Skip to main content
Clinical Trials/NCT05013970
NCT05013970
Withdrawn
N/A

Transcatheter Arterial Embolization as a Treatment for Knee Pain in Patients With Mild to Moderate Osteoarthritis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
Universitaire Ziekenhuizen KU Leuven
Primary Endpoint
Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Status
Withdrawn
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
December 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire

Time Frame: Within 30 days after catheter-directed embolization

To evaluate symptoms and limitations in patients with knee osteoarthritis

Visual Analog Scale (VAS) for Knee Pain

Time Frame: Within 30 days after catheter-directed embolization

To measure pain in patients with knee osteoarthritis

MRI imaging

Time Frame: At day 30 after catheter-directed embolization

To depict potential asymptomatic, but radiologically visible side-effects

Similar Trials