Clinical trial NCT05013970: Transcatheter Arterial Embolization in Patients With Mild to Moderate Osteoarthritis
Official title: Transcatheter Arterial Embolization as a Treatment for Knee Pain in Patients With Mild to Moderate Osteoarthritis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis
Catheter-directed embolotherapy
Poly-vinyl alcohol microspheres
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with mild to moderate knee osteoarthritis
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Analog Scale (VAS) for Knee Pain
timeFrame: Within 30 days after catheter-directed embolization
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
timeFrame: Within 30 days after catheter-directed embolization
measure: MRI imaging
timeFrame: At day 30 after catheter-directed embolization
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Geert Maleux
role: PRINCIPAL_INVESTIGATOR
References: