Genicular Artery Embolization as Pain Treatment of Knee Osteoarthritis
NCT ID: NCT05360329
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2022-09-20
2023-12-19
Brief Summary
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Detailed Description
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It may form the grounding for further research in the shape of a larger randomized clinical trial.
The hypothesis is, that GAE will reduce synovitis and thereby pain in the patient group. This may secondary improve physical function and reduce consumption of analgesics.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mild to moderate knee osteoarthritis (Kellgren Lawrence Score 1-3)
Geniculate artery embolization will be performed in all eligible participants.
Transarterial geniculate artery embolization
The procedure will be performed in local anaesthesia. An antegrade percutaneous transfemoral approach with super-selective catheterisation of geniculate neovesselswill be performed and subsequently the target will be pruned with microspherical embolic material.
Interventions
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Transarterial geniculate artery embolization
The procedure will be performed in local anaesthesia. An antegrade percutaneous transfemoral approach with super-selective catheterisation of geniculate neovesselswill be performed and subsequently the target will be pruned with microspherical embolic material.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
30 Years
ALL
No
Sponsors
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Amager- and Hvidovre Hospital, Denmark
UNKNOWN
Rigshospitalet, Denmark
OTHER
Responsible Party
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Louise Hindso
Doctor of Medicine
Principal Investigators
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Lars Lönn, Professor
Role: STUDY_DIRECTOR
Department of Radiology, University Hospital of Copenhagen, Denmark
Locations
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Copenhagen University Hospital, Rigshospitalet
Copenhagen, , Denmark
Countries
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Other Identifiers
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H-20081451
Identifier Type: -
Identifier Source: org_study_id