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

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

This study is testing if a special treatment called embolization can help people with knee pain after knee replacement surgery feel better and move more easily.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 112 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Societe Francaise de Rhumatologie (Academic / other)
• Locations: 11 sites (Créteil and 10 other locations)
• Trial ID: NCT06466330 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40 to 80 years with persistent knee pain following total knee replacement surgery for at least three months.

Not a fit: Patients with local infections, neuropathic pain, or those who have contraindications to the procedure may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide significant pain relief for patients with chronic knee pain after total knee replacement.

How similar studies have performed: Previous studies have shown promising results with embolization techniques in small patient populations, indicating potential for success in this larger randomized controlled trial.

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.

Where this trial is running

Créteil and 10 other locations

• Centre Hospitalier Henri Mondor — Créteil, France (Not_yet_recruiting)
• Centre Hospitalier Dijon — Dijon, France (Recruiting)
• Centre Hospitalier Universitaire de Grenoble — Grenoble, France (Recruiting)
• Centre Hospitalier Saint-Philibert — Lomme, France (Not_yet_recruiting)
• Hôpital Saint Philibert — Lomme, France (Not_yet_recruiting)
• CHU Marseille — Marseille, France (Not_yet_recruiting)
• Centre Hospitalier Universitaire de Nice — Nice, France (Recruiting)
• Centre Hospitalier de Nîmes — Nîmes, France (Not_yet_recruiting)
• Hôpital Lariboisière — Paris, France (Not_yet_recruiting)
• Hôpital Saint-Antoine — Paris, France (Not_yet_recruiting)
• Hospices Civils de Strasbourg — Strasbourg, France (Not_yet_recruiting)

Study contacts

• Principal investigator: Christian Roux, Pr, MD — Centre Hospitalier Universitaire de Nice
• Study coordinator: Pascale Thevenot

Conditions Knee Pain Chronic; Knee Pain Swelling; total hip replacement; pain