Clinical Trial Protocol Description:
The purpose of this study is to evaluate a new investigational medical device, Nexsphere-F, manufactured by Next Biomedical Company, Ltd., used to treat patients who have arthritis of the knee and have inadequate pain relief with usual noninvasive treatment. Nexsphere-F is a material injected into blood vessels in the knee area (embolization therapy) with the intention to reduce knee pain.
This study is randomized 1:1 with intervention and control standard of care group. Study duration will be approximately 1 year post procedure.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 40 years of age or older.
- Are ambulatory and weight-bearing.
- Have localized knee pain (can point to the pain with your finger).
You will be excluded from the study if any of the following criteria apply to you:
- Have previously been unable to tolerate intra-articular CS knee injection.
- Have had intra-articular CS knee injection within the last 3 months.
- Have rheumatoid, infectious, or autoimmune arthritis (including fibromyalgia).
- Have a known sensitivity or allergy to implant materials (e.g. gelatin).
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.
Study Details
Clinical Trial Investigator
Contact Information