Genicular Artery Embolization as Pain Treatment of Mild to Moderate Knee Osteoarthritis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Changes in Visual Analog Scale (VAS) as a measure of efficacy
Study Overview
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 measurements (PROMs), physical tests and several image modalities will be conducted.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Body Mass Index < 35 kg / m
- •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
- •Local infection in knee or groin areas.
- •Moderate to severe pain in ipsilateral lower limb joints; VAS >
- •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.
Arms & Interventions
Mild to moderate knee osteoarthritis (Kellgren Lawrence Score 1-3)
Geniculate artery embolization will be performed in all eligible participants.
Intervention: Transarterial geniculate artery embolization (Procedure)
Outcomes
Primary Outcomes
Changes in Visual Analog Scale (VAS) as a measure of efficacy
Time Frame: 6 months post GAE
Reported as worst pain experienced during walking in the last 24 hours on a 100 mm scale from "No pain" to "Pain as bad as it could possibly be".
Secondary Outcomes
- Changes in IPAQ (international physical activity questionnaire)(Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE)
- Changes in use of analgesics(Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE)
- Changes in 30 seconds Chair Stand Test(Baseline vs. 1 and 6 months post GAE.)
- Changes in Stair Climb Test(Baseline vs. 1 and 6 months post GAE.)
- MRI(Baseline vs. 1 and 6 months post GAE)
- Ultrasound(Baseline vs. 1 and 6 months post GAE)
- Dexa scan(Baseline vs 6 months post GAE)
- Changes in Visual Analog Scale (VAS) as a measure of efficacy(1 week, 1, 2, 3, 4, and 5 months post GAE)
- Changes in Knee injury and Osteoarthritis Outcome Score (KOOS)(Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE.)
- Subjective response to the treatment on a five point Likert scale(6 months post GAE)
- Changes in 40 meters Fast Paced Walk Test(Baseline vs. 1 and 6 months post GAE.)
Investigators
Louise Hindso
Doctor of Medicine
Rigshospitalet, Denmark