Not provided
Not provided
Not provided
Not provided
The trial was terminated due to infeasible enrollment. Only one participant was enrolled, and the comparator arm was not initiated.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Taiwan University Hospital, Yun-Lin Branch | OTHER |
Not provided
Not provided
Not provided
Not provided
This study investigates genicular artery embolization (GAE) as a minimally invasive alternative to ntra-articular corticosteroid injections (IA) or treating knee osteoarthritis (OA) pain. Designed as a randomized controlled tria, the study compares pain relief effectiveness and safety between GAE and IA over a 12-month follow-up. Eligible participants are aged over 40 with symptomatic knee OA resistant to conservative treatment. Primary outcomes focus on pain reduction (NRS score), while secondary measures include function, quality of life, imaging findings, and adverse events.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm: GAE (IPM/CS). | Experimental | Genicular artery embolization with imipenem/cilastatin (IPM/CS). |
|
| Comparator: IA (corticosteroids) | Active Comparator | The patient will receive IA procedure and sham GAE procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genicular artery embolization | Procedure | The patient will receive GAE procedure and sham IA procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Endpoint: numeric rating scale (NRS) | Changes of pain score (NRS) at the 3-month compared with the baseline. | Post-intervention 3 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Efficacy: numeric rating scale (NRS) | Maximum decreased of pain score (NRS) | In the one-year period after intervention. |
| Clinical Efficacy: WOMAC | Western Ontario and McMaster Universities Arthritis Index (WOMAC) *Clinical success defined as ≥ 40% improvement of the WOMAC score. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Monitoring | The society of interventional radiology AE classification system, 2017 modification. | Pre-intervention, post-1, 3, 6, 12 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hosiptal Yunlin Branch | Douliu | Yunlin | 640 | Taiwan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Intra-articular injection with corticosteroids. | Procedure | The patient will receive IA procedure and sham GAE procedure. |
|
| Pre-intervention, post-1, 3, 6, 12 months |
| Clinical Efficacy: Lequesne'Index | Lequesne index for knee osteoarthritis severity. | Pre-intervention, post-1, 3, 6, 12 months |
| Clinical Outcome: PGIC | Self-report measure Patient Global Impression of Change (PGIC). | Pre-intervention, post-1, 3, 6, 12 months |
| Clinical Outcome: Analgesic Usage and other Pain Control Treatments | Use of narcotics or non-steroidal anti-inflammatory drugs (NSAID's); other pain control treatments. | Pre-intervention, post-1, 3, 6, 12 months |
| Clinical Outcome: Quality of Life | EQ-5D-5L questionnaire | Pre-intervention, post-1, 3, 6, 12 months |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided