N/A
N=20
Geniculate Artery Embolization for the Treatment of Knee Pain
Osteoarthritis Of Knee
Bottom Line
View on ClinicalTrials.gov: NCT02850068 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Patient Function (Units on a Scale) — 31 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Geniculate Artery Embolization (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Function (Units on a Scale) |
31 | — |
| PRIMARY Patient Pain (mm) |
31 | — |
| SECONDARY Reduction in Medication (Percentage of Participants With a Reduction in Medication Therapy at Month 6) |
65 | — |
Summary
This study is to test a new treatment method, geniculate artery embolization (GAE), to reduce the severity of pain and disability caused by knee osteoarthritis.
Eligibility Criteria
Inclusion Criteria
- Moderate to severe knee pain (visual analog scale (VAS) > 50 mm), and
- Pain refractory to at least 3 months* of conservative therapies (anti-inflammatory drugs, or physical therapy, or muscle strengthening, or intra-articular injections), and
- Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee.
Exclusion Criteria
- Current local infection, or
- Life expectancy less than 6 months, or
- Known advanced atherosclerosis, or
- Rheumatoid or infectious arthritis, or
- Prior knee surgery, or
- Uncorrectable coagulopathy including international normalized ratio (INR) > 2.5 or platelets 1.6 dl/mg obtained within the past 30 days.
Data sourced from ClinicalTrials.gov (NCT02850068). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.