Trials / Recruiting
RecruitingNCT06859164
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- University of Chicago · Academic / Other
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study (SHAM-PAIN) is a NIH-NIAMS funded project designed to assess enrollment feasibility and detect any differences between GAE and a similar sham intervention in reducing KOA-related pain at 3 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore. Additionally, this study aims to determine the magnitude of difference in pain response between GAE and sham to adequately power a larger, more definitive randomized sham-controlled trial (RCT). The influence of psychosocial and psychocognitive factors, changes in analgesic use, and conditions of knee joint cartilage and effusion will similarly be explored to determine their impacts on perceived pain response to GAE.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Genicular Artery Embolization | Embolization of genicular arteries that demonstrate neoangiogenesis or blush on angiogram. |
| DEVICE | Lipiodol | 3:1 emulsion of Lipiodol to Optiray |
| PROCEDURE | Simple angiogram | Simple angiogram of the genicular arteries |
Timeline
- Start date
- 2025-05-01
- Primary completion
- 2026-08-31
- Completion
- 2026-11-30
- First posted
- 2025-03-05
- Last updated
- 2025-05-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06859164. Inclusion in this directory is not an endorsement.