Pilot Study: Geniculate Artery Embolization in Knee Osteoarthrosis.

Osteoarthritis, Knee Clinical Trial

Official title:

Pilot Study: Geniculate Artery Embolization in Knee Osteoarthrosis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04113681
• Other study ID #: Geniculate embolization.
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: Maisonneuve-Rosemont Hospital
• Contact: Alexandre Cengarle-Samak, MD
• Phone: 514-252-3400
• Email: alexandre.cengarle-samak[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Geniculate Artery Embolization
Conscious sedation : midazolam and fentanyl Local anesthesia : Lidocaine 2% subcutaneous Retrograde or anterograde common femoral artery access - 4Fr introducer Sub-therapeutic anticoagulation (heparin 2000 IU IA) Lower extremity arteriography Selective and supra-selective catheterization of geniculate arteries supplying painful region of the knee If abnormal arterial blushes are demonstrated selective and supra-selective embolization will be performed with Embozene microspheres (100 microns to 200 microns) - cold saline or ice-packs sac to be applied to overlying skin if significant cutaneous arteries are demonstrated at angiography. Angiographic end-points: embolization of abnormal blush while preserving the parent vessel Arteriotomy closure (manual compression or closure device)

Locations

Country	Name	City	State
Canada	CIUSSS de l'Est-de-l'Île-de-Montréal, Installation Hopital Maisonneuve-Rosemont	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain control VAS	The pain intensity is assessed using VAS (horizontal line 100 mm in length). Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain".; Expected mean VAS pre treatment: 7; Expected mean VAS at 1, 3, 6 and 12 months: 3-4 (50% reduction)	12 months
Secondary	Function	Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subcategories of pain (5 items), stiffness (2 items), and physical function (17 items). Individuals select the level of difficulty they have performing various tasks using a 5 points Likert scale (0=None, 1=Slightly, 3=Very, 4=Extremely). Results are scored with a total maximum score of 96. A higher score indicates more difficulty in each of the categories.; Expected mean WOMAC score pre treatment: 50; Expected mean WOMAC score at 1, 3, 6 and 12 months: 25 (50% reduction).	12 months
Secondary	Radiological examinations	Knee x-ray examinations; Knee MRI (if a complication is suspected clinically); Sustained response expected to be less likely with increased KL grade	12 months