An interventional study of Transarterial embolization with resorbable gelatin microspheres and Sham embolization procedure in Arthritis, sponsored by Istituto Ortopedico Rizzoli. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn whether transarterial embolization (TAE) can relieve pain and improve well-being in adults with inflammatory arthritis that remains active in only one large joint (wrist, elbow, shoulder, ankle, knee or hip) despite anti-inflammatory drugs, joint injections and physiotherapy. The researchers expect that more people treated with TAE than with a sham (simulated) procedure will reach low pain and a good overall assessment of their health one month after the procedure.
The main questions it aims to answer are:
TAE is a minimally invasive procedure. A thin catheter is guided through an artery in the groin or wrist to the small vessels that feed the inflamed lining of the joint, and tiny resorbable gelatin particles are injected to temporarily reduce the abnormal blood flow that sustains inflammation and pain. Researchers will compare TAE with a sham procedure to find out whether any benefit comes from the embolization itself rather than from the experience of undergoing a procedure.
Participants will:
After 3 months, participants who received the sham procedure will be offered TAE.
Background and rationale
Inflammatory arthritis, including rheumatoid arthritis and the spondyloarthritides, may present with or persist as synovitis of a single joint, even in patients at target according to composite disease activity indices. Patients with monoarthritis have been excluded from registration trials of disease-modifying antirheumatic drugs, and when local treatments fail, escalation to systemic immunosuppression exposes them to class-wide risks (such as serious infections) for a benefit limited to one joint. Repeated intra-articular glucocorticoid injections carry cumulative local risks. Transarterial embolization (TAE) is a minimally invasive procedure that occludes the pathological neovessels of the inflamed synovium without systemic immunosuppression. Evidence on musculoskeletal embolization comes mainly from knee osteoarthritis, where sham-controlled trials have shown discordant results and a large response to the procedural context. In inflammatory arthritis, data are limited to case reports and small series. ADVENTURE is, to our knowledge, the first randomized sham-controlled trial of TAE in inflammatory arthritis.
Design
Single-centre, randomized, sham-controlled, parallel-group superiority trial conducted at IRCCS Istituto Ortopedico Rizzoli (IOR), Bologna, Italy. Potential participants are identified in the rheumatology clinics of IOR and of Azienda USL di Bologna, which refers eligible patients to IOR for consent and enrollment. Participants are randomized 1:1 to TAE or sham procedure using a computer-generated sequence stratified by joint site (upper limb: wrist, elbow, shoulder; lower limb: ankle, knee, hip). The procedure is performed within 4 weeks of randomization. Each participant is followed for 3 months, with visits at baseline, 1 week, 1 month and 3 months after the procedure.
Blinding
Participants and the rheumatologist who assesses outcomes are blinded to allocation for the entire 3-month follow-up. The allocation is communicated only to the interventional radiology team, which cannot be blinded, and procedural data are recorded on a separate case report form, stored separately from clinical data until the end of the trial. The protocol title describes the trial as single-blind; because the assessing rheumatologist is also blinded, masking is recorded here as Participant and Outcomes Assessor.
Interventions
Both procedures are performed in the same angiography suite, by the same team, with identical light sedation (midazolam 2 mg intravenously) and local anaesthesia, and last about 60 minutes. TAE is performed through ultrasound-guided femoral or radial arterial access: after superselective angiography of the arteries supplying the target joint, resorbable porcine gelatin microspheres (Nexsphere-F, 100-300 micrometres; CE-marked class III device) are injected until the pathological synovial blush disappears. Embolization is not performed if superselective angiography shows anatomical or vascular contraindications listed in the device instructions for use. In the sham procedure, a peripheral venous line is placed and a superficial subcutaneous puncture is made at the access site corresponding to the target joint, without arterial access; saline is infused and standardized angiographic sequences are displayed on the monitor. No contrast medium or ionizing radiation is administered in the sham arm. After either procedure, participants are observed for 4-5 hours and receive standardized instructions (compressive dressing for 3 days, local ice, paracetamol and, if needed, low-dose NSAIDs as rescue analgesia).
Open-label crossover
After the 3-month visit, participants allocated to sham are offered open-label TAE, with a follow-up visit 1 month after the procedure. These data are analysed separately and do not contribute to the randomized comparison.
Sample size and statistical analysis
Assuming a primary response rate of 60% with TAE and 10% with sham, a two-sided alpha of 0.05, 80% power and 10% loss to follow-up, 30 participants (15 per group) will be enrolled. The primary analysis follows the intention-to-treat principle, with missing data handled by multiple imputation by chained equations; the primary outcome is compared between groups with Fisher's exact test and the difference in proportions is reported with its 95% confidence interval. A per-protocol analysis is performed as sensitivity analysis. Secondary outcomes are analysed with non-parametric or parametric tests as appropriate and with linear mixed models for repeated measures; they are considered exploratory.
Safety monitoring
An independent Data Safety Monitoring Board (a biostatistician, an interventional radiologist and an orthopaedic surgeon) reviews recruitment, data quality, protocol adherence and adverse events before recruitment begins, after the first 10 participants, annually and whenever a relevant serious adverse event occurs. Data are collected in REDCap with automated range and consistency checks.
3,555 studies on the registry are indexed under Arthritis; 313 are open to participants now.
This study's planned enrollment of 30 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Participants undergo transarterial embolization of the target joint in the angiography suite under light sedation (midazolam 2 mg intravenously) and local anaesthesia. Through ultrasound-guided femoral or radial arterial access, a microcatheter is advanced into the arteries supplying the inflamed synovium and resorbable gelatin microspheres (100-300 micrometres) are injected until the pathological blush disappears. The procedure lasts about 60 minutes and is performed within 4 weeks of randomization.
Device: Transarterial embolization with resorbable gelatin microspheres
Participants undergo a simulated procedure in the same angiography suite, with the same team, identical light sedation (midazolam 2 mg intravenously) and local anaesthesia, and similar duration (about 60 minutes). A superficial subcutaneous puncture is made at the access site corresponding to the target joint, without arterial access; saline is infused and standardized angiographic sequences are displayed on the monitor. No contrast medium, embolic agent or ionizing radiation is administered. After the 3-month visit, participants are offered open-label transarterial embolization.
Device: Sham embolization procedure
Superselective transarterial embolization of the arteries supplying the inflamed synovium of the target joint, using resorbable porcine gelatin microspheres (100-300 micrometres; CE-marked class III device) injected through a coaxial microcatheter until the pathological blush disappears. Ultrasound-guided femoral or radial access, light sedation with midazolam 2 mg IV and local anaesthesia. Single procedure.
Simulated embolization procedure in the angiography suite with identical sedation (midazolam 2 mg IV), local anaesthesia and duration as the active procedure. Superficial subcutaneous puncture at the access site without arterial access, saline infusion and display of standardized angiographic sequences. No contrast medium, embolic agent or ionizing radiation. Single procedure.
Proportion of participants with pain VAS ≤15 mm and Patient Global Assessment ≤20 mm.
The proportion of participants achieving both a pain visual analogue scale (VAS) score \<15 mm, referred to the target joint, and a Patient Global Assessment (PGA) of health status \<20 mm, both measured on a 0-100 mm scale (higher scores indicate worse status). Thresholds are derived from the pain and patient global components of the minimal disease activity criteria for psoriatic arthritis. The proportion is compared between the transarterial embolization and sham arms by intention to treat.
Time frame: 1 month after the procedure.
Change in pain VAS from baseline.
Change from baseline in pain visual analogue scale (VAS), referred to the target joint, on a 0-100 mm scale (higher scores indicate worse pain).
Time frame: Baseline, 1 week and 3 months after the procedure.
Change in Patient Global Assessment from baseline.
Change from baseline in Patient Global Assessment (PGA) of health status on a 0-100 mm visual analogue scale (higher scores indicate worse status).
Time frame: Baseline, 1 week and 3 months after the procedure.
Health-related quality of life measured with the EQ-5D
EQ-5D index score and EQ-5D visual analogue scale (0-100; higher scores indicate better health).
Time frame: Baseline, 1 week, 1 month and 3 months after the procedure.
Health-related quality of life measured with the SF-36.
Short Form-36 Health Survey domain and summary scores (0-100; higher scores indicate better health).
Time frame: Baseline, 1 week, 1 month and 3 months after the procedure.
Change in medication use.
Use of systemic medication (conventional synthetic DMARDs, NSAIDs, glucocorticoids) and topical medication, recorded in participant diaries and verified by the rheumatologist at each visit.
Time frame: From baseline to 3 months after the procedure.
Incidence of adverse events.
Number of participants with procedural and post-procedural adverse events, with type and severity, coded with MedDRA and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: From the procedure to 3 months after the procedure.
Patient satisfaction and willingness to repeat the procedure.
Satisfaction with the procedure and willingness to repeat it, each rated on a 5-point Likert scale (1-5; higher scores indicate greater satisfaction).
Time frame: 1 month and 3 months after the procedure.
Success of blinding.
Participants are asked which treatment they believe they received (embolization, sham procedure, or don't know). The proportion of correct guesses and the James blinding index are reported by arm.
Time frame: 1 week after the procedure.
Outcomes after open-label embolization in the sham arm.
In participants allocated to the sham procedure who receive open-label transarterial embolization after the 3-month visit: proportion with pain VAS \<15 mm and Patient Global Assessment \<20 mm, change in pain VAS and PGA from the pre-crossover assessment, and adverse events. Analysed as a separate non-randomized cohort.
Time frame: 1 month after the open-label procedure.
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared. The informed consent approved by the ethics committee restricts access to participant data to the sponsor, the investigators, the ethics committee and regulatory authorities, and provides for dissemination of results in aggregate form only. Aggregate results will be published in peer-reviewed journals.
Start is estimated for Nov 2026; primary completion for Dec 2028, 25 months later.
Of 352 non-industry interventional studies with no phase under Arthritis, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's planned 25 months is close to that.
Counting every sponsor, half of 399 studies reached it within 26 months; a quarter within 11 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.