Transcatheter Arterial Embolization in Patients With Mild to Moderate Osteoarthritis

NCT05013970 | Withdrawn

• 1 other identifier: S62757
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis, Knee

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Visual Analog Scale (VAS) for Knee Pain

  To measure pain in patients with knee osteoarthritis

  Within 30 days after catheter-directed embolization

• Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire

  To evaluate symptoms and limitations in patients with knee osteoarthritis

  Within 30 days after catheter-directed embolization

• MRI imaging

  To depict potential asymptomatic, but radiologically visible side-effects

  At day 30 after catheter-directed embolization

Study Arms (1)

Knee osteoarthritis

OTHER

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

Other: Clinical assessment; Other: Radiographic imaging

Interventions

Clinical assessment OTHER

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

Knee osteoarthritis

Radiographic imaging OTHER

MRI of the knee

Knee osteoarthritis

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Phantoms, Imaging

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Geert Maleux

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with mild to moderate knee osteoarthritis

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 20, 2021
• Study Start: August 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share