Genicular artery embolization for knee osteoarthritis: Results of the LipioJoint-1 trial.
Marc Sapoval, Charles Querub, Helena Pereira...
https://pubmed.ncbi.nlm.nih.gov/38102013Actively Recruiting
Age: 40Years +
All Genders
ID07140367
Transarterial Microembolization (TAME) in Inflammatory Knee Pathology: Prospective Observational Study
Led by Istituto Ortopedico Rizzoli · Updated on 2026-04-07
43
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
I
Istituto Ortopedico Rizzoli
Lead Sponsor
O
Ospedale San Giuseppe Moscati, Avellino
Collaborating Sponsor
AI-Summary
What this Trial Is About
Knee osteoarthritis (OA) is a common degenerative and inflammatory joint disease causing pain and limited mobility, affecting millions worldwide. This research evaluates the clinical results of treating patients with knee OA and chronic pain that has not improved after at least three months of conventional conservative therapy. The study focuses on selective arterial embolization as a treatment option for patients who are not candidates for or refuse surgery and suffer from refractory chronic pain. The treatment involves transarterial microembolization, which selectively targets and blocks blood vessels causing inflammation in the knee. This procedure uses micro-catheters to inject embolizing material into pathological genicular arterial branches, followed by diagnostic arteriography to confirm successful embolization. The study includes 43 patients who will undergo this procedure after providing informed consent. Patients will be followed up with clinical evaluations at 1, 3, 6, 12, and 24 months after treatment or until they drop out for other reasons. Participants will be involved in regular clinical assessments to monitor pain levels using the Visual Analog Scale (VAS) and other measures like quality of life (SF-36), joint function (WOMAC score), range of motion, and overall treatment assessment over two years. Researchers will also measure bilateral knee circumferences to evaluate changes. The study aims to understand the treatment's impact on pain reduction and joint function over time, with ongoing safety and progress monitoring throughout the follow-up period.
CONDITIONS
Brief Title
"Transarterial Microembolization (TAME) in Inflammatory Knee Pathology"
Who Can Participate
Age: 40Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with degenerative knee disease
- Age over 40 years
- Moderate knee osteoarthritis (grade 2-3 by Kellgren-Lawrence score) with indication for total knee arthroplasty
- Knee osteoarthritis with inflammatory symptoms like night pain, pain at rest, recurrent effusion, swelling, or redness
- Persistent moderate or severe knee pain (VAS score > 4)
- Failure of at least 3 months of conservative therapies including physical therapy, NSAIDs, pain relievers, hyaluronic acid injections, corticosteroids, or orthobiologics
- Signed informed consent
- Eligibility confirmed by internal multidisciplinary discussion
You will not qualify if you...
- Mentally incompetent patients
- Trauma to the knee within the past 6 months
- Malignant neoplasms
- Rheumatic diseases
- Use of anticoagulant or antiaggregant therapy (even if stopped 5 days before)
- Abuse of alcohol, drugs, or medications
- Knee surgery within the previous 12 months
- INR less than 2
- Platelet count below 30,000
- Severe renal dysfunction (GFR < 30 ml/min)
- Pregnancy
- Allergy to iodinated contrast
- Inability to undergo MRI examination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single procedure
Participants undergo the transarterial microembolization procedure to treat knee osteoarthritis by targeting hypervascularization in pathological genicular arterial branches.
1 visit (in-person)
Follow-up
Duration - Up to 24 months
Participants are followed up with clinical evaluations to assess pain reduction and joint function at multiple time points after treatment.
Visits at 1, 3, 6, 12, and 24 months post-treatment
Trial Site Locations
Total: 1 location
1
IRCCS Istituto Ortopedico Rizzoli
Bologna, Bologna, Italy, 40136
Actively Recruiting
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Research Team
G
Giancarlo Facchini, Medicine and Surgery
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Genicular Artery embolisation in Patients with Osteoarthritis of the Knee (GENESIS) Using Permanent Microspheres: Long-Term Results.
M W Little, A O'Grady, J Briggs...
https://pubmed.ncbi.nlm.nih.gov/38819473Transcatheter arterial embolization as a treatment for medial knee pain in patients with mild to moderate osteoarthritis.
Yuji Okuno, Amine Mohamed Korchi, Takuma Shinjo...
https://pubmed.ncbi.nlm.nih.gov/24993956