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

NCT ID: NCT04417686

Last Updated: 2021-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-22
• Study Completion Date: 2024-02-29

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

patient

Group Type: EXPERIMENTAL

arterial embolization

Intervention Type: PROCEDURE

arterial embolization of the geniculated arteries for reduction of pain after installation of total knee prosthesis

Interventions

arterial embolization

arterial embolization of the geniculated arteries for reduction of pain after installation of total knee prosthesis

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

EMILIE GARRIDO PRADALIE

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

vincent VIDAL

Role: CONTACT

vincent.vidal@ap-hm.fr

Facility Contacts

Role: primary

drci@ap-hm.fr

Other Identifiers

2019-A00746-51

Identifier Type: OTHER

Identifier Source: secondary_id

2019-22

Identifier Type: -

Identifier Source: org_study_id