Osteoarthritis, KneeEmbolizationNCT05013970
Transcatheter Arterial Embolization in Patients With Mild to Moderate Osteoarthritis
A study testing Clinical assessment and Radiographic imaging in people with Osteoarthritis, Knee, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
Disabling symptoms of osteoarthritis are seen in approximatively 10% of people over 55 years old. Many patients suffer from persistent pain symptoms from moderate osteoarthritis despite optimal medical treatment. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Clinical assessment and Radiographic imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to Dec 2022
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of knee pain
- Kellgren-Lawrence (KL) grade 1-3 assessed by weight-bearing knee radiographs
- Local tenderness around the knee
- Clinical failure after 3 months or more of conservative therapies, including oral nonsteroidal anti-inflammatory drugs and/or oral opioid agents and physical therapy, stretching, muscle strengthening and/or intra-articular injection of hyaluronic acid
- Persistent moderate to severe knee pain (VAS > 50 mm) for more than 3 months
- Patient is able to give consent
Who cannot join
- Previous knee surgery
- Local infection
- BMI > 40 kg/m2
- Advanced atherosclerosis
- Rheumatoid arthritis, malignancy, renal insufficiency, other conditions contra-indicating femoropopliteal angiography
- Usage of anticoagulants such as eliquis or coumarine (Asaflow allowed)
- Allergy to iodinated contrast medium or any other allergy
About this study
Official title: Transcatheter Arterial Embolization as a Treatment for Knee Pain in Patients With Mild to Moderate Osteoarthritis
Disabling symptoms of osteoarthritis are seen in approximatively 10% of people over 55 years old. Many patients suffer from persistent pain symptoms from moderate osteoarthritis despite optimal medical treatment. For these patients, several minimally-invasive surgical treatments have been proposed, including arthroscopic lavage and debridement; however, none of these treatments have been proven effective compared to sham treatment.
Recently, catheter-directed embolotherapy of the geniculate arteries has been propagated as a real alternative to medical management in patients with mild to moderate knee osteoarthritis unresponsive to conservative medical management.
Read the detailed description
Disabling symptoms of osteoarthritis are seen in approximatively 10% of people over 55 years old. Traditionally, treatment of symptomatic knee osteoarthritis is based on administration of pain relievers, including nonsteroidal anti-inflammatory drugs, in case of mild to moderate symptoms; major joint replacement surgery (total joint arthroplasty) is performed in cases of severe and end-stage osteoarthritis.
However, many patients suffer from persistent pain symptoms from moderate osteoarthritis despite optimal medical treatment. For these patients, several minimally-invasive surgical treatments have been proposed, including arthroscopic lavage and debridement; however, none of these treatments have been proven effective compared to sham treatment.
Recently, catheter-directed embolotherapy of the geniculate arteries has been propagated as a real alternative to medical management in patients with mild to moderate knee osteoarthritis unresponsive to conservative medical management.
Transcatheter embolotherapy was performed using imipenem/cilastin sodium or 75 micron calibrated Embozene microspheres and follow-up was performed by physical examination, questionnaires (VAS-score and WOMAC-scores) and MR-imaging (WORMS-score). Results of these trials confirmed that catheter-directed embolotherapy is a safe procedure without any major adverse events. WOMAC pain scores dropped dramatically from 12.2 +/- 1.9 before the procedure to 3.3 +/- 2.1 at 1 month after the procedure and to 1.7 +/- 2.2 at 4 months after the procedure. Additionally, MR imaging at 2 years of follow-up could not demonstrate any osteonecrosis or progression of degenerative changes.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Clinical assessment, Radiographic imaging
- Keywords
- Osteoarthritis, Catheter-directed embolotherapy, Poly-vinyl alcohol microspheres
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical assessmentOther
Clinical assessment including Visual Analog Scale (VAS) for Knee Pain, and Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Radiographic imagingOther
MRI of the knee
| Study group | Role | What they receive |
|---|---|---|
| Knee osteoarthritis | Other | Patients with mild to moderate osteoarthritis who suffer from persistent knee pain treated with catheter-directed geniculate artery embolization Receives: Other: Clinical assessment; Other: Radiographic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) for Knee Pain
To measure pain in patients with knee osteoarthritis
Measured: Within 30 days after catheter-directed embolization
Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
To evaluate symptoms and limitations in patients with knee osteoarthritis
Measured: Within 30 days after catheter-directed embolization
MRI imaging
To depict potential asymptomatic, but radiologically visible side-effects
Measured: At day 30 after catheter-directed embolization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start1 Aug 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: No financial agreement could be found for this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Model description
- Patients with mild to moderate knee osteoarthritis
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geert Maleux, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013970
- Sponsor's protocol ID
- S62757
- Acronym
- Embolization
- Status last verified
- Dec 2023
- First submitted
- 12 Aug 2021
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Arterial Embolization as a Treatment for Knee Pain in Patients With Mild to Moderate Osteoarthritis
- ClinicalTrials.gov ID
- NCT05013970
- Acronym / sponsor ID
- Embolization / S62757
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Catheter-directed embolotherapy, Poly-vinyl alcohol microspheres
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No financial agreement could be found for this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 20 Aug 2021 (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.
Disabling symptoms of osteoarthritis are seen in approximatively 10% of people over 55 years old. Many patients suffer from persistent pain symptoms from moderate osteoarthritis despite optimal medical treatment. For these patients, several minimally-invasive surgical treatments have been proposed, including arthroscopic lavage and debridement; however, none of these treatments have been proven effective compared to sham treatment.
Recently, catheter-directed embolotherapy of the geniculate arteries has been propagated as a real alternative to medical management in patients with mild to moderate knee osteoarthritis unresponsive to conservative medical management.
Detailed description
Disabling symptoms of osteoarthritis are seen in approximatively 10% of people over 55 years old. Traditionally, treatment of symptomatic knee osteoarthritis is based on administration of pain relievers, including nonsteroidal anti-inflammatory drugs, in case of mild to moderate symptoms; major joint replacement surgery (total joint arthroplasty) is performed in cases of severe and end-stage osteoarthritis.
However, many patients suffer from persistent pain symptoms from moderate osteoarthritis despite optimal medical treatment. For these patients, several minimally-invasive surgical treatments have been proposed, including arthroscopic lavage and debridement; however, none of these treatments have been proven effective compared to sham treatment.
Recently, catheter-directed embolotherapy of the geniculate arteries has been propagated as a real alternative to medical management in patients with mild to moderate knee osteoarthritis unresponsive to conservative medical management.
Transcatheter embolotherapy was performed using imipenem/cilastin sodium or 75 micron calibrated Embozene microspheres and follow-up was performed by physical examination, questionnaires (VAS-score and WOMAC-scores) and MR-imaging (WORMS-score). Results of these trials confirmed that catheter-directed embolotherapy is a safe procedure without any major adverse events. WOMAC pain scores dropped dramatically from 12.2 +/- 1.9 before the procedure to 3.3 +/- 2.1 at 1 month after the procedure and to 1.7 +/- 2.2 at 4 months after the procedure. Additionally, MR imaging at 2 years of follow-up could not demonstrate any osteonecrosis or progression of degenerative changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with mild to moderate knee osteoarthritis
| Arm | Type | Receives |
|---|---|---|
| Knee osteoarthritis | Other | Other: Clinical assessment, Other: Radiographic imagingPatients with mild to moderate osteoarthritis who suffer from persistent knee pain treated with catheter-directed geniculate artery embolization |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Presence of knee pain
- Kellgren-Lawrence (KL) grade 1-3 assessed by weight-bearing knee radiographs
- Local tenderness around the knee
- Clinical failure after 3 months or more of conservative therapies, including oral nonsteroidal anti-inflammatory drugs and/or oral opioid agents and physical therapy, stretching, muscle strengthening and/or intra-articular injection of hyaluronic acid
- Persistent moderate to severe knee pain (VAS > 50 mm) for more than 3 months
Key exclusion criteria (7 listed)
- Previous knee surgery
- Local infection
- BMI > 40 kg/m2
- Advanced atherosclerosis
- Rheumatoid arthritis, malignancy, renal insufficiency, other conditions contra-indicating femoropopliteal angiography
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 |
|---|---|---|
| Clinical assessmentClinical assessment including Visual Analog Scale (VAS) for Knee Pain, and Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire | Other | Knee osteoarthritis |
| Radiographic imagingMRI of the knee | Other | Knee osteoarthritis |
Primary outcome
Visual Analog Scale (VAS) for Knee Pain
Time frame: Within 30 days after catheter-directed embolization
To measure pain in patients with knee osteoarthritis
Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Time frame: Within 30 days after catheter-directed embolization
To evaluate symptoms and limitations in patients with knee osteoarthritis
MRI imaging
Time frame: At day 30 after catheter-directed embolization
To depict potential asymptomatic, but radiologically visible side-effects
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Geert Maleux principal investigator
Universitaire Ziekenhuizen KU Leuven
Questions about this trial
What is this clinical trial studying?
A study testing Clinical assessment and Radiographic imaging in people with Osteoarthritis, Knee, run by Universitaire Ziekenhuizen KU Leuven.
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 6 inclusion and 7 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: withdrawn, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Visual Analog Scale (VAS) for Knee Pain (time frame: Within 30 days after catheter-directed embolization). The study lists 3 primary outcomes in all. 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 3 Jan 2024.