Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain

Knee Osteoarthritis Clinical Trial

Official title:

Genicular Artery Embolization for the Treatment of Moderate to Severe Osteoarthritic Knee Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04472091
• Other study ID #: 57046
• Secondary ID: IDE G200111
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: November 1, 2024

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this investigation is to evaluate the safety of the geniculate artery embolization (GAE) procedure with HydroPearl® Microspheres in 30 patients with knee pain caused by osteoarthritis with 24 months follow-up. The GAE procedure is an arterial embolization procedure that blocks abnormal blood vessels caused be knee arthritis in order to evaluate the effect on knee pain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Provide informed consent

2. Age = 40 years

3. Moderate to severe knee pain (VAS >40 mm)

4. Pain refractory to 3 months of conservative treatments, including at least one of the following:

• a. Anti-inflammatory medications

• b. Physical therapy

• c. Intra-articular injections

5. Kellgren-Lawrence radiographic grade 1, 2, or 3 disease

6. MRI features of active synovitis (synovial thickening and/or enhancement on MRI).

7. Ineligibility or refusal of surgical management.

8. Local knee tenderness

Exclusion Criteria:

1. Rheumatoid or infectious arthritis

2. Advanced lower extremity atherosclerosis that would limit selective angiography

3. Local knee infection

4. Prior knee surgery (excluding arthroscopic/meniscal interventions)

5. Uncorrectable coagulopathy (INR>1.8, platelets<50,000/µL)

6. Iodine allergy resulting in anaphylaxis

7. Chronic renal insufficiency (serum creatinine >2 mg/dL)

8. Life expectancy less than 6 months

Related Conditions & MeSH terms

• Arterial Occlusion
• Arterial Occlusive Diseases
• Knee Arthritis
• Knee Osteoarthritis
• Knee Pain Chronic
• Knee Pain Swelling
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Genicular artery embolization (GAE)
Participants will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ).

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Andrew Picel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with treatment related adverse events	Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	1 month post GAE
Primary	Number of patients with treatment related adverse events	Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	6 months post GAE
Primary	Number of patients with treatment related adverse events	Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	12 months post GAE
Primary	Number of patients with treatment related adverse events	Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	24 months post GAE
Secondary	Mean change from baseline pain scores	Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents "no pain" and 100 mm represents "worse possible pain."	Baseline to 1 month post GAE
Secondary	Mean change from baseline pain scores	Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents "no pain" and 100 mm represents "worse possible pain."	Baseline to 6 months post GAE
Secondary	Mean change from baseline pain scores	Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents "no pain" and 100 mm represents "worse possible pain."	Baseline to 12 months post GAE
Secondary	Mean change from baseline pain scores	Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents "no pain" and 100 mm represents "worse possible pain."	Baseline 24 months post GAE
Secondary	Mean change from baseline knee function scores	Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of "0" indicates no symptoms and "4" indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.	Baseline to 1 month post GAE
Secondary	Mean change from baseline knee function scores	Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of "0" indicates no symptoms and "4" indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.	Baseline to 6 months post GAE
Secondary	Mean change from baseline knee function scores	Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of "0" indicates no symptoms and "4" indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.	Baseline to 12 months post GAE
Secondary	Mean change from baseline knee function scores	Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of "0" indicates no symptoms and "4" indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.	Baseline to 24 months post GAE