Skip to content

Transcatheter Arterial Embolization in Patients With Mild to Moderate Osteoarthritis

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05013970
Acronym
Embolization
Enrollment
0
Registered
2021-08-20
Start date
2021-08-01
Completion date
2022-12-31
Last updated
2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis, Catheter-directed embolotherapy, Poly-vinyl alcohol microspheres

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.

Interventions

OTHERClinical assessment

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

MRI of the knee

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Patients with mild to moderate knee osteoarthritis

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scale (VAS) for Knee PainWithin 30 days after catheter-directed embolizationTo measure pain in patients with knee osteoarthritis
Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaireWithin 30 days after catheter-directed embolizationTo evaluate symptoms and limitations in patients with knee osteoarthritis
MRI imagingAt day 30 after catheter-directed embolizationTo depict potential asymptomatic, but radiologically visible side-effects

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026