure: Incidence of treatment related adverse events
timeFrame: Up to 4 weeks (Post Embolization Surgery)
Secondary outcomes:
measure: Change in knee pain as assessed by VAS
timeFrame: Baseline, up to 52 weeks (Post Embolization Surgery)
measure: Change in knee pain
timeFrame: Baseline, up to 52 weeks (Post Embolization Surgery)
measure: Incidence of adverse events
timeFrame: Up to 52 weeks (Post Embolization Surgery)
measure: WORMS Score for Synovitis
timeFrame: Baseline, up to 52 weeks (Post Embolization Surgery)
measure: Kellgren-Lawrence Grade
timeFrame: Baseline, up to 52 weeks (Post Embolization Surgery)
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Felipe Ferreira De Souza
role: PRINCIPAL_INVESTIGATOR
References: