Degenerative Joint Disease of Knee, Knee Osteoarthritis
Conditions
Keywords
Microspheres, Artery Embolization, Knee Osteoarthritis, Chronic Pain, Embozene
Brief summary
The purpose of this clinical research study is to examine whether Embozene treatment of the genicular artery is a safe and effective way to treat arthritic knee pain. Embozene is a medical device made by Boston Scientific approved in the United States for the treatment of hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic spheres that are injected into the artery in the knee going to the region of pain. One of the causes of pain in the setting of knee arthritis is increased blood flow going to the specific area of pain. The goal of this procedure is to decrease the blood flow (embolize) to the specific region of the knee that is causing your pain. This is done by infusing Embozene particles into the specific blood vessel (genicular artery) supplying the area of pain in the knee.
Detailed description
This is a phase 2, single-center, prospective, single arm investigational study to evaluate the safety and efficacy of genicular artery embolization (GAE) for treatment of symptomatic knee osteoarthritis (OA). Subjects will be treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres will be delivered in a saline-contrast medium solution and will be delivered to the arteries supplying the areas of the subject's pain. The primary objective of this investigation is to assess safety of genicular artery embolization (GAE) for knee osteoarthritis (OA) using Embozene particles.
Interventions
DEVICEEmbozene MicroSpheres
Embozene is a medical device made by Boston Scientific approved in the United States for the treatment of hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic spheres that are injected into the artery in the knee going to the region of pain. One of the causes of pain in the setting of knee arthritis is increased blood flow going to the specific area of pain. The goal of this procedure is to decrease the blood flow (embolize) to the specific region of the knee that is causing your pain. This is done by infusing Embozene particles into the specific blood vessel (genicular artery) supplying the area of pain in the knee.
Sponsors
Boston Scientific Corporation
Siddharth Padia, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The stratification will not be randomized, but each category will be limited to 20 patients.
Eligibility
Sex/Gender
ALL
Age
40 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Provided informed consent * Age ≥ 40 years and ≤ 80 years * Life expectancy greater than 12 months * Ineligibility for or refusal of surgical management * Moderate-severe knee pain as determined by visual analog scale \> 4 * Osteoarthritis based on xray * Local knee tenderness * Resistant/failed conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection)
Exclusion criteria
• Mild knee pain as determined by visual analog scale \< 4 * Chronic renal insufficiency (serum creatinine \>2 mg/dL) * Uncorrectable bleeding diathesis: international normalized ratio (INR) \>1.6, Platelets \<50,000 * Significant arterial atherosclerosis that would limit selective angiography * Allergy to iodinated contrast agents that is not responsive to steroid management * Active Infection or malignancy * Appropriate candidate for knee replacement surgery determined by clinical and physical examination * Recent (within 3 months) or active cigarette use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety | Up to 12 Months after GAE | Treatment-related AEs from gennicular artery embolization during the study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a Measure of Efficacy | 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 |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale as a Measure of Efficacy | 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. |
| Change From Baseline in Visual Analog Scale (VAS) as a Measure of Efficacy | 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). |
Countries
United States
Participant flow
Recruitment details
Of 65 individuals assessed for eligibility, 20 did not meet inclusion criteria and 5 declined to participate
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Genicular Artery Embolization (GAE) With Embozene Microspheres | — |
|---|---|---|
| Age, Continuous | 69 years | — |
| Body Mass Index (BMI) | 29.3 kg/m^2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 40 Participants | — |
| Sex: Female, Male Female | 31 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
| Visual Analog Scale (VAS) pain score | 8 units on a scale | — |
| WOMAC Index | 52 units on a scale | — |
| WOMAC Pain Score | 11 units on a scale | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 9 / 40 |
| serious Total, serious adverse events | 1 / 40 |
Outcome results
Primary
Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety
Treatment-related AEs from gennicular artery embolization during the study period
Time frame: Up to 12 Months after GAE
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Genicular Artery Embolization (GAE) With Embozene Microspheres | Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety | Groin hematoma | 1 Participants |
| Genicular Artery Embolization (GAE) With Embozene Microspheres | Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety | Self-resolving focal skin ulceration | 7 Participants |
| Genicular Artery Embolization (GAE) With Embozene Microspheres | Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety | Asymptomatic small bone infarct on MRI | 2 Participants |
Secondary
Change From Baseline in Visual Analog Scale (VAS) as a Measure of Efficacy
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).
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Genicular Artery Embolization (GAE) With Embozene Microspheres | Change From Baseline in Visual Analog Scale (VAS) as a Measure of Efficacy | Month 1 | -4.5 score on a scale |
| Genicular Artery Embolization (GAE) With Embozene Microspheres | Change From Baseline in Visual Analog Scale (VAS) as a Measure of Efficacy | Month 3 | -4.5 score on a scale |
| Genicular Artery Embolization (GAE) With Embozene Microspheres | Change From Baseline in Visual Analog Scale (VAS) as a Measure of Efficacy | Month 6 | -5.0 score on a scale |
| Genicular Artery Embolization (GAE) With Embozene Microspheres | Change From Baseline in Visual Analog Scale (VAS) as a Measure of Efficacy | Month 12 | -5.0 score on a scale |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a Measure of Efficacy
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
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Genicular Artery Embolization (GAE) With Embozene Microspheres | 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 |
| Genicular Artery Embolization (GAE) With Embozene Microspheres | 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 |
| Genicular Artery Embolization (GAE) With Embozene Microspheres | 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 |
| Genicular Artery Embolization (GAE) With Embozene Microspheres | 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 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale as a Measure of Efficacy
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.
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Genicular Artery Embolization (GAE) With Embozene Microspheres | 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 |
| Genicular Artery Embolization (GAE) With Embozene Microspheres | 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 |
| Genicular Artery Embolization (GAE) With Embozene Microspheres | 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 |
| Genicular Artery Embolization (GAE) With Embozene Microspheres | 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 |