Transcatheter Arterial Embolization in Patients With Mild to Moderate Osteoarthritis

Not Applicable

Withdrawn

• Conditions: Osteoarthritis, Knee

• 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.

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2021-08-12
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-20
• Primary Completion: 2022-12
• Study Completion: 2022-12
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-28
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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