Geniculate Artery Embolization for Knee Osteoarthritis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04951479

Acronym

GAE

Enrollment

Registered

2021-07-06

Start date

2021-11-03

Completion date

2023-10-26

Last updated

2025-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Brief summary

The purpose of this study is to perform a prospective case series to determine efficacy of transcatheter arterial embolization in treating knee osteoarthritis related pain, improving functionality, and reducing opiate usage in patients with mild to moderate knee osteoarthritis who have failed conservative management. The Gel-Bead embolization particles will be used to perform geniculate artery embolization (GAE) for the purposes of treatment of osteoarthritis-related knee pain.

Detailed description

Management of mild and moderate knee osteoarthritis is curated to each specific patient and their needs, their quality of life, and desired goals. Weight loss is advised for overweight and obese patients. All patients should attempt extended-duration exercise/physical therapy and realignment therapy. If these conservative lifestyle modifications fail to reduce pain, topical and oral non-steroidal anti-inflammatories are indicated. Escalation of care from here is controversial. Some clinicians opt for adjunctive treatments such as intra-articular injection of steroids or viscosupplementation. Unfortunately, pain alleviation from intra-articular steroids is short-lasting and a recent meta-analysis demonstrated no significant difference between intra-articular hyaluronic acid injection and placebo injection. Finally, weak opioids are an option for patients who continue to have pain despite all the aforementioned treatment measures. Joint replacement is reserved for patients with severe osteoarthritis. Patients who fail conservative, medical management pose a challenge to clinicians. For decades, there have been no interventions available to these patients between the controversial intra-articular hyaluronic acid injection and joint replacement. Interventional radiology (IR) may provide one possible solution. Geniculate artery embolization (GAE) is a minimally-invasive procedure that has historically been performed for patients with recurrent hemarthrosis. It was recently applied to patients with moderate osteoarthritis refractory to maximal medical management. Several studies have been performed and have found that GAE is safe and improves pain.

Interventions

DEVICEGel-Bead embolization

OptiSphere is FDA approved for the embolization of hypervascular tumors. The product is crosslinked with glutaraldehyde, which improves the mechanical strength of the spheres and provides controlled degradation after implant. The spherical shape provides smooth embolic delivery and even, predictable distribution. In this study the Optispheres will be used for Geniculate artery embolization (GAE) which is a minimally-invasive procedure that has historically been performed for treatment of patients with recurrent knee hemarthrosis. Embolization is a procedure in which material is used to block small blood vessels. Angiogenesis, or growth of new vessels, has been implicated in the initiation and maintenance of joint inflammation. GAE has been applied to patients with moderate osteoarthritis-related pain refractory to maximal medical management with preliminary studies demonstrating a reduction in patient pain.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Patients between ages 18 and 75 with moderate/severe knee pain secondary to primary osteoarthritis. Moderate/severe pain will be defined as pain 30 mm to 100 mm on the Visual Analog Pain Scale (where 0 denotes 'no pain' and 100 mm denotes worst pain imaginable') 2. Grade 1, 2, or 3 osteoarthritis on the Kellgren-Lawrence grading scale on knee x-ray in the last 6 months 3. Pain must be refractory to 3 months of medical management (which may include a combination of oral analgesics, intraarticular steroids, viscosupplementation, opioid therapy, etc) 4. Patients willing and able to consent to the study

Exclusion criteria

1. Kidney dysfunction defined as an estimated GFR \< 60 mL/min 2. Acute knee injury 3. Current local infection 4. Prior ipsilateral knee replacement surgery 5. Infectious or inflammatory arthritis 6. History of contrast allergy resulting in anaphylaxis 7. INR (International Normalization Ratio) \> 1.6 8. Platelets \< 50,000 9. Significant atherosclerosis that would limit angiography 10. Active malignancy 11. Active pregnancy 12. Appropriate candidate for knee replacement surgery determined by clinical and physical examination 13. Recent within 3 months, or active cigarette user

Design outcomes

Primary

Measure	Time frame	Description
Change in KOOS Pain Score	Baseline and 6 months from treatment	Change in pain score of at least 10 points based on the KOOS Pain questionnaire. The KOOS Pain score runs from 0 (no pain) to 100 (worst pain). The change in KOOS pain score will be the primary outcome measure. Minimum score is 0 and maximum is 100. higher score is better outcome

Secondary

Measure	Time frame	Description
Change in Knee-related Functionality	Baseline and 6 months from treatment	Average change in the KOOS Function in Sport and Recreation (FSR). The KOOS FSR score runs from 0 (no symptoms) to 100 (worst symptoms).
Change in KOOS Quality of Life Scale	Baseline and 6 months from treatment	Average change in in the KOOS Quality of Life Scale (QoL) score. The KOOS QoL score runs from 0 (no symptoms) to 100 (worst symptoms). An increase in this value is considered improvement.
Change in 30-second Chair Stand Test	Baseline and 6 months from treatment	Average change in 30-second chair stand test in number of chair stands. An increase in this value is considered improvement.
6-minute Walk Test	Baseline and 6 months from treatment	distance walked (meters) in 6 minutes

Countries

United States

Participant flow

Participants by arm

Arm	Count
Gel-Bead Embolization Gel-Bead embolization: Gelbead is FDA approved for the embolization of hypervascular tumors. The product is crosslinked with glutaraldehyde, which improves the mechanical strength of the spheres and provides controlled degradation after implant. The spherical shape provides smooth embolic delivery and even, predictable distribution. In this study the Gelbeads will be used for Geniculate artery embolization (GAE) which is a minimally-invasive procedure that has historically been performed for treatment of patients with recurrent knee hemarthrosis. Embolization is a procedure in which material is used to block small blood vessels. Angiogenesis, or growth of new vessels, has been implicated in the initiation and maintenance of joint inflammation. GAE has been applied to patients with moderate osteoarthritis-related pain refractory to maximal medical management with preliminary studies demonstrating a reduction in patient pain.	10
Total	10

Arm

Count

Gel-Bead Embolization

Gel-Bead embolization: Gelbead is FDA approved for the embolization of hypervascular tumors. The product is crosslinked with glutaraldehyde, which improves the mechanical strength of the spheres and provides controlled degradation after implant. The spherical shape provides smooth embolic delivery and even, predictable distribution. In this study the Gelbeads will be used for Geniculate artery embolization (GAE) which is a minimally-invasive procedure that has historically been performed for treatment of patients with recurrent knee hemarthrosis. Embolization is a procedure in which material is used to block small blood vessels. Angiogenesis, or growth of new vessels, has been implicated in the initiation and maintenance of joint inflammation. GAE has been applied to patients with moderate osteoarthritis-related pain refractory to maximal medical management with preliminary studies demonstrating a reduction in patient pain.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Pre-existing Acute Knee Injury	1

Baseline characteristics

Characteristic	Gel-Bead Embolization	—
Age, Continuous	53 years STANDARD_DEVIATION 11.8	—
KOOS Pain Score	42 score on a scale	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	6 Participants	—
Sex: Female, Male Male	4 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 10
other Total, other adverse events	5 / 10
serious Total, serious adverse events	0 / 10

Outcome results

Primary

Change in KOOS Pain Score

Change in pain score of at least 10 points based on the KOOS Pain questionnaire. The KOOS Pain score runs from 0 (no pain) to 100 (worst pain). The change in KOOS pain score will be the primary outcome measure. Minimum score is 0 and maximum is 100. higher score is better outcome