Pilot Study of Transcatheter Arterial Embolization as a Treatment for Knee Pain in Patients With Mild to Moderate Osteoarthritis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Knee osteoarthritis Patients with mild to moderate osteoarthritis who suffer from persistent knee pain treated with catheter-directed geniculate artery embolization |
Other: Clinical assessment
Clinical assessment including Visual Analog Scale (VAS) for Knee Pain, and Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Other: Radiographic imaging
MRI of the knee
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Presence of knee pain
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Kellgren-Lawrence (KL) grade 1-3 assessed by weight-bearing knee radiographs
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Local tenderness around the knee
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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
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Persistent moderate to severe knee pain (VAS > 50 mm) for more than 3 months
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Patient is able to give consent
Exclusion Criteria:
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Previous knee surgery
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Local infection
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BMI > 40 kg/m2
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Advanced atherosclerosis
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Rheumatoid arthritis, malignancy, renal insufficiency, other conditions contra-indicating femoropopliteal angiography
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Usage of anticoagulants such as eliquis or coumarine (Asaflow allowed)
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Allergy to iodinated contrast medium or any other allergy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UZ Leuven | Leuven | Vlaams-Brabant | Belgium | 3000 |
Sponsors and Collaborators
- Universitaire Ziekenhuizen Leuven
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- S62757