Osteoarthritis (OA) of the Knee
Conditions
Keywords
knee osteoarthritis, genicular artery embolization, imipenem/cilastatin, intra-articular corticosteroid injection
Brief summary
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.
Interventions
PROCEDUREGenicular artery embolization
The patient will receive GAE procedure and sham IA procedure.
PROCEDUREIntra-articular injection with corticosteroids.
The patient will receive IA procedure and sham GAE procedure.
Sponsors
National Taiwan University Hospital, Yun-Lin Branch
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 40 years 2. Symptomatic knee pain, with numeric rating scale (NRS) ≥ 4. 3. Insufficient or resistant to conservative treatment, including oral analgesics, physical therapy, intra-articular injections for at least 3 months, before the enrollment. 4. Weight bearing X ray of knee: osteoarthritis of Kellgren-Lawrence grade 1, 2, or 3.
Exclusion criteria
1. History of trauma in recent 6 months. 2. Bleeding tendency. 3. Poor renal function (serum creatinine \> 2.0 mg/dL). 4. Pregnancy or breast-feeding. 5. Severe peripheral arterial occlusive disease (PAOD). 6. Local infections or inflammatory arthritis of knee. 7. Rheumatoid arthritis or other rheumatological diseases. 8. Prior knee surgeries (arthroscopic surgery, menisci repair, cruciate ligament reconstruction, arthroplasty of knee) due to knee pain. 9. Malignancy 10. ECOG \> grade 2 11. Life expectancy less than 2 years. 12. Any other condition related to the patient's health, regarded exclusionary in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint: numeric rating scale (NRS) | Post-intervention 3 month. | Changes of pain score (NRS) at the 3-month compared with the baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Efficacy: numeric rating scale (NRS) | In the one-year period after intervention. | Maximum decreased of pain score (NRS) |
| Clinical Efficacy: WOMAC | Pre-intervention, post-1, 3, 6, 12 months | Western Ontario and McMaster Universities Arthritis Index (WOMAC) \*Clinical success defined as ≥ 40% improvement of the WOMAC score. |
| Clinical Efficacy: Lequesne'Index | Pre-intervention, post-1, 3, 6, 12 months | Lequesne index for knee osteoarthritis severity. |
| Clinical Outcome: Analgesic Usage and other Pain Control Treatments | Pre-intervention, post-1, 3, 6, 12 months | Use of narcotics or non-steroidal anti-inflammatory drugs (NSAID's); other pain control treatments. |
| Clinical Outcome: Quality of Life | Pre-intervention, post-1, 3, 6, 12 months | EQ-5D-5L questionnaire |
| Clinical Outcome: PGIC | Pre-intervention, post-1, 3, 6, 12 months | Self-report measure Patient Global Impression of Change (PGIC). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events Monitoring | Pre-intervention, post-1, 3, 6, 12 months | The society of interventional radiology AE classification system, 2017 modification. |
Countries
Taiwan
Outcome results
None listed