Genicular Artery Embolization as Pain Treatment of Knee Osteoarthritis

NCT05360329 | Completed

• 1 other identifier: H-20081451
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Embolization; Geniculate Artery Embolization; Knee Osteoarthritis; Trans-arterial Embolization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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.

• 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

Other Outcomes (1)

• Adverse events

  6 months

Study Arms (1)

Mild to moderate knee osteoarthritis (Kellgren Lawrence Score 1-3)

EXPERIMENTAL

Geniculate artery embolization will be performed in all eligible participants.

Procedure: Transarterial geniculate artery embolization

Interventions

Transarterial geniculate artery embolization PROCEDURE

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.

Mild to moderate knee osteoarthritis (Kellgren Lawrence Score 1-3)

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index \< 35 kg / m2.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Amager Hospital: collaborator

Study Sites (1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Lars Lönn, Professor

  Department of Radiology, University Hospital of Copenhagen, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 4, 2022
• Study Start: September 20, 2022
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

DK (1)