Geniculate Artery Embolization for Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

— GAE  

Official title:

Geniculate Artery Embolization for Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04951479
• Other study ID #: STUDY19010266
• Status: Completed
• Phase: N/A
• Start date: November 3, 2021
• Est. completion date: October 26, 2023

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 26, 2023
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Gel-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.

Locations

Country	Name	City	State
United States	UPMC Shadyside	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Anish Ghodadra

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall efficacy of treatment	Average change in pain 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 percentage of patients with at least 10 point increase in KOOS pain score will be the primary outcome measure.	Baseline and 6 months from treatment
Secondary	Change in knee-related functionality	Average change in the KOOS Function in Sport and Recreation (FSR). The KOOS FSR score runs from 0 (no symptoms) to 100 (worst symptoms).	Baseline and 6 months from treatment
Secondary	Change in KOOS Quality of Life Scale	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.	Baseline and 6 months from treatment
Secondary	6-minute walk test	Average change in in 6-minute walk test in meters.	Baseline and 6 months from treatment
Secondary	30-second chair stand test	Average change in 30-second chair stand test in number of chair stands. An increase in this value is considered improvement.	Baseline and 6 months from treatment