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Clinical Trial Summary

Among knee degenerative osteoarthritis patients aged 50 or older, it will prove the therapeutic effect and safety of Nexsphere-F embolization for patients who need additional treatment because pain is not controlled even if conventional treatments are taken.


Clinical Trial Description

This clinical trial is a single arm, single center, open label, and pilot clinical trial to prove the performance and safety of Nexsphere-F in patients over the age of 50 who need additional treatment because pain is not controlled even after conventional treatments are taken. Since consent cannot be obtained during surgery from a subject who meets the inclusion and exclusion criteria, a written consent is obtained in advance between four weeks before the procedure and the day. As one of the usual orthopedic evaluations, baseline MRI will be performed and WORMS will be evaluated. In addition, the WOMAC score and the VAS score will be measured before the procedure and used as a baseline for evaluation variables. Since it is a pilot study to evaluate the validity, all subjects will undergo a Transcatheter Arterial Micro-Embolization (TAME). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05917028
Study type Interventional
Source Next Biomedical Co., Ltd.
Contact Min Jung
Phone +82-32-454-4800
Email next@nextbiomedical.co.kr
Status Recruiting
Phase N/A
Start date October 23, 2023
Completion date December 2025

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