Evaluating the effectiveness of embolization for knee pain in total knee prosthesis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical investigation aims to assess the effectiveness of arterial embolization using microparticles in patients experiencing persistent knee pain after total knee prosthesis (TKP) surgery. The study will involve a double-blind, sham-controlled design, where participants will be randomized to receive either the embolization treatment or a saline injection. The primary outcomes will include improvements in pain levels, mobility, and the use of pain medications over a three-month period. The study will enroll up to 112 subjects who have had knee pain for at least three months despite conservative treatment efforts.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centre Hospitalier Dijon
  Dijon, France Recruiting
• Centre Hospitalier Universitaire de Grenoble
  Grenoble, France Recruiting
• Centre Hospitalier Universitaire de Nice
  Nice, France Recruiting
• Centre Hospitalier Henri Mondor
  Créteil, France Not yet recruiting
• Centre Hospitalier Saint-Philibert
  Lomme, France Not yet recruiting
• Hôpital Saint Philibert
  Lomme, France Not yet recruiting

Study contacts

• Principal investigator: Christian Roux, Pr, MD — Centre Hospitalier Universitaire de Nice
• Study coordinator: Pascale Thevenot
• Email: recherche@rhumatologie.asso.fr
• Phone: +33(0)1.42.50.00.18

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.