An observational study in Inflammatory Articular Diseases and Knee Osteoarthristis, sponsored by Istituto Ortopedico Rizzoli. Recruiting at 1 site in Italy. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by Istituto Ortopedico Rizzoli · Observational
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.
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.
843 studies on the registry are indexed under Arthritis; 118 are open to participants now.
This study's planned enrollment of 43 is below the median of 151 across 202 observational studies indexed under Arthritis.
Browse Arthritis studies →Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 103 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients affected by inflammatory arthropathy of the knee who underwent genicular artery microembolization.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- Patients with degenerative knee disease:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Transarterial Microembolization
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).
Also known as: TAME, embolization, transarterial embolization
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.
Time frame: 1 year
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).
Time frame: 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.
Time frame: 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°.
Time frame: 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.
Time frame: 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.
Time frame: 2 years
Plan to share: No — Privacy concerns
Started Sep 2025 (actual). Primary completion is estimated for Sep 2029, 48 months after the start.
Of 53 non-industry observational studies under Arthritis, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 289. This study's planned 48 months is below that.
Counting every sponsor, half of 87 studies reached it within 83 months; a quarter within 33 and three quarters within 223.
How these figures are worked out, and which studies are left out of them.
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