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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcatheter Arterial Micro-Embolization | Experimental | If abnormal blood vessels related to pain are identified by angiography, selective embolization is performed using Nexsphere-F. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Arterial Micro-Embolization | Device | Participants will undergo TAME with Nexsphere-F. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of WOMAC Score Reduction | The rate of change of WOMAC Score before and after application of medical devices for clinical trials. The definition of clinical success is a reduction of more than 50% of baseline scores (WOMAC and VAS) in six-month observations after at least one knee vascular embolization without additional combination treatment. | 1 day, 14 days, 1 month, 3 months, 6 months |
| Rate of VAS Score (patient pain intensity) Reduction | The rate of change of VAS Score before and after application of medical devices for clinical trials. The definition of clinical success is a reduction of more than 50% of baseline scores (WOMAC and VAS) in six-month observations after at least one knee vascular embolization without additional combination treatment. | 1 day, 14 days, 1 month, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of change in WORMS (Whole-Organ Magnetic Resonance Imaging Score) | The rate of change of WORMS before and after application of medical devices for clinical trials. MRI images of cartilage, marrow abnormality, bone cysts, bone attrition, ostephytes, menisci, ligaments, and synovitis are scored and recorded. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with abnormal cases during follow-up (AVN, skin necrosis, dermal toxicity, acute lower extremity ischemia) | Abnormal cases that occurred after the application of medical devices for clinical trials (AVN, skin necrosis, dermal toxicity, acute lower extremity ischemia) | 1 day, 14 days, 1 month, 3 months, 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyuckmin Kwon | Contact | +82-32-454-4800 | next@nextbiomedical.co.kr | |
| Sungmo Moon | Contact | +82-32-454-4800 | next@nextbiomedical.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Hyuckmin Kwon | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Recruiting | Seoul | Seodaemun-gu | 03722 | South Korea |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| The rate of reduction of medication |
The rate of change of medication before and after application of medical devices for clinical trials. |
| 6 months |
| The rate of discontinuation of combination treatment | The rate of change of combination treatment before and after application of medical devices for clinical trials. | 6 months |