Osteoarthritis of the knee Musculoskeletal Diseases
Conditions
Interventions
At baseline, the participant will score their pain using a Visual Analogue Scale (VAS) and score their symptoms and level of disability using the Knee injury and Osteoarthritis Outcome Score (KOOS).
Sponsors
University of Reading
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to give informed consent for participation in the study 2. Aged 45 years or above 3. Grade 1-3 knee OA on X-ray as per Kellgren-Lawrence Grading Scale 4. Knee pain for at least 6 months resistant to conservative treatment 5. Able to lie flat for at least 6 h. This will be assessed by asking how participants sleep (bed, chair recumbent, semi-recumbent) and assessing what prevents them from lying flat overnight (breathlessness, back pain, etc).
Exclusion criteria
Exclusion criteria: 1. Rheumatoid arthritis or infectious arthritis 2. Severe knee OA (grade 4 on X-ray as per Kellgren-Lawrence Grade) 3. Renal impairment: eGFR <45 ml/min/1.73m2. Assessed from medical records or a blood test if required as is part of standard clinical practice when considering a patient for a therapeutic intervention. 4. Patients with a bleeding diathesis, or other bleeding risk such as patients on warfarin that cannot be stopped easily (e.g. patients with metallic heart valves). This is assessed by asking the patient and from medical records. 5. Requires oxygen on ambulation. This is assessed by asking the patient and from medical records. 6. Low life expectancy (<1 year) 7. Communication difficulty due to language barriers 8. Contraindication to MRI 9. Any other significant disease or disorder which, in the opinion of the recruiting physician, may put either the participants at risk because of participation in the study, or may influence the result of the study or the participant's ability to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain caused by knee osteoarthritis assessed using a visual analogue scale (VAS) at baseline and 6 weeks, 3 months, 1 year and 2 years after the procedure 2. Patients evaluation of their knee symptoms assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS) at baseline and 6 weeks, 3 months, 1 year and 2 years after the procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety assessed by collecting all complications attributable to the GAE procedure prospectively as recorded in the patient's electronic medical notes and study file 2. Neural and behavioural indicators of predisposition to central facilitation of pain using the pre-procedural assessments carried out at CINN, University of Reading 3. Patient satisfaction with procedure using Patient Satisfaction Questionnaire after the procedure 4. Structural knee changes assessed using Whole-Organ Magnetic Resonance Imaging Score (WORMS) at baseline and 1 year post-procedure 5. Quality of life assessed using components of the Knee injury and Osteoarthritis Outcome Score (KOOS) before and after the procedure 6. Analgesic use assessed by asking patients if they are taking paracetamol, NSAIDS or opiates pre-procedure and at 6 weeks, 3 months, 1 year and 2 years after the procedure | — |
Countries
England, United Kingdom
Contacts
Public ContactSarah MacGill
Outcome results
None listed