Clinical trial NCT02850068: Geniculate Artery Embolization for the Treatment of Knee Pain
Official title: Geniculate Artery Embolization for the Treatment of Knee Pain Secondary to Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis Of Knee
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Purpose: The primary aims of this study are to determine if geniculate artery embolization (GAE) will reduce the severity of pain as well as global disability (resulting from the combination of pain, stiffness and difficulty performing daily activities) caused by knee OA and if it can be performed safely. The secondary aim is to determine if GAE can result in the decreased necessity for ongoing conservative OA therapies such as medication therapy and joint injections.

Participants: Twenty patients with knee osteoarthritis resulting in knee pain that is refractory to conservative therapies, who are not planning to undergo surgery within 6 months.

Procedures (methods): This will be an open label 24-month pilot study with a small population undergoing GAE 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, 1, 3 \& 6 months. An MRI will be performed at the 1-month visit to detect a change in synovial vascularity and to exclude complication.

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 \< 30,000, or
* Iodine allergy resulting in anaphylaxis, or
* Renal dysfunction as defined by serum creatinine \>1.6 dl/mg obtained within the past 30 days.

Primary outcomes:
measure: Patient Function (Units on a Scale)
timeFrame: 6 months
measure: Patient Pain (mm)
timeFrame: 6 months
Secondary outcomes:
measure: Reduction in Medication (Percentage of Participants With a Reduction in Medication Therapy at Month 6)
timeFrame: 6 months
Other outcomes:
measure: Patient Complications (Number of Participants With Complications at Month 6)
timeFrame: 6 months
Locations:
city: Chapel Hill
country: United States
facility: UNC Hospitals
state: North Carolina
city: Woodbridge
country: United States
facility: Vascular Institute of Virginia
state: Virginia
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Ari Isaacson, MD
role: PRINCIPAL_INVESTIGATOR
References: