Geniculate Artery Embolization for the Treatment of Knee Pain (GAE)

University of North Carolina (UNC)

Status: Completed

Conditions: Osteoarthritis Of Knee

Treatments: Device: Geniculate Artery Embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT02850068

16-1969

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Geniculate Artery Embolization

Experimental group

Description:

Patients in this study will receive the geniculate artery embolization (GAE) procedure. The primary aims will be to determine if geniculate artery embolization (GAE) will reduce pain and disability (resulting from pain, stiffness and difficulty performing daily activities) caused by knee osteoarthritis (OA).

Treatment:

Device: Geniculate Artery Embolization