Osteoarthritis, Knee
Conditions
Keywords
Osteoarthritis, Catheter-directed embolotherapy, Poly-vinyl alcohol microspheres
Brief summary
Disabling symptoms of osteoarthritis are seen in approximatively 10% of people over 55 years old. Many patients suffer from persistent pain symptoms from moderate osteoarthritis despite optimal medical treatment. For these patients, several minimally-invasive surgical treatments have been proposed, including arthroscopic lavage and debridement; however, none of these treatments have been proven effective compared to sham treatment. Recently, catheter-directed embolotherapy of the geniculate arteries has been propagated as a real alternative to medical management in patients with mild to moderate knee osteoarthritis unresponsive to conservative medical management.
Detailed description
Disabling symptoms of osteoarthritis are seen in approximatively 10% of people over 55 years old. Traditionally, treatment of symptomatic knee osteoarthritis is based on administration of pain relievers, including nonsteroidal anti-inflammatory drugs, in case of mild to moderate symptoms; major joint replacement surgery (total joint arthroplasty) is performed in cases of severe and end-stage osteoarthritis. However, many patients suffer from persistent pain symptoms from moderate osteoarthritis despite optimal medical treatment. For these patients, several minimally-invasive surgical treatments have been proposed, including arthroscopic lavage and debridement; however, none of these treatments have been proven effective compared to sham treatment. Recently, catheter-directed embolotherapy of the geniculate arteries has been propagated as a real alternative to medical management in patients with mild to moderate knee osteoarthritis unresponsive to conservative medical management. Transcatheter embolotherapy was performed using imipenem/cilastin sodium or 75 micron calibrated Embozene microspheres and follow-up was performed by physical examination, questionnaires (VAS-score and WOMAC-scores) and MR-imaging (WORMS-score). Results of these trials confirmed that catheter-directed embolotherapy is a safe procedure without any major adverse events. WOMAC pain scores dropped dramatically from 12.2 +/- 1.9 before the procedure to 3.3 +/- 2.1 at 1 month after the procedure and to 1.7 +/- 2.2 at 4 months after the procedure. Additionally, MR imaging at 2 years of follow-up could not demonstrate any osteonecrosis or progression of degenerative changes.
Interventions
Clinical assessment including Visual Analog Scale (VAS) for Knee Pain, and Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
MRI of the knee
Sponsors
Study design
Intervention model description
Patients with mild to moderate knee osteoarthritis
Eligibility
Inclusion criteria
* Presence of knee pain * Kellgren-Lawrence (KL) grade 1-3 assessed by weight-bearing knee radiographs * Local tenderness around the knee * Clinical failure after 3 months or more of conservative therapies, including oral nonsteroidal anti-inflammatory drugs and/or oral opioid agents and physical therapy, stretching, muscle strengthening and/or intra-articular injection of hyaluronic acid * Persistent moderate to severe knee pain (VAS \> 50 mm) for more than 3 months * Patient is able to give consent
Exclusion criteria
* Previous knee surgery * Local infection * BMI \> 40 kg/m2 * Advanced atherosclerosis * Rheumatoid arthritis, malignancy, renal insufficiency, other conditions contra-indicating femoropopliteal angiography * Usage of anticoagulants such as eliquis or coumarine (Asaflow allowed) * Allergy to iodinated contrast medium or any other allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) for Knee Pain | Within 30 days after catheter-directed embolization | To measure pain in patients with knee osteoarthritis |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire | Within 30 days after catheter-directed embolization | To evaluate symptoms and limitations in patients with knee osteoarthritis |
| MRI imaging | At day 30 after catheter-directed embolization | To depict potential asymptomatic, but radiologically visible side-effects |