GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA

• Status: Not yet recruiting
• Trial end date: 2027-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This multicenter, prospective, interventional trial is designed to assess the outcome of subjects with symptomatic knee osteoarthritis (OA) that are randomized to treatment with either genicular artery embolization (GAE) using Embosphere Microspheres or steroid injection over a period of 24 months.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merit Medical Systems, Inc.

Criteria

General Inclusion Criteria:

1. Subject provides written informed consent before any study-specific investigations or procedures.

2. Subject is male or female, with an age ≥21 years at the time of enrollment/randomization.

3. Subject is willing to undergo all follow-up assessments according to the specified schedule over 24 months.

4. Subject has mild to severe knee pain, defined as a numerical rating scale (NRS) score of ≥4 out of 10 (of the target knee).

5. Subject has pain refractory to conservative therapies (anti-inflammatory drugs, or physical therapy, or muscle strengthening, or intra-articular injections) for at least 90 days prior to enrollment/randomization (in the target knee).

6. Kellgren-Lawrence grade 1, 2, 3 or 4 on radiograph of the knee within 6 months of enrollment/randomization (of the target knee).

7. Subject is able to identify the site of maximal knee pain.

8. Subject has MRI evidence of: a) joint space narrowing, b) osteophytes, c) synovial thickening, d) bone edema, or e) meniscal degeneration.

9. Subject has had a prior intra-articular steroid injection within the target knee >90 days prior to randomization and has received clinical benefit.

Angiographic Inclusion Criteria:

1. Subject has confirmed evidence of knee OA, defined as an angiographic 'blush' pattern (radiographic) in one or more of the target genicular artery(ies).

2. Subject requires ≤ 4 genicular arteries to be treated.

Exclusion Criteria:

1. Subject has any planned major surgical or endovascular procedures ≤ 30 days after the index procedure.

2. Subject has known advanced atherosclerosis of the target extremity.

3. Subject has known history of rheumatoid or infectious arthritis.

4. Subject has had a prior knee replacement surgery of the target knee.

5. Subject requires or has planned contralateral knee surgery within 6 months following enrollment.

6. Subject received corticosteroid injection(s) in the target knee ≤ 90 days of enrollment/ randomization.

7. Subject has imaging evidence of bone tumor in the target knee.

8. Subject has MRI evidence of any bony structural defect present on the femur or tibia, acute displaced meniscal tears, acute anterior cruciate ligament (ACL) rupture, or patellar or quadriceps tendon defect.

9. Subject has a mechanical block within the target knee joint space.

10. Subject has a loose body within the target knee >5mm.

11. Subject has an acute cortical fracture in the target knee.

12. Subject has a complete cruciate ligament tear in the target knee.

13. Subject has evidence of osteonecrosis (bone infarction).

14. Subject has a hypersensitivity to contrast agents that cannot be adequately treated or premedicated.

15. Subject has a hypersensitivity to gelatin.

16. Subject has known history of uncontrolled coagulopathy.

17. Subject has a stroke diagnosis within 90 days prior to enrollment.

18. Subject has a history of unstable angina or myocardial infarction within 60 days prior to enrollment.

19. Subject has a contraindication to antiplatelet, anticoagulant, or thrombolytic therapies.

20. Subject has a known contraindication to MRI (e.g., pacemaker, defibrillator, metallic foreign body in the eye, wires other than sternal wires, etc.).

21. Subject has a known local infection of the target knee or a known or suspected active systemic infection at the time of enrollment.

22. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-medicated.

23. Subject is currently pregnant or breastfeeding or planning to become pregnant within the next 12 months.

24. Subject has a significant co-morbidity that, in the opinion of the Investigator, would limit life expectancy to less than 12 months.

25. Subject is participating in another research study involving an investigational product (pharmaceutical, biologic, or medical device).

26. Subject has a history of substance abuse, including opioids.

27. Subject has a history of narcotic/opioid usage for pain management for knee osteoarthritis within ninety (90) days prior to enrollment. Note: This does not exclude prn usage of narcotics/opioids for breakthrough pain over the course of ninety (90) days prior to enrollment (prn usage defined as no more than three (3) days of narcotic/opioid usage for breakthrough pain within the ninety (90) days prior to enrollment).

28. Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.

Angiographic Exclusion Criteria:

1. Subject has evidence of arterial occlusion precluding catheterization.

2. Subject has occlusion of the genicular arteries on the target knee.