Transcatheter Arterial Embolization in Patients With Mild to Moderate Osteoarthritis

NCT ID: NCT05013970

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-12-31

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Knee osteoarthritis

Patients with mild to moderate osteoarthritis who suffer from persistent knee pain treated with catheter-directed geniculate artery embolization

Group Type: OTHER

Clinical assessment

Intervention Type: OTHER

Clinical assessment including Visual Analog Scale (VAS) for Knee Pain, and Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire

Radiographic imaging

Intervention Type: OTHER

MRI of the knee

Interventions

Clinical assessment

Clinical assessment including Visual Analog Scale (VAS) for Knee Pain, and Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire

Intervention Type: OTHER

Radiographic imaging

MRI of the knee

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geert Maleux

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Other Identifiers

S62757

Identifier Type: -

Identifier Source: org_study_id