Efficacy of Microparticle Geniculate Artery Embolization in Total Knee Prosthesis Patients With Pain Resistant to Medical Treatment. A Prospective Randomized Controlled Trial

Launched by SOCIETE FRANCAISE DE RHUMATOLOGIE · Jun 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment option for patients suffering from persistent knee pain after having a total knee replacement. Specifically, the study will evaluate the effectiveness of a procedure called arterial embolization, which involves blocking small blood vessels in the knee to reduce pain. Participants will be people aged 40 to 80 who have had knee pain for at least three months despite trying various pain relief medications. They must also have had their knee replacement for over a year and pass certain health checks to ensure they qualify.

If you decide to participate, you will be randomly assigned to either the treatment group, where you will receive the embolization procedure, or a control group, where you will only undergo a diagnostic test without any treatment. The study will track your pain levels, mobility, and any side effects for up to a year. This trial is not yet recruiting participants, but it aims to help people who have not found relief with traditional treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Man or woman aged between 40 and 80 years with a TKR for more than one year.
• • TKR pain with a VAS ≥ 40 mm having progressed for at least 3 months despite the initiation of a well-conducted medical treatment including stage I and II analgesics and NSAIDs in the absence of contraindication.
• • Investigations within 6 months to rule out malposition, loosening and sepsis (conventional X-rays, bone scan, knee CT scan and biological work-up for inflammatory syndrome).
• • No revision surgery envisaged.
• • Echodoppler hyperemia over the painful area of the knee.
• • Subjects affiliated to social security.
• • Signed consent to the study.
• Exclusion Criteria:
• • Local infection of the TKR or systemic infection.
• • Algoneurodystrophy.
• • Prosthesis loosening.
• • Neuropathic pain.
• • Allergy to contrast media.
• • Fibromyalgia.
• • Chronic or acute renal failure (clearance \< 30 ml/mn).
• • Hemostasis disorders (platelet count \< 50,000/mm3 or patient activated partial thromboplastin time (aPTT)/control aPTT\>1.2 or prothrombin ratio \< 50%).
• • Operative indication for removal of the prosthesis retained
• • Patient with severe obliterative arteriopathy of the lower limbs (Leriche et Fontaine stage 3).
• • Lidocaine contraindication: known hypersensitivity to lidocaine hydrochloride, amide-bonded local anesthetics or any of the excipients; patients with recurrent porphyria.
• • Vulnerable persons (minors, patients under guardianship or curatorship, deprived of liberty, under court protection, etc.).
• • Pregnant patients: for patients of childbearing age, a pregnancy test will be performed during the screening visit.