Embolization with Embosphere Microspheres for Knee Osteoarthritis Pain
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Shivank Bhatia
Disqualifiers: Rheumatoid arthritis, Osteonecrosis, Active malignancy, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this research study is to evaluate the effectiveness and safety of a permanent embolic (Embosphere Microspheres) for embolization of the geniculate artery for the treatment of moderate to severe knee osteoarthritis.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, since it mentions a failed response to certain therapies, you might be able to continue them. It's best to discuss this with the trial team.
What data supports the effectiveness of the treatment Embosphere Microspheres for knee osteoarthritis pain?
Research shows that using microspheres for embolization can help relieve pain in conditions like osteoarthritis and painful tumors. Studies comparing similar microspheres, like tris-acryl gelatin microspheres, suggest they can effectively block blood flow to reduce pain.
12345Is Embosphere Microspheres treatment generally safe for humans?
Embosphere Microspheres have been used safely in humans for conditions like uterine fibroids and benign prostatic hyperplasia, showing good safety with mild side effects compared to other treatments.
12678How is the treatment with Embosphere Microspheres different from other treatments for knee osteoarthritis pain?
Embosphere Microspheres are used in a procedure called embolization, where tiny particles are injected into blood vessels to block them, reducing pain by targeting the blood supply to areas causing discomfort. This approach is different from typical treatments like pain medications or physical therapy, as it directly addresses the blood vessels and nerves contributing to pain.
123910Eligibility Criteria
This trial is for adults aged 40-80 with moderate to severe knee osteoarthritis who haven't improved after at least 12 weeks of standard treatments like NSAIDs, steroid injections, or physical therapy. Participants must have synovitis, be able to undergo an MRI, and not have advanced arthritis (Kellgren-Lawrence grade >3), prior knee replacement, certain health conditions that affect embolization procedures, allergies to contrast agents without prophylaxis options, active cancers (except skin cancer), local infections in the knee area or a sensitivity to gelatin.Inclusion Criteria
Synovitis present as assessed by WORMS
My knee or hip pain is severe, based on a score above 30.
I have tried treatments like painkillers, injections, or physical therapy for my knee arthritis for at least 12 weeks without improvement.
+6 more
Exclusion Criteria
My target knee is infected.
Kellgren-Lawrence grade >3
I have a cancer diagnosis that is not non-melanoma skin cancer.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Embosphere Microspheres during scheduled SOC embolization surgery for knee osteoarthritis
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
52 weeks
Multiple visits (in-person and virtual) over 52 weeks
Participant Groups
The study tests Embosphere Microspheres used in geniculate artery embolization as a treatment for pain from moderate to severe knee osteoarthritis. The goal is to see how effective and safe this permanent blockage procedure is compared to other treatments.
1Treatment groups
Experimental Treatment
Group I: Embosphere Microspheres groupExperimental Treatment1 Intervention
Participants in this group who are receiving standard of care (SOC) embolization surgery for the treatment of moderate to severe knee osteoarthritis will receive the Embospheres Microspheres during scheduled SOC surgery.
Embosphere Microspheres is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Embosphere Microspheres for:
- Uterine fibroid embolization
🇪🇺 Approved in European Union as Embosphere Microspheres for:
- Uterine fibroid embolization
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MiamiMiami, FL
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Who Is Running the Clinical Trial?
Shivank BhatiaLead Sponsor
References
Evaluating the Safety and Effectiveness of Quick-Soluble Gelatin Sponge Particles for Genicular Artery Embolization for Chronic Knee Pain Associated with Osteoarthritis. [2023]To evaluate the effectiveness and safety of genicular artery embolization (GAE) using quick-soluble gelatin sponge particles (QS-GSPs) to alleviate chronic knee pain associated with osteoarthritis.
Embolic effects of superabsorbent polymer microspheres in rabbit renal model: comparison with tris-acryl gelatin microspheres and polyvinyl alcohol. [2016]We have developed a spherical embolic agent, superabsorbent polymer microspheres (SAP-MS). The aim of this study was to examine the embolic effects of SAP-MS in comparison with polyvinyl alcohol (PVA) particles and tris-acryl gelatin microsphere (Embosphere Microsphere; EM) in a rabbit renal model.
Clinical Utility of Bland Embolization Using Microspheres for Painful Malignant Musculoskeletal Tumors. [2023]To evaluate retrospectively whether bland embolization using microspheres is safe and useful for relieving pain in patients with painful malignant musculoskeletal (MSK) tumors.
Genicular artEry embolizatioN in patiEnts with oSteoarthrItiS of the Knee (GENESIS) Using Permanent Microspheres: Interim Analysis. [2021]Planned interim analysis of GENESIS; a prospective pilot study investigating the role of genicular artery embolization (GAE) in patients with mild to moderate osteoarthritis of the knee using permanent microspheres.
[Optimization and property evaluation of gelatin microspheres for embolization]. [2017]To optimize the preparation of gelatin microspheres for embolization and to evaluate the physicochemical properties of the optimized microspheres.
Initial experience with use of tris-acryl gelatin microspheres for uterine artery embolization for leiomyomata. [2019]To assess the safety and effectiveness of tris-acryl gelatin microspheres (Embospheres) in the treatment of leiomyomata by uterine artery embolization.
Transplantation of Gelatin Microspheres Loaded with Wharton's Jelly Derived Mesenchymal Stem Cells Facilitates Cartilage Repair in Mice. [2023]Knee osteoarthritis (KOA) is a prevalent chronic joint disease caused by various factors. Mesenchymal stem cells (MSCs) therapy is an increasingly promising therapeutic option for osteoarthritis. However, the chronic inflammation of knee joint can severely impede the therapeutic effects of transplanted cells. Gelatin microspheres (GMs) are degradable biomaterial that have various porosities for cell adhesion and cell-cell interaction. Excellent elasticity and deformability of GMs make it an excellent injectable vehicle for cell delivery.
Clinical Study on the Treatment of Benign Prostatic Hyperplasia by Embolization of Prostate Artery Based on Embosphere Microspheres and Gelatin Sponge Granules. [2022]Prostatic hyperplasia can cause dysuria, such as frequent urination, urgency of urination, increased nocturia, poor urination, and other symptoms, which seriously affect the quality of life of old men. We aim to compare and analyze the safety and clinical effect of embolization of the target blood vessels of ruptured prostatic hyperplasia with gelatin sponge particles and embosphere microspheres. Methods. The transcatheter MRI was performed in 422 patients. Among them, 198 patients were treated with gelfoam particles and 224 patients were treated with embosphere microspheres. The clinical effect and adverse reactions were observed and analyzed by biochemical and imaging examination. Four hundred and twenty two cases were hemostasis. In the gelatin sponge group, 34 patients had recurrent bleeding 24-36 hours after embolization, 122 patients had different degrees of elevation of prostatic hyperplasia transaminase (31 cases increased to more than 1000 U/L), 198 patients had different degrees of elevation of bilirubin; in the microsphere group, there was no significant difference in prostatic hyperplasia function indexes between the two groups. Conclusion. Compared with the gelfoam embolic agent, the embosphere embolic microsphere has a good efficacy and safety in the treatment of prostatic hyperplasia rupture and hemorrhage, with a light adverse reaction, a low probability of recanalization, and little damage to the postoperative prostatic hyperplasia function, which is conducive to the benign recovery of perioperative patients and is worthy of clinical application.
Transcatheter arterial embolization as a treatment for medial knee pain in patients with mild to moderate osteoarthritis. [2015]Osteoarthritis is a common cause of pain and disability. Mild to moderate knee osteoarthritis that is resistant to nonsurgical options and not severe enough to warrant joint replacement represents a challenge in its management. On the basis of the hypothesis that neovessels and accompanying nerves are possible sources of pain, previous work demonstrated that transcatheter arterial embolization for chronic painful conditions resulted in excellent pain relief. We hypothesized that transcatheter arterial embolization can relieve pain associated with knee osteoarthritis.
Gelatin microspheres: initial clinical experience for the transcatheter arterial embolization. [2008]The purpose of this study is to evaluate the embolization effects of gelatin microspheres (GMSs) when used as an embolic material for transcatheter arterial embolization (TAE) for several organs.