Knee OsteoarthritisGAENCT04951479
Geniculate Artery Embolization for Knee Osteoarthritis
A study testing Gel-Bead embolization in people with Knee Osteoarthritis, run by Anish Ghodadra at 1 site in United States.
Trial summary
The purpose of this study is to perform a prospective case series to determine efficacy of transcatheter arterial embolization in treating knee osteoarthritis related pain, improving functionality, and reducing opiate usage in patients with mild to moderate knee osteoarthritis who have failed conservative management. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Gel-Bead embolization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2021to 26 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between ages 18 and 75 with moderate/severe knee pain secondary to primary osteoarthritis. Moderate/severe pain will be defined as pain 30 mm to 100 mm on the Visual Analog Pain Scale (where 0 denotes 'no pain' and 100 mm denotes worst pain imaginable')
- Grade 1, 2, or 3 osteoarthritis on the Kellgren-Lawrence grading scale on knee x-ray in the last 6 months
- Pain must be refractory to 3 months of medical management (which may include a combination of oral analgesics, intraarticular steroids, viscosupplementation, opioid therapy, etc)
- Patients willing and able to consent to the study
Who cannot join
- Kidney dysfunction defined as an estimated GFR < 60 mL/min
- Acute knee injury
- Current local infection
- Prior ipsilateral knee replacement surgery
- Infectious or inflammatory arthritis
- History of contrast allergy resulting in anaphylaxis
Show all 13Show fewer
- INR (International Normalization Ratio) > 1.6
- Platelets < 50,000
- Significant atherosclerosis that would limit angiography
- Active malignancy
- Active pregnancy
- Appropriate candidate for knee replacement surgery determined by clinical and physical examination
- Recent within 3 months, or active cigarette user
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to perform a prospective case series to determine efficacy of transcatheter arterial embolization in treating knee osteoarthritis related pain, improving functionality, and reducing opiate usage in patients with mild to moderate knee osteoarthritis who have failed conservative management.
The Gel-Bead embolization particles will be used to perform geniculate artery embolization (GAE) for the purposes of treatment of osteoarthritis-related knee pain.
Read the detailed description
Management of mild and moderate knee osteoarthritis is curated to each specific patient and their needs, their quality of life, and desired goals. Weight loss is advised for overweight and obese patients. All patients should attempt extended-duration exercise/physical therapy and realignment therapy. If these conservative lifestyle modifications fail to reduce pain, topical and oral non-steroidal anti-inflammatories are indicated. Escalation of care from here is controversial. Some clinicians opt for adjunctive treatments such as intra-articular injection of steroids or viscosupplementation. Unfortunately, pain alleviation from intra-articular steroids is short-lasting and a recent meta-analysis demonstrated no significant difference between intra-articular hyaluronic acid injection and placebo injection. Finally, weak opioids are an option for patients who continue to have pain despite all the aforementioned treatment measures. Joint replacement is reserved for patients with severe osteoarthritis.
Patients who fail conservative, medical management pose a challenge to clinicians. For decades, there have been no interventions available to these patients between the controversial intra-articular hyaluronic acid injection and joint replacement. Interventional radiology (IR) may provide one possible solution. Geniculate artery embolization (GAE) is a minimally-invasive procedure that has historically been performed for patients with recurrent hemarthrosis. It was recently applied to patients with moderate osteoarthritis refractory to maximal medical management. Several studies have been performed and have found that GAE is safe and improves pain.
- Conditions
- Knee Osteoarthritis
- Being tested
- Gel-Bead 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.
Gel-Bead embolizationDevice
OptiSphere is FDA approved for the embolization of hypervascular tumors. The product is crosslinked with glutaraldehyde, which improves the mechanical strength of the spheres and provides controlled degradation after implant. The spherical shape provides smooth embolic delivery and even, predictable distribution. In this study the Optispheres will be used for Geniculate artery embolization (GAE) which is a minimally-invasive procedure that has historically been performed for treatment of patients with recurrent knee hemarthrosis. Embolization is a procedure in which material is used to block small blood vessels. Angiogenesis, or growth of new vessels, has been implicated in the initiation and maintenance of joint inflammation. GAE has been applied to patients with moderate osteoarthritis-related pain refractory to maximal medical management with preliminary studies demonstrating a reduction in patient pain.
| Study group | Role | What they receive |
|---|---|---|
| Gel-Bead Embolization | Experimental | This is the arm undergoing the genicular artery embolization procedure Receives: Device: Gel-Bead embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in KOOS Pain Score
Change in pain score of at least 10 points based on the KOOS Pain questionnaire. The KOOS Pain score runs from 0 (no pain) to 100 (worst pain). The change in KOOS pain score will be the primary outcome measure. Minimum score is 0 and maximum is 100. higher score is better outcome
Measured: Baseline and 6 months from treatment
Secondary outcomes (4)
Change in Knee-related Functionality
Average change in the KOOS Function in Sport and Recreation (FSR). The KOOS FSR score runs from 0 (no symptoms) to 100 (worst symptoms).
Measured: Baseline and 6 months from treatment
Change in KOOS Quality of Life Scale
Average change in in the KOOS Quality of Life Scale (QoL) score. The KOOS QoL score runs from 0 (no symptoms) to 100 (worst symptoms). An increase in this value is considered improvement.
Measured: Baseline and 6 months from treatment
Change in 30-second Chair Stand Test
Average change in 30-second chair stand test in number of chair stands. An increase in this value is considered improvement.
Measured: Baseline and 6 months from treatment
6-minute Walk Test
distance walked (meters) in 6 minutes
Measured: Baseline and 6 months from treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start3 Nov 2021
- Primary completion26 Oct 2023
- Study completion26 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anish Ghodadra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anish Ghodadra, University of Pittsburgh
- Investigators
- Anish Ghodadra, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951479
- Sponsor's protocol ID
- STUDY19010266
- Acronym
- GAE
- Status last verified
- Apr 2025
- First submitted
- 28 Jun 2021
- Last updated
- 9 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geniculate Artery Embolization for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04951479
- Acronym / sponsor ID
- GAE / STUDY19010266
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Anish GhodadraUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 6 Jul 2021 (actual)
- Results
- Posted 9 Apr 2025
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 study is to perform a prospective case series to determine efficacy of transcatheter arterial embolization in treating knee osteoarthritis related pain, improving functionality, and reducing opiate usage in patients with mild to moderate knee osteoarthritis who have failed conservative management.
The Gel-Bead embolization particles will be used to perform geniculate artery embolization (GAE) for the purposes of treatment of osteoarthritis-related knee pain.
Detailed description
Management of mild and moderate knee osteoarthritis is curated to each specific patient and their needs, their quality of life, and desired goals. Weight loss is advised for overweight and obese patients. All patients should attempt extended-duration exercise/physical therapy and realignment therapy. If these conservative lifestyle modifications fail to reduce pain, topical and oral non-steroidal anti-inflammatories are indicated. Escalation of care from here is controversial. Some clinicians opt for adjunctive treatments such as intra-articular injection of steroids or viscosupplementation. Unfortunately, pain alleviation from intra-articular steroids is short-lasting and a recent meta-analysis demonstrated no significant difference between intra-articular hyaluronic acid injection and placebo injection. Finally, weak opioids are an option for patients who continue to have pain despite all the aforementioned treatment measures. Joint replacement is reserved for patients with severe osteoarthritis.
Patients who fail conservative, medical management pose a challenge to clinicians. For decades, there have been no interventions available to these patients between the controversial intra-articular hyaluronic acid injection and joint replacement. Interventional radiology (IR) may provide one possible solution. Geniculate artery embolization (GAE) is a minimally-invasive procedure that has historically been performed for patients with recurrent hemarthrosis. It was recently applied to patients with moderate osteoarthritis refractory to maximal medical management. Several studies have been performed and have found that GAE is safe and improves pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gel-Bead Embolization | Experimental | Device: Gel-Bead embolizationThis is the arm undergoing the genicular artery embolization procedure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients between ages 18 and 75 with moderate/severe knee pain secondary to primary osteoarthritis. Moderate/severe pain will be defined as pain 30 mm to 100 mm on the Visual Analog Pain Scale (where 0 denotes 'no pain' and 100 mm denotes worst pain imaginable')
- Grade 1, 2, or 3 osteoarthritis on the Kellgren-Lawrence grading scale on knee x-ray in the last 6 months
- Pain must be refractory to 3 months of medical management (which may include a combination of oral analgesics, intraarticular steroids, viscosupplementation, opioid therapy, etc)
- Patients willing and able to consent to the study
Key exclusion criteria (13 listed)
- Kidney dysfunction defined as an estimated GFR < 60 mL/min
- Acute knee injury
- Current local infection
- Prior ipsilateral knee replacement surgery
- Infectious or inflammatory arthritis
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 |
|---|---|---|
| Gel-Bead embolizationOptiSphere is FDA approved for the embolization of hypervascular tumors. The product is crosslinked with glutaraldehyde, which improves the mechanical strength of the spheres and provides controlled degradation after implant. The spherical shape provides smooth embolic delivery and even, predictable distribution. In this study the Optispheres will be used for Geniculate artery embolization (GAE) which is a minimally-invasive procedure that has historically been performed for treatment of patients with recurrent knee hemarthrosis. Embolization is a procedure in which material is used to block small blood vessels. Angiogenesis, or growth of new vessels, has been implicated in the initiation and maintenance of joint inflammation. GAE has been applied to patients with moderate osteoarthritis-related pain refractory to maximal medical management with preliminary studies demonstrating a reduction in patient pain. | Device | Gel-Bead Embolization |
Primary outcome
Change in KOOS Pain Score
Time frame: Baseline and 6 months from treatment
Change in pain score of at least 10 points based on the KOOS Pain questionnaire. The KOOS Pain score runs from 0 (no pain) to 100 (worst pain). The change in KOOS pain score will be the primary outcome measure. Minimum score is 0 and maximum is 100. higher score is better outcome
4 secondary outcomes
Change in Knee-related Functionality
Time frame: Baseline and 6 months from treatment
Change in KOOS Quality of Life Scale
Time frame: Baseline and 6 months from treatment
Change in 30-second Chair Stand Test
Time frame: Baseline and 6 months from treatment
6-minute Walk Test
Time frame: Baseline and 6 months from treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Anish Ghodadra, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gel-Bead embolization in people with Knee Osteoarthritis, run by Anish Ghodadra 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 4 inclusion and 13 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 9 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 9 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 KOOS Pain Score (time frame: Baseline and 6 months from treatment). 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 9 Apr 2025.