Trial Outcomes & Findings for Genicular Artery Embolization for the Treatment of Knee Osteoarthritis (NCT NCT03491397)

Results Overview

Treatment-related AEs from gennicular artery embolization during the study period

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Up to 12 Months after GAE

Results posted on

2022-11-30

Participant Flow

Of 65 individuals assessed for eligibility, 20 did not meet inclusion criteria and 5 declined to participate

Participant milestones

Participant milestones
Measure	Genicular Artery Embolization (GAE) With Embozene Microspheres Subjects were treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres were delivered in a saline-contrast medium solution and delivered to the arteries supplying the areas of the subject's pain.
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Genicular Artery Embolization (GAE) With Embozene Microspheres n=40 Participants Subjects were treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres were delivered in a saline-contrast medium solution and delivered to the arteries supplying the areas of the subject's pain.
Age, Continuous	69 years n=40 Participants
Sex: Female, Male Female	31 Participants n=40 Participants
Sex: Female, Male Male	9 Participants n=40 Participants
Region of Enrollment United States	40 Participants n=40 Participants
Body Mass Index (BMI)	29.3 kg/m^2 n=40 Participants
WOMAC Index	52 units on a scale n=40 Participants
WOMAC Pain Score	11 units on a scale n=40 Participants
Visual Analog Scale (VAS) pain score	8 units on a scale n=40 Participants

PRIMARY outcome

Timeframe: Up to 12 Months after GAE

Treatment-related AEs from gennicular artery embolization during the study period

Outcome measures

Outcome measures
Measure	Genicular Artery Embolization (GAE) With Embozene Microspheres n=40 Participants Subjects were treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres were delivered in a saline-contrast medium solution and delivered to the arteries supplying the areas of the subject's pain.
Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety Groin hematoma	1 Participants
Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety Self-resolving focal skin ulceration	7 Participants
Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety Asymptomatic small bone infarct on MRI	2 Participants

SECONDARY outcome

Timeframe: Baseline, Month 1, Month 3, Month 6, Month 12

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered questionnaire consisting of 24 items divided into 3 subscales. Each item is scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). With a total possible range of 0-96, higher scores indicate worse pain, stiffness, and functional limitations. Pain (5 items, possible range 0-20): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items, possible range 0-8): after first waking and later in the day Physical Function (17 items, possible range 0-68): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties

Outcome measures

Outcome measures
Measure	Genicular Artery Embolization (GAE) With Embozene Microspheres n=40 Participants Subjects were treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres were delivered in a saline-contrast medium solution and delivered to the arteries supplying the areas of the subject's pain.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a Measure of Efficacy Month 1	-20.5 score on a scale Interval -71.0 to 20.0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a Measure of Efficacy Month 3	-29.5 score on a scale Interval -74.0 to 26.0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a Measure of Efficacy Month 6	-26.5 score on a scale Interval -81.0 to 19.0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a Measure of Efficacy Month 12	-29.0 score on a scale Interval -82.0 to 19.0

SECONDARY outcome

Timeframe: Baseline, Month 1, Month 3, Month 6, Month 12

The WOMAC Pain Subscale is a self-administered questionnaire of 5 items to assess Pain: during walking, using stairs, in bed, sitting or lying, and standing upright. Each item is scored on a scale of 0-4: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4), with a possible total score range of 0-20.

Outcome measures

Outcome measures
Measure	Genicular Artery Embolization (GAE) With Embozene Microspheres n=40 Participants Subjects were treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres were delivered in a saline-contrast medium solution and delivered to the arteries supplying the areas of the subject's pain.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale as a Measure of Efficacy Month 1	-6 score on a scale Interval -17.0 to 3.0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale as a Measure of Efficacy Month 3	-7 score on a scale Interval -15.0 to 6.0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale as a Measure of Efficacy Month 6	-7 score on a scale Interval -14.0 to 6.0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale as a Measure of Efficacy Month 12	-7.5 score on a scale Interval -14.0 to 6.0

SECONDARY outcome

Timeframe: Baseline, Month 1, Month 3, Month 6, Month 12

The patient-reported severity of knee pain was quantified using a visual analog scale (VAS) score ranging from 0 (indicating no pain) through 10 (indicating the worst pain imaginable).

Outcome measures

Outcome measures
Measure	Genicular Artery Embolization (GAE) With Embozene Microspheres n=40 Participants Subjects were treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres were delivered in a saline-contrast medium solution and delivered to the arteries supplying the areas of the subject's pain.
Change From Baseline in Visual Analog Scale (VAS) as a Measure of Efficacy Month 1	-4.5 score on a scale Interval -9.0 to 2.0
Change From Baseline in Visual Analog Scale (VAS) as a Measure of Efficacy Month 3	-4.5 score on a scale Interval -10.0 to 2.0
Change From Baseline in Visual Analog Scale (VAS) as a Measure of Efficacy Month 6	-5.0 score on a scale Interval -8.5 to -1.0
Change From Baseline in Visual Analog Scale (VAS) as a Measure of Efficacy Month 12	-5.0 score on a scale Interval -9.0 to 0.0

Adverse Events

Genicular Artery Embolization (GAE) With Embozene Microspheres

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Genicular Artery Embolization (GAE) With Embozene Microspheres n=40 participants at risk Subjects were treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres were delivered in a saline-contrast medium solution and delivered to the arteries supplying the areas of the subject's pain.
Injury, poisoning and procedural complications Groin hematoma	2.5% 1/40 • Number of events 1 • 12 months Adverse Events were recorded, per protocol, only if determined to be at least possibly related to study intervention

Other adverse events

Other adverse events
Measure	Genicular Artery Embolization (GAE) With Embozene Microspheres n=40 participants at risk Subjects were treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres were delivered in a saline-contrast medium solution and delivered to the arteries supplying the areas of the subject's pain.
Skin and subcutaneous tissue disorders Focal skin ulceration	17.5% 7/40 • Number of events 7 • 12 months Adverse Events were recorded, per protocol, only if determined to be at least possibly related to study intervention
Musculoskeletal and connective tissue disorders Asymptomatic bone infarct	5.0% 2/40 • Number of events 2 • 12 months Adverse Events were recorded, per protocol, only if determined to be at least possibly related to study intervention

Additional Information

Siddharth A. Padia, MD

University of California Los Angeles

Phone: 310-825-2992

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place