Back to results

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

Primary Purpose

Knee Osteoarthritis

Status

Active

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Transarterial geniculate artery embolization

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Embolization, Geniculate Artery Embolization, Knee Osteoarthritis, Trans-arterial Embolization

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Copenhagen University Hospital, Rigshospitalet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Geniculate artery embolization will be performed in all eligible participants.

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

Dexa scan

Changes in bone mineral density

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".

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.

Changes in IPAQ (international physical activity questionnaire)

Questionnaire on daily physical activity

Changes in use of analgesics

(paracetamol, NSAID, opioid, or neuropathic agent)

Changes in 30 seconds Chair Stand Test

The maximum number of chair stand repetitions in a 30 second period.

Changes in Stair Climb Test

The time (in seconds) it takes to ascend and descend a flight of stairs.

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.

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)

MRI

Changes in synovial thickness (CE-MRI), effusion (Non CE-MRI) and synovial perfusion (DCE-MRI).

Ultrasound

Changes in synovial thickness, effusion and perfusion (doppler).

Full Information

NCT ID

NCT05360329

First Posted

April 25, 2022

Last Updated

July 11, 2023

Sponsor

Rigshospitalet, Denmark

Collaborators

Amager- and Hvidovre Hospital, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT05360329

Brief Title

Genicular Artery Embolization as Pain Treatment of Knee Osteoarthritis

Acronym

GETKO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 20, 2022 (Actual)

Primary Completion Date

September 2024 (Anticipated)

Study Completion Date

September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

Collaborators

Amager- and Hvidovre Hospital, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Geniculate artery embolization will be performed in all eligible participants.

Intervention Type

Procedure

Intervention Name(s)

Transarterial geniculate artery embolization

Intervention Description

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.

Primary Outcome Measure Information:

Title

Changes in Visual Analog Scale (VAS) as a measure of efficacy

Description

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".

Time Frame

6 months post GAE

Secondary Outcome Measure Information:

Title

Dexa scan

Description

Changes in bone mineral density

Time Frame

Baseline vs 6 months post GAE

Title

Changes in Visual Analog Scale (VAS) as a measure of efficacy

Description

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".

Time Frame

1 week, 1, 2, 3, 4, and 5 months post GAE

Title

Changes in Knee injury and Osteoarthritis Outcome Score (KOOS)

Description

Time Frame

Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE.

Title

Changes in IPAQ (international physical activity questionnaire)

Description

Questionnaire on daily physical activity

Time Frame

Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE

Title

Changes in use of analgesics

Description

(paracetamol, NSAID, opioid, or neuropathic agent)

Time Frame

Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE

Title

Changes in 30 seconds Chair Stand Test

Description

The maximum number of chair stand repetitions in a 30 second period.

Time Frame

Baseline vs. 1 and 6 months post GAE.

Title

Changes in Stair Climb Test

Description

The time (in seconds) it takes to ascend and descend a flight of stairs.

Time Frame

Baseline vs. 1 and 6 months post GAE.

Title

Changes in 40 meters Fast Paced Walk Test

Description

A fast-paced walking test that is timed over 4*10 meters for a total of 40 meters.

Time Frame

Baseline vs. 1 and 6 months post GAE.

Title

Subjective response to the treatment on a five point Likert scale

Description

Time Frame

6 months post GAE

Title

MRI

Description

Changes in synovial thickness (CE-MRI), effusion (Non CE-MRI) and synovial perfusion (DCE-MRI).

Time Frame

Baseline vs. 1 and 6 months post GAE

Title

Ultrasound

Description

Changes in synovial thickness, effusion and perfusion (doppler).

Time Frame

Baseline vs. 1 and 6 months post GAE

Other Pre-specified Outcome Measures:

Title

Adverse events

Description

Continually recorded from baseline till ended trial

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lars Lönn, Professor

Organizational Affiliation

Department of Radiology, University Hospital of Copenhagen, Denmark

Official's Role

Study Director

Facility Information:

Facility Name

Copenhagen University Hospital, Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

Genicular Artery Embolization as Pain Treatment of Knee Osteoarthritis

We'll reach out to this number within 24 hrs