Clinical trial NCT04113681: Pilot Study: Geniculate Artery Embolization in Knee Osteoarthrosis.
Official title: Pilot Study: Geniculate Artery Embolization in Knee Osteoarthrosis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Embolization, Osteoarthritis, Knee, Geniculate Artery
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients will be stratified into two groups:

* Group 1: Patients between 18-50 years old with KL grade 3-4
* Group 2: Patients age 50 years old and over with KL grade 1-4
Primary purpose: TREATMENT

Brief summary: Geniculate Artery Embolization (GAE) has recently been described and studied as a palliative treatment for osteoarthrosis-related knee pain in patients un-eligible for surgical intervention. This treatment is based on the hypothesis that hypervascularization and associated increased nerve proliferation are possible sources of chronic pain following the morphological changes of osteoarthrosis. A large animal model has shown digital subtraction arteriography to be well correlated to both the histological findings of synovial inflammation and synovial contrast enhancement on magnetic resonance imaging. This embolization technique has also been applied to other regions of the musculoskeletal system including the elbow and the shoulder.

Detailed description: Primary Objective Confirm the efficacy and the effectiveness of geniculate artery embolization for pain control in knee osteoarthrosis.

Secondary Objective Evaluate the effectiveness of geniculate artery embolization for pain control in specific population: young patients between 18 and 50 years old with advanced osteoarthritis (KL grade 3 or 4) for whom an orthopedic surgeon has deemed a total knee arthroplasty is not an appropriate therapy, and whom have failed conservative management for at least 6 months.

Investigators propose a prospective pilot study on 40 patients with osteoarthrosis.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Moderate to severe knee pain (visual analog scale (VAS) \> 70 mm)
* Pain refractory to at least 6 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or muscle strengthening, or intra-articular injections)
* Localized pain on physical examination
* Kellgren-Lawrence (KL) Score on knee X-Ray
* Patients 50 years old and over : grade 1, 2, 3 or 4
* 18-50 years old: KL grade 3 or 4

Exclusion Criteria:

* Current local infection
* Life expectancy less than 6 months
* Known advanced atherosclerosis
* Rheumatoid or infectious arthritis
* Prior knee surgery
* Uncorrectable coagulopathy including international normalized ratio (INR) \> 1.5 or platelets \< 50,000
* Iodine allergy
* Renal dysfunction as defined by GFR \< 60ml/min obtained within the past 30 days.
* Diabetic patient
* Previous embolization of the geniculate arteries during the last year

Primary outcomes:
measure: Pain control VAS
timeFrame: 12 months
Secondary outcomes:
measure: Function
timeFrame: 12 months
measure: Radiological examinations
timeFrame: 12 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CIUSSS de l'Est-de-l'Île-de-Montréal, Installation Hopital Maisonneuve-Rosemont
state: Quebec
Study officials:
affiliation: CIUSSS de l'Est-de-l'Ile-de-Montreal
name: Alexandre Cengarle-Samak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Baardewijk LJ, Hoogeveen YL, van der Geest ICM, Schultze Kool LJ. Embolization of the Geniculate Arteries Is an Effective Treatment of Recurrent Hemarthrosis Following Total Knee Arthroplasty That Can Be Safely Repeated. J Arthroplasty. 2018 Apr;33(4):1177-1180.e1. doi: 10.1016/j.arth.2017.11.002. Epub 2017 Nov 24.
citation: Bagla S, Rholl KS, van Breda A, Sterling KM, van Breda A. Geniculate artery embolization in the management of spontaneous recurrent hemarthrosis of the knee: case series. J Vasc Interv Radiol. 2013 Mar;24(3):439-42. doi: 10.1016/j.jvir.2012.11.011.
citation: Okuno Y, Korchi AM, Shinjo T, Kato S, Kaneko T. Midterm Clinical Outcomes and MR Imaging Changes after Transcatheter Arterial Embolization as a Treatment for Mild to Moderate Radiographic Knee Osteoarthritis Resistant to Conservative Treatment. J Vasc Interv Radiol. 2017 Jul;28(7):995-1002. doi: 10.1016/j.jvir.2017.02.033. Epub 2017 Mar 30.
citation: Okuno Y, Korchi AM, Shinjo T, Kato S. Transcatheter arterial embolization as a treatment for medial knee pain in patients with mild to moderate osteoarthritis. Cardiovasc Intervent Radiol. 2015 Apr;38(2):336-43. doi: 10.1007/s00270-014-0944-8. Epub 2014 Jul 4.
citation: Iwamoto W, Okuno Y, Matsumura N, Kaneko T, Ikegami H. Transcatheter arterial embolization of abnormal vessels as a treatment for lateral epicondylitis refractory to conservative treatment: a pilot study with a 2-year follow-up. J Shoulder Elbow Surg. 2017 Aug;26(8):1335-1341. doi: 10.1016/j.jse.2017.03.026.
citation: Okuno Y, Iwamoto W, Matsumura N, Oguro S, Yasumoto T, Kaneko T, Ikegami H. Clinical Outcomes of Transcatheter Arterial Embolization for Adhesive Capsulitis Resistant to Conservative Treatment. J Vasc Interv Radiol. 2017 Feb;28(2):161-167.e1. doi: 10.1016/j.jvir.2016.09.028. Epub 2016 Dec 19.
citation: Okuno Y, Oguro S, Iwamoto W, Miyamoto T, Ikegami H, Matsumura N. Short-term results of transcatheter arterial embolization for abnormal neovessels in patients with adhesive capsulitis: a pilot study. J Shoulder Elbow Surg. 2014 Sep;23(9):e199-206. doi: 10.1016/j.jse.2013.12.014. Epub 2014 Mar 4.