SakuraBead Embolization for Osteoarthritis
(SURE Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: CrannMed
Disqualifiers: Severe knee OA, Autoimmune arthritis, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?An open label, prospective, two-arm, multicenter, randomized controlled trial comparing SakuraBead genicular artery embolization (GAE) with a control (corticosteroid injection).
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves treatments for knee osteoarthritis, it's best to discuss your current medications with the trial team to ensure there are no conflicts.
What data supports the effectiveness of the treatment SakuraBead Embolization for Osteoarthritis?
Research shows that corticosteroid injections can reduce pain and inflammation in knee osteoarthritis, providing relief for some patients. This suggests that the corticosteroid component of the SakuraBead treatment may help alleviate symptoms in osteoarthritis.
12345Is SakuraBead Embolization for Osteoarthritis safe for humans?
Corticosteroid injections, which are similar to SakuraBead treatments, have been shown to have some side effects, especially in women, such as abnormal menstruation and facial flushing. In a study of 1000 patients, 1% experienced severe complications like bone damage, with women being more affected. Overall, these treatments are generally considered safe, but there are risks to be aware of.
34678How does the corticosteroid injection treatment for osteoarthritis differ from other treatments?
Corticosteroid injections for osteoarthritis are unique because they are administered directly into the joint, providing rapid relief from inflammation and pain. This method is well-established and can be repeated safely, unlike some other treatments that may not offer the same direct and immediate effect.
134910Eligibility Criteria
This trial is for adults aged 40-80 with knee osteoarthritis (OA) who haven't found relief from pain after at least 3 months of anti-inflammatory drugs, physical therapy, or injections. Participants must be able to give consent and attend all treatments and follow-ups. They need confirmed OA evidence via specific angiographic patterns in the knee.Inclusion Criteria
I am between 40 and 79 years old.
Able to comply with all treatments and follow-up visits
I experience moderate to severe knee pain.
+4 more
Exclusion Criteria
I have a blood clotting disorder that cannot be corrected.
I have severe knee arthritis.
My affected joint is currently infected.
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either SakuraBead genicular artery embolization or corticosteroid injection for knee osteoarthritis
6 months
Multiple visits for treatment and assessment
Follow-up
Participants are monitored for safety and effectiveness after treatment
18 months
Regular follow-up visits
Participant Groups
The study compares SakuraBead genicular artery embolization (GAE), a procedure that blocks certain blood vessels in the knee to reduce pain and inflammation, against corticosteroid injections which are commonly used for OA pain relief.
2Treatment groups
Experimental Treatment
Active Control
Group I: Genicular Artery Embolization (GAE)Experimental Treatment1 Intervention
Temporary Embolization of Genicular Arteries using Resorbable Microspheres
Group II: Corticosteroid InjectionActive Control1 Intervention
Corticosteroid injection in the knee
Corticosteroid Injection is already approved in European Union, United States, Canada, Australia for the following indications:
πͺπΊ Approved in European Union as Corticosteroid injection for:
- Acromioclavicular joint pain
- Shoulder impingement syndrome
- Rotator cuff disease
- Adhesive capsulitis
- Glenohumeral osteoarthritis
πΊπΈ Approved in United States as Corticosteroid injection for:
- Acromioclavicular joint pain
- Shoulder impingement syndrome
- Rotator cuff disease
- Adhesive capsulitis
- Glenohumeral osteoarthritis
π¨π¦ Approved in Canada as Corticosteroid injection for:
- Acromioclavicular joint pain
- Shoulder impingement syndrome
- Rotator cuff disease
- Adhesive capsulitis
- Glenohumeral osteoarthritis
π¦πΊ Approved in Australia as Corticosteroid injection for:
- Acromioclavicular joint pain
- Shoulder impingement syndrome
- Rotator cuff disease
- Adhesive capsulitis
- Glenohumeral osteoarthritis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
IR CentersRaleigh, NC
Loading ...
Who Is Running the Clinical Trial?
CrannMedLead Sponsor
References
Magnetic resonance imaging guided corticosteroid injection of sacroiliac joints in patients with spondylarthropathy. Are multiple injections more beneficial? [2018]Efficacy of a second magnetic resonance (MR) imaging guided corticosteroid injection of inflamed sacroiliac joints (SIJ) in patients with spondylarthropathy. Thirty-one patients received 50 injections in an outpatient basis. Fifteen of 31 patients who relapsed or were non-responders received a second injection. All had MR guided injection of 40 mg triamcinolone acetonide into SIJ using an open 0.2 Tesla unit. Twenty of 31 patients after the first injection, and 9 of 15 patients after the second injection reported subjective improvement, which lasted for a mean of 8.7+/-10.9 and 16.1+/-15.8 months for each group. Subchondral bone marrow edema resolved in 15 of 20 patients who reported subjective improvement, after the first injection. No complications occurred. MR guided steroid injection of SIJ is effective and safe. Since there is no exposure to radiation it could be performed many times. Repeated injections seem to be beneficial for primary non-responders and patients who relapsed.
The Magnitude and Duration of the Effect of Intra-articular Corticosteroid Injections on Pain Severity in Knee Osteoarthritis: A Systematic Review and Meta-Analysis. [2021]The aims of the study were to clarify the evidence on the magnitude and duration of treatment effect of intra-articular corticosteroid injections for knee osteoarthritis compared with placebo, to evaluate a treatment effect by steroid type, and to describe the reported adverse effects.
Corticosteroid injection into the osteoarthritic knee: drug selection, dose, and injection frequency. [2012]Although some disagreement exists amongst practitioners as to the efficacy of corticosteroid injection into the osteoarthritic knee, this procedure remains the most common reason to perform knee joint injection. There is disagreement too over the most efficacious corticosteroid for the procedure; the dose required at injection; the frequency, and total quantity of corticosteroid that can be injected into the knee. This paper examines the controversies surrounding the efficacy of corticosteroid injection into the osteoarthritic knee, and attempts to provide guidance as to appropriate corticosteroid selection, dose, and treatment interval.
Safety and efficacy of long-term intraarticular steroid injections in osteoarthritis of the knee: a randomized, double-blind, placebo-controlled trial. [2023]To evaluate the safety and efficacy of long-term intraarticular (IA) steroid injections for knee pain related to osteoarthritis (OA).
Do Clinical Correlates of Knee Osteoarthritis Predict Outcome of Intraarticular Steroid Injections? [2023]To determine whether clinical correlates of knee osteoarthritis (OA) affect the outcome of intraarticular steroid injections (IASI) in symptomatic knee OA.
Corticosteroid Injections: A Review of Sex-Related Side Effects. [2022]Corticosteroid injections are used as a nonoperative modality to combat acute inflammation when conservative treatments fail. As female patients are regularly seen by orthopedic physicians, it is essential to identify and understand potential sex-related side effects. The aim of this article is to examine available literature for sex-related side effects of orthopedic-related corticosteroid injections. Although the incidence is low, sex-related side effects, such as abnormal menstruation, lactation disturbances, facial flushing, and hirsutism, are associated with corticosteroid injections. Physicians should be aware of these female-specific side effects and relay this information as part of the informed consent process. [Orthopedics. 2017; 40(2):e211-e215.].
Intraarticular Steroid Injection in Hip and Knee with Fluoroscopic Guidance: Reassessing Safety. [2022]Background Intraarticular corticosteroid (IACS) injections are frequently performed for hip and knee osteoarthritis (OA); however, there are conflicting data about the benefits and complications of IACS injections and a lack of large studies with follow-up. Purpose To determine the number of patients with complications after hip and knee IACS injections in a large study sample with long-term follow-up. Materials and Methods This retrospective single-center case series included patients who received a corticosteroid injection in the hip (n = 500) or knee (n = 500) and who underwent clinical and radiologic follow-up (conventional radiography, fluoroscopy, CT, or MRI) between 1 and 12 months after injection (January 2016 to May 2020). General descriptive statistics and the χ2 test were applied. P < .05 was indicative of a significant difference. Results Of the 1000 patients (mean age, 57 years ± 16 [SD]; 545 women), 10 patients (1%) developed severe complications. Four patients developed osteonecrosis; three, insufficiency fractures; and three, rapid progressive OA. All 10 complications occurred between 2 and 9 months after injection: six (60%) in the hip and four (40%) in the knee. Of the included 1000 patients, 545 (54%) were women, but they had nine of the 10 (90%) complications (P = .02). Conclusion Intraarticular steroid injection had a substantially lower complication rate than that reported in previous smaller studies. The rate of severe complications was disproportionally higher in women than in men. © RSNA, 2022 See also the editorial by Jennings in this issue.
Intra-articular corticosteroid injections increase the risk of requiring knee arthroplasty. [2020]Recent studies have suggested that corticosteroid injections into the knee may harm the joint resulting in cartilage loss and possibly accelerating the progression of osteoarthritis (OA). The aim of this study was to assess whether patients with, or at risk of developing, symptomatic osteoarthritis of the knee who receive intra-articular corticosteroid injections have an increased risk of requiring arthroplasty.
Joint aspiration and injection. [2015]Joint aspiration/injection is an invaluable procedure for the diagnosis and treatment of joint disease. The knee is the commonest site to require aspiration although any non-axial joint is accessible for obtaining synovial fluid. Septic arthritis and crystal arthritis can be readily diagnosed by aspirating synovial fluid. Intra-articular injection of long-acting insoluble corticosteroids produces rapid resolution of inflammation in most injected joints and is a well established procedure in rheumatological practice. The technique involves only a knowledge of basic anatomy and should not be unduly painful for the patient. Provided sterile equipment and a sensible, aseptic approach are used it is a safe procedure. This chapter addresses the indications, technical principals, expected benefits and risks of intra-articular corticosteroid injection. The use of other intra-articular injections including osmic acid, radioisotopes and hyaluronic acid, which are less universally utilised than intra-articular corticosteroid, will also be addressed.
[Corticosteroid injections of the sacroiliac joint during magnetic resonance: preliminary results]. [2013]The aim of this study was to evaluate the advantages of MRguided injections of corticosteroids into the sacroiliac joints (SIJ) in patients suffering from refractory sacroiliitis despite appropriate oral therapy.