Treatment of pain associated with osteoarthritis of the knee Musculoskeletal Diseases
Conditions
Interventions
This project looks to explore the effectiveness of a novel interventional radiological procedure, genicular artery embolisation (GAE), as a treatment option to reduce pain, and improve joint mobility,
Sponsors
Aneurin Bevan University Health Board
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Moderate to severe knee pain (VAS > 50 mm), and 2. Pain refractory to at least 3 months of conservative therapies (anti-inflammatory drugs, physical therapy, muscle strengthening, or intra-articular injections), and 3. Mild-moderate osteoarthritis of the knee as determined by Trauma and Orthopaedic procedure (previous Kellgren-Lawrence grade 1, 2 or 3 on a radiograph of the knee) 4. Ages > 40 years old
Exclusion criteria
Exclusion criteria: 1. Current local infection 2. Life expectancy less than 6 months 3. Known advanced atherosclerosis, which is known lower extremity vascular or lower extremity symptoms thought to be secondary to arterial vascular disease (eg claudication, ischemic rest pain) 4. Rheumatoid or infectious arthritis 5. Prior knee surgery 6. Uncorrectable coagulopathy including INR > 2.5 or platelets < 30,000 7. Iodine allergy resulting in anaphylaxis 8. Renal dysfunction as defined by GFR (eGFR) of <45 obtained within the past 60 days 9. Contraindications for MR Imaging (such as claustrophobia, metallic fragment or foreign bones, implants or prosthesis) 10. IV contrast allergy characterized by anaphylaxis or anaphylactoid reactions. 11. Unable to provide written informed consent 12. Unable to understand written English Language (required to complete validated PROMs)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety measured using adverse events logs and clinical data throughout the study: 1. Adverse events 2. Procedural outcomes 3. Technical complications 4. Side effects of the procedure Efficacy measured using PROMs including validated questionnaires to ascertain reduction in pain and improvement in quality of life at baseline and then at 1, 3, 6, 12 and 24 months following the procedure: 1. Pain measured using the Visual Analogue Scale (VAS) validated tool 2. Pain and Quality of life measured using the EuroQol 5 Dimension instrument (EQ-5D-5L) 3. Pain and Quality of life measured using the Oxford Knee Score (OKS) 4. Pain and Quality of life measured using the Western Ontario and McMaster Osteoarthritis Index (WOMAC) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient experience and tolerability measured using patient-reported experience measures (PREMs) at baseline and at 3 months 2. Effectiveness of genicular artery embolisation (GAE) from a technical perspective measured using clinical data throughout the study | — |
Countries
United Kingdom, Wales
Contacts
Public ContactResearch & Development Department
Outcome results
None listed