NCT04417686

ARTERIAL EMBOLIZATION OF PERSISTENT GENICULATE ARTERIES FOR CHRONIC PAIN MANAGEMENT AFTER TOTAL KNEE-REPLACEMENT ARTHROPLASTY(KNEE EMBOLISATION)

ARTERIAL EMBOLIZATION OF PERSISTENT GENICULATE ARTERIES FOR CHRONIC PAIN MANAGEMENT AFTER TOTAL KNEE-REPLACEMENT ARTHROPLASTY: A FEASIBILITY STUDY (KNEE EMBOLISATION)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Recent works in interventional radiology have shown interesting results in the treatment of musculoskeletal inflammatory sites by arterial embolization. Supra-selective arterial embolization has been successfully developed by Dr. Okuno (Japan) to manage moderate to severe knee osteoarthritis. Also, inflammation of the surgical site mediated via geniculate arteries is a major cause for persistent chronic post-operative gonalgia.

Detailed description

Hypothesis: Selective arterial embolization of persistent geniculate arteries could reduce chronic post-operative gonalgia after TKA with minimally invasive approach. Objective: To evaluate the feasibility of selective arterial embolization of persistent geniculate arteries to reduce chronic post-operative gonalgia after TKA. Material and methods: This study is a single-center, prospective, feasibility study. Patients will be recruited after rheumatology consultation for chronic post-operative gonalgia, more than 6 months after TKA for moderate to severe gonarthrosis. Eligible patients are adults with moderate to severe chronic post-operative gonalgia (Visual Analysis Scale (VAS) \> 50mm) and degraded life quality (assessed by SF36 score), despite at least 3 months of optimal medical treatment. Non-inclusion criteria are mainly other rheumatologic or orthopedic severe diseases, severe surgical complications. Under local anesthesia, with homolateral antegrade femoral access, patient will undergo selective arterial embolization of persistent and aberrant peri-prosthetic arteries using HydroPearl® 200µm Mircospheres. Follow-up consultations will be scheduled at D1, M1, M3, M6 and M12. For a significance level of α=0.05 and power of 80% we require a cohort of 24 patients.

Conditions

• Musculoskeletal Inflammatory

Interventions

Type	Name	Description
PROCEDURE	arterial embolization	arterial embolization of the geniculated arteries for reduction of pain after installation of total knee prosthesis

Timeline

• Start date: 2021-06-22
• Primary completion: 2023-08-01
• Completion: 2024-02-01
• First posted: 2020-06-05
• Last updated: 2021-08-12

Locations

1 site across 1 country: France