Status:
COMPLETED
Genicular Artery Embolization as Pain Treatment of Knee Osteoarthritis
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Amager- and Hvidovre Hospital, Denmark
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
30+ years
Phase:
NA
Brief Summary
The aim of this study is to investigate the safety and efficacy of geniculate artery embolization (GAE) as pain treatment in patients with mild to moderate knee osteoarthritis.
Detailed Description
This is a single arm, prospective, pilot study investigating the safety and efficacy of GAE as pain treatment in patients with mild to moderate knee osteoarthritis. Patient related outcome measurement...
Eligibility Criteria
Inclusion
- Body Mass Index \< 35 kg / m2.
- X-ray verified mild to moderate KOA (Kellgren Lawrence grade 1-3 \[24\]), obtained maximum 6 months prior to inclusion.
- Moderate to severe knee pain during walking (Visual Analog Scale (VAS) \> 50 mm) - resistant to minimum 3 months physiotherapy.
- Willing, able, and mentally competent to provide informed consent.
Exclusion
- Local infection in knee or groin areas.
- Moderate to severe pain in ipsilateral lower limb joints; VAS \> 2.
- Intermittent claudication.
- Rheumatoid arthritis or seronegative arthropathies.
- Prior ipsilateral open knee surgery.
- Ipsilateral arthroscopy within 6 months.
- Ipsilateral intra-articular knee injection within 6 months.
- Current/recent (within 4 weeks) use of oral corticosteroids.
- Generalized pain syndrome (e.g. fibromyalgia) or nerve root compression syndromes.
- Pregnant or planned pregnancy during the study period.
- Lactation.
- Active malignancy.
- Known history of allergy to contrast media.
- Contra-indications for MRI (e.g. metallic foreign bodies, etc).
- Manifest hyperthyroidism.
- Diabetes (I+II).
- Liver disease.
- Only one kidney, former kidney surgery, reduced kidney function or failure (chronic or acute).
- Estimated glomerular filtration rate \< 60 ml / min / 1.73 m2 (All participants: blood sample maximum 30 days prior to GAE. Participants \> 60 years: another blood sample maximum 3 months prior to last MRI scan with contrast agents).
- INR \> 1.4, Platelets ≤ 40 x 109 / l (All participants: blood sample maximum 30 days prior to GAE).
- Antithrombotic treatment except acetylsalicylic acid.
- Diseases affecting the bone metabolism (E.g. severe osteoporosis, Paget's disease, or hyperparathyroidism).
- American Society of Anesthesiologists classification \> 3.
Key Trial Info
Start Date :
September 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT05360329
Start Date
September 20 2022
End Date
December 19 2023
Last Update
December 20 2024
Active Locations (1)
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1
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100