Knee OsteoarthritisGETKONCT05360329
Genicular Artery Embolization as Pain Treatment of Knee Osteoarthritis
A study testing Transarterial geniculate artery embolization in people with Knee Osteoarthritis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Transarterial geniculate artery embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Sep 2022to 19 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 23Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Transarterial geniculate artery embolization
- Keywords
- Embolization, Geniculate Artery Embolization, Knee Osteoarthritis, Trans-arterial Embolization
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial geniculate artery embolizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Mild to moderate knee osteoarthritis (Kellgren Lawrence Score 1-3) | Experimental | Geniculate artery embolization will be performed in all eligible participants. Receives: Procedure: Transarterial geniculate artery embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 6 months post GAE
Secondary outcomes (11)
Dexa scan
Changes in bone mineral density
Measured: 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".
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 6 months post GAE
MRI
Changes in synovial thickness (CE-MRI), effusion (Non CE-MRI) and synovial perfusion (DCE-MRI).
Measured: Baseline vs. 1 and 6 months post GAE
Ultrasound
Changes in synovial thickness, effusion and perfusion (doppler).
Measured: Baseline vs. 1 and 6 months post GAE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start20 Sep 2022
- Primary completion19 Dec 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Amager Hospital
- Responsible party
- Principal investigator, Louise Hindso, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lars Lönn, Professor, Study director, Department of Radiology, University Hospital of Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360329
- Sponsor's protocol ID
- H-20081451
- Acronym
- GETKO
- Status last verified
- Dec 2024
- First submitted
- 25 Apr 2022
- Last updated
- 20 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genicular Artery Embolization as Pain Treatment of Mild to Moderate Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05360329
- Acronym / sponsor ID
- GETKO / H-20081451
- Conditions
- Knee Osteoarthritis
- Keywords
- Embolization, Geniculate Artery Embolization, Knee Osteoarthritis, Trans-arterial Embolization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Amager Hospital
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mild to moderate knee osteoarthritis (Kellgren Lawrence Score 1-3) | Experimental | Procedure: Transarterial geniculate artery embolizationGeniculate artery embolization will be performed in all eligible participants. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transarterial geniculate artery embolizationThe 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. | Procedure or surgery | Mild to moderate knee osteoarthritis (Kellgren Lawrence Score 1-3) |
Primary outcome
Changes in Visual Analog Scale (VAS) as a measure of efficacy
Time frame: 6 months post GAE
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".
11 secondary outcomes
Dexa scan
Time frame: Baseline vs 6 months post GAE
Changes in Visual Analog Scale (VAS) as a measure of efficacy
Time frame: 1 week, 1, 2, 3, 4, and 5 months post GAE
Changes in Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE.
Changes in IPAQ (international physical activity questionnaire)
Time frame: Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE
Changes in use of analgesics
Time frame: Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE
Changes in 30 seconds Chair Stand Test
Time frame: Baseline vs. 1 and 6 months post GAE.
Changes in Stair Climb Test
Time frame: Baseline vs. 1 and 6 months post GAE.
Changes in 40 meters Fast Paced Walk Test
Time frame: Baseline vs. 1 and 6 months post GAE.
Subjective response to the treatment on a five point Likert scale
Time frame: 6 months post GAE
MRI
Time frame: Baseline vs. 1 and 6 months post GAE
Ultrasound
Time frame: Baseline vs. 1 and 6 months post GAE
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Lönn, Professor study director
Department of Radiology, University Hospital of Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transarterial geniculate artery embolization in people with Knee Osteoarthritis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Visual Analog Scale (VAS) as a measure of efficacy (time frame: 6 months post GAE). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.