Genicular Artery Embolization as Pain Treatment of Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

— GETKO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05360329
• Other study ID #: H-20081451
• Status: Completed
• Phase: N/A
• Start date: September 20, 2022
• Est. completion date: December 19, 2023

Study information

• Verified date: December 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 19, 2023
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital, Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Amager- and Hvidovre Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Continually recorded from baseline till ended trial	6 months
Primary	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	Dexa scan	Changes in bone mineral density	Baseline vs 6 months post GAE
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	MRI	Changes in synovial thickness (CE-MRI), effusion (Non CE-MRI) and synovial perfusion (DCE-MRI).	Baseline vs. 1 and 6 months post GAE
Secondary	Ultrasound	Changes in synovial thickness, effusion and perfusion (doppler).	Baseline vs. 1 and 6 months post GAE