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

  • STATUS
    Recruiting
  • End date
    Feb 21, 2024
  • participants needed
    24
  • sponsor
    Assistance Publique Hopitaux De Marseille
Updated on 21 August 2021

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.

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 200m Mircospheres. Follow-up consultations will be scheduled at D1, M1, M3, M6 and M12. For a significance level of =0.05 and power of 80% we require a cohort of 24 patients.

Details
Condition Musculoskeletal Inflammatory
Treatment Arterial Embolization
Clinical Study IdentifierNCT04417686
SponsorAssistance Publique Hopitaux De Marseille
Last Modified on21 August 2021

Eligibility

Yes No Not Sure

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
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