Transcatheter Arterial Micro-Embolization (TAME) Using Nexsphere-F in Patients With Knee Degenerative Osteoarthritis
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Transcatheter Arterial Micro-Embolization If abnormal blood vessels related to pain are identified by angiography, selective embolization is performed using Nexsphere-F. |
Device: Transcatheter Arterial Micro-Embolization
Participants will undergo TAME with Nexsphere-F.
|
Outcome Measures
Primary Outcome Measures
- Rate of WOMAC Score Reduction [1 day, 14 days, 1 month, 3 months, 6 months]
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.
- Rate of VAS Score (patient pain intensity) Reduction [1 day, 14 days, 1 month, 3 months, 6 months]
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.
Secondary Outcome Measures
- Rate of change in WORMS (Whole-Organ Magnetic Resonance Imaging Score) [1 month]
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.
- The rate of reduction of medication [6 months]
The rate of change of medication before and after application of medical devices for clinical trials.
- The rate of discontinuation of combination treatment [6 months]
The rate of change of combination treatment before and after application of medical devices for clinical trials.
Other Outcome Measures
- Number of participants with abnormal cases during follow-up (AVN, skin necrosis, dermal toxicity, acute lower extremity ischemia) [1 day, 14 days, 1 month, 3 months, 6 months]
Abnormal cases that occurred after the application of medical devices for clinical trials (AVN, skin necrosis, dermal toxicity, acute lower extremity ischemia)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Those who fall under Kellgren-Lawrence grade 2 to 3 according to the criteria in accordance with ACR guidelines and X-ray findings used within 12 months
-
VAS score exceeding 50mm
-
An adult male and female over 50 years of age
-
Preservative therapy Glucosamine chondroitin sulfate/physiological therapy and rehabilitation exercises, and joint injections of hyaluronic acid for more than 12 weeks
-
A person who agrees to allow existing drug treatment during the clinical trial, but not to be subject to additional drug administration or new conservative treatment for symptom control
Exclusion Criteria:
-
A locally infected patient
-
A person whose life expectancy is less than six months
-
A person with symptoms of lower extremities that are considered secondary to atherosclerosis or arterial vascular disease (ex: claudication ischemic rest pain)
-
A person diagnosed with rheumatism or infectious arthritis
-
Who had previous knee surgery
-
INR 2.5 or less than 30,000 platelets
-
Anaphylaxis-causing iodine allergy
-
Patients with renal dysfunction or impaired renal function who have been diagnosed with less than 45 GFR (eGFR) within the last 60 days
-
Those who have a taboo on MR videos
-
Pregnant women
-
Other cases where it is deemed inappropriate to participate in this clinical trial at the discretion of the researcher
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Next Biomedical Co., Ltd.
Investigators
- Principal Investigator: Min Jung, Severance Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NS-F TAME001