Knee degenerative osteoarthritis Knee pain
Conditions
Interventions
NBGM200, developed by NEXTBIOMEDICAL CO., LTD., is Class III embolic material that is resorbable within 2-8 hours, or/and the rate of resorption can be tuned depending on the type of intervention, and
Sponsors
NEXTBIOMEDICAL CO., LTD.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients must satisfy all of the following inclusion criteria. 1) Adult men and women aged 50 years and over. 2) Osteoarthritis proven by MR-imaging. 3) Kellgren-Lawrence (KL) grade 1-3. 4) Visual Analogue Scale (VAS) pain score of >=5 (on a scale of 0 to 10). 5) Patients who do not respond to conservative therapies (including exercise, weight loss, pharmacological agents, transcutaneous electrical nerve stimulation, knee bracing, foot orthoses, thermotherapy, oral supplements, or dry needling) for at least 24 weeks prior to receiving Musculoskeletal Embolization (MSKE).
Exclusion criteria
Exclusion criteria: Patients with one or more of the following criteria should not be included in this trial. 1) Significant intra-articular lesions that could be the cause of complaints or KL grade 4 OA. 2) Current local infection. 3) Life expectancy less than 6 months. 4) Known advanced atherosclerosis, with known lower extremity vascular or lower extremity symptoms thought to be secondary to arterial vascular disease (e.g., claudication or ischemic rest pain). 5) Rheumatoid or infectious arthritis. 6) Prior knee replacement surgery on the target knee at any time. 7) Knee surgery on the target knee within the past 10 years (procedures such as micro-perforation or cartilage repair). 8) Uncorrectable coagulopathy including INR > 2.5 or platelets < 30,000/µL. 9) Iodine allergy resulting in anaphylaxis. 10) Renal dysfunction as defined by GFR (eGFR) of <45 mL/min/1.73m2 obtained within the past 60 days. 11) Ligament ruptures. 12) Contraindications for MR Imaging (such as claustrophobia, metallic fragment or foreign bodies implants, or prosthesis). 13) Dementia. 14) Pregnancy or breastfeeding. 15) Gelatin allery resulting immun reaction. 16) Other cases where participation in this clinical trial is judged inappropriate according to the judgment of the investigator. 17) No “Blush” is seen on the angiography and who do not experience “Pain” in the area concerned.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving clinical success, defined as a 30% or greater reduction from baseline in KOOS-12 at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Change from baseline in pain relief (VAS) at 6 months post-procedure. • Percentage of patients achieving clinical success, defined as a 30% or greater reduction from baseline in WORMS at 6 months. | — |
Countries
Belgium, Netherlands
Contacts
Public ContactSubin Yu
NEXTBIOMEDICAL CO., LTD.
Outcome results
None listed