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Genicular artery embolisation for osteoarthritis of the knee in Wales

Not Applicable
Conditions
Musculoskeletal Diseases
Treatment of pain associated with osteoarthritis of the knee
Registration Number
ISRCTN82978621
Lead Sponsor
Aneurin Bevan University Health Board
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Ongoing
Sex
All
Target Recruitment
31
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

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)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Safety measured using adverse events logs and clinical data throughout the study:<br>1. Adverse events <br>2. Procedural outcomes <br>3. Technical complications <br>4. Side effects of the procedure<br><br>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:<br>1. Pain measured using the Visual Analogue Scale (VAS) validated tool<br>2. Pain and Quality of life measured using the EuroQol 5 Dimension instrument (EQ-5D-5L)<br>3. Pain and Quality of life measured using the Oxford Knee Score (OKS) <br>4. Pain and Quality of life measured using the Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Secondary Outcome Measures
NameTimeMethod
1. Patient experience and tolerability measured using patient-reported experience measures (PREMs) at baseline and at 3 months<br>2. Effectiveness of genicular artery embolisation (GAE) from a technical perspective measured using clinical data throughout the study
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