Inflammatory Articular DiseasesTAME-OANCT07140367
"Transarterial Microembolization (TAME) in Inflammatory Knee Pathology"
An observational study of Inflammatory Articular Diseases and Knee Osteoarthristis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Patients with knee OA and chronic pain refractory to at least 3 months of conventional conservative therapy will be included in the study, which will evaluate the clinical results obtained after treatment with selective arterial embolization (selection and enrollment, treatment with selective arterial embolization… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Inflammatory Articular Diseases, Knee Osteoarthristis
- What is being tested?
- Transarterial Microembolization
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 43 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2025to 1 Sep 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by inflammatory arthropathy of the knee who underwent genicular artery microembolization.
Who may be able to join
- Patients with degenerative knee disease:
- Age over 40 years;
- Moderate knee OA (grade 2-3 according to the Kellgren-Lawrence score) for which an indication for total knee arthroplasty surgery has already been given;
- Knee OA with an inflammatory component (night pain, pain at rest, recurrent episodes of effusion, swelling and/or redness);
- Persistent and moderate or severe knee pain (VAS score > 4);
- Failure after at least 3 months of conservative therapies (e.g., physical therapy, drug therapy with NSAIDs and pain relievers, hyaluronic acid infiltration, corticosteroids, or orthobiologics).
- Signature of informed consent
- Case declared eligible for treatment following discussion at internal multidisciplinary meeting on degenerative-inflammatory disease
Who cannot join
- Mentally incompetent patients;
- Patients with trauma in the 6 months prior to treatment;
- Patients with malignant neoplasms;
- Patients with rheumatic diseases;
- Patients on anticoagulant-antiaggregant therapy (including if therapy can be discontinued 5 days earlier);
- Patients abusing alcoholic beverages, drugs, or medications;
Show all 13Show fewer
- Patients undergoing surgery of the affected knee in the previous 12 months;
- INR <2;
- Platelet count <30,000;
- Renal function: GFR<30ml/min;
- Pregnancy;
- Allergy to iodinated contrast.
- Ineligibility to perform MRI examination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Rizzoli
Bologna, Bologna, 40136
Giancarlo Facchini, Medicine and Surgery, +39 0516366836, giancarlo.facchini@ior.it
Michela Carta, Biotechnology, +39 0516366376, michela.carta@ior.it
About this study
Official title: "Transarterial Microembolization (TAME) in Inflammatory Knee Pathology: Prospective Observational Study."
Patients with knee OA and chronic pain refractory to at least 3 months of conventional conservative therapy will be included in the study, which will evaluate the clinical results obtained after treatment with selective arterial embolization (selection and enrollment, treatment with selective arterial embolization, follow-up checks). Forty-three patients will be included in the study and will undergo the transarterial microembolization procedure after signing the informed consent form for participation in the study and the collection of anamnestic data. Subsequently, patients will be followed up with clinical evaluation at 1, 3, 6, 12, and 24 months of follow-up or until possible dropout for other treatment.
Read the detailed description
Degenerative and inflammatory joint disease is a common and debilitating condition that causes pain and limited mobility, with osteoarthritis (OA) being the most common form. The knee is the most commonly affected joint, with an estimated 600 million people worldwide currently living with unilateral or bilateral knee OA, marking a 113% increase since 1990. Although risk factors include obesity, advanced age, and female gender, most individuals are susceptible to the pathophysiological cascade of OA, which likely explains the dramatic global burden of the disease and its associated economic consequences. These joint disorders have a significant impact on individuals' quality of life. When they occur in mild or moderate form, a series of therapeutic strategies can be implemented, but these rarely lead to a significant reduction in pain and do not alter the course of the disease. Standard treatment includes exercise, postural measures, weight control, and pharmacotherapy. Intra-articular injections of hyaluronic acid or platelet-rich plasma (PRP) have emerged as new non-surgical treatment options. Surgical joint replacement is reserved for the most severe cases, with intense pain and functional disability. However, many patients suffer from refractory chronic pain, are not candidates for surgery, or refuse it. In addition, some patients may experience complications associated with long-term pharmacotherapy, such as renal or hepatic failure, opioid dependence, or local problems resulting from injections, such as infections. In recent years, geniculate artery embolization has emerged as a promising option for patients with knee pain due to OA who are refractory to conservative therapies and who are not eligible for or choose not to undergo arthroplasty surgery.
Patients with knee OA and chronic pain refractory to at least 3 months of conventional conservative therapy will be included in the study, which will evaluate the clinical results obtained after treatment with selective arterial embolization (selection and enrollment, treatment with selective arterial embolization, follow-up checks). Forty-three patients will be included in the study and will undergo the transarterial microembolization procedure after signing the informed consent form for participation in the study and the collection of anamnestic data. Subsequently, patients will be followed up with clinical evaluation at 1, 3, 6, 12, and 24 months of follow-up or until possible dropout for other treatment.
- Being tested
- Transarterial Microembolization
- Keywords
- embolization, transarterial microembolization, TAME, arthritis, inflammatory articular disease, arthropathy, knee, osteoarthritis
- Medical subject headings
- Arthritis, Joint Diseases, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial MicroembolizationProcedure or surgery
Also called TAME, embolization, transarterial embolization
Identification of the hypervascularization of the knee. Selective and super-selective catheterization of pathological genicular arterial branches, through the use of micro-catheters. - Injection of embolizing material (Nexsphere-F - Kardia) - Control of technical success: the embolization will be followed by diagnostic arteriography that will evaluate the success of the procedure (occlusion of more than 90 percent of the pathologic vasculature).
| Study group | Role | What they receive |
|---|---|---|
| Performed microembolization | Not described Receives: Procedure: Transarterial Microembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of pain (VAS score)
Clinical assessment regarding pain by Visual Analogue Scale (VAS) score (0-100 mm), in which 0 represents no pain, and 100 represents maximum pain imaginable.
Measured: 1 year
Secondary outcomes (5)
Improvement in quality of life (SF-36)
Clinical assessment regarding quality of life by SF-36 questionnaire. The SF-36 is a widely used tool to measure health-related quality of life. It has 36 questions covering 8 domains: Physical Functioning, Role Limitations due to Physical Health, Bodily Pain, General Health, Vitality, Social Functioning, Role Limitations due to Emotional Problems, Mental Health.
Plus, there is one item on health change over the past year.
Scoring:
Once items are recoded so that higher scores always = better health, domain scores are computed by averaging item scores, then transforming to a 0-100 scale (0 = worst health, 100 = best).
Measured: 2 years
Pain, stiffness, and physical functioning of the joints (WOMAC score)
It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68), which mainly concern daily activities (e.g., getting up from a sitting position, bending over, going up and down stairs, etc.). The score is then normalized on a scale of 0-100. Higher values indicate a worse outcome.
Measured: 2 years
Range of motion
Objective parameter used to assess joint mobility and functional ability.
- Good/Normal ROM:
Extension: 0° (up to -5°/-10° hyperextension can be physiological).
Flexion: 130°-150°.
- Clinically acceptable ("good enough" for daily life):
Flexion >120°.
Full extension (0°) is essential; even small deficits are significant.
- Reduced:
Flexion <110°.
Extension loss >5°.
Measured: 2 years
Overall assessment of treatment
The patient will be asked to indicate their level of satisfaction (on a scale from 0 to 10) with the treatment received at each follow-up visit during the clinical trial.
Measured: 2 years
Bilateral Trans- and Suprapatellar Circumferences
To compare muscle mass and joint swelling/edema between the injured and non-injured side.
- Good/Normal: difference ≤1 cm between sides.
- Borderline/Reduced: difference 1.5-2 cm → may indicate muscle atrophy or swelling.
- Significant abnormality: >2 cm difference.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Sep 2025
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Articular DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale San Giuseppe Moscati, Avellino, Azienda Ospedaliero-Universitaria, Catania, Azienda Ospedaliera di Perugia, San Salvatore Hospital, AST Pesaro-Urbino, A.O.U. Città della Salute e della Scienza - Molinette Hospital
- Responsible party
- Principal investigator, Giancarlo Facchini, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140367
- Sponsor's protocol ID
- CE AVEC: 350/2025/Oss/IOR
- Acronym
- TAME-OA
- Status last verified
- Apr 2026
- First submitted
- 18 Aug 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy concerns
Publications
Sapoval M, Querub C, Pereira H, Pellerin O, Boeken T, Di Gaeta A, Ahmar MA, Lefevre-Colau MM, Nguyen C, Daste C, Lacroix M, Laredo JD, Sabatier B, Martelli N, Chatellier G, Dean C, Rannou F. Genicular artery embolization for knee osteoarthritis: Results of the LipioJoint-1 trial. Diagn Interv Imaging. 2024 Apr;105(4):144-150. doi: 10.1016/j.diii.2023.12.003. Epub 2023 Dec 14.
PubMed 38102013Little MW, O'Grady A, Briggs J, Gibson M, Speirs A, Al-Rekabi A, Yoong P, Ariyanayagam T, Davies N, Tayton E, Tavares S, MacGill S, McLaren C, Harrison R. Genicular Artery embolisation in Patients with Osteoarthritis of the Knee (GENESIS) Using Permanent Microspheres: Long-Term Results. Cardiovasc Intervent Radiol. 2024 Dec;47(12):1750-1762. doi: 10.1007/s00270-024-03752-7. Epub 2024 May 31.
PubMed 38819473Okuno Y, Korchi AM, Shinjo T, Kato S. Transcatheter arterial embolization as a treatment for medial knee pain in patients with mild to moderate osteoarthritis. Cardiovasc Intervent Radiol. 2015 Apr;38(2):336-43. doi: 10.1007/s00270-014-0944-8. Epub 2014 Jul 4.
PubMed 24993956
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Transarterial Microembolization (TAME) in Inflammatory Knee Pathology: Prospective Observational Study."
- ClinicalTrials.gov ID
- NCT07140367
- Acronym / sponsor ID
- TAME-OA / CE AVEC: 350/2025/Oss/IOR
- Keywords
- embolization, transarterial microembolization, TAME, arthritis, inflammatory articular disease, arthropathy, knee, osteoarthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Collaborators
- Ospedale San Giuseppe Moscati, Avellino, Azienda Ospedaliero-Universitaria, Catania, Azienda Ospedaliera di Perugia, San Salvatore Hospital, AST Pesaro-Urbino, A.O.U. Città della Salute e della Scienza - Molinette Hospital
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 24 Aug 2025 (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.
Patients with knee OA and chronic pain refractory to at least 3 months of conventional conservative therapy will be included in the study, which will evaluate the clinical results obtained after treatment with selective arterial embolization (selection and enrollment, treatment with selective arterial embolization, follow-up checks). Forty-three patients will be included in the study and will undergo the transarterial microembolization procedure after signing the informed consent form for participation in the study and the collection of anamnestic data. Subsequently, patients will be followed up with clinical evaluation at 1, 3, 6, 12, and 24 months of follow-up or until possible dropout for other treatment.
Detailed description
Degenerative and inflammatory joint disease is a common and debilitating condition that causes pain and limited mobility, with osteoarthritis (OA) being the most common form. The knee is the most commonly affected joint, with an estimated 600 million people worldwide currently living with unilateral or bilateral knee OA, marking a 113% increase since 1990. Although risk factors include obesity, advanced age, and female gender, most individuals are susceptible to the pathophysiological cascade of OA, which likely explains the dramatic global burden of the disease and its associated economic consequences. These joint disorders have a significant impact on individuals' quality of life. When they occur in mild or moderate form, a series of therapeutic strategies can be implemented, but these rarely lead to a significant reduction in pain and do not alter the course of the disease. Standard treatment includes exercise, postural measures, weight control, and pharmacotherapy. Intra-articular injections of hyaluronic acid or platelet-rich plasma (PRP) have emerged as new non-surgical treatment options. Surgical joint replacement is reserved for the most severe cases, with intense pain and functional disability. However, many patients suffer from refractory chronic pain, are not candidates for surgery, or refuse it. In addition, some patients may experience complications associated with long-term pharmacotherapy, such as renal or hepatic failure, opioid dependence, or local problems resulting from injections, such as infections. In recent years, geniculate artery embolization has emerged as a promising option for patients with knee pain due to OA who are refractory to conservative therapies and who are not eligible for or choose not to undergo arthroplasty surgery.
Patients with knee OA and chronic pain refractory to at least 3 months of conventional conservative therapy will be included in the study, which will evaluate the clinical results obtained after treatment with selective arterial embolization (selection and enrollment, treatment with selective arterial embolization, follow-up checks). Forty-three patients will be included in the study and will undergo the transarterial microembolization procedure after signing the informed consent form for participation in the study and the collection of anamnestic data. Subsequently, patients will be followed up with clinical evaluation at 1, 3, 6, 12, and 24 months of follow-up or until possible dropout for other treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Performed microembolization | – | Procedure: Transarterial Microembolization |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by inflammatory arthropathy of the knee who underwent genicular artery microembolization.
Key inclusion criteria (8 listed)
- Patients with degenerative knee disease:
- Age over 40 years;
- Moderate knee OA (grade 2-3 according to the Kellgren-Lawrence score) for which an indication for total knee arthroplasty surgery has already been given;
- Knee OA with an inflammatory component (night pain, pain at rest, recurrent episodes of effusion, swelling and/or redness);
- Persistent and moderate or severe knee pain (VAS score > 4);
Key exclusion criteria (13 listed)
- Mentally incompetent patients;
- Patients with trauma in the 6 months prior to treatment;
- Patients with malignant neoplasms;
- Patients with rheumatic diseases;
- Patients on anticoagulant-antiaggregant therapy (including if therapy can be discontinued 5 days earlier);
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 MicroembolizationAlso: TAME, embolization, transarterial embolizationIdentification of the hypervascularization of the knee. Selective and super-selective catheterization of pathological genicular arterial branches, through the use of micro-catheters. - Injection of embolizing material (Nexsphere-F - Kardia) - Control of technical success: the embolization will be followed by diagnostic arteriography that will evaluate the success of the procedure (occlusion of more than 90 percent of the pathologic vasculature). | Procedure or surgery | Performed microembolization |
Primary outcome
Reduction of pain (VAS score)
Time frame: 1 year
Clinical assessment regarding pain by Visual Analogue Scale (VAS) score (0-100 mm), in which 0 represents no pain, and 100 represents maximum pain imaginable.
5 secondary outcomes
Improvement in quality of life (SF-36)
Time frame: 2 years
Pain, stiffness, and physical functioning of the joints (WOMAC score)
Time frame: 2 years
Range of motion
Time frame: 2 years
Overall assessment of treatment
Time frame: 2 years
Bilateral Trans- and Suprapatellar Circumferences
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Results publication: PubMed 38102013Sapoval M, Querub C, Pereira H, Pellerin O, Boeken T, Di Gaeta A, Ahmar MA, Lefevre-Colau MM, Nguyen C, Daste C, Lacroix M, Laredo JD, Sabatier B, Martelli N, Chatellier G, Dean C, Rannou F. Genicular artery embolization for knee osteoarthritis: Results of the LipioJoint-1 trial. Diagn Interv Imaging. 2024 Apr;105(4):144-150. doi: 10.1016/j.diii.2023.12.003. Epub 2023 Dec 14.
- Results publication: PubMed 38819473Little MW, O'Grady A, Briggs J, Gibson M, Speirs A, Al-Rekabi A, Yoong P, Ariyanayagam T, Davies N, Tayton E, Tavares S, MacGill S, McLaren C, Harrison R. Genicular Artery embolisation in Patients with Osteoarthritis of the Knee (GENESIS) Using Permanent Microspheres: Long-Term Results. Cardiovasc Intervent Radiol. 2024 Dec;47(12):1750-1762. doi: 10.1007/s00270-024-03752-7. Epub 2024 May 31.
- Results publication: PubMed 24993956Okuno Y, Korchi AM, Shinjo T, Kato S. Transcatheter arterial embolization as a treatment for medial knee pain in patients with mild to moderate osteoarthritis. Cardiovasc Intervent Radiol. 2015 Apr;38(2):336-43. doi: 10.1007/s00270-014-0944-8. Epub 2014 Jul 4.
- Individual participant dataSharing planned: No. Privacy concerns
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Articular Diseases and Knee Osteoarthristis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 8 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: looking for participants now, as of the sponsor's last update on 7 Apr 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giancarlo Facchini, Medicine and Surgery (+39 0516366836, giancarlo.facchini@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of pain (VAS score) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07140367, which also lists 3 linked publications.
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 7 Apr 2026.