N/A N=21 Randomized Double-blind Treatment

Geniculate Artery Embolization for Knee Pain Secondary to Osteoarthritis (OA)

Osteo Arthritis Knee

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View on ClinicalTrials.gov: NCT03362957 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: Mean WOMAC Scores at Month 6 — 29; 26 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Geniculate Artery Embolization (Device); Sham Procedure (Diagnostic_test)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Apr 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean WOMAC Scores at Month 6	29; 26	—
PRIMARY Mean Patient Pain as Measured by VAS at Month 6	20.3; 19.2	—
PRIMARY Mean WOMAC Scores at Month 1	34.7; 65.9; 46.3	—
PRIMARY Mean Patient Pain as Measured by VAS at Month 1	30.5; 78.4; 39.8	—
PRIMARY Mean WOMAC Scores at Month 3	19.7; 39.5	—
PRIMARY Mean Patient Pain as Measured by VAS at Month 3	21.3; 41.2	—
SECONDARY Number of Participants With Reduction in Medication	5; 0; 1	—

Summary

Purpose: To evaluate embolization as a treatment for OA related knee pain versus placebo to demonstrate the actual effect of embolization on pain and disability. Participants: There will be 21 subjects enrolled over the age 40 with knee pain secondary to arthritis. Procedures (methods): This will be a single-blinded randomized-controlled study of GAE versus placebo in a small population with knee pain secondary to arthritis to determine safety and efficacy. Clinical procedures and evaluations will consist of a preoperative screening assessment to determine if the potential study subject meets the inclusion and exclusion criteria, enrollment, surgical procedure for geniculate artery embolization, and follow-up visits at 24 hours, 2 weeks, 1, 3, 6, & 12 months. An MRI may be performed after the 1-month visit.

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 or estimated glomerular filtration rate (eGFR) <60 obtained within the past 30 days.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03362957). 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.