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

Musculoskeletal Inflammatory Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04417686
• Other study ID #: 2019-22
• Secondary ID: 2019-A00746-51
• Status: Recruiting
• Phase: N/A
• Start date: June 22, 2021
• Est. completion date: February 2024

Study information

• Verified date: August 2021
• Source: Assistance Publique Hopitaux De Marseille
• Contact: vincent VIDAL
• Email: vincent.vidal[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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® 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: February 2024
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Inflammatory

Intervention

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

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	arterial embolization		12 MONTHS
Secondary	VAS pain score		12MONTHS
Secondary	Western Ontario and Universities Osteroarthritis Index (WOMAC) score		12MONTHS
Secondary	SF36 quality of life score		12 MONTHS