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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Musculoskeletal Inflammatory

Intervention / Treatment
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* Procedure: arterial embolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient (male or female) aged 18-85 Suffering from moderate to severe chronic pain (EVA > 50mm) more than 6 months after total prosthetic knee replacement surgery for severe gonarthrosis with impact on quality of life. And having followed for at least 3 months a well-conducted conservative medical treatment (anti-inflammatory, analgesic, masso-kinesiotherapy). The patient may initially have had a single or bilateral replacement. The period of 6 months must be respected for each side, between the intervention and the inclusion for homolateral pain. Patient willing to participate in the study and with signed informed consent. Patient willing to undergo post-operative monitoring for one year. Exclusion Criteria: Orthopaedic or rheumatological pathologies: Rheumatoid arthritis Psoriatic rheumatism Spondylarthropathies History of primary or secondary bone tumor, in remission or active. Myeloma Operational criteria: Infection of the surgical site Re-operation Severe bleeding Use of turnstile per-operative Wound of popliteal artery Diabetic patient Comorbidities: General condition responsible for objective hemostasis disorder (hemophilia, Willebrand disease, thrombocytopenia) and anticoagulant treatments. Pads 100 G/L

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient<br> | Procedure: arterial embolization<br>* arterial embolization of the geniculated arteries for reduction of pain after installation of total knee prosthesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial embolization |  | 12 MONTHS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain score |  | 12MONTHS | 
| Western Ontario and Universities Osteroarthritis Index (WOMAC) score |  | 12MONTHS | 
| SF36 quality of life score |  | 12 MONTHS |