ARTERIAL EMBOLIZATION OF PERSISTENT GENICULATE ARTERIES FOR CHRONIC PAIN MANAGEMENT AFTER TOTAL KNEE-REPLACEMENT ARTHROPLASTY(KNEE EMBOLISATION)
2 other identifiers
interventional
24
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2020
CompletedFirst Posted
Study publicly available on registry
June 5, 2020
CompletedStudy Start
First participant enrolled
June 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedAugust 12, 2021
August 1, 2021
2.1 years
June 2, 2020
August 5, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
arterial embolization
12 MONTHS
Secondary Outcomes (3)
VAS pain score
12MONTHS
Western Ontario and Universities Osteroarthritis Index (WOMAC) score
12MONTHS
SF36 quality of life score
12 MONTHS
Study Arms (1)
patient
EXPERIMENTALInterventions
arterial embolization of the geniculated arteries for reduction of pain after installation of total knee prosthesis
Eligibility Criteria
You may qualify if:
- 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).
- Patient willing to participate in the study and with signed informed consent.
- Patient willing to undergo post-operative monitoring for one year.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hopitaux de Marseille
Marseille, 13354, France
Study Officials
- STUDY DIRECTOR
EMILIE GARRIDO PRADALIE
Assistance Publique Hopitaux De Marseille
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2020
First Posted
June 5, 2020
Study Start
June 22, 2021
Primary Completion
August 1, 2023
Study Completion
February 1, 2024
Last Updated
August 12, 2021
Record last verified: 2021-08