Knee OsteoarthritisNCT05112926
Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis
A study testing Embosphere Microspheres in people with Knee Osteoarthritis, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the effectiveness and safety of a permanent embolic (Embosphere Microspheres) for embolization of the geniculate artery for the treatment of moderate to severe knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Embosphere Microspheres
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2022to 2 Jun 2026
- 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
- Subject has signed informed consent
- Subject is age 40-80
- Subject is able to have an MRI
- Minimum of prior 12 weeks of failed response to conservative therapy for knee osteoarthritis, which may include one or more of:
- Oral or topical NSAIDS, opioid medications, intra-articular injection of glucocorticoids or hyaluronic acid, physical therapy.
- Localized tenderness in anterior knee area
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- Kellgren-Lawrence grade 1, 2, or 3 as assessed by weight-bearing knee radiographs
- Synovitis present as assessed by WORMS
- VAS >50 mm
- WOMAC score >30
Who cannot join
- Rheumatoid arthritis
- Local infection of the target knee(s)
- Kellgren-Lawrence grade >3
- Osteonecrosis evident by MRI
- Prior knee arthroplasty
- Allergy to iodinated contrast agents that cannot be managed by prophylaxis
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- Hypersensitivity to gelatin products
- Any known condition that limits catheter-based intervention or is a contraindication to embolization
- Active malignancy other than non-melanomatous skin cancer
- Subject is pregnant, breastfeeding, or pre-menopausal and intending to become pregnant
- Any other condition related to the subject's health and wellbeing deemed exclusionary in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Single Arm Investigation to Assess Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis
The purpose of this research study is to evaluate the effectiveness and safety of a permanent embolic (Embosphere Microspheres) for embolization of the geniculate artery for the treatment of moderate to severe knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- Embosphere Microspheres
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embosphere MicrospheresDevice
Embosphere Microspheres are 100-300μm small, compressible, hydrophilic, biocompatible spheres made of acrylic polymer and porcine-derived gelatin used for embolization of geniculate artery.
| Study group | Role | What they receive |
|---|---|---|
| Embosphere Microspheres group | Experimental | Participants in this group who are receiving standard of care (SOC) embolization surgery for the treatment of moderate to severe knee osteoarthritis will receive the Embospheres Microspheres during scheduled SOC surgery. Receives: Device: Embosphere Microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knee pain as assessed by the WOMAC
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain index assesses participants' pain on a scale ranging from 0 (none) to 4 (extreme). The pain subscale consists of 5 items and total scores can range from 0-20, with larger scores indicating greater pain.
Measured: Baseline, 24 Weeks (Post Embolization Surgery)
Incidence of treatment related adverse events
Procedure-related and target knee osteoarthritis-related adverse events as assessed by treating physician
Measured: Up to 4 weeks (Post Embolization Surgery)
Secondary outcomes (5)
Change in knee pain as assessed by VAS
Visual Analog Scale (VAS) has a total score ranging from 0-10 with the higher score indicating greater pain
Measured: Baseline, up to 52 weeks (Post Embolization Surgery)
Change in knee pain
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain index assesses participants' pain on a scale ranging from 0 (none) to 4 (extreme). The pain subscale consists of 5 items and total scores can range from 0-20, with larger scores indicating greater pain.
Measured: Baseline, up to 52 weeks (Post Embolization Surgery)
Incidence of adverse events
Procedure-related and target knee osteoarthritis-related adverse events as assessed by treating physician
Measured: Up to 52 weeks (Post Embolization Surgery)
WORMS Score for Synovitis
Whole-Organ Magnetic Resonance Imaging Score (WORMS) has a score ranging from zero representing no knee problems and 332 representing knee problems
Measured: Baseline, up to 52 weeks (Post Embolization Surgery)
Kellgren-Lawrence Grade
As assessed by X-Ray. Radiograph imaging graded on scale 1 (no arthritis) to 4 (severe arthritis)
Measured: Baseline, up to 52 weeks (Post Embolization Surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start8 Dec 2022
- Primary completion2 Jun 2026
- Study completion2 Jun 2026
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 University of MiamiThe 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Ferreira De Souza, University of Miami
- Investigators
- Felipe Ferreira De Souza, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112926
- Sponsor's protocol ID
- 20210848
- Status last verified
- Jul 2026
- First submitted
- 1 Nov 2021
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Arm Investigation to Assess Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05112926
- Acronym / sponsor ID
- 20210848
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 2 Jun 2026 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 9 Nov 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.
The purpose of this research study is to evaluate the effectiveness and safety of a permanent embolic (Embosphere Microspheres) for embolization of the geniculate artery for the treatment of moderate to severe knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Embosphere Microspheres group | Experimental | Device: Embosphere MicrospheresParticipants in this group who are receiving standard of care (SOC) embolization surgery for the treatment of moderate to severe knee osteoarthritis will receive the Embospheres Microspheres during scheduled SOC surgery. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject has signed informed consent
- Subject is age 40-80
- Subject is able to have an MRI
- Minimum of prior 12 weeks of failed response to conservative therapy for knee osteoarthritis, which may include one or more of:
- Localized tenderness in anterior knee area
Key exclusion criteria (11 listed)
- Rheumatoid arthritis
- Local infection of the target knee(s)
- Kellgren-Lawrence grade >3
- Osteonecrosis evident by MRI
- Prior knee arthroplasty
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 |
|---|---|---|
| Embosphere MicrospheresEmbosphere Microspheres are 100-300μm small, compressible, hydrophilic, biocompatible spheres made of acrylic polymer and porcine-derived gelatin used for embolization of geniculate artery. | Device | Embosphere Microspheres group |
Primary outcome
Change in knee pain as assessed by the WOMAC
Time frame: Baseline, 24 Weeks (Post Embolization Surgery)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain index assesses participants' pain on a scale ranging from 0 (none) to 4 (extreme). The pain subscale consists of 5 items and total scores can range from 0-20, with larger scores indicating greater pain.
Incidence of treatment related adverse events
Time frame: Up to 4 weeks (Post Embolization Surgery)
Procedure-related and target knee osteoarthritis-related adverse events as assessed by treating physician
5 secondary outcomes
Change in knee pain as assessed by VAS
Time frame: Baseline, up to 52 weeks (Post Embolization Surgery)
Change in knee pain
Time frame: Baseline, up to 52 weeks (Post Embolization Surgery)
Incidence of adverse events
Time frame: Up to 52 weeks (Post Embolization Surgery)
WORMS Score for Synovitis
Time frame: Baseline, up to 52 weeks (Post Embolization Surgery)
Kellgren-Lawrence Grade
Time frame: Baseline, up to 52 weeks (Post Embolization Surgery)
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 17 Jul 2026.
- 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.
Felipe Ferreira De Souza principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embosphere Microspheres in people with Knee Osteoarthritis, run by University of Miami at 1 site in United States.
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 10 inclusion and 11 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 17 Jul 2026. 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 United States. 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?
Change in knee pain as assessed by the WOMAC (time frame: Baseline, 24 Weeks (Post Embolization Surgery)). The study lists 2 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 17 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.