BridgeMD
Tests treatment safety and results for Knee Pain Chronic
Official title Efficacy of Microparticle Geniculate Artery Embolization in Total Knee Prosthesis Patients With Pain Resistant to Medical Treatment. A Prospective Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06466330
What this study is testing
- What it's testing
- The goal of this clinical investigation is to evaluate the effectiveness on pain of arterial occlusion (embolization) of neovessels by microparticle in a double-blind sham controlled randomised trial in patients with persistent pain on a total knee prosthesis (TKP), inserted for gonarthrosis, despite well-conducted medical treatment. The study patient population will consist of up to 112 subjects with knee pain for at least 3 months that is resistant to conservative treatment measures.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 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...
- Investigations within 6 months to rule out malposition, loosening and sepsis (conventional X-rays, bone scan, knee CT scan and biological work-up for...
- No revision surgery envisaged.
- Echodoppler hyperemia over the painful area of the knee.
You likely can't join if
- Local infection of the TKR or systemic infection.
- Algoneurodystrophy.
- Prosthesis loosening.
- Neuropathic pain.
- Allergy to contrast media.
- Fibromyalgia.
See the full eligibility 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.
- people affiliated to social security.
- Signed consent to the study.
- 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 \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Créteil, France
- Dijon, France
- Grenoble, France
- Lomme, France
- Marseille, France
- Nice, France
- Nîmes, France
- Paris, France
- Strasbourg, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Créteil, France; Dijon, France; Grenoble, France; Lomme, France; Marseille, France; Nice, France and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.