Genicular Artery Embolization as Pain Treatment of Knee Osteoarthritis (GETKO)

Genicular Artery Embolization as Pain Treatment of Mild to Moderate Knee Osteoarthritis

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: Transarterial geniculate artery embolization

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Copenhagen University Hospital, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mild to moderate knee osteoarthritis (Kellgren Lawrence Score 1-3); Geniculate artery embolization will be performed in all eligible participants.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Visual Analog Scale (VAS) as a measure of efficacy	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".	6 months post GAE

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dexa scan	Changes in bone mineral density	Baseline vs 6 months post GAE
Changes in Visual Analog Scale (VAS) as a measure of efficacy	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".	1 week, 1, 2, 3, 4, and 5 months post GAE
Changes in Knee injury and Osteoarthritis Outcome Score (KOOS)	KOOS assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.	Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE.
Changes in IPAQ (international physical activity questionnaire)	Questionnaire on daily physical activity	Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE
Changes in use of analgesics	(paracetamol, NSAID, opioid, or neuropathic agent)	Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE
Changes in 30 seconds Chair Stand Test	The maximum number of chair stand repetitions in a 30 second period.	Baseline vs. 1 and 6 months post GAE.
Changes in Stair Climb Test	The time (in seconds) it takes to ascend and descend a flight of stairs.	Baseline vs. 1 and 6 months post GAE.
Changes in 40 meters Fast Paced Walk Test	A fast-paced walking test that is timed over 4*10 meters for a total of 40 meters.	Baseline vs. 1 and 6 months post GAE.
Subjective response to the treatment on a five point Likert scale	(none=no good at all, ineffective treatment; poor=some effect but unsatisfactory; fair=reasonable effect but could be better; good=satisfactory effect with occasional episodes of pain or stiffness; excellent=ideal response, virtually pain free)	6 months post GAE
MRI	Changes in synovial thickness (CE-MRI), effusion (Non CE-MRI) and synovial perfusion (DCE-MRI).	Baseline vs. 1 and 6 months post GAE
Ultrasound	Changes in synovial thickness, effusion and perfusion (doppler).	Baseline vs. 1 and 6 months post GAE

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Continually recorded from baseline till ended trial	6 months

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Amager- and Hvidovre Hospital, Denmark
• Investigators: Study Director: Lars Lönn, Professor, Department of Radiology, University Hospital of Copenhagen, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2022
• Primary Completion (Actual): December 19, 2023
• Study Completion (Actual): December 19, 2023

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: April 29, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Knee Osteoarthritis; Embolization; Geniculate Artery Embolization; Trans-arterial Embolization
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: H-20081451

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No