Clinical trial NCT05360329: Genicular Artery Embolization as Pain Treatment of Knee Osteoarthritis
Official title: Genicular Artery Embolization as Pain Treatment of Mild to Moderate Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Embolization
Geniculate Artery Embolization
Knee Osteoarthritis
Trans-arterial Embolization
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Amager- and Hvidovre Hospital, Denmark
First posted: 2022-05-04
Enrollment: 17
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Changes in Visual Analog Scale (VAS) as a measure of efficacy
timeFrame: 6 months post GAE
Secondary outcomes:
measure: Dexa scan
timeFrame: Baseline vs 6 months post GAE
measure: Changes in Visual Analog Scale (VAS) as a measure of efficacy
timeFrame: 1 week, 1, 2, 3, 4, and 5 months post GAE
measure: Changes in Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE.
measure: Changes in IPAQ (international physical activity questionnaire)
timeFrame: Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE
measure: Changes in use of analgesics
timeFrame: Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE
measure: Changes in 30 seconds Chair Stand Test
timeFrame: Baseline vs. 1 and 6 months post GAE.
measure: Changes in Stair Climb Test
timeFrame: Baseline vs. 1 and 6 months post GAE.
measure: Changes in 40 meters Fast Paced Walk Test
timeFrame: Baseline vs. 1 and 6 months post GAE.
measure: Subjective response to the treatment on a five point Likert scale
timeFrame: 6 months post GAE
measure: MRI
timeFrame: Baseline vs. 1 and 6 months post GAE
measure: Ultrasound
timeFrame: Baseline vs. 1 and 6 months post GAE
Other outcomes:
measure: Adverse events
timeFrame: 6 months
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet
Study officials:
affiliation: Department of Radiology, University Hospital of Copenhagen, Denmark
name: Lars Lönn, Professor
role: STUDY_DIRECTOR
References: