Transcatheter Arterial Embolization in Patients With Mild to Moderate Osteoarthritis
- Conditions
- Osteoarthritis, Knee
- Interventions
- Other: Clinical assessmentOther: Radiographic imaging
- Registration Number
- NCT05013970
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Knee osteoarthritis Radiographic imaging Patients with mild to moderate osteoarthritis who suffer from persistent knee pain treated with catheter-directed geniculate artery embolization Knee osteoarthritis Clinical assessment Patients with mild to moderate osteoarthritis who suffer from persistent knee pain treated with catheter-directed geniculate artery embolization
- Primary Outcome Measures
Name Time Method 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
Visual Analog Scale (VAS) for Knee Pain Within 30 days after catheter-directed embolization To measure pain in patients with knee osteoarthritis
MRI imaging At day 30 after catheter-directed embolization To depict potential asymptomatic, but radiologically visible side-effects
- Secondary Outcome Measures
Name Time Method