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Can osteoarthritis of the knee be treated by blocking abnormal blood vessels in the knee? (Study 2)

Genicular artEry embolisatioN in patiEnts with oSteoarthrItiS of the knee II (GENESIS II)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15723381
Enrollment
74
Registered
2021-03-12
Start date
2021-05-01
Completion date
Unknown
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the knee Musculoskeletal Diseases Arthrosis

Interventions

Those participants adhering to the study inclusion criteria will be assessed by the interventional radiology research team. They will have knee embolisation discussed as an option for treatment, stres

Sponsors

University of Reading
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Participants aged 45 years or above 3. Grade 3 knee OA on X-ray as per Kellgren-Lawrence (KL) Grading Scale 4. Knee pain for at least 3 months resistant to conservative treatment 5. Be able to lie flat for at least 6 hours-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. 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 which cannot be stopped easily (e.g. patients with metallic heart valves). assessed by asking the patient and from medical records 5. Requires oxygen on ambulation. 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

MeasureTime frame
Pain assessed at baseline and one year using: 1. The Knee Injury and Osteoarthritis Outcome Score (KOOS) 2. Visual Analogue Scales (VAS) 3. Analgesia diary

Secondary

MeasureTime frame
1. Safety at 1 year MRI and any adverse event timepoint 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 indicators assessed at baseline psychometric assessment & baseline MRI neuroimaging 3. Patient acceptability of GAE procedure is measured using a patient satisfaction questionnaire at 1 month 4. Health economic cost effectiveness is measured at the trial end using standard NHS costing

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026