Status:
UNKNOWN
ARTERIAL EMBOLIZATION OF PERSISTENT GENICULATE ARTERIES FOR CHRONIC PAIN MANAGEMENT AFTER TOTAL KNEE-REPLACEMENT ARTHROPLASTY(KNEE EMBOLISATION)
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Musculoskeletal Inflammatory
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
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 feasi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04417686
Start Date
June 22 2021
End Date
February 1 2024
Last Update
August 12 2021
Active Locations (1)
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1
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354