Knee osteoarthritis Musculoskeletal Diseases
Conditions
Interventions
The study will be a multi-centre two-arm randomised controlled trial with 1:1 allocation, comparing the clinical efficacy of genicular artery embolisation with a placebo procedure. Participants and fo
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of painful knee OA 2. Radiographic evidence of OA (KL 2-4) 3. Previously treated with NICE non-operative intervention, as determined by the treating clinician 4. Moderate/severe pain (to be confirmed when completing the baseline questionnaire ahead of the procedure measured by the pain Visual Analogue Scale [VAS] score) (35-74 moderate, 75-100 severe) 5. Not listed for or being considered as a candidate for joint replacement surgery 6. Aged 18 years or above 7. Knee hypervascularity suitable for embolisation (to be confirmed with an angiogram during the study procedure) 8. Patient willing and able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Patient previously participated in the GEKO trial (only one knee can be entered into the trial) 2. Received a steroid injection in the study knee in the past 6 weeks, or is scheduled to have a steroid injection prior to the study procedure 3. Infection or malignancy around the knee 4. Inflammatory arthropathy 5. History of acute injury to the knee (within 6 months) 6. Surgery to the involved knee in the past 6 months 7. Previous knee replacement (partial or total) in either limb 8. Severe allergic reaction to radiological contrast media, including iodine-based CT-contrast or Gadolinium-based MRI contrast 9. Objection (religious or personal) to the use of medical materials made from pigs 10. Allergy to gelatine from pigs (which is within the micro-beads used in the intervention) 11. Known significant renal impairment 12. Peripheral artery disease of the affected leg 13. Pregnant or lactating 14. Hepatic impairment 15. Clotting abnormality 16. Osteonecrosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain measured using the visual analogue scale (VAS) at 6 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline, 6 weeks, 3, 6 and 12 months: 1. Pain measured using VAS 2. Knee function measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS) 3. Pain measured using painDETECT 4. Health-related quality of life measured using EQ-5D-5L 5. Health resource use measured using a bespoke questionnaire | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed